PREVENTION OF

MOTHER-TO-CHILD TRANSMISSION
OF HIV

PART 1
PROTOCOL

April 2011
 Prevention of
mother-to-child transmission
of HIV

Part 1
PROTOCOL

APRIL 2011
 © Médecins Sans Frontières – April 2011
All rights reserved for all countries. No reproduction, translation and adaptation may be done
without the prior permission of the Copyright owner.
 Prevention of mother-to-child
transmission of HIV

Part 1
PROTOCOL

Authors:
MSF International AIDS Working Group

Design and layout: Evelyne Laissu

Table of contents

Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
HIV testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Clinical staging and determination of CD4 count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Preparation and counselling of the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

PMTCT antiretroviral protocols – HIV-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

A. Women already on HAART when getting pregnant, or planning a pregnancy . . . 19
B. HAART for HIV-infected pregnant women who need treatment for
their own health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
C. ARV prophylaxis for HIV infected women who do not need immediate
treatment for their own health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
D. Special situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

PMTCT antiretroviral protocols – HIV-2 or HIV-1 & 2 co-infection . . . . . . . . . . . . . . . 31

A. Pregnant women in need of HAART for their own health . . . . . . . . . . . . . . . . . . 33
B. Pregnant women not in need of HAART for their own health . . . . . . . