Operational Guidelines

for ART Centers

MAY 2008

National AIDS Control Organisation

Ministry of Health & Family Welfare
Government of India
FOREWORD
 C ONTENTS
Section 1: Introduction 1
Section 2: Guidelines for Service Providers 3
2.1 The Goal and Objectives of NACP 3
2.1.1 Goal 3
2.1.2 Objectives 3
2.2 Functions of ART center: 3
2.2.1 Medical Functions 3
2.2.2 Psychological Functions 4
2.2.3 Social Functions 4
2.3 Eligibility Criteria for Setting-up ART center 4
2.3.1 Feasibility Assessment for ART centers 4
2.4 Preparedness of Institution 4
2.5 Infrastructure 4
2. 5.1 Location and Access to ART center 4
2.5.2 Space for ART center 5
2.5.3 Furniture and general equipment 5
2.5.4 Medical equipment and Accessories 5
2.5.5 CD 4 machines: 6
2.5.6 Computer and accessories and Audio-visual equipment 6
2.6 Human Resources 6
2.6.1 ART team 6
2.6.3 Trained Institutional Faculty 7
2.6.4 Human Resources & their Job Responsibilities 7
2.7 Drugs & Medicines 11
2.7.1 ARV Drugs 11
2.7.2 Drugs for Opportunistic Infections 12
2.8 Linkages and Referrals 13
2.8.1 Referrals within the Institute 13
2.8.2 Referrals outside the Institutions 14
2.8.2.1 Community Care centers 14
2.9 Monitoring & Evaluation 15
2.9.1 Monitoring Tools 15
2.9.2 Recording information 15
2.9.3 Reporting, Data Transmission and Analysis 16
2.9.4 Communication tools 17
 2.10 Responsibility of the SACS 17
2.10.1 Job Responsibilities of Nodal Officer (ART), SACS 17
2.10.2 Supply and Monitoring of ARV Drugs 17
2.10.3 Documents, Guidelines and Monitoring Tools 17
2.10.4 Increase in Coverage of ART 17
2.11 Financial Management 18
2.11.1 Bank Account 18
2.11.2 Audit of Accounts: 18
2.11.3 Guidelines for Expenditure: 18

Section 3: Patient Focused Guidelines 21

3.1 Disease Stages 21
3.1.1 Stage 1: From seeking health care to diagnosis 21
3.1.2 Stage 2: Process from diagnosis till need for ART 21
3.1.3 Stage 3: Process from decision to start ART 22
3.2 Confidentiality and Discrimination Issues 23
3.3 Supports from NGOs and Positive Network Groups 23

Section 4: Standard Operating Procedures (SOP) 25

4.1 Entry into HIV Care 25
4.2 Flow of Patient at the ART center 25
4.2.1 The initial visit 26
4.2.2 The Second Visit 26
4.2.3 Visit after ART is started (After 2 weeks of NVP initiation) 26
4.2.4 Subsequent Follow-ups Visits (Once a month) 27
4.2.5 Further follow up visits 27
4.2.6 Patient Flow in the ART centre (Pre ART) 28
4.2.7 Patient Flow at ART centre (ART Care) 29

Section 5: Public Private Partnership on ART 31

5.1 Expansion of ART programme to NGO/PSUs/Corporate Sector/Trust/Charitable Hospitals 31
5.2 Selection of NGO/Trust/Charitable organisation for PPP 31

Section 6 : Link ART Cenres (LAC) Concept & Guidelines 33

Annexure I 35
Annexure II 37
Annexure III 39
Annexure IV 41
Annexure V 43
Annexure VI 45
Annexure VII 59
SECTION

1 Introduction

India has an estimated 2.6 million HIV-infected India has the capacity to scale up ART with
people. The free ART initiative of the Government advantages that many other countries do not have.
of India was launched on 1st April, 2004 at eight These include having an established domestic drug
institutions in six high prevalent states and the manufacturing base and the enviable pool of trained
National Capital Territory of Delhi. Since then, it health professionals. However, the unprecedented
is being scaled up in a phased manner. By April challenges for programme management and
2008, a total of 163 ART centers in 31 States service delivery must be candidly identified, and
and Union Territories are functional. More than addressed in a systematic manner.
1,41,000 patients are receiving free antiretroviral
(ARV) drugs at these centers. In addition another A public health approach for the provision of ART
35,000 patients are receiving free ART at NGO/ implies that ART regimens should be standardised,
inter-sectoral ART centers. It is expected about easy to use and have minimal adverse affects. Scaling
300,000 patients will be on free ART at 250 ART up ARV treatment also calls for early involvement of
centers and 650 link ART Centres under NACP- a range of stake-holders, including those with HIV
III. and other community members.

The plan to expand and scale up ART services in Selection of first line regimen is determined on
India includes the basis of a number of considerations such as
potency, profile of side-effects, ability to keep future
a) Identification of the institutions
treatment options open, ease of adherence, risks
b) Strengthening of laboratory infrastructure during pregnancy and the potential for developing
in the form of CD4 machine (or linkages) resistant viral strains. The current recommendation
c) Capacity building of faculty of the host in all circumstances is for a triple drug regimen.
institute, including the contractual staff
by training on ART It is desirable to have certain specific services,
facilities and protocols in place before starting
d) Procurement of ARV and OI drugs. ART. These are necessary due to the complexity of
accessing and continuing the therapy, the need for
As we are expanding the access to ART rapidly, close clinical and laboratory monitoring and the
it is very important to raise the standards of care cost of therapy. These services include:
and programme management to ensure that
ART is carried out efficiently and that it is well 1. Easy access to an ART center, ideally located in
documented and coordinated. There is therefore the medical OPD of the hospital with adequate
a need for establishing and maintaining a well space and privacy for examination, counselling
set up and run national ART monitoring and and group therapy and with medical and
surveillance (M & E) system that will provide general equipment necessary to carry out best
accurate data and also assist in supervision of practices
the programme. Efforts to prevent or delay drug 2. Medical services with trained physicians and
resistance have to be optimised as only first line other health care personnel capable of iden-
ARV are available in the national programme tifying and treating common HIV-related ill-
and second line drugs are ten times costlier than nesses and OIs as well as effective OI prophy-
the first line. laxis
 2 Operational Guidelines for ART Centers March 2008

3. Care and support services to provide treat- pregnancy testing, complete blood count
ment adherence counselling and psychosocial and serum bio-chemical tests. Access
support to PLHA and their families. These to a laboratory capable of performing
services should ideally involve trained health CD4 count which is essential to monitor
care providers, people living with HIV/AIDS therapy.
and community based care organisations. 5. Reliable and affordable access to quality
4. Reliable laboratory services capable of antiretroviral drugs, and drugs to prevent
performing routine laboratory investi- and treat OIs and other related illnesses.
gations such as HIV antibody testing,
SECTION

Guidelines for
2 Service Providers

These guidelines focus on the objectives, criteria comprehensive services to eligible persons with
for selection, required infrastructure, equipment, HIV/AIDS. The specific objectives of an ART center
supplies and human resources, monitoring tools are to:
and financial guidelines for an ART center. These
i. Identify eligible persons with HIV/AIDS
will provide directions for setting up new ART
requiring ART through laboratory services
centers and guide the existing ones to effective (HIV testing, CD4 Count and other required
implementation of services. investigations)

2.1 The Goal and ii. Provide free ARV drugs to eligible persons
with HIV/AIDS continuously
Objectives of NACP
iii. Provide counselling services before and
2.1.1 Goal during treatment for ensuring drug
adherence
The goal of NACP III is to halt and reverse the
iv. Educate persons and escorts on nutritional
epidemic in India over the next 5 years by integrating
requirements, hygiene and measures to
programmes for prevention and care, support & prevent transmission of infection
treatment. To achieve this goal , NACP III will pursue
four main objectives: v. Refer patients requiring specialised services
or admission.
2.1.2 Objectives vi. Provide comprehensive package of services
including condoms and prevention
1. Prevention of new infections in high risk groups education
and general population through:
a. Saturation of coverage of high risk groups 2.2 Functions of ART center:
with targeted interventions (TIs)
PLHA should be given holistic care at ART centers.
b. Scaled up interventions in the general This is possible only if the team is committed
population and has a comprehensive understanding of the
problem and care. Functions of ART center can be
2. Increasing the proportion of people living categorised as medical, psychological and social as
with HIV/AIDS who receive care, support and indicated below
treatment
2.2.1 Medical Functions
3. Strengthening the infrastructure, systems and
human resources in prevention and treatment To diagnose and treat Opportunistic
programmes at the district, state and national Infections
levels. To screen PLHA for eligibility to initiate
ART
2.1.3 Objectives of ART centers To monitor patients on ART and manage side-
effects, if any
Keeping the above in mind, the main objective To provide in-patient care as and when
of Anti-retroviral Therapy (ART) is to provide required.
 4 Operational Guidelines for ART Centers March 2008

To facilitate linkages between other service vii. Commitment to regularly furnish information
providers on facilities, services and outcomes in
To facilitate easy access to specialist’s care as prescribed formats to SACS and NACO
necessary.
2.3.1 Feasibility Assessment for
2.2.2 Psychological Functions ART centers
To provide psychological support to PLHA A feasibility assessment team comprising of officers
accessing the ART center from NACO, SACS and independent referees/
To provide counselling for adherence to ARV consultants would visit identified sites before
drugs sanctions are issued for setting up new ART centers.
To educate PLHA on proper nutrition The team would assess feasibility of starting the
To advise for risk reduction behaviour ART center on the basis of check-list on parameters
including usage of condoms given in para 2.3 above

2.2.3 Social Functions 2.4 Preparedness of

To facilitate PLHA to access available resources
Institution
provided by government and NGO agencies Once an ART center has been sanctioned for
To facilitate linkages between other service a hospital, a 10 member ART team consisting
providers and patients, like educational of faculty members from the Departments of
help for the children and Income generation Medicine, Paediatrics, Obstetrics & Gynaecology and
programmes Dermatology (and/orVenereology) Surgery,TB chest,
Microbiology, Community medicine, Psychiatry
2.3 Eligibility Criteria for should be selected by the hospital. This team shall
Setting-up ART center be headed by the Dean/Medical Superendant of
the institution. This team shall ensure that all PLHA's
The following criteria would be used to set-up attanding hospital are provided care without any
ART centers in Government Sector, Public Sector stigma and discrimination. The ART Centre shall be
Undertakings and Non-government organisations: headed by he Head of the Department of Medicine
who will be Nodal Officer. The HOD Medicine can
i. Prevalence of HIV infection in the State/
appoint a senior faculy member of same department
District (preference given to category “A’ & ‘B’
districts) and estimated number of persons as Nodal Officer. A team of 2-4 physicians, 1-2 TB
with HIV/AIDS chest specialist, 1-2 paedeatrician, 1-2 gynaecologist
and 1-2 dermatologist and 1 community medicine
ii. Availability of existing ART services in the specialist is then sent for a 4 day training at NACO
State/Region/District identified training centre. This team is turn shall
iii. Services provided and human resources carry out training of other staff members in dept.
available in critical departments in the of Medicine. TB-chest, Paediatrics, OB & GY, skin &
hospital (Medicine, Microbiology, Obstetrics VD & community medicine. Medical Officers and
& Gynaecology, Paediatrics, Dermatology / other contractual staff appointed to the ART center
Venereology) will also undergo a 12 day job-oriented training at
iv. Availability of adequate space for setting up NACO identified ART training institutes.
ART center within the hospital area
v. Willingness to assign minimum one faculty from
2.5 Infrastructure
Departments of Medicine and Microbiology to
support ART center on a daily basis
2. 5.1 Location and Access to
ART Center
vi. Agreeing to follow NACP technical and
operational guidelines prescribed by GOI The ART center should be located ideally in the
Guidelines for Service Providers 5

of the particular center. As NGO and peer

Medicine OPD. If this is not feasible, the hospital in
support at the center itself has proved to
consultation with the SACS should choose a place
be an asset to patients and to the hospital,
within the same campus which is accessible to
space should also be provided for volunteers
patients and keeping in mind cross-referral to and from these organisations
from various departments. Signs depicting directions
to the ART center should be clearly placed by the In case the institution does not have enough
institution at strategic locations so that there is no constructed area for ART Centre, but have vacant
difficulty in locating the center within the hospital. space, they will send a proposal to NACO for
The boards for such marking may be created and building an ART Centre with adequate space and
put in place by the institution concerned or by the facilities like waiting space, drinking water and
SACS for uniformity within a state. toilet facilities.

2.5.2 Space for ART Center The ART center should be kept neat and tidy and
should maintain the highest standards of cleanliness
A minimum of 800 sq. ft. area is required for an ART and hygiene, have proper ventilation, lighting,
center having on average 500 patients (i.e. 20/day) electric supply and water supply for effectively
on roll. It should have adequate number of rooms carrying out examination, counselling, laboratory
each measuring at least ten feet by ten feet (10’ x tests and record keeping, while helping to prevent
10’) for the following staff/services listed below: the spread of nosocomial infections.
a. Examination Room: for Medical Officers to
examine the patients 2.5.3 Furniture and general
b. Counselling Room: For individual, group and
equipment
family counselling The ART center should be furnished adequately but
c. Pharmacy: For stocking ARV & OI drugs must have the following:
with a window or counter for dispensing a. Tables, chairs and stools for staff and
the drugs. The medicines should be stored patients
in a manner that is safe from theft, direct
sunlight, exposure to moisture, rodents and b. Examination Table with curtains
other factors that could harm or destroy the c. Office shelves for supplies, records and
drugs. There should also be a separate facility stationery etc.
in the same room for storage of paediatric
ARV preparations d. Appropriate furniture for computer and
printer and office stationery
d. Laboratory: For collection and storage of
samples and carrying out tests by the lab. e. Secure Cupboards for storing patient records,
technician ARV and other medicines, laboratory kits,
consumables and other equipment. These
e. Office Space: for registration, record keeping cupboards should have locks to prevent
and data entry by Record Keeper cum theft of material and data
Computer Operator (Data Manager)
f. Drinking water and waste disposal systems
f. Waiting Area: This should be of adequate
area where patients and accompanying These items can be procured from the contingency
persons can wait and where group therapy/ grant provided for the ART center.
counselling could also be conducted.
Television and other audio-visual facilities
may be installed here for educational
2.5.4 Medical equipment and
purposes Accessories
g. Adequate space should be individually A set of general medical equipment like a
identified and provided for different ART weighing balance, height measurement pole,
centers taking into consideration the need blood pressure (BP) apparatus, stethoscope,
 6 Operational Guidelines for ART Centers March 2008

ophthalmoscope, otoscope, torch or another not available in the concerned town or city)
suitable light source and knee hammer should Internet connection. Expenditure on Internet
be available for each medical officer at the ART connection including recurring expenses can
center. These items may procured by the SACS. be incurred out of contingency grant provided
In addition, models and charts, demonstration to the ART center every year. For educational
and counselling aids, such as a penis model for purpose, a TV with accessories may be procured
condoms and pill boxes should also be made and installed in the Group-Counselling Room/
available at the center. Waiting Area. The CDs shall be provided by
NACO/SACS.
2.5.5 CD 4 machines
2.6 Human Resources
Each ART center should have access to CD4 tests
either directly or by a clear linkage mechanism 2.6.1 ART team
for conducting regular uninterrupted CD4 counts
at a designated center. The center must follow The ART team should consist of trained faculty from
the instructions on collection and transport of the Department of Medicine and Departments
samples (and not patients) from testing site to the commonly linked with care and support of PLHA
identified site where the test is to be conducted. (Microbiology, Obstetrics & Gynaecology, Paediatrics,
The reagents and other consumables needed Dermatology and Venereology) Surgery, TB Chest
for CD4 test would be procured by NACO and and Community Medicine. In addition, the team
supplied to the centers. The machines should be should also have dedicated staff sanctioned for the
utilised optimally to ensure that there is minimal ART centers and appointed through redeployment
waiting period for CD4 test. or on contractual basis. In case of contractual
appointments, an open advertisement followed
All those patients who are screened for ART by interview of eligible applicants should be
or are on ART will have their CD4 count done undertaken to select the most suitable candidates.
free of cost to a maximum of two tests per year The appointment of contractual staff should be
unless desired more frequently by the clinician. done by the steering committee in the institution.
But if a patient desires to get it done more than This steering committee will interview, appoint
twice a year, he shall have to pay Rs. 250 per the contractual staff, and renew the contract and
additional test. approve the yearly increment. This committee can
terminate the appointment if a situation arises for
2.5.6 Computers and Audio it.
–Visual Equipemnt
The steering committee should be headed by the Head
All ART centers are provided funds for of the Institution, and the Nodal Officer ART shall be
procurement of a desktop computer. This the Member Secretary. The appointing authority will
PC should conform to currently acceptable be the Head of the Steering committee (the head of
specifications and should include a reliable the institution). During the appointment of contractual
chipset, motherboard, at least 256 MB of RAM, staff, SACS representative should be invited as a
at least 40 GB of hard disk space, a fifteen inch special invitee. Attitude of candidates should be given
picture tube (CRT) colour monitor, a keyboard, due weightage in the selection process. Experienced,
optical scroll mouse, a DVD reader cum CD/ retired persons can also be re-appointed up to the
DVD writer, an appropriate cabinet with power age of 62 years. Contractual appointments should
supply, FDD, two to four USB ports, a UPS preferably be made for a period of 3 years to ensure
capable of giving necessary power back up of continuity. For contractional saff an annual appraisal
minimum 30 minutes and a built in modem. In system based on PMDS has been devised based on
addition, computer peripherals should include which continuation should be decided.
a laser printer (black and white), a scanner
and a broadband (or other, if broadband is To avoid delay in salary disbursement, NACO shall
Guidelines for Service Providers 7

N0. of PLHA alive and on ART (9.6)

Post
<500 500-1000 1000– 2000 >2000
Senior Medical Officer 1 1 1 1
Medical Officer None 1 1 2
Lab. Technician 1 1 1 1
Counselor 1 1 2 4
Pharmacist None 1 1 1
Record keeper cum DEO 1 1 1 1
Nurse 1 1 1 1
Community Care Coordinator None 1 1 1

disperse the whole year money for ART component at the center should be headed by the Head of
as one installment to SACS, with the instruction the Department (HoD) of Medicine. The HoD may
to SACS to transfer total amount to individual nominate a senior faculty of Medicine as the nodal
institutions/ART centers with in 30 days time. officer of the ART center. In addition, two to four
physicians, two paediatricians, two obstetrician-
As the number of patients on ART is increasing and has gynaecologists and one or two dermatologists
crossed 1000 at many centers, it has been decided that (or venereologists) should be part of the team.
additional posts sanctioned for ART centers would be NACO will train all the members of the team for
in proportion to the number of patients enrolled for continuous supervision and optimal utilisation of
ART at each center. The following structure has been the center. A sense of ownership should prevail
proposed under NACP III. in the Department of Medicine of which the ART
center is an integral part. The faculty deputed
While one nurse is provided by the programme on a for training should be willing and should have
contractual basis, the hospital should also provide 1 minimum 3 years of service left before retirement
nurse who shall be trained on a Counsellor training and they should actively participate in HIV delivery
curriculum of 12 days at an identified centre.. In in the institution. The institutions which excel in
addition the hospital should ensure that cleaning integration of HIV services without any stigma
and other support staff are provided to the ART and discrimination shall be developed as Model
center as are to other departments of the hospital. Centers and some of them shall be developed as
The department of medicine should also post senior centres of excellance (COE) in HIV care.
residents and consultants – and the department of
paediatrics should post paediatricians to the ART 2.6.4 Human Resources & their
center on a regular basis to assist and guide the
Job Responsibilities:
center and also to provide quality care to PLHA
receiving ART.
2.6.4.1 Nodal Officer of ART Cen-
While additional human resources would be tre (Head, Dept. of Medicine/
provided under NACP, HoD of Medicine Department
Nodal Officer deputed by the
has the authority to utilise their services in the
department and utilise services of experienced
HOD)
persons already available in the Department for Overall responsibility of the functioning of
rendering ART services. the ART centre
All administrative matters relating to the
2.6.3 Trained Institutional centre.
Faculty Act as a team leader to constantly guide
and mentor the ART staff (Medical Officers,
The ART center is an integral part of the Counsellor, Laboratory Technician, staff nurse,
Department of Medicine. Therefore the ART team Pharmacist (if any) and Data manager
 8 Operational Guidelines for ART Centers March 2008

Coordinate and develop referral system and including CD4 count, review the investigations
linkages with other Departments of the and prescribe the treatment (this includes
hospital and other facilities developed under ART, referral to other departments such as
NACP, NGOs, and Positive Network Groups RNTCP centers for treatment of tuberculosis,
etc. treatment of STIs and prophylaxis and/or
Ensure adherence to the highest standards of treatment of opportunistic infections)
quality and excellence in patient care. Refer the cases to the ART center in-charge
Ensure that PLHAs are not discriminated in or any other specialist for further expert
the hospital and are not denied admission/ opinion, intervention including admission
care. and inpatient care, if required
Review and monitor the functioning of the Ensure drug adherence and counsel the
centre every week and ensure submission of patient towards safe sex, condom usage,
reports as required. proper nutrition and positive living
Complete and/or supervise the recording
2.6.4.2 Senior Medical Officer (ART) of information in the various recording and
reporting tools used by the ART center,
The Senior Medical Officer (SMO) of the ART center including software for data recording, if and
should ideally be a specialist (MD) in Internal when installed. It should be ensured that
Medicine, trained in ART by NACO at one of the these records are updated on a daily basis and
designated training centers and capable of dealing reports are sent to the correct authorities, in
with medical complications of HIV/AIDS and the side the correct format and on time
effects of ARVs. In the event that a physician cannot Coordinate various functions of the ART
be appointed, the SMO may be a post-graduate center under supervision of the Nodal Officer
degree holder of any other clinical speciality. of ART center
Monitor the consumption and availability
(S)he should be able to supervise the administrative of ARVs, other medicines and supplies and
and medical functions of the ART center on a day- to alert the concerned authorities in case of
to-day basis and provide leadership to the staff to impending shortage well in advance so as
work as a cohesive team and deliver the services to enable adequate replenishment without
effectively. The SMO should also directly supervise disruption of ART care and support to PLHA.
the staff at the center, ensure that record keeping These Posts of SMO & MO are now being
and reporting are carried out properly and on time regularised so that they are integral Part of
and see that all the guidelines for running and Department of Medicine.
maintaining the ART center are abided by.
Training schedule for ART medical officer is at
2.6.4.3 Medical Officer (ART) Annexure V.

The Medical Officer (MO) should be at least MBBS and 2.6.4.4 Counselor
trained by NACO at one of the designated training
centers. The MO will, in the absence of the SMO, look The counselor at the ART center should hold a masters
after all his/her tasks and responsibilities and ensure degree in social work (preferably specialised in
the proper running of the ART center. Routinely, the psychiatric social work) or in psychology and should
MO should support the SMO in ensuring quality also be trained by NACO at one of the designated
services and care to PLHA on ART as per the guidelines training centers. Qualified and competent PLHA, if
and standards set by the national programme. available, should be given preference while appointing
a counselor. The candidate would undergo a 2-week
Specific tasks of the SMO and MO will include: training programme in counselling at a designated
First contact for the patient regarding his training institution. Alternatively, a qualified Graduate
medical needs. They should examine the Nurse in service can be redeployed, or a retired nurse
patient, advise required investigations can be appointed on contract against the post of
Guidelines for Service Providers 9

Counselor. In both these situations, the Counselor condoms

Nurse would take up a one-month training programme Complete the required sections in the
on counselling in designated training institutions in recording and reporting tools kept by the ART
the country. center (details are mentioned separately)

The counselor plays a very important role as a 2.6.4.5 Pharmacist (for ART centers
member of ART team and his/her responsibilities with > 500 patients on ART)
are crucial for the success of the programme and
improved outcomes of the patients. The counselor The pharmacist should be qualified and hold a
deals with the following: degree or a diploma in pharmacy. This important
member of the staff at the ART center is appointed
Disclosure to the family of the HIV+ persons after the center starts at least five hundred patients
Address issues of stigma and discrimination on ART. Till such a time athat a pharmacist is posted,
and rights of PLHA ARV drugs may be distributed by the nursing
Address issues related to ARV treatment. staff posted by the hospital in the ART center. The
These should include: pharmacist should perform the following tasks:
Pre ART or treatment readiness exercises, Dispense the drugs for OIs and ARV drugs
encourages and helps in finding guardian Maintain the drug stock and drug dispensing
support registers
Explains the details of treatment and its Ensure that the center has stock of ARV drugs
importance, side effects of the ARV drugs for at least 3 months
and limitations of ART (e.g. issues concerning Inform the ART Nodal Officer of the center as
failure of first line therapy and lack of options and when the stock falls below the 3 month
for HIV 2 infection at present) backup stock
Adherence counselling and monitoring, Ensure adequate stock of drugs required for
identification of barriers to adherence treatment and prophylaxis of OIs
and suggestions (remedies) to remove Advise the patients and family about
these barriers. The councellor should do importance of adherence during each visit
pill countinueing for PLHAS on ART. Advise the patient on possible drug toxicities
Formula for calculating adherence of a Patient and reporting of the same if significant
on ART in as below: Maintain a monthly sheet for expiry of drug
Adherence of a paient for a particular time stock.
period Do Pill count and report any adverse effects
= The extent/ proporation/ fraction/ of drugs or any OIs.
percentage by which the patient adhered
(sticked to) the treatment regimen during
that particular time period
2.6.4.6 Data Manager

= (no. of tablets/doses actually taken by a The Data Manager should be a graduate (preferably
patinet for a particular time period) ÷ (no. of from commerce/accaounts background) with
tablets/doses the paint should have taken Diploma in Computer Applications (from a
during this same time period) x100 recognised institute or university) or ‘O’ Level course
Provide emotional, social, and psychological from DOEACC. He/She should also be trained by
support to patients and/or direct the patient NACO in monitoring and evaluation (M & E) of the
to the concerned person or organisation that programme aimed to build the capacity of the
can do so. person in recording data, preparing and sending
Direct patients to linked or referred centers reports and maintaining records properly. Following
and departments and assist in palliative and are specific tasks of Data Manager:
home-based care
Repeatedly stress on positive living, Register patients in the ART centre and fill
prevention and condom use and dispense in the patient ID card, enter/transfer data in
 10 Operational Guidelines for ART Centers March 2008

Pre-ART and ART enrolment registers and Counselling of patients

computer from registers and treatment cards Assisting in record keeping and maintenance
when required (details are mentioned under of patient documents
record keeping) Streamlining and guiding patients at the
Prepare and send monthly report ART center and helping the center t ( o run
Prepare and send cohort reports under efficiently and in an orderly fashion
supervision of the Nodal Officer Coordinating and tracking the referrals made
Assist in academic activities and undertaking within the hospital by establishing linkage
analysis of data for special studies under with various departments and in-patient
supervision of the Nodal Officer of the ART wards
centre. Nursing care and follow-up of patients
Maintain the accounts of the ART centre. admitted in the hospital

2.6.4.7 Laboratory Technician 2.6.4.9 Community Care Coordinator

The Laboratory Technician (LT) should be trained The CC Coordinator should preferably be a
in Medical Laboratory Technology (MLT) from an PLHA,educated to intermediate(12th) standard,
institution recognised by AICTE or State/Central should have working knowledge of English and
Government. (S)he should be trained by NACO in the local language.He can also be a volunteer from
ART related laboratory work, including CD4 count an NGO that is already working towards care and
testing. The Lab technician is expected to perform support of PLHA. (S)he will be expected to carry out
following duties: the following:

Perform HIV tests at the ART center Provide assistance to PLHA enrolled at the
Collect the specimen for CD4 counts at the ART center, within the hospital (OP and IP)
ART center and take these samples to the Coordinate with the linked Community Care
Department of Microbiology, test them and Center
furnish the report to the ART center Keep track of drug adherence of patients on
In case the ART center does not have a CD4 ARV, counseling them on the importance of
machine, the LT will be expected to transport regularity of visits and ARV dosage
samples of blood to a linked CD4 laboratory Augment the efforts of the counselor and
and to collect the results when ready other staff of the center in promoting positive
Assist in performing tests in the Microbiology living
laboratory Assist in patient retrieval, where necessary
Prepare and provide CD4 monthly report to and as far as possible
ART centre. Any other duty assigned by ART Centre
incharge
2.6.4.8 Nursing staff Transfer drugs to LAC, if required.

One or two nurses (depending upon the volume of 2.6.4.10 Cleaning and other support
patients) should be deputed to the ART center by the staff from institute
hospital (or institution). They should be in addition
to one contractual nurse supported by NACO The hospital should also provide cleaning staff
(qualification being same as far appointment of and attendants for day-to-day maintenance of
nurses in the hospital). Nurses play a very important hygiene and running of the center as done for other
role at the ART center and their responsibilities departments or sections of the hospital. The level
include the following: of hygiene and cleanliness of the ART center should
be that of the highest standards, especially keeping
Dispensing of ARV drugs (till a pharmacist is in mind the lowered immune status of people living
added to the team) with HIV/AIDS
Guidelines for Service Providers 11

It is of utmost importance that the ART center (as many of our patients have TB co-infection
is run with positive and synergistic team spirit. and need simultaneous ATT and ART). The
While job responsibilities outlined above are patient should be shifted to NVP after ATT is
desirable in an ideal situation, the Nodal Officer complete.
can redistribute the tasks in a given situation and
specific requirements in a manner that would Based on these norms, requirement of drugs have
improve the quality of services provided by the been calculated and the requirement for a unit
center. of 100 patients per year is given below. These
proportions are revised as per feedback from
2.7 Drugs & Medicines centers/exports.

2.7.1 ARV Drugs: The drugs are supplied in 2-3 instalments in a

year. The drugs supply chain management is
All ART centers are provided with ARV drugs directly being done presently by an independent agency,
by NACO. The number of patients for which drugs Strategic Alliance, which shall be responsible for
are supplied is estimated in consultation with the monitoring drug stocks, expiry and relocation of
ART center concerned. The drugs are generally drugs and ensuring that all Centres have minimum
procured annually. The different types of ARV drugs 3 months buffer stock. All centers should ensure
and their proportions being supplied to ART centers that they have a minimum stock of drugs for three
are as below: months at their center. New patients should not be
enrolled for ART without having 3 months stock of
The ratio of Zidovudine Vs Stavudine based medicine. In such situations, information should
combination is 55:45 be sent regarding non-availability of drugs to the
The proportion of Efaviranz is 20% of total following:
S. No. ARV Drug Combination Containing Ingredients for Adults No. of Tablets
Two drug combination tablets containing
1. 7110
Stavudine 30mg plus Lamivudine 150mg
Two drugs combination tablets containing
2. 8690
Zidovudine 300mg plus Lamivudine 150mg
Three drugs combination tablets containing
3. 25740
Stavudine 30 mg plus Lamivudine 150 mg plus Nevirapine 200 mg
Three drug combination tablets containing
4. 31460
Zidovudine 300mg plus Lamivudine 150mg plus Nevirapine 200mg
5. Tablet Effaviranz 600mg 7300

The following Drugs are used or Pediatric HIV management for children weighing up to 20 kgs:

1. FDC 6 (dual) Stavudine 6 mg+ Lamivudine 30 mg

2. FDC 10 (Dual) Stavudine 10 mg + Lamivudine 40 mg

3. FDC 6 (triple) Stavudine 6 mg + Lamivudine 30 mg + Nevarapine 50 mg

4. FDC 10 (triple) Stavudine 10 mg + Lamivudine 40 mg + Nevarapine 70 mg

5. Tab Efivarenz (Top up) Efivarenz 200 mg

6. Syr/Tab Efivarenz (top up) Efivarenz 50 mg
7. Cotrimoxazole (SS) tablet Cotrimoxazole (400 mg SMX, 80 mg TMP
8. Cotrimoxazole Suspension Corimoxazole (200 mg SMX, 40 mg TMP)
* For children weighing more than 20 kgs. FDC of d4T or AZT (adult) are used as per body weight.
 12 Operational Guidelines for ART Centers March 2008

NACO: Joint Director (C&T) ART with copy to to the consignee of ART center who would accept
National Programme Officer (ART) SACS & Strategic and receive drugs and store in medical store of the
Alliance & PO (Paediatrics) for Paediatric ARV drugs. hospital/institution. Weekly/fortnightly indents
would be sent by the ART center to the Store. Drug
The drugs shall be stored in the main pharmacy stock register should be kept with the store-keeper
of the institution and the centre will utilize them and a sub-stock register should be maintained at
following first in first out principle. The drugs the ART center by Staff Nurse/Pharmacist.
for PEP shall be made available in the casualty
and one more are where they have easy round 2.7.1.4 Process of reporting ARV drug
the clock accessibility. status
NACO has appointed Regional Co-ordinates (RCs) Monthly report would be sent by ART center to SACS
on CST to ensure adherence to ART guidelines - and NACO indicating quantity of drugs received,
both operations & technical, by ART centres. They utilised, balance and additional requirement, if
are supposed to visit all ART centres & CCCs in their any. Empty bottles should be destroyed to prevent
region atteast once is 2 months and send reports to recirculation
NACO/SACS for further action. Monthly meeting of
RCs is also held at NACO for review of issues of ART 2.7.1.5 Impending drug expiry
Centres.
Poor planning, over supply, lack of communication,
Phone, fax numbers and e-mail of officers dealing decrease in patient load, faulty expected number
with ART are given at Annexure-1. could lead to impending drug expiry. Regular
reporting and timely intimation to SACS, NACO
2.7.1.1 Process for requisition and ac- and RCs is necessary to avoid such situations. ART
ceptance of ARV drugs center should inform NACO/SACS when expiry date
of drugs supplied is within 6 months.
Nodal Officer of ART center should send requisition
for ARV drugs to NACO under information to SACS. 2.7.2 Drugs for Opportunistic
The requisition should indicate full consignee
Infections:
address (Nodal Officer, ART) with pin code, phone/
fax numbers and e-mail and quantity of each Requirement of different drugs required for
drug received, utilised, balance available and treatment of Opportunistic Infections may vary from
additional requirement. Supply would be made place to place. Bulk supplying all drugs may lead to
Drugs to be supplied by the
Drugs to be procured by SACS and Drugs to be procured by SACS/
Institution where ART center is
supplied to ART centers) centre as per requirement)
located
1 Metronidazole 400mg 1 Nitazoxanide 500 mg 1 Fluconazole IV- 200 mg
2 Albendazole 400 mg 2 TMP-SMX DS 160/800mg 2 Acyclovir IV 250mg
3 Ciprofloxacin 500mg 3 Azithromycin 500mg 3 Inj.Ganciclovir 500mg
4 Prednisolone 10 mg 4 Fluconazole 150 mg 4 Cap.Ganciclovir 250 mg
5 Fluconazole 400mg 5 Itraconazole 200mg
6 Clotrimazole tubes 6 Clarithromycin 500mg
7 Clindamycin 300 mg 7 Ethambutol 800mg
8 Sulfadiazine 500 mg
9 Inj Amphotericin B 50 mg
10 Acyclovir 400 mg
11 Cefotaxime 1g
12 Levofloxacin 500 mg
13 Cap.Amoxyclav 625
Guidelines for Service Providers 13

expiry of uncommonly used drugs and shortage linkages and referral system need to be set up with
of more frequently used drugs. It has been seen other departments within the institution where ART
that some of the drugs required for management center is located and with service providers and
of OI’s are available in the hospitals formularies organisations outside the institution as elaborated
for treating these infections in non HIV infected below:
persons. Hence the drugs for OI can be divided into
three categories. 2.8.1 Referrals within the
Institute
2.8 Linkages and Referrals
Persons living with HIV/AIDS for comprehensive
Mechanisms for establishing linkages and referral care needs access to various departments/
systems are necessary to meet immediate and services depending upon disease stage
long-term needs of the persons enrolled in a and occurrence of opportunistic infections.
comprehensive HIV care program. PLHAs would To facilitate effective referral system, a co-
need a wide range of services through out their ordination committee chaired by Head of
span with HIV/AIDS, which may be different during the institute (Principal/Dean or Medical
the course of HIV infection and stage of the disease. Superintendent) with HoDs of Medicine,
These needs are related to: Microbiology, Obstetrics & Gynaecology,
Paediatrics, Dermatology / Venereology and I/c
Physical health Chest Diseases/DOTS, Surgery and Community
Psycho-social (and spiritual) health Medicine as members, should be constituted.
Nutritional status This committee should meet monthly/quarterly
Economic status and concern for financial to review ART services.
stability/security
Quality of life ART center should have referral linkages with the
following:
Age and gender of the PLHA are also important as Integrated Counselling and Testing center
they are critical determinants of access to services. (ICTC)

In the present health care delivery system, many Antenatal clinics and Gynaecology
of these services cannot be provided under one Department
roof. There is, therefore, need to develop linkages
and referral systems to take care of these needs. Microbiology Department (for CD4 count and
Following steps would help in establishing linkages other investigations)
within a district/region:
Paediatric Department
Identification of organisations and facilities Dermatology and Venereology Department
dealing with HIV/AIDS;
Mapping of such organisations in the district/ Chest Diseases / Tuberculosis center
region;
Consultation for setting up linkages and 2.8.1.1 HIV- TB Coordination
referrals systems including procedures and
schedules; and Patients attending ART centers with persistent
cough for 3 weeks or more, accompanied by
Evolving formats for referrals and feedbacks. one or more of the following symptoms such
as weight loss, chest pain, tiredness, shortness
It will be advisable if representatives of all the of breath, fever, particularly with rise of
centers meet regularly to discuss problems, if any so temperature in the evening, loss of appetite
that the referral system is made effective and user- and night sweats must be suspected to have
friendly. Looking at the various needs of the PLHAs, Tuberculosis.
 14 Operational Guidelines for ART Centers March 2008

When a person is suspected for TB, he should be On completion of TB treatment such patients can
referred to the nearest Designated Microscopy be switched back to Nevirapine after 2 weeks of
center (DMC) of RNTCP for examination. The HIV- completion of ATT and this substitution does not
TB activities require close co-ordination and for require lead in dose of NVP.
the same a Technical Working Group has been
constituted at NACO along with central TB Dieseas 2.8.2 Referrals outside the
for monthly review of co-ordination between HIV &
Institutions
TB program. Similar mehanism has been developed
at state & district level. The detailed guidelines for Certain needs will demand a referral to facility
HIV & TB are placed at NACO website. that lies outside the institution where ART center
is located. The counselor may be the best person
Patient flow for DOTs to identify such needs and suggest the place of
referrals. Hence, it is important that the counselor
After receiving the sputum results, the MO has a list of centers for referrals and is also acquainted
of the ART centre is responsible for the with the person to whom referral is to be made. The
categorisation of the patient for starting various possible places for linkages and referral may
TB treatment, determining the DOT center include the following:
which is convenient and near to the patients
residence. DOT provider who is acceptable and NGOs actively working in the field of HIV/
accessible to the patient and accountable to AIDS including those involved in Targeted
the health system and making the patient-wise Interventions for High Risk Groups (CSW, IDU,
TB treatment box available at the DOT center MSM etc.)
along with the TB treatment Card, TB Identity Other Government Hospitals & Private
Card and sputum containers for morning Hospitals
samples for follow-up sputum examinations. Community Care centers
The feedback to the treating physician who Drop -in centers
has referred for treatment is provided as soon
as the patient is received at the DOTS center Home Based Organisations
within the district and through the District TB Local PLHA networks
Control Officer (DTCO) if the patient is started Rehabilitation centers
on treatment outside the district. If the patient
is admitted in the hospital then the treatment is It is important to track and document the result of the
started by the DOTS center of the hospital and referral. SMO is the key person responsible for making
on discharge the patient is provided medicine the referrals to other departments. Counselor/Nurse
for 1 week and referred to the nearest DOT would be responsible to keep track of referrals made
center for continuation of TB treatment. outside the hospital. ART center should maintain
account of all the referrals made to the facilities
Anti tuberculosis therapy and antiretroviral within/outside the hospital. If feasible, PLHA network
therapy (ART) or a drop in center may be given the responsibility to
coordinate linkages and referrals.
All TB patients co-infected with HIV should
be treated with a rifampicin containing Anti- The Referral form and the Transfer out forms are at
tubercular regimen under DOTS as per National annexure II
Policy. In TB patients co-infected with HIV, TB
treatment should be started first followed by ART 2 2.8.2.1 Community Care centers
weeks to 2 months later depanding on CD4 count
(Refer to ART Technical Guidelines). In patients Community Care Centers (CCC) is a community based
requiring concomitant administration of ART and facility for accessible, affordable and sustainable
anti-TB treatment, the ARV regimen should be counselling, support and treatment of PLHA’s in a
modified by replacing Nevirapine with Efavirenz. home based environment. They play a critical role
Guidelines for Service Providers 15

in providing treatment, care and support to people Care and Treatment Records
living with HIV/AIDS (PLHA). Under NACP III, these i. Patient ID Card (Green Book)
Centers are linked with ART Centers and ensure ii. Pre-ART Register
that PLHA are provided (a) counseling for ARV drug iii. ART Enrollment Register
adherence, nutrition and prevention (b) treatment iv. Patient Antiretroviral Treatment Record (white
of Opportunistic Infections (c) referral and outreach card)
services for follow up and (d) social support services. Drug Dispensing and Stock Management Registers
It is targeted to set up 350 CCC under NACP III. v. Antiretroviral Drug Dispensing Register
vi. Antiretroviral Drug Stock Register
These Centers are mandated to seek better Programme Performance Monitoring Reports
community and family response towards a PLHA vii. Monthly/Quarterly ART center Report
through family counseling. For better treatment viii. Cohort Analysis Report
outcome, the centers provide families of PLHA Supervision, Quality Assurance and Feedback Forms
counseling on the patient’s nutritional needs, ix. ART Treatment center Appraisal Form
treatment adherence and psychological support.
x. ART Supervisory Checklist
A CCC is strengthened by the presence of Doctor
xi. Summary Recommendations of Supervisory Visit
(1/2), Project Coordinator, Nurses (3), Outreach
Health Workers (4), Counselor, Lab Technician, Cook
and Janitors. 2.9.2 Recording information
From being standalone short stay home under Information is recorded and filled in the prescribed
NACP II, CCC have metamorphosed to being a place area and columns by relevant staff member of ART
for providing comprehensive services to PLHA. They center as indicated below:
play a critical role in enabling PLHA to access ART, as
well as provide monitoring, follow- up, counseling (i) Patient ID card: This should be made by the
support to Pre ART and ART patients, positive counselor and completed at every visit by the treating
prevention, drug adherence, nutritional counseling doctor. The card is to be given to the patient.
etc.
(ii) Pre ART Register: Information of all persons
With a varied range of services, including out- who are HIV positive and registered for HIV care
patient, in-patient, referral, outreach, home based (not necessarily receiving ART) is recorded in
care and linkages and referrals to ICTC, DOTS, PPTCT this register. Once the person is put on ART, (s)
and Link ART Centers, treatment, CCC serves as a he is registered in the ART enrolment register
vital link in providing holistic support to the PLHA. and followed there. It is important to remember
that one row in pre ART register is related to one
2.9 Monitoring & Evaluation HIV+ person.
a) Columns 1 to 12 are filled by the counselor
Continuous monitoring and supervision of
all activities carried out at all the ART centers b) Columns 13 to 22 are completed by the
(Government, PSUs, Non-Government Sector) are treating doctor.
important for monitoring effectiveness and quality The pre ART register provides information
of services. To facilitate a uniform and systematic on profile of registered patients, documents
monitoring, it is necessary to develop common process from Care to ART (Checklist) and
monitoring tools and systems. provided data for the monthly report.

2.9.1 Monitoring Tools (iii) Patient Anti-retroviral Treatment Record

(White Card): The white card should be filled
Following set of registers and reporting formats once the patient is registered in care (Pre ART)
have been developed by NACO and should be used
a) Area 1 to 3 to be filled by the counselor;
uniformly by all the ART centers:
 16 Operational Guidelines for ART Centers March 2008

b) Areas 4 to 12 to be completed by the treating

if the center does not have a pharmacist. The
doctor.
drug stock register helps in monitoring drug
c) The columns 10 and 15 needs to be filled or stock, provides information to alert stock-outs
reconfirmed by the counselor. and provides data required for the monthly
d) Area 11 should be completed at every visit. report.

This record is triple folded card for patient

Each ART center is given a computer and application
information, for patient monitoring
software for computerisation of data on a daily
and programme monitoring to assess
basis.
effectiveness of ART. The Information from
these records is fed into the monthly ART
center report. 2.9.3 Reporting, Data
Transmission and
(iv) ART Enrolment Register: Once a person is put
on ART, (s)he is enrolled and followed in this Analysis
register. Henceforth, no entries are made in the Information from the prescribed records and
pre-ART register. registers is compiled and used in filling up
various monitoring reports (see Annexure),
a) Columns 1 to 8 and column 18 are completed
which are forwarded to SACS and NACO. Monthly
by counselor or record keeper with assistance
from the counselor reports should be forwarded by 2nd of every
month to CIMS with a copy by email to JD (ART)
b) Columns 9 to 17 are completed by the treating and NPO (ART) at NACO. Quarterly reports are
doctor. The record keeper may update the to be forwarded in the months of July, October,
columns 9 to 12 under supervision of the January and April every year. It is intended to use
treating physician. electronic means of data recording and reporting
This register has list of all patients on ART system wherein ART data will be fed into the
with medical details and monthly treatment CMIS at the state, district or even ART center
status and contains information that is fed level. A pilot project using an electronic smart
into the monthly ART center report and card system for ART patients is also being tested
cohort analysis. This register can be updated
and will be implemented under NACP-III.
by the record keeper with assistance of
The responsibility for information collection,
the relevant staff, based on patient ART
reporting, management and analysis rests at four
treatment records (White card).
levels.
(v) Anti-retroviral Drug Dispensing Register:
This register contains place for patients’ i. ART centers: Data generation, maintenance
name and signature, tablets dispensed. A of patient records and registers, reporting to
separate page is maintained for each day. SACS and NACO and using the information
This register is maintained by pharmacist in patient management, drug stocking and
or the staff nurse, if the ART center does referral.
not have a pharmacist. It monitors daily
drug consumption, ensures accountability ii. State AIDS Control Societies (SACS): Data
and contains information which is carried analysis, quality control, assessment of ART
forward to drug stock register. centers, supervision, feedback and dissemination
of information to state-level stakeholders and
(vi) Anti-retroviral Drug Stock Register: In this NACO.
register, a separate page is maintained for
each drug or drug combination. It contains iii. NACO: Compilation, analysis, monitoring,
information on name of the drug, opening stock, evaluation, planning, advocacy resource
stock received, stock dispensed, drugs expired allocation, drug supply and dissemination
and the balance remaining. This register is also of information to national and international
maintained by the pharmacist or the staff nurse stakeholders.
Guidelines for Service Providers 17

iv. National Research Institutions: Conducting Coordination of ART services with active
special evaluation studies and operational participation of NGOs and PLHA networks.
research. Collate, compile and forward information
relating to ART centers to NACO
2.9.4 Communication tools Organise training of various personnel
involved in ART services
Apart from internet connection, ART center Monitoring of supply and utilisation of
should be phone connections for external and ARV and OI drugs and diagnostic kits and
internal (hospital) communication. The ART equipment
center will be expected to keep phone and Increase in coverage of ART services in eligible
Internet lines open and available to NACO, SACS, persons with HIV/AIDS.
NGOs, CBOs, FBOs, Positive Network Groups,
patients as well as to other departments of the 2.10.2 Supply and Monitoring of
hospital. The staff manning the center should
ARV Drugs
get into the habit of routinely communicating
(even reporting) through e-mail, while the The management of supply logistics in respect
use of the telephone should be used mainly of ARV drugs will be ensured by NACO. Only first
for emergencies and to contact local support line regimen will be offered as specified. Supplies
groups or persons. Each ART center should set will directly reach the ART centers. Any change in
up a free e-mail address with a company that the procurement and distribution in future will be
is user friendly and has the ability to send and separately intimated by NACO. The Project Directors
store large volumes of data. should closely monitor availability and utilisation of
ARV drugs in each ART center and also ensure that
Communication using postal or courier services under no circumstances the center runs out of ARV
should be retained for letters and documents that drugs. Intimation on receipt, utilisation, stocks and
require signatures of officials. In urgent matters, requirement of ARV drugs should be sent to NACO
documents with appropriate signatures may be on a monthly basis.
scanned and sent as attachments through e-mail.
2.10.3 Documents, Guidelines
2.10 Responsibility of the and Monitoring Tools
SACS NACO/SACS should ensure that each ART center
Project Director, SACS should identify a senior has following documents and items:
technical officer, preferably, Additional Project ART Technical Guidelines
Director (or Joint Director) as the Nodal Officer for ART Operational Guidelines
ART programme. ART Training Manual (specialists and MOs)
National Guidelines on Counselling;
2.10.1 Responsibilities of Nodal Handbook for Counselors
Officer for ART at SACS National Guidelines on OIs, CD4 testing
(including linkages), HIV testing
Supervision and monitoring of ART List of ART centers in India
implementation in the State (should visit Adequate stock of Registers, Treatment Cards,
each ART at least once in 3 months). Reporting Formats, Referral Forms
Coordination with Principals/Deans of Medical LAC & CCC guidelines.
Colleges and Medical Superintendents/
Director of District Hospitals/Other Hospitals 2.10.4. Increase in Coverage of
Identification of sites for new ART centers as
ART
per NACO criteria
Identification of ART teams and organise their To ensure high coverage of eligible AIDS adults
sensitisation on ART Services (CD4 Count<200) and children (CD<20%), who
 18 Operational Guidelines for ART Centers March 2008

should receive ART, active identification of eligible 2.11.1 Bank Account

patients and linkages with various facilities need
to be established... To facilitate this task, following The ART center should open a separate bank
activities need to be organised by the SACS in a account for management of funds. The account can
systematic manner: be opened in the name of ‘ART center – XXXX (name
of the institution)’ to be operated jointly by 2 – 3
2.10.4.1 Public Awareness persons including Nodal Officer of ART center. This
is essential for proper and timely utilisation of funds
There is evidence to show that level of general made available to ART center. Payment should
awareness towards HIV/AIDS has increased in the be made by cheques except for small contingent
population. However, knowledge and utilisation expenses. A cash book will be maintained by ART
about various services available for prevention, center to meet petty cash expenses. For this purpose,
counselling, testing, care and treatment is low. This the nodal officer may draw imprest money not
has resulted in sub-optimal utilisation of various exceeding Rs. 5000 at a time. The account should
services. SACS should publicise availability of be managed by Data Manager at ART centre.
services offered in details through various means
of communication (TV, Radio, Newspapers, and 2.11.2 Audit of Accounts:
Brochures). Location and services offered by ICTC,
CCC, TIs, ART centers, TB centers and STD Clinics SACS will get accounts of each ART center audited.
need to be disseminated at State/District level. Audited Statement of Accounts and Utilisation
Channels and newspapers should be selected based Certificate for the preceding financial year of each
on targeted audience and coverage. Funds available ART center should be submitted to SACS with copy to
to SACS for IEC may be utilised for this purpose. NACO by 30th June each year. Further release of grants
would be subject to submission of these documents.
2.10.4.2 Referral System & Linkages
2.11.3Guidelines for expenditure:
There is lack of adequate linkage and referral system
between ART centers and other facilities. People found ART center would incur expenditure as per norms
to be HIV+ should be referred to ART centers and if given in table below:
CD4 count is less than critical level, should be put on
ART. There should be linkages between these centers For SMO an increment of Rs 750 p.a. and for MO
and ART centers as indicated in para 2.8.1 and 2.8.2: an increment of Rs. 500 p.a. has been approved.
For other contractual employees the increment is
2.11 Financial Management Rs. 400 p.a. All contractual employees are entitled
to 30 days accrued/earned leave (i.e. 2 1/2 per
Funds required for running an ART center are month) & 10 days sick leave
provided to each ART center for utilisation as per
guidelines.
Operational Guidelines for ART Centers March 2008 19

Proposed Salary range

Post
(Rs. pm)
SMO 25000–30000
MO 20000–25000
LAB Tech 6500–8500
Pharmacist 6500–8500
Counselor 8000–10000
Data Manager 8000–10000
Staff Nurse 10000–12000
Care Coordinator 3000–4000
Total cost of salaries per year Rs. 10.44 – 12.96 lakhs
Contingency Rs. 0.5 lakhs
Operational costs per year
(Telephone, Internet, stationary, printer cartridge, postal charges, 1 lakh
local travel)
Non recurring one time grant
( Computer & accessories, TV & DVD, Furniture, Almirah, Storage 2 lakh
racks )
Total per year Rs.13 lakhs – Rs. 14.5 lakhs
The salary shall start from the basic level for each post and
increment/continuation of staff shall be based on PMDS

New Art center Existing ART Center

GIA to ART Center
S. No. Unit Cost (Rs. In Lakh) Unit Cost (Rs. In Lakh)
Minior Civil Works &
Non-recurring GIA Renovation* 2.5 -
for ART Center
I Furnituture Computer,
TV, DVD, Water
2.0 -
Cooler, refrigerator etc.

Salaries 11.5 12.0

Recurring GIA for

II ART Center OPerational Costs And 1.5 1.5
Contingency

GIa for Universal

Work Precautions 1.0 1.0

TOTAL 18.5 14.5

*This can be revised on case to case basis as per request from ART center/SACS
The female contractual staff at ART Centre is entitled to 60 days half pay maternity leave. There is no provision of
paternity leave and encashment of leave and the accrued leave shall not be carried forward to the next contract period.
20 Operational Guidelines for ART Centers March 2008
SECTION

3 Patient Focused Guidelines

3.1 Disease Stages before (pre-test) and after (post-test) testing. The
patient at this stage may be asymptomatic or have
In the course of an HIV infection and its progression, symptoms suggestive of HIV infection or AIDS.
the person goes through various stages from a When there are no symptoms, the patient should
healthy state to full blown AIDS. These are described be directed to Community Based Organisations
below: (CBO). The emphasis of management of
asymptomatic patients should be through
3.1.1 Stage 1: From seeking counselling, on the need to involve families,
health care to diagnosis motivate patients towards positive attitude
and thinking. The patient is referred to the ART
At this stage the HIV status of the patient is center for registration in the Pre-ART Register.
unknown. Any patient who seeks medical care The patients should be screened periodically
generally visits the out-patient department for and managed for Sexually Transmitted Infections
assistance. Although any department may be (STI), Tuberculosis (TB) and various Opportunistic
visited, depending on the nature of the clinical Infections (OI). WHO clinical staging and CD4
presentation, most of those suffering from the count should be established and documented.
symptoms of HIV infection tend to visit the Early diagnosis and management of OIs including
medicine OPD. The patient undergoes a clinical prophylaxis form the main stay of management
check-up followed up often with laboratory in this stage.
support to establish a diagnosis. In the event that
there are symptoms and signs or other evidence Counselling should be aimed at ensuring risk
suggestive of HIV infection (Annexure III), then reduction behaviour of the patient. At the same
the patient is referred to a Integrated Counselling time, efforts should be made to elicit family and
and Testing center (ICTC) or a Prevention of Parent community support for the patient. (S)he should also
to Child Transmission (PPTCT) center, where be counselled to (i) promote positive healthy living,
the patient undergoes pre-test counselling, HIV (ii) have an appropriate balanced diet (iii) return to
testing and post-test counselling. work, or if the same not possible, redirected to other
acceptable job profiles and (iv) seek appropriate
The importance of early identification of HIV positive health and social support.
status cannot be overstated as this could help
prevent and significantly delay morbid conditions When appropriate, and if necessary, (i) early referral
as well as help prevent transmission of the infection to community support systems, (ii) treatment for
to others. It is also important that OIs are identified substance abuse and (iii) management of co-morbid
early so as to be able to reduce their impact on psychiatric illness should be carried out.
patients and improve the quality of live.
As many of the patients at this stage are likely to
3.1.2 Stage 2: Process from proceed to receiving ART at some point in the future,
diagnosis till need for repeated counselling should also be targeted at
ensuring adherence to ARVs, when ART is started.
ART Patients and families should be convinced that
The HIV status should be made known to a patient adherence is integral to a positive and successful
at ICTC or PPTCT center where (s)he is counselled outcome once ART is started.
 22 Operational Guidelines for ART Centers March 2008

Several patients are ill when they come to know Broadly, patients coming for follow up visits fall into
of the positive HIV status. Such persons should be three categories, namely:
examined in the Department of Medicine (or other
(a) Those who are seriously ill,
concerned department) as out-patients and based
on clinical features and laboratory investigations, (b) Those who have significant illness(es) and
diagnosis is established and appropriate treatment (c) Those who are free of any complaints.
given. When stable, the patient should be referred
back to ART center. Those suffering from severe forms of illnesses,
including drug reactions, IRIS, OIs and disease
3.1.3 Stage 3: Process from manifestations should be attended to immediately
decision to start ART by the medical personnel at the ART center or in
the emergency room, if the patient were to present
Patients who have a confirmed HIV positive there. They should be admitted and treated in the
status and fulfil the criteria for starting ART could Department of Medicine (or another department,
belong to two groups, (a) those who are already as per the nature of the problem).
registered at ART centers in the pre-ART care and
(b) those who have just been recognised and Patients who are moderately ill, but do not
are hitherto unregistered with the ART center. require admission may present with physical
Those who fall in the former category should signs and symptoms of their illness. They may
have their WHO clinical stage (Annexure IV) and also be suffering from psychological disturbances,
CD4 count documented in addition to clinical depression or other psychiatric manifestations.
and laboratory screening as recommended by Such patients may be managed at the ART center
the national programme. Adherence counselling or referred to the Department of Medicine (or other
should be given or repeated and family (or appropriate department) for further assessment
guardian) support established. The patient can and management. Patients who do not maintain
then be started on ART and registered in the ART acceptable adherence levels and those with mild
enrolment Register. to moderate psychiatric problems, should undergo
intensive counselling at the ART center in addition
Patients who are being seen for the first time at to being provided medical care and support.
the ART center and who are clinically eligible for
receiving ART, should receive intensive adherence The third group of patients are those who are
counselling on at least two sittings while they are symptom free and have maintained adequate
undergoing clinical and laboratory screening. adherence levels. They should undergo a routine
The WHO clinical staging and CD4 counts should counselling session including adherence counselling
be documented at this time. Family and/or social and be examined by the medical officers of the ART
support, including guardianship support also needs center. Routinely, all patients should be examined for
to be established at this stage. An NGO linkage is TB, IRIS, new OIs and drug related side effects. A pill
also essential for follow up of the patient. Finally, count should be done to check adherence. If there
when all these issues have been dealt with, the are no issues, they may collect their ARVs and leave.
patient can be started on ART and registered in the
ART enrolment register. In all the above conditions, irrespective of the
patient’s condition, the ART center should provide
During the first fifteen days of ART a close watch counselling for
needs to be kept on patient, especially to look for
side effects of Nevirapine. Group and individual (i) Adherence;
counselling to address adherence issues and risk
reduction behaviour and counselling to help the (ii) Family and social support;
patient lead a positive healthy lifestyle should be
repeated during each visit of the patient, especially (iii) Risk reduction behaviour particularly use of
during the early days of ART. condoms;
Patients Focused Guidelines 23

(iv) Substance abuse; In order to ensure good adherence and for tracking the
patients lost to follow up , it is desirable that patient is
(v) Proper dietary intake; enrolled at ART center nearest to his current place of
stay. He should be asked to furnish the documentary
(vi) Positive healthy living; and evidence of address proof in form of voter card/ ration
card/ electricity or telephone bill etc. For patients from
(vii) Accessing appropriate health care services, rural areas, a letter from the Panchayat chief will suffice
when required. as address proof. The ART Medical officer should get
full contact details of patient including phone numbers
In addition and as per the ART technical guidelines, before starting ART.
patients should also have periodic CD4 count
testing, weight check, ambulatory status and routine 3.3 Supports from NGOs
laboratory investigations, including Hb, carried out.
and Positive Network
3.2 Confidentiality and Groups
Discrimination Issues In order to improve the quality of care provided to
HIV/AIDS patients, the hospital should have effective
Irrespective of HIV status of a person, all patients linkages with Community Based Organisations
are entitled to receive general and specialty (CBO), Faith Based Organisations (FBO) and with
out-patient and in-patient services in a hospital. Positive Network Groups in the region. Rapport
Confidentiality should be maintained at all levels building and development of positive relationships
irrespective of HIV status as per accepted medical with these organisations will also help reduce the
ethics and the law. Maintenance of confidentiality burden on the hospital. Such NGOs may provide
should help to reduce discrimination against vocational (or occupational) rehabilitation to
PLHA during the management of the patient in deserving PLHA and family members, support
any hospital. It may also be noted that hospital CLHA and OVC by providing educational support
infection control policies and measures, when and/or care homes. They could also provide legal
observed properly and maintained at all levels support when PLHA or their family members are
and Post Exposure Prophylaxis (PEP) for all deprived of their rights. In addition, they are often
staff, if followed as per norms, will create a safe well equipped to provide psychosocial support
environment for health care providers to manage and even nutritional support to the patients and, if
PLHA appropriately. necessary, their families.
SECTION

Standard Operating
4 Procedures (SOP)

The SOP address the detailed process of patient 4.1 Entry into HIV Care
flow as well as serve as a source of instructions to
the staff of ART center that will optimally lead to The ART center should enroll the person once
good quality service delivery of ART, following the he has a confirmed HIV test result. If a person has
national guidelines. SOP are required for each of the suggestions of the HIV disease but is not serologically
following: confirmed, the person should be referred for HIV
testing at ICTC. The common referral form should
Entry of patient into the care be used for all referrals in the program.
Flow of patient in the center
Referral system for the patients

4.2 Flow of Patient at the ART center

Patient presents to center

Triage counselor/nurse

HIV status confirmed HIV status not confirmed

Goes for registration Referred to ICTC by counselor

Patient ambulatory Patient's general condition not good

Attended by counselor Attend by doctor

 26 Operational Guidelines for ART Centers March 2008

4.2.1 The initial visit If eligible for ART, doctor treats active OI and
prescribes prophylaxis; sends for pre ART
In order to ensure good adherence and for tracking counseling or treatment readiness exercises;
the patients lost to follow up , it is desirable that Pre-ART counseling may take 2-4 sessions
patient is enrolled at ART center nearest to his on an average. Counselor should make
current place of stay. He should be asked to furnish sure that the patient understands the life
the documentary evidence of address proof in form long treatment, has gained knowledge
of voter card, ration card, electricity or telephone about the treatment, is willing to take ART
bill etc. For patients from rural areas, a letter from and follows the adherence guidelines.
the Panchayat chief will suffice as address proof. Counselor encourages family involvement/
The ART Medical officer should get full contact guardianship
details of patient including phone numbers before Doctor gives follow up date after treatment
starting ART readiness exercise after discussing with
counselor.
Having confirmed the HIV status, the patient is Once ART is initiated, the pre ART register is
registered in the Pre-ART care by the counselor. completed and the ART enrollment register
The counselor also makes patient ID card and and ART treatment record is filled by counselor
refers to the doctor. The principles of 5 A’s in and the MO (as per the guidelines).
any chronic illness should be followed (Assess, Doctor prescribes ARV and other necessary
Advise, Agree, Assist and Arrange). Doctor drugs
carries out a detailed medical examination Patient collects drugs from dispensing
during which he should counter

Looks for OIs 4.2.3 Visit after ART is started

Classify the patient according to the WHO
(After 2 weeks of NVP
clinical staging
Advise laboratory work-up - baseline test, initiation)
OI investigation, CD4 count as indicated Patient goes to counselor. Counselor assesses
in technical guidelines
Discuss briefly with patient and Adherence to treatment
attendant (who knows the HIV Barriers in adherence, if any
status) about management of HIV Any side effects, mentioned by patients
with ART Consider taking written consent for home visits
Give interim treatment, as required Sends to MO
Call the patient for review after he gets
the results of investigations
Complete the information in the Pre-ART The Medical Officer
register
Examines the patient
Establish the status of previous OIs and symptoms
4.2.2 The Second Visit Looks for side effects of ART
Explains the possibility of IRIS
Patient returns with result of investigations Makes any referral for patient, if needed
Meets the counselor who re-emphasises Mentions the alarming signs and symptoms of
about ART adherence; builds rapport. side effects of the drug regime used
Calls for follow-up after 1 month
Refers to Doctor, who reviews all the
investigations and takes decision about
eligibility for starting ART as per guidelines During the visit, respective columns in the ART
If the patient is not eligible, gives pre-ART treatment record are filled by the counselor and the
care and advises for follows up visits. Medical Officer
Standard Operating Procedures (SOP) 27

4.2.4 Subsequent Follow-ups 4.2.5 Further follow up visits

Visits (Once a month)
Responsibilities of various personnel during The patient is asymptomatic
monthly follow-up visits are as under: There is no weight loss or loss of
appetite
Counselor: The oral cavity is normal ( no ulcers, or
oral thrush)
Monitor adherence and ask for any potential or
identified barriers
Notes if any referral is required and informs the
person in-charge for referral (SMO/MO or nurse) If the person is already on ART for 3 months, and
Links the patient to community based does not wish to visit the doctor (has come to collect
organization and rehabilitation centers, if medicines), the same may be done after the nurse
available and desired. Should at least inform the
has looked for that:
patient about the existence of various support
groups.
Counseling of guardian In such cases, the patient may meet the counselor
Completes the columns in the ART record (White and nurse, take the required medicines and leave
card) after the follow up date is given.
Sends to the nurse, if available or to the MO, if
nurse is not available
CD4 counts and other laboratory investigations
should be done as per guidelines or as required.
Staff Nurse:
It is important to realise that HIV infection often
Assess adherence
See for side effects
affects the family rather than only an individual.
Look for IRS Hence, the ART team should try and determine
Stress the importance for adherence the status of those not on care and treatment (like
Make any required referrals parents of a child under treatment, spouse of HIV
Explain to patient that it may not be necessary infected etc). The counselor, nurse and doctor
to see MO every time. However, he should do so should try and identify the family members with
when asked by the ART center staff
Gives follow up date after a month.
the HIV status and get them into care.

In order to ensure good adherence and for tracking

Doctor (SMO/MO) the patients lost to follow up , it is desirable that
patient is enrolled at ART center nearest to his
current place of stay. He should be asked to furnish
Take vital parameters the documentary evidence of address proof in form
Take weight
of voter card/ ration card/ electricity or telephone
See for oral thrush
Ask for symptoms bill etc. For patients from rural areas, a letter from
Make the entries in the relevant columns in the the Panchayat chief will suffice as address proof.
ART record The ART Medical officer should get full contact
Sends the patient to MO details of patient including phone numbers before
starting ART.
28 Operational Guidelines for ART Centers March 2007

4.2.6 Patient Flow at ART center (Pre ART)

Standard Operating Procedures (SOP) 29

4.2.7 Patient Flow at ART center (ART Care)

These SOP Should address the detailed process of patient flow as well as serve as a source of
instructions to the staff of ART centre.
SECTION

Public Private
5 Partnership on ART

5.1 Expansion of ART However for treatment being provided to the

programme to NGO/ community at these centers, NACO/ will provide
kits for diagnosis and drugs for ART/OIs.
PSUs/Corporate
Sector/Trust/ II. Responsibilities Of NGO/Corporate/PSUs
Charitable Hospitals
1) To provide all health services related to
It has been seen that many patients approach provision of ART and treatment of opportunistic
various NGO/Trust/Charitable Hospitals for HIV care infections, free of cost to patients who require
including ART e.g. YRG Care, Chennai; CMC, Vellore; treatment and shall not deny services to any
KLES Hospital, Belgaum; KMC Hospital, Manipur person living with HIV on any ground.
and AIDS Health Care Foundation, New Delhi. In
addition, there are a number of hospitals under 2) To comply with all the laws for the time being in
organisations like Railways, ESIC, Armed Forces force in India in the running of the ART center.
Medical Services as well as PSUs like SAIL, Coal India
Ltd., BHEL, NFL etc. which are already providing 3) To follow the National ART guidelines (drug
some services to HIV infected persons including regimen as well as physical standards) issued by
ART in some of their hospitals. These services need NACO from time to time.
to be streamlined as per National ART Guidelines
and operational protocols. 4) To bear the costs related to the staff ’s
salary (doctors, counselors, nutritionist,
In this regard a Memorandum of Understanding pharmacist, nurses, medical records officer and
(MOU) for starting ART in NGOs/Corporate Sector/ administrative staff ) and the cost related to the
PSUs has been developed at NACO and approved infrastructure.
by the Department of Legal Affairs, Ministry of Law
and Justice and National AIDS Control Board. The 5) It shall conform to any guidelines issued by
salient features of MOU are NACO from time to time.

I. Responsibilities of NACO The pattern of assistance to various sectors by NACO

is as below
1) To provide support for one time training of
personnel of these organisations. A copy of the MOUs approved for NGO and PSU/
Corporate centers is placed at Annexure VI.
2) To provide regular updates on National ART
guidelines from time to time. 5.2 Selection of NGO/Trust/
Charitable organisation
3) For NGO collaborators, NACO shall provide
diagnostic kits, ART and OI drugs for a specified for PPP
number of patients for a period of three years. For The selection criteria for NGO are
PSUs/Corporate ART centers, the organisation
shall bear the entire cost of drugs, tests etc. for i) It should be run by a registered Society/Trust in
the treatment of its employees & their families. India;
 32 Operational Guidelines for ART Centers March 2008

Assistance to ART centers in various sectors under NACP

Public
Other Govt. Corporate
Health PSUs NGOs
Sector Sector
Sector
Component Medical Rly, Defence, Remarks
Criteria Criteria
Colleges, ESI, GOI
as per as per
Distt. Paramilitary undertakings
scheme scheme
Hosp. etc.
Only for new
Land X X X X X
constructions
Infrastructure
X X X X Under NACP-III
Development
Equipment (CD4 machine) X X X X
* Only
Additional Human
X X X counselor if
Resources
patients>1000
Diagnostic Kits (HIV/CD4)
** For eligible
ARV Drugs (First Line) patients from
community
Drugs for Opportunistic
Infections
TA/DA by
Training of key personnel sponsoring
agency
IEC material
Operational Costs

ii) It should have sound financial position and to NACO using M&E tools. They should not use
should give commitment to support services the data collected without NACO’s consent;
for 3-5 years;
NACO shall give an advertisement in national
iii) It should have at least 2 years experience in ART newspaper about the PPP and invite applications.
provisioning; However to start with, this shall be implemented
with the organisations which have already applied
iv) They should have facilities for CD4 and other to NACO for the same. Before start/signing of MOU,
lab tests needed at center or should have clear the center shall be visited by an expert team of 3-
workable linkages for the same; 5 persons including Programme officer at NACO,
National /State ART Consultant, one national HIV
v) They should follow the same man-power for expert and one person from Administration/finance
ART centers as is done at government run section. The team shall use the standard ART
centers; site visit format (AnnexureVII). After satisfactory
appraisal, the center shall sign an MOU with NACO
vi) They should follow NACO guidelines and report as per annexure.
SECTION

LINK ART
6 CENTERS (LAC)

sector

6.1 Rationale
Since inception of Anti-retroviral Treatment (ART) Following criteria will be used to open LAC on
in 2004, there has been significant upscaling of priority:
ART services. Currently 163 ART centres are fully
functional providing services to more than 1,40,000
PLHAs. These centers have been mainly set up in 1. High Prevalence (category A & B districts)
Medical Colleges, Tertiary Hospitals and some big
2. ART centers where patient load is high
district hospitals. As a result, many a times, patients
(>1000 PLHAs on ART)
have to travel long distances to get the treatment.
Once on ART, the patient has to take drugs life long 3. ART centers where patients are coming
with high level of drug adherence. Presently ARV from neighboring districts in large num-
drugs are dispenses on a monthly basis to ensure bers
drug adherence, assessment of response and to 4. ART centers where drug adherence is re-
rule out any adverse effects. Also monthly visits ported to be >90%.
lead to lot of rush at ART centres, leading to long 5. There are minimum of 50 PLHAs on ART
waiting hours and inconvenience to patients. The from the catchment area of LAC (relaxed to
monthly visits may also entail the patient’s stay in 25 PLHAs in hilly/desert areas where popu-
the city leading to additional costs in addition to lation density is low).
travel cost. All these factors have been perceived as
potential barriers to an optimal adherence for ART.
To minimize the need for the patients stable on ART,
it is envisaged to have identify and designate Link 6.3 Human Resources &
ART Centers (LAC) for distribution of ARV drugs and
monitoring of drug adherence in stabilized patients.
Training
This center will be like an extension facility to the No additional human resource shall be provided
main ART center. by NACO. Job-oriented hand on training will be
imparted to 2 Medical Officers, Nurse, Counselor
6.2 Eligibility for Link ART and Pharmacist (one each) in these facilities at the
Centers nodal centre on the additional responsibility of ARV
dispensing. The main responsibility of the main
These centers can be opened in places where centre shall include:
services of a doctor, nurse, counselor and pharmacist
1. Adherence counseling and monitoring
are available, Thus following facilities may qualify for
designation as LAC 2. Identification of the critical side effected of ART
/ OI medication,
1. Integrated Counseling and Testing Centers in
Government Hospitals including Rural/Taluka 3. Identify symptoms suggestive of OI, side effect
Hospitals and CHCs of drugs.
2. Community Care Centres in Non-Government 4. Referral to the main ART centre at the earliest.
 34 Operational Guidelines for ART Centers March 2008

All the patients who are referred to the ART link

6.4 Infrastructure centers are to be followed up at the nodal ART
requirement center once in every 6 months, mandatorily. Dur-
ing this visit, they will be monitored on clinical
Two rooms about 10 x 10 feet are required for LAC: and immunological parameters including repeat
One for the drug storage and dispensing and the other
CD4 count, as well as other relevant investigations
for record keeping and counseling. The M.O. will see
as per the technical guidelines will be performed.
the patients in his general OPD.

6.7 Supply and Monitoring

of ARV Drugs
6.5 Recording and reporting
tools The nodal ART center shall transfer the PLHA to
Each link center will have a monthly reporting format
that will address: the link center after giving him the stock for current
1. The number of PLHAs linked to it month. Thereafter, his drugs for the next three months
2. The drug stocks and the number of months of shall be transferred to the link center, and the same
drugs for each patient regimen shall be documented in the drug stock and dispens-
3. Number of referral that were required back to ing registers at both the centers. The responsibility to
ART center before the 6 months and reasons for monitor the link centers, their performance, monthly
the referral reports and drug stocks at the link centers will be the
4. Adherence level of each patient and specific issues responsibility of the nodal ART center in charge.
for barrier to adherence
Following documents will be maintained at the LAC:
1. Drug stock register 6.8 Financial Assistance
2. Drug dispensing register Estimated costs for opening up an LAC is on the fol-
3. Patient ID booklets (green booklet) to document lowing:
weight, adherence (pill count) and drugs dis- 1. One time contingency grant for furnishing of
pensed. centre = Rs. 15,000/-

2. Cost of training of staff – to be borne by training

6.6 Selection of patients institutes recurring grant :

No new Ratient will be started on ART at LAC

1. Internet connection @ Rs. 650/- p.m. x 12 =
Following patients will be eligible for transfer out to Rs. 7,800/- p.a.
LAC from the nodal centre:
2. Cost of stationery, records and contingency =
1. Patients stabilized on ART for 6 months. Rs. 10,000 p. a.
2. Those patients who have exhibited weight gain,
and increase in CD4 count 6 months after initiat- 3. Cost of travel for ORW and to main centre
ing ART, and do not have any active OI. = Rs.20, 000 / p.a.

3. Those who are willing to be transferred, once the The Operational guidelines for Link ART centre are
above two conditions are fulfilled. under preparation and will be disseminated to all
SACS as soon as they are final.
 Annexure I

Name of officer Tel number email

Ms. Sujatha Rao. IAS 23325331;
Additional Secretary & Director General, 23351700 [email protected]
National AIDS Control Organization (fax) 23731746
Dr. Jotna Sokhey
23325337,
Addl. Project Director (Technical) [email protected]
23351714(fax)
National AIDS Control Organization
Dr.Damodar Bachani
Joint Director (ART), 43509915 [email protected]
National AIDS Control Organization
Dr. B.B. Rewari
National Program Officer (ART), 43509677 [email protected]
National AIDS Control Organization
Dr. Vimlesh Purahit
Programme Officer (Round VI) 43509622 [email protected]
National AIDS Control Organisation
Dr. Rohini Ramamurthy
Programm Officer (Councelling) 43509906 [email protected]
National AIDS Control Organisation
Ms. Pradnya Paithankar
Programm Officer (M&E) 43509978 [email protected]
National AIDS Control Organisation
Dr. Karun Dev Sharma
Senior Technical Officer (ART - Trg) 4350995 [email protected]
National AIDS Control Organisation
 CONTACT DETAILS OF REGIONAL COORDINATORS (CST)
Name of States Place of
S. No. Name of Regional E-mail & Phone No. Postal Address
Covered postive

[email protected], Tamil Nadu State AIDS

1 Dr Aiswarya Rao Tamil Nadu, Pondicherry Chennai 044-2819-2976/2819-0891, Control Society,417,Pantheon
98410-13672 Road,Egmore,Chennai -600008
Andhra Pradeshesh Andhra Pradesh State AIDS Control Society,
[email protected];
2 Dr. P Sathesh Hyderabad Directorate of Medical and Health Services,
9963111021 / 9966136631
Sultan Bazar, Hyderabad – 500059.
Unit-F,Gemini Park,V.N.Purav Marg,Opp.
rekha.jain@intensivist.
Anushakti Nagar New Mandala Gate no.6,
3 Dr. Rekha Jain Maharashtra, Goa Mumbai org / [email protected];
Mankhurd, Mumbai-400 088
9322258069 / 9833153939

[email protected]; 5/A, Trupti Appartments, Behind Old High

Gujarat, Rajasthan, MP,
4 Dr. Manoj R. Shevkani Ahmedabad [email protected]; Court Navrangpura, Ahmedabad-380 009
Chattisgarh
9825431324; 079-27542640@

[email protected]; WBSAPCS, swasthya Bhawan , GN -29,

5 Dr. Rajkumar Manna West Bengal and NE Kolkatta
09830289369 Sector -V, salt Lake , Kolkatta 700091

9431808285 / 9430002957 /
Bihar State AIDS Control Society, SIHFW
UP, Uttarakhand Bihar, 9433070912 ;
6 Dr. Geetanjali Kumari Patna Building, Sheikhpura, Patna. - 800014
Jharkhand, Orissa [email protected] ,
[email protected]
 Annexure II

Transfer out form (Form For transfer to Other ART center)

Name and address of the transferring ART center _____________________________

Name and address of ART center where patient is transferred ______________________

Name of Patient :

Address:

Reason for transfer Date of transfer:

Date of starting ART: _____/____/_______ (Date/Month/Year); Cohort _____________

Next date for dispensing drug is ______/_______/______

Please find the following documents handed to the patient:

1. ART Treatment Card ( Xerox)
2. Patient I D card/OPD card
3. Others, if any (mention)

Name and Signature of SMO/MO Phone no and E mail of SMO/MO:

______________________________________________________________________________

______________________________________________________________________________

To be filled by the receiving ART center and sent to the transferring ART center by post / email

………………………………..(Name of Patient), referred by you on date…/. . ./… has reported and been
registered with us on…./…../…….. The documents sent by you have been received.

Name and Signature of SMO/MO Phone no with e mail of SMO/MO

______________________________________________________________________________

______________________________________________________________________________

(Back of this page has address of the ART center, transferring out the patient
38 Operational Guidelines for ART Centers March 2008

Referral form
Date of referral: day / month / year _________ /_________ /_________
Referring Unit (please tick)
– ART center – ICTC
– PPTCT – Referral coordinating Body
– DOTs center – STD clinics
Name of contact at referring body

Name of Patient

Age and sex

Referred to
– ART center – ICTC
– PPTCT – Other departments (please mention)
– RNTCP – Community care center
– Referral coordinating body (for referrals outside institute, in community)
Purpose of referral
– Opinion – Enrollment in care
– Social support – Psychological support
– Nutritional support – Peer group formation/registration
– other ( please specify)
Back ground information about the patient

Feedback on The referral

Medical referrals.
Presumptive diagnosis
Suggested intervention or intervention done
Community based referrals( the referral coordinating body like drop in center should send the documented
proof of the result of the referral)
– Referral completed – Problems identified in referrals
 Annexure III

WHO case definitions for AIDS surveillance in Minor signs

adults and adolescent where HIV testing facilities
are not available. Persistent cough for more than 1 month
Generalised pruritic dermatitis
The case definition for AIDS is fulfilled if at History of herpes zoster
least 2 major signs and at least I minor sign are Oropharyngeal candidiasis
present. Chronic progressive or disseminated herpes
simples infection
Major signs Generalised lymphadenopathy

Weight loss>10% of body weight The presence of either generalised Kaposi sarcoma
Chronic diarrhea for more than 1 month. or cryptococcal meningitis is sufficient for the case
Prolonged fever for more than 1 month. definition of AIDS.
 Annexure IV

Clinical stage 1
Asymptomatic
Persistent generalised lymphadenopathy
Clinical stage 2
Unexplained moderate weight loss (<10% of presumed or measured body weight)1
Recurrent respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis)
Herpes zoster
Angular cheilitis
Recurrent oral ulceration
Papular pruritic eruptions
Seborrhoeic dermatitis
Fungal nail infections
Clinical stage 3
Unexplained2 severe weight loss (>10% of presumed or measured body weight )8
Unexplained chronic diarrhoea for longer than one month
Unexplained persistent fever (above 37.5oC intermittent or constant for longer than one month)
Persistent oral candidiasis
Oral hairy leukoplakia
Pulmonary tuberculosis
Severe bacterial infections (e.g. pneumonia, empyema, pyomyositis, bone or joint infection, meningitis, bacteraemia,)
Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis
Unexplained anaemia (<8 g/dl ), neutropenia (<0.5 x 109 /L) and or chronic thrombocytopenia (<50 X 109 /L3)
Clinical stage 43
HIV wasting syndrome
Pneumocystis pneumonia
Recurrent severe bacterial pneumonia
Chronic herpes simplex infection (orolabial, genital or anorectal of more than one month’s duration or visceral at any site)
Oesophageal candidiasis (or candidiasis of trachea, bronchi or lungs)
Extrapulmonary tuberculosis
Kaposi’s sarcoma
Cytomegalovirus infection (retinitis or infection of other organs)
Central nervous system toxoplasmosis
HIV encephalopathy
Extrapulmonary cryptococcosis including meningitis
Disseminated non-tuberculous mycobacteria infection
Progressive multifocal leukoencephalopathy
Chronic cryptosporidiosis
Chronic isosporiasis
Disseminated mycosis (extrapulmonary histoplasmosis, coccidiomycosis)
Recurrent septicaemia (including non-typhoidal salmonella)
Lymphoma (cerebral or B cell non-Hodgkin)
Invasive cervical carcinoma
Atypical disseminated leishmaniasis
Symptomatic HIV associated nephropathy or Symptomatic HIV associated cardiomyopathy

1
Assessment of body weight in pregnant woman needs to consider expected weight gain of pregnancy.
2
Unexplained refers to where the condition is not explained by other conditions.
3
Some additional specific conditions can also be included in regional classifications (e.g. reactivation of American trypanosomiasis
(meningoencephalitis and/or myocarditis) in Americas region, Penicilliosis in Asia).
 Annexure V

Training schedule for ART Medical Officers

Day 1- Monday:
8- 9.30 am : Welcome, registration, orientation
9.30- 10.30 am : Pre test, ice breaking
10.45- 12 noon : Universal precautions and waste disposal
12- 1 pm : My hospital, my work
2- 3 pm : Epidemiology of HIV infection-Overview of NACP
3- 4.30 pm : Psychosocial aspects, including counseling

Day 2- Tuesday:
8 am- 12.30 pm : Ward visit- review of universal precautions and waste disposal in the ward;
interaction with positive people on issues of stigma and discrimination;
1.30- 2.15 pm : Principles of HIV prevention and care
2.15- 3.15 pm : Natural history of HIV infection
3.30- 4.15 pm : Testing related to HIV
4.15- 5 pm : My hospital, my work

Day 3- Wednesday:
8 am- 12.30 pm : Ward visit- visit to laboratory; visit to VCCTC and review of use of NACO
approves kits for testing
1.30- 2 pm : Clinical pharmacology of ARV drugs
2- 3.45 pm : Anti retroviral therapy
4- 4.30 pm : Adherence issues
4.30- 5 pm : Post exposure prophylaxis

Day 4- Thursday:
8 am- 12.30 pm : Ward visit- visit to ART clinic; spending time on pre ARV counseling,
counseling for ART, for counseling and adherence estimation. Discussion
on ART initiation in some patients; follow up of patients on HAART
1.30- 2.15 pm : ART team
2.15- 3.45 pm : Monitoring and Evaluation
4- 5 pm : My hospital, my work

Day 5- Friday:
8 am- 12.30 pm : Ward visit- visit to ART clinic- working of record keeper/ data entry operator,
maintenance of records/ registers; writing some actual prescriptions
1.30- 1.45 pm : Approach to opportunistic infections
1.45- 2.45 pm : Fever and lung manifestations in HIV
2.45- 3.30 pm : Gastro intestinal manifestations in HIV
3.45- 4.45 pm : Neurological manifestations in HIV
44 Operational Guidelines for ART Centers March 2007

Day 6- Saturday:
8 am- 12.30 pm : Ward visit- bed side discussions on PLHA admitted with opportunistic
infections
Day 7- Sunday : No sessions

Day 8- Monday:
8 am- 12.30 pm : Ward visit- bed side discussions on PLHA admitted with opportunistic
infections
1.30- 2.30 pm : HIV and tuberculosis
2.30- 3.30 pm : STI and HIV
3.45- 4.30 pm : Dermatological issues in HIV
4.30- 5.00 pm : Therapy in Special situations

Day 9- Tuesday:
8 am- 12.30 pm : Ward visit- bed side discussions on PLHA admitted with opportunistic
infections. Visit to DOTS clinic
1.30- 2.30 pm : Women and HIV, including PPTCT
2.30- 5 pm : Paediatric aspects of HIV

Day 10- Wednesday:

8 am- 12.30 pm : Ward visit- visit to PPTCT program, labour room, paediatric wards
1.30- 5 pm : Paediatric aspects of HIV

Day 11- Thursday:

8 am- 12.30 pm : Ward visit- visit to paediatric wards
1.30- 2.15 pm : Nutritional aspects
2.15- 3 pm : Palliative care
3- 3.30 pm : Impact of HIV and HAART
3.45- 4.15 pm : Socio economic correlates of HIV
4.15 - 5 pm : Stigma and discrimination, including Jyoti’s hope (a video produced by
ITech/GHTM, Tambaram)

Day 12- Friday:

8 am- 12.30 pm : Ward visit- bedside discussions on patients on ART presenting with
problems- IRIS, side effects, failure of therapy.
1.30- 2.00 pm : Blood banking
2.00- 3.30 pm : Problem solving and Prescription writing
3.45- 5 pm : Clinical exercises

Day 13- Saturday:

8- 9 am : Post test
9-11a.m : Ward visit- Case discussions of admitted PLHA
11- 12.30 noon : Post test score distribution, and post test answers discussion
12.30 p.m : WRAP UP
 Annexure VI
Agreement between
National AIDS Control Organisation ( NACO)
Government of India
&
XXYYZZ (Name of NGO and Place)

This Agreement is made on _______ day of _______ 2006 by and between the President of India acting
through [name of Additional Secretary and Director General], Additional Secretary and Director General,
National AIDS Control Organisation, Department of Health, Ministry of Health and Family Welfare,
Government of India, 9th Floor, Chandralok Building, 36, Janpath, New Delhi 110 001 (hereinafter
referred to as “NACO”)
AND
XXYYZZ, a society / trust registered under the Societies Registration Act or [State] Public Trusts Act and
bearing registration number ______ and having its registered office at _______________ acting through
_______________, the authorised signatory, hereinafter referred to as “XXYYZZ”, which expression shall,
unless repugnant to the context, include its successor in business, administrators, liquidators and assigns or
legal representatives.
WHEREAS NACO is providing first line antiretroviral treatment (hereinafter referred to as ART) to persons
living With HIV/AIDS (hereinafter referred to as PLHAs) in India through designated public hospitals as
per the guidelines issued by the National AIDS Control Organisation (hereinafter referred to as NACO)
from time to time;
AND WHEREAS NACO coordinates the aforementioned provision of ART at designated public
hospitals by limiting the selection, procurement, distribution and rational use of drugs,
including antiretroviral drugs, and prescribing guidelines for treatment of opportunistic
infections and provision of ART;
AND WHEREAS NACO is desirous of extending the provision of ART to more PLHAs in collaboration with not-
for-profit non-governmental organisations;
AND WHEREAS XXYYZZ is a not-for-profit organisation registered under the Societies Registration Act or
[State] Public Trusts Act with the object interalia of extending AIDS related treatment , care and other
services to PLHAs regardless of ability to pay;
AND WHEREAS XXYYZZ has been running an HIV clinical programme at ___, which was initiated in………….
and is presently providing ART to __ number of persons.
AND WHEREAS XXYYZZ has approached NACO and expressed its interest to assist NACO in addressing the
above need at its sites in India;
AND WHEREAS the parties hereto have agreed to set up a collaborative ART project and hereby reduce the
terms of the agreement to writing;
 46 Operational Guidelines for ART Centers March 2008

NOW THEREFORE THIS AGREEMENT WITNESSES AS FOLLOWS:

I. PURPOSE OF COLLABORATIVE ART PROJECT
The purpose of the present Agreement is to set up collaborative ART project between NACO and XXYYZZ
that would seek to be a model for high quality provision of ART and associated healthcare and medical
management of PLHAs in its sites in India.

II. RESPONSIBILITIES OF NACO

4) NACO shall provide and ensure an uninterrupted supply of antiretroviral medications and medications
for the treatment of common bacterial, parasitic and fungal opportunistic infections to XXYYZZ for
the number of patients as set out in Schedule II for a period of [three / five years] from the date of
execution of this Agreement.
5) NACO shall organise training or provide support for training of personnel of XXYYZZ involved in the
collaborative ART project.
6) NACO shall provide to XXYYZZ regular updates on National ART guidelines from time to time.
7) NACO and XXYYZZ shall form a committee comprising of representative from NACO, Director of
XXYYZZ, which shall supervise and monitor the collaborative ART project to ensure provision of quality
services.
8) On an application by XXYYZZ for certification of a site as a “designated ART center” NACO team shall
inspect the site to ascertain facilities for providing treatment and counselling and financial status
subject to its satisfaction as to clause 3 of part III, certify the site as a “designated ART center”.
9) NACO will provide drugs on a [three] monthly basis on receipt of a requisition/s from XXYYZZ and
certificate of utilisation of drugs in a prescribed format supplied earlier.

III. RESPONSIBILITIES OF XXYYZZ

6) XXYYZZ has set up a center / plans to set up a center (s) at _________________ and has appointed
Dr.___________, as the official contact for the proposed collaborative ART Project.
7) XXYYZZ represents that it provides / proposes to provide various health services to PLHAs, a description
of which is set out at Schedule III to the present Agreement.
8) XXYYZZ undertakes that it will comply with all the laws for the time being in force in India in the running
of the ART center. Further, as a condition precedent to the certification of the site as a “designated
ART center, XXYYZZ shall have obtained all necessary government approvals and have appointed the
necessary staff with the requisite technical qualifications.
9) XXYYZZ shall strictly follow the National ART guidelines (drug regimen as well as physical standards) issued
by NACO from time to time, follow the terms of reference for staff including qualifications as specified by
NACO and will ensure that mechanisms needed for good treatment adherence are in place.
10) XXYYZZ shall respect the autonomy and privacy of the patients, and to this end provide pre- and post-
test counselling, obtain written informed consent from the patient prior to a test or treatment, and
maintain confidentiality of the patients on the principle of shared confidentiality.
11) XXYYZZ shall provide for data protection systems to ensure that the confidential records of the patients
are computerised and are protected so that they are not accessible to any unauthorised person.
12) XXYYZZ shall provide a copy of all medical records to the patients on their request.
13) XXYYZZ shall provide all health services related to provision of ART and treatment of opportunistic
infections, including those listed in Schedule III, free of cost to patients who require treatment. XXYYZZ
shall not deny services to any person living with HIV on any ground.
Annexure 47

14) XXYYZZ shall maintain all the registers and reporting formats as per NACO ART guidelines. They will
send report of all adverse drug reactions to NACO.
15) XXYYZZ shall use standard NACO Monitoring and Evaluation tools.
16) XXYYZZ shall provide standard, anonymous monthly reports of patient numbers and relevant details
for the previous month to NACO by the 7th of each month in prescribed formats in accordance with
the guidelines laid down by NACO from time to time. NACO will be free to use the data so sent to them
in an anonymous manner.
17) XXYYZZ shall provide details of the ART team at their center to NACO along with the names and
technical qualifications of the staff and keep this updated from time to time.
18) XXYYZZ shall entirely bear the costs related to the staff ’s salary (doctors, counselors, pharmacist, nurses,
medical records officer and administrative staff ) and the cost related to the infrastructure. XXYYZZ
represents that it has enough funds to run the programme for the next three / five years. XXYYZZ will
permit NACO to inspect its documents relating to the balance sheets, profit and loss accounts, grants
and donors, financial and other documents so that NACO can verify the representation of sustainability
of the collaborative ART project.
19) XXYYZZ shall establish a network with NGOs involved in HIV care and support as well as with the
Indian Network for People Living With HIV/AIDS or PLHA groups in the area for increasing access to
treatment and for follow-up support.
20) The designated representatives of XXYYZZ shall attend the coordination meeting with NACO at their
own costs.
21) XXYYZZ shall not permit research or clinical trial, whether relating to the allopathic system of medicine
or any alternate system of medicine or any combination thereof, at the designated ART center, except
with the approval of the Drugs Controller General of India for the conduct of such clinical trial. Further,
in the event of an approved clinical trial, the Party of the Second Part will ensure that ethical protocols
are complied with.
22) Use of any data obtained by XXYYZZ during the course of its collaborative ART project shall be done in
an anonymised manner such that the identity of the patients enrolled at the collaborative ART project
is not revealed in any manner.
23) XXYYZZ shall maintain the records for a period of five years from the time that this Agreement is
terminated or lapses by efflux of time.
24) XXYYZZ shall constitute a grievance redressal mechanism. [A model grievance redressal mechanism
is annexed hereto.] Further, XXYYZZ shall forward to NACO in an anonymised manner the nature of
complaints received and action taken thereon on a monthly basis.

IV. COMMENCEMENT
1) This Agreement shall become effective upon signature by both the Parties and certification of the site
of the collaborative ART project as “designated ART center” by NACO as per clause 5 of part II of this
Agreement. It shall remain in full force and effect for a period of three / five years thereafter.

V. RENEWAL OF AGREEMENT
1) This Agreement is renewable at the option of NACO.
2) Six months prior to the expiry of the Agreement due to efflux of time NACO shall intimate XXYYZZ if it
intends to renew or not to renew the Agreement.
3) In the event that NACO decides not to renew the Agreement, XXYYZZ shall intimate NACO about
its ability to continue to provide treatment free of charge to the patients enrolled. If XXYYZZ fails to
 48 Operational Guidelines for ART Centers March 2008

continue to provide treatment free of charge or expresses its inability to do so, they shall give notice to
the patients and NACO about this and refer the patients to the nearest government hospital providing
treatment for opportunistic infections and ART, as directed by NACO. Further, upon such referral,
XXYYZZ shall forthwith forward a copy of all medical records of the patients to such hospital and to
NACO or a person designated by NACO to receive such medical records. Thereupon, NACO will be
responsible for ensuring that the patients continue to receive the drugs.
4) In the event that NACO desires to renew the Agreement, the terms and conditions of this Agreement,
as may be amended, will apply de novo. It is made expressly clear that in that event, XXYYZZ will have
to re-apply for and re-obtain certification.
5) Both parties shall ensure that there is no treatment interruption of the patients.

VI. TERMINATION OF AGREEMENT

1) Any party may terminate this Agreement after giving three months notice to the other party at the
address provided in this Agreement for correspondence or the address last communicated for the
purpose and acknowledged in writing by the other party.
2) On such notice of termination being received by any party, XXYYZZ shall intimate NACO about its
ability to continue to provide treatment free of charge to the patients enrolled. If XXYYZZ cannot
continue to provide treatment free of charge, they shall give notice to the patients and NACO about
this and refer the patients to the nearest government hospital providing treatment for opportunistic
infections and ART, as directed by NACO. Further, upon such referral, XXYYZZ shall forthwith forward
a copy of all medical records of the patients to such hospital and to NACO or a person designated by
NACO to receive such medical records. Thereupon, NACO will be responsible for ensuring that the
patients continue to receive the drugs.

VII. BREACH BY XXYYZZ

1) In case XXYYZZ is not able to provide services as per agreement or defaults on the provision of this
Agreement or declines the patients to provide medication or directly or indirectly makes any charges
for the treatment of opportunistic infections or ART or otherwise enters into any malpractices, it shall
be liable for breach of agreement and breach of trust and other consequences which may include
black listing with NACO, MOHFW, Ministry of Home affairs and External Affairs. This action shall also be
intimated to their parent/ International NGO also for necessary action by them.
2) If XXYYZZ is found to have made any charges for the treatment which was to be given free of charge
under this Agreement or to have not provided the medicines to the named patients or to have
otherwise misappropriated the funds or goods released by NACO to XXYYZZ, then without prejudice
to any other right or consequence or mode of recovery, NACO may recover the amount thereof from
XXYYZZ and/or its office bearers as arrears of land revenue.

VIII. SETTLEMENT OF DISPUTES

1. Any dispute or difference or question arising at any time between the parties hereto arising out of or
in connection with or in relation to this Agreement shall be referred to and settled by arbitration under
the provisions of the Arbitration and Conciliation Act, 1996 or any modification or replacement thereof
as applicable for the time being in India.
2. The arbitration shall be referred to an arbitrator nominated by Secretary Department of Legal Affairs,
Ministry of Law and Justice, Govt. of India Delhi. The Arbitrator may, if he so feels necessary, seek
opinion of any health care personnel with experience of working in the field of HIV and care and
treatment of PLHAs.
3. The place of arbitration shall be either New Delhi or the site of the collaborative ART project, which
shall be decided by the arbitral tribunal bearing in mind the convenience of the parties.
4. The decision of the arbitrator shall be final and binding on both the parties.
Annexure 49

LAW APPLICABLE
This Agreement shall be construed and governed in accordance with the laws of India.

IX. ADRESSES FOR CORRESPONDENCE

In witness thereof, the parties herein have appended their respective signatures the day and the year above
stated.
[In case the contract is entered into by the President through the DG, NACO, this needs to comply with the
Rules of Business laid down in this behalf.]

SCHEDULE I
MODEL LIST OF DRUGS TO BE PROVIDED BY NACO TO XXYYZZ

Signed For and on behalf of XXYYZZ Signed For and on behalf of

President of India
AABBCC Director General
Director
XXYYZZ NACO
Signature .................................................................................. Signature ..................................................................................
Date ............................................................................................ Date ............................................................................................
In the presence of In the presence of

Name and Signature ........................................................... Name and Signature .............................................................

.......................................................................................................
.......................................................................................................
Date ............................................................................................
Date ............................................................................................

1. Treatment for Opportunistic Infections

TMP SMX, Acyclovir, Fluconazole, Ciprofloxacin
Amphotericin B

2. First line ART (in fixed dose combinations)

(a) Stavudine
(b) Lamivudine
(c) Nevirapine
(d) Zidovudine
(e) Efavirenz
50 Operational Guidelines for ART Centers March 2008

SCHEDULE II

MODEL FOR A FIVE YEAR AGREEMENT

Number of PLHAs for whose treatment
Year Centre
stock is to be provided
2006–07
2007–08
2008–09
2009–10
2010–11

Number of PLHAs for whose treatment

Year Centre
for OIs is to be provided
2006–07
2007–08
2008–09
2009–10
2010–11

MODEL FOR A THREE YEAR AGREEMENT

Number of PLHAs for whose treatment
Year Centre
stock is to be provided
2006–07
2007–08
2008–09

Number of PLHAs for whose treatment

Year Centre
OIs for is to be provided
2006–07
2007–08
2008–09

SCHEDULE III
MODEL OF DESCRIPTION OF SERVICES PROVIDED / PROPSOED TO BE PROVIDED
Address of site
Outpatient
Days Monday to Saturday
Timings 0830 am to 330 pm (As per hospital timings)
Inpatient care
Number of patients registered
Number of patients receiving ART
Average number of patients attending
OPD everyday
Criteria followed in administering ARVs WHO criteria. Attach any other criteria being followed
Treatment for OIs
First line regimen AZT/d4T+ 3TC+ NVP/EFV
Description of follow-up of patients
Facilities available
Personnel and their qualifications
Annexure 51

MODEL GRIEVANCE REDRESSAL MECHANISM

[Note: This portion has been taken from the draft law on HIV/AIDS and it would be advisable for XXYYZZ
to constitute a grievance redressal mechanism at the outset.]

(a) XXYYZZ shall appoint a person of senior rank, working full time in the organisation, as the Complaints
Officer, who shall, on a day-to-day basis, deal with complaints received from an aggrieved person or
an authorised representative of such person.

(b) Every aggrieved person or an authorised representative of such person, who has a grievance against
the XXYYZZ about the services provided or refused, has the right to approach the Complaints Officer
to attend to such complaint and shall be informed of such rights by XXYYZZ.

(c) The Complaints Officer may inquire suo motu, and shall inquire, upon a complaint made by any
aggrieved person or authorised representative of such person, into the complaint.

(d) The Complaints Officer shall act in an objective and independent manner when inquiring into
complaints made.

(e) The Complaints Officer shall inquire into and decide a complaint promptly and, in any case, within
seven working days. Provided that in cases of emergency, the Complaints Officer shall decide the
complaint within one day.

(f ) The Complaints Officer, if satisfied that there has been an unfair/arbitrary refusal of services or
deficiency in the services provided, shall (i) first direct XXYYZZ to rectify the cause of the grievance,
(ii) then counsel the person alleged to have committed the act and require such person to undergo
training and social service. Upon subsequent violations by the same person, the Complaints Officer
shall recommend to XXYYZZ to, and the institution shall, initiate disciplinary action against such
person.

(g) The Complaints Officer shall inform the complainant of the action taken in relation to the complaint.
 52 Operational Guidelines for ART Centers March 2008

Agreement
between
National AIDS Control Organisation ( NACO)
Government of India
&
XXYYZZ (Name of corporate Organisation)

This Agreement is made on _______ day of _______ 2006 by and between the President of India acting
through [name of Additional Secretary and Director General], Additional Secretary and Director General,
National AIDS Control Organisation, Department of Health, Ministry of Health and Family Welfare, Government
of India, 9th Floor, Chandralok Building, 36, Janpath, New Delhi 110 001 (hereinafter referred to as “NACO”)
AND
XXYYZZ, a Corporate Organisation bearing registration number ______ and having its registered office
at _______________ acting through _______________, the authorised signatory, hereinafter referred to
as “XXYYZZ”, which expression shall, unless repugnant to the context, include its successor in business,
administrators, liquidators and assigns or legal representatives.
WHEREAS NACO is providing first line antiretroviral treatment (hereinafter referred to as ART) to persons
living With HIV/AIDS (hereinafter referred to as PLHAs) in India through designated public hospitals as
per the guidelines issued by the National AIDS Control Organisation (hereinafter referred to as NACO)
from time to time;
AND WHEREAS NACO coordinates the aforementioned provision of ART at designated public hospitals by
limiting the selection, procurement, distribution and rational use of drugs, including antiretroviral
drugs, and prescribing guidelines for treatment of opportunistic infections and provision of ART;
AND WHEREAS NACO is desirous of extending the provision of ART to more PLHAs in collaboration with not-
for-profit non-governmental organisations;
AND WHEREAS XXYYZZ is a Corporate Organisation registered under the Companies Registration Act. It has
established/wants to establish a center to extend AIDS related treatment , care and other services to its
employees and their families living with HIV/AIDS and to extend these services to PLHA’s in the nearby
areas as a part of their corporate social responsibility;
AND WHEREAS the parties hereto have agreed to set up a collaborative ART project and hereby reduce the
terms of the agreement to writing;

NOW THEREFORE THIS AGREEMENT WITNESSES AS FOLLOWS:

I. PURPOSE OF COLLABORATIVE ART PROJECT
The purpose of the present Agreement is to set up collaborative ART project between NACO and XXYYZZ
that would seek to be a model for high quality provision of ART and associated healthcare and medical
management of PLHAs in its sites in India.

II. RESPONSIBILITIES OF NACO

10) NACO shall organise training or provide support for training of personnel of XXYYZZ involved in the
collaborative ART project.
11) NACO shall provide to XXYYZZ regular updates on National ART guidelines from time to time.
12) NACO and XXYYZZ shall form a committee comprising of representative from NACO, Director of XXYYZZ,
which shall supervise and monitor the collaborative ART project to ensure provision of quality services.
Annexure 53

13) On an application by XXYYZZ for certification of a site as a “designated ART center” NACO team shall
inspect the site to ascertain facilities for providing treatment and counselling and financial status
subject to its satisfaction as to clause 3 of part III, certify the site as a “designated ART center”.
14) NACO will provide drugs on a [three] monthly basis on receipt of a requisition/s from XXYYZZ and
certificate of utilisation of drugs in a prescribed format supplied earlier.

III. RESPONSIBILITIES OF XXYYZZ

25) XXYYZZ has set up a center / plans to set up a center (s) at _________________ and has appointed
Dr.___________, as the official contact for the proposed collaborative ART Project.
26) XXYYZZ represents that it provides / proposes to provide various health services to PLHAs, a description
of which is set out at Schedule III to the present Agreement.
27) XXYYZZ undertakes that it will comply with all the laws for the time being in force in India in the running
of the ART center. Further, as a condition precedent to the certification of the site as a “designated
ART center, XXYYZZ shall have obtained all necessary government approvals and have appointed the
necessary staff with the requisite technical qualifications.
28) XXYYZZ shall strictly follow the National ART guidelines (drug regimen as well as physical standards) issued
by NACO from time to time, follow the terms of reference for staff including qualifications as specified by
NACO and will ensure that mechanisms needed for good treatment adherence are in place.
29) XXYYZZ shall respect the autonomy and privacy of the patients, and to this end provide pre- and post-
test counselling, obtain written informed consent from the patient prior to a test or treatment, and
maintain confidentiality of the patients on the principle of shared confidentiality.
30) XXYYZZ shall provide for data protection systems to ensure that the confidential records of the patients
are computerised and are protected so that they are not accessible to any unauthorised person.
31) XXYYZZ shall provide a copy of all medical records to the patients on their request.
32) XXYYZZ shall provide all health services related to provision of ART and treatment of opportunistic
infections, including those listed in Schedule III, free of cost to patients who require treatment. XXYYZZ
shall not deny services to any person living with HIV on any ground. The ARV drugs used for community
will be supplied by NACO
33) XXYYZZ shall maintain all the registers and reporting formats as per NACO ART guidelines. They will
send report of all adverse drug reactions to NACO
34) XXYYZZ shall use standard NACO Monitoring and Evaluation tools.
35) XXYYZZ shall provide standard, anonymous monthly reports of patient numbers and relevant details
for the previous month to NACO by the 7th of each month in prescribed formats in accordance with
the guidelines laid down by NACO from time to time. NACO will be free to use the data so sent to them
in an anonymous manner.
36) XXYYZZ shall provide details of the ART team at their center to NACO along with the names and
technical qualifications of the staff and keep this updated from time to time.
37) XXYYZZ shall entirely bear the costs related to the staff ’s salary (doctors, counselors, pharmacist, nurses,
medical records officer and administrative staff ) and the cost related to the infrastructure. XXYYZZ
represents that it has enough funds to run the programme for the next three / five years. XXYYZZ will
permit NACO to inspect its documents relating to the balance sheets, profit and loss accounts, grants
and donors, financial and other documents so that NACO can verify the representation of sustainability
of the collaborative ART project.
38) XXYYZZ shall bear the entire cost of drugs, diagnostic reagents & kits required for the treatment
of its employees & their families. For treatment being provided to the community, NACO/ XXXSACS
 54 Operational Guidelines for ART Centers March 2008

will provide drugs for ART on receipt of a requisition/s from XXYYZZ and certificate of utilisation of
drugs in a prescribed format supplied earlier
39) XXYYZZ shall establish a network with NGOs involved in HIV care and support as well as with the
Indian Network for People Living With HIV/AIDS or PLHA groups in the area for increasing access to
treatment and for follow-up support.
40) The designated representatives of XXYYZZ shall attend the coordination meeting with NACO at their
own costs.
41) XXYYZZ shall not permit research or clinical trial, whether relating to the allopathic system of medicine or
any alternate system of medicine or any combination thereof, at the designated ART center, except with the
approval of the Drugs Controller General of India for the conduct of such clinical trial. Further, in the event of
an approved clinical trial, the Party of the Second Part will ensure that ethical protocols are complied with.
42) Use of any data obtained by XXYYZZ during the course of its collaborative ART project shall be done in
an anonymised manner such that the identity of the patients enrolled at the collaborative ART project
is not revealed in any manner.
43) XXYYZZ shall maintain the records for a period of five years from the time that this Agreement is
terminated or lapses by efflux of time.
44) XXYYZZ shall constitute a grievance redressal mechanism. [A model grievance redressal mechanism
is annexed hereto.] Further, XXYYZZ shall forward to NACO in an anonymised manner the nature of
complaints received and action taken thereon on a monthly basis.

IV. COMMENCEMENT
2) This Agreement shall become effective upon signature by both the Parties and certification of the site
of the collaborative ART project as “designated ART center” by NACO as per clause 5 of part II of this
Agreement. It shall remain in full force and effect for a period of three / five years thereafter.

V. RENEWAL OF AGREEMENT
6) This Agreement is renewable at the option of NACO.
7) Six months prior to the expiry of the Agreement due to efflux of time NACO shall intimate XXYYZZ if it
intends to renew or not to renew the Agreement.
8) In the event that NACO decides not to renew the Agreement, XXYYZZ shall intimate NACO about
its ability to continue to provide treatment free of charge to the patients enrolled. If XXYYZZ fails to
continue to provide treatment free of charge or expresses its inability to do so, they shall give notice to
the patients and NACO about this and refer the patients to the nearest government hospital providing
treatment for opportunistic infections and ART, as directed by NACO. Further, upon such referral,
XXYYZZ shall forthwith forward a copy of all medical records of the patients to such hospital and to
NACO or a person designated by NACO to receive such medical records. Thereupon, NACO will be
responsible for ensuring that the patients continue to receive the drugs.
9) In the event that NACO desires to renew the Agreement, the terms and conditions of this Agreement,
as may be amended, will apply de novo. It is made expressly clear that in that event, XXYYZZ will have
to re-apply for and re-obtain certification.
10) Both parties shall ensure that there is no treatment interruption of the patients.

VI. TERMINATION OF AGREEMENT

3) Any party may terminate this Agreement after giving three months notice to the other party at the
address provided in this Agreement for correspondence or the address last communicated for the
purpose and acknowledged in writing by the other party.
Annexure 55

4) On such notice of termination being received by any party, XXYYZZ shall intimate NACO about its
ability to continue to provide treatment free of charge to the patients enrolled. If XXYYZZ cannot
continue to provide treatment free of charge, they shall give notice to the patients and NACO about
this and refer the patients to the nearest government hospital providing treatment for opportunistic
infections and ART, as directed by NACO. Further, upon such referral, XXYYZZ shall forthwith forward
a copy of all medical records of the patients to such hospital and to NACO or a person designated by
NACO to receive such medical records. Thereupon, NACO will be responsible for ensuring that the
patients continue to receive the drugs.

VII. BREACH BY XXYYZZ

3) In case XXYYZZ is not able to provide services as per agreement or defaults on the provision of
this Agreement or declines the patients to provide medication or directly or indirectly makes
any charges for the treatment of opportunistic infections or ART or otherwise enters into any
malpractices, it shall be liable for breach of agreement and breach of trust and other consequences
which may include black listing with NACO, MOHFW, Ministry of Home affairs and External Affairs.
This action shall also be intimated to their parent/ International NGO also for necessary action by
them.
4) If XXYYZZ is found to have made any charges for the treatment which was to be given free of charge
under this Agreement or to have not provided the medicines to the named patients or to have
otherwise misappropriated the funds or goods released by NACO to XXYYZZ, then without prejudice
to any other right or consequence or mode of recovery, NACO may recover the amount thereof from
XXYYZZ and/or its office bearers as arrears of land revenue.

VIII. SETTLEMENT OF DISPUTES

5. Any dispute or difference or question arising at any time between the parties hereto arising out of or
in connection with or in relation to this Agreement shall be referred to and settled by arbitration under
the provisions of the Arbitration and Conciliation Act, 1996 or any modification or replacement thereof
as applicable for the time being in India.
6. The arbitration shall be referred to an arbitrator nominated by Secretary Department of Legal Affairs,
Ministry of Law and Justice, Govt. of India Delhi. The Arbitrator may, if he so feels necessary, seek
opinion of any health care personnel with experience of working in the field of HIV and care and
treatment of PLHAs.
7. The place of arbitration shall be either New Delhi or the site of the collaborative ART project, which
shall be decided by the arbitral tribunal bearing in mind the convenience of the parties.
8. The decision of the arbitrator shall be final and binding on both the parties.

LAW APPLICABLE
This Agreement shall be construed and governed in accordance with the laws of India.

IX. ADRESSES FOR CORRESPONDENCE

In witness thereof, the parties herein have appended their respective signatures the day and the year above
stated.
 56 Operational Guidelines for ART Centers March 2008

Signed For and on behalf of XXYYZZ Signed For and on behalf of

President of India
AABBCC Director General
Director
XXYYZZ NACO
Signature .................................................................................. Signature ..................................................................................
Date ............................................................................................ Date ............................................................................................
In the presence of In the presence of

Name and Signature ........................................................... Name and Signature .............................................................

.......................................................................................................
.......................................................................................................
Date ............................................................................................
Date ............................................................................................

[In case the contract is entered into by the President through the DG, NACO, this needs to comply with the
Rules of Business laid down in this behalf.]

SCHEDULE I
MODEL LIST OF DRUGS TO BE PROVIDED BY NACO TO XXYYZZ

1. Treatment for Opportunistic Infections

TMP SMX, Acyclovir, Fluconazole, Ciprofloxacin
Amphotericin B
2. First line ART (in fixed dose combinations)
(a) Stavudine
(b) Lamivudine
(c) Nevirapine
(d) Zidovudine
(e) Efavirenz
Annexure 57

SCHEDULE II

MODEL FOR A FIVE YEAR AGREEMENT

Number of PLHAs for whose treatment
Year Centre
stock is to be provided
2006–07
2007–08
2008–09
2009–10
2010–11

Number of PLHAs for whose treatment

Year Centre
for OIs is to be provided
2006–07
2007–08
2008–09
2009–10
2010–11

MODEL FOR A THREE YEAR AGREEMENT

Number of PLHAs for whose treatment
Year Centre
stock is to be provided
2006–07
2007–08
2008–09

Number of PLHAs for whose treatment

Year Centre
OIs for is to be provided
2006–07
2007–08
2008–09

SCHEDULE III
MODEL OF DESCRIPTION OF SERVICES PROVIDED / PROPSOED TO BE PROVIDED
Address of site
Outpatient
Days Monday to Saturday
Timings 0830 am to 330 pm (As per hospital timings)
Inpatient care
Number of patients registered
Number of patients receiving ART
Average number of patients attending
OPD everyday
Criteria followed in administering ARVs WHO criteria. Attach any other criteria being followed
Treatment for OIs
First line regimen AZT/d4T+ 3TC+ NVP/EFV
Description of follow-up of patients
Facilities available
Personnel and their qualifications
 58 Operational Guidelines for ART Centers March 2008

MODEL GRIEVANCE REDRESSAL MECHANISM

[Note: This portion has been taken from the draft law on HIV/AIDS and it would be advisable for XXYYZZ to
constitute a grievance redressal mechanism at the outset.]
(a) XXYYZZ shall appoint a person of senior rank, working full time in the organisation, as the Complaints
Officer, who shall, on a day-to-day basis, deal with complaints received from an aggrieved person or
an authorised representative of such person.
(b) Every aggrieved person or an authorised representative of such person, who has a grievance against
the XXYYZZ about the services provided or refused, has the right to approach the Complaints Officer
to attend to such complaint and shall be informed of such rights by XXYYZZ.
(c) The Complaints Officer may inquire suo motu, and shall inquire, upon a complaint made by any
aggrieved person or authorised representative of such person, into the complaint.
(d) The Complaints Officer shall act in an objective and independent manner when inquiring into
complaints made.
(e) The Complaints Officer shall inquire into and decide a complaint promptly and, in any case, within
seven working days. Provided that in cases of emergency, the Complaints Officer shall decide the
complaint within one day.
(f ) The Complaints Officer, if satisfied that there has been an unfair/arbitrary refusal of services or
deficiency in the services provided, shall (i) first direct XXYYZZ to rectify the cause of the grievance,
(ii) then counsel the person alleged to have committed the act and require such person to undergo
training and social service. Upon subsequent violations by the same person, the Complaints Officer
shall recommend to XXYYZZ to, and the institution shall, initiate disciplinary action against such
person.
(g) The Complaints Officer shall inform the complainant of the action taken in relation to the complaint.
 Annexure VII

Format to assess the preparedness of an ART center

(This is one time assessment conducted prior to starting ART center in order to evaluate wheather the treatement unit is
ready for delivery of ART services)

Name of ARV Rx Unit: ______________________ Date of visit________________________________

Name of Supervisor: ______________________________________________________________________
Name of ARV Rx Unit In charge: ______________________________________________________________

Indicator Readiness status Problem identified

Organisation & Infrastructure
1) Head of the health care facility (M.S) committed to provide
Yes No
ART care and support
2) Ten member ART team identified for referrals Yes No
3) ART unit strategically located in medical OPD Yes No
Space Requirement
4) Medical Examination Rooms – 2 Nos. Yes No
5) Counseling cabins – 2 Nos. Yes No
6) Patient waiting area Yes No
7) Medical records, drug & supplies room Yes No
8) Blood and specimen collection room Yes No
Human Resources
9) Medical Officer in-charge ART center in place Yes No
10) Ten member ART team for referrals trained Yes No
11) Trained lab. personnel (microbiologists & bio-chemists)
Yes No
available in the health care facility
12) ART counselor recruited Yes No
13) ART counselor trained Yes No
14) ART record keeper recruited Yes No
15) ART record keeper trained Yes No
16) ART Pharmacist available Yes No
 60 Operational Guidelines for ART Centers March 2008

Indicator Readiness status Problem identified

Availability of Drugs
17) Adequate stock of first line drugs available Yes No
18) Adequate drugs for opportunistic infections available Yes No
Partnerships
19) PLHA networks contacted and involved Yes No
20) NGOs contacted and involved Yes No
21) Private providers contacted and involved Yes No
22) Other support groups contacted and involved Yes No
Documents Available
23) NACO registers, monthly report and cohort report format
Yes No
available
24) Adequate recording / reporting forms available Yes No
25) National ART guidelines Yes No
26) National guidelines on OIs, CD4 testing, and HIV testing Yes No
27) National guidelines on counseling (adherence) Yes No
Laboratory Services Available
28) Microbiology Lab with adequate space and technical
Yes No
expertise to perform following tests
29) HIV testing Yes No
30) Laboratory diagnosis of OIs, STIs Yes No
31) Enumeration of CD4 cells Yes No
32) Monitoring of patient on ART (viral load)? Yes No
33) Biochemistry and haematology labs with adequate space
Yes No
and technical expertise to perform the following tests
34) CBC and other routines biochemistry investigations Yes No
35) LFT Yes No
36) Blood sugar Yes No
37) Lipid profile Yes No
38) S. Creatinine Yes No
39) S. Lactate Yes No
40) S. Lipase Yes No
41) Pregnancy test Yes No

Overall Preparedness Recommended for starting service delivery Not recommended

Problems Suggested follow-up actions

1.
2.

Signature of the appraisal team leaderOther Comments _________________________________________________

Annexure 61

Format for subsequent supervisory visits to ART center

(This checklist is to be used by the designated supervisory team in conjunction with the ARV treatment unit staff during their
visit to an ART center. The aim is to see the quality of services offered, their conformity to national guidelines, to identify
problems and take corrective actions. Each ART center in the State should be visited at least once a year by identified team
from other state)

Name of ARV Rx Unit: ______________________ Date of visit________________________________

Name of Supervisor: ______________________________________________________________________
Name of ARV Rx Unit In charge: _____________________________________________________________

I Discuss with key leadership and staff

1) Is there high commitment to the national ART programme: this will be indicated by no of
Yes No
individuals accessing ART?
2) Are the ART services well organised: will be indicated by the channel of movement of the
Yes No
patient to access services as required (clinical, lab, drugs, counseling).
3) Is the ARV unit staffed as per the NACO guidelines? Yes No
4) Is there adequate co-ordination of the ART unit with other intake departments of the
Yes No
hospital to maximise uptake of patients?
5) Has the institution made adequate efforts to build partnerships with NGOs, PLWHAs,
Yes No
community based organisations & other support groups?
6) Has sensitisation of all the hospital staff been carried out? Yes No
7) Has the sensitisation of private doctors been carried out? Yes No
II Review records
8) Are the NACO specified patient and programme monitoring records being maintained (
Yes No
Pre ART, ART Enrollment, Drug Stock, Drug Dispensing, Patient Treatment record)?
9) Is confidentiality of records maintained? Yes No
10) Are the eligibility criteria for initiating ARVs being followed? Yes No
11) Are the patient treatment records up to date?? Yes No
12) Are the entries on patient treatment card correct and legible? Yes No
13) Are the national guidelines for ART being followed? Yes No
14) Is adherence issue being given due importance (adherence counseling)? Yes No
15) Has an internal SOP for the functioning of the ART center been developed?(specifies roles
Yes No
and responsibilities, patient flow, etc)
III Observe drug stocks
16) Is the drug stock register up to date? Yes No
17) Are there adequate drugs for the next 3 months(stock position)? Yes No
18) Are the drugs stored as per the specifications? Yes No
19) Is the “First In First Out” principle followed? Yes No
20) Were there any drug stock-out situations in the past year? Yes No
21) Are there adequate measures in place to prevent pilferage? Yes No
IV Laboratory Services Availability
22) Microbiology Lab with adequate space and technical expertise to perform the following
Yes No
tests
23) HIV testing Yes No
24) Laboratory diagnosis of OIs, STIs Yes No
 62 Operational Guidelines for ART Centers March 2008

25) Enumeration of CD4 cells Yes No

26) Monitoring of patient on ART (viral load)? Yes No
27) Biochemistry and hematology labs with adequate space and technical expertise to
Yes No
perform the following tests
28) CBC and other routines biochemistry investigations Yes No
29) LFT Yes No
30) Blood sugar Yes No
31) Lipid profile Yes No
32) S. Creatinine Yes No
33) S. Lactate Yes No
34) S. Lipase Yes No
35) Pregnancy test Yes No
IV Carry out exit interview (circle appropriate response)
36) How many patients are satisfied with staff ’s attitude towards them? 01 2 3 4 5
37) How many know that ARV treatment is life-long? 01 2 3 4 5
38) How many know the importance of taking medicines regularly and on time? 01 2 3 4 5
39) How many brought the empty blister packet back from the previous month? 01 2 3 4 5
40) How many know the importance of practicing safe sex even while on ART? 01 2 3 4 5

Other Comments__________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
Annexure 63

II Review records at the center

Step by Step Instructions for Supervisory Visits

This section will help supervisors assess the functioning of the recording and reporting system
1) Ask the ART center in charge to show you the 4 NACO ART Registers
2) Check that the all 4 registers are completed and up to date (see date of last entry)
3) Check where the Patient Treatment Record (white 3 page fold out) is stored
4) Take a random patient treatment record and check for last entry of patient follow-up visit (section 11)
5) Ask the ART in charge to show you where this patient’s information is recorded in the ART Enrollment
register
6) Compare the patient information (CD4 count, Clinical stage, weight, functional status) in the patient
treatment record (section 11: 3, 4 & section 12) with the ART enrollment register column 10, 11, 12) for
6, 12, 24 month visits if applicable
7) Compare other variables such as adherence, etc
8) Repeat this exercise for a second or third patient
9) Ask the ART In charge to show you the last monthly ART center report
10) Make sure that all sections in the monthly report format have been completed.
11) Compare the total number of patients ever started on ART (8.4 in the monthly report) with the number
in the enrollment register
12) Compare the cumulative number of deaths in the monthly report (9.1) and count the number of
deaths recorded in the ART enrollment register (section 18) (this may not be possible for ART centers
with more than 500 patients)
13) Compare the cumulative number of patients Lost to Follow-up (LFU) in the monthly report (9.4) and
count the number of LFU in the ART enrollment register (section 18)
14) Take a look at the DOTS and ART treatment rate in the monthly report (section 9.7). Discuss treatment
issues with the ART center in charge
15) Take a look at the treatment adherence rate in the monthly report (section 10). Discuss issues of
adherence with the ART center in charge and the counselors.
16) Take a look at the number of patients on other regimens (or second line) in the monthly report (Section
11) Discuss with the ART center in charge.
17) Check for Drug stock outs reported in the monthly report and the action taken (Section 12)
18) Check the involvement of NGOs. Discuss issues with the ART center in charge.

IV Patient Interview at the center

ART Patient Satisfaction Form (new patients)
This question form is undertaken to evaluate the quality of services provided of the ART Center. Your honest
comments would help us to improve the quality of care and support we provide. Kindly read each statement
carefully and be frank about your opinion. The information provided by you will be kept confidential. Do not
mention your name on this form and fill it up in private.
Name of the ART Center:
1) I had no problem locating the ART center in the hospital/institution. Y/N
2) There was place for me to sit while I was waiting Y/N
 64 Operational Guidelines for ART Centers March 2008

3) I felt comfortable while talking to the staff. Y/N

4) ART Counselor was attentive and listened to my problem Y/N
5) ART center staff explained to me about AIDS treatment Y/N
a. AIDS has no cure Y/N
b. Treatment is life long Y/N
c. Treatment has side effects Y/N
d. Adherence to treatment is crucial Y/N
e. Practicing safe sex while on treatment is important Y/N
6) I felt that other health concerns were taken care off. Y/N
7) I felt comfortable asking questions to the ART center staff. Y/N
8) I feel ART center staff treated me with respect was supportive and helpful. Y/N
9) I felt that my personal information was kept confidential. Y/N
10) I understood everything that I was told. Y/N
11) I plan to visit the ART Center again. Y/N
12) I intend to tell others about the ART Center. Y/N
13) My overall experience in the ART Center was good / ok / bad

Old patients:
14) I have missed 10% - 20% - 30% of my appointments
15) I have problems with side effects Y/N
16) I brought my empty blister package in this visit Y/N

Any other comments.

_______________________________________________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________

_______________________________________________________________________________________
Annexure 65

Summary Recommendations of Supervisory Visit

(This report should be prepared in consultation with the ARV Rx unit in charge)
Name of ARV Rx Unit: ______________________________ Date of Visit ____________________________

Name of Supervisor: _______________________________________________________________________

Name of ARV Rx Unit In charge: ______________________________________________________________

Problem Identified Recommendations Responsible Person

A. Commitment

B. Organisation of services

C. Uptake

D. Treatment and Follow-up

including adherence issues

E. Drugs and Logistics

F. Record Maintenance

G. Others

Signatures of the team members along with the ART center in charge ______________________________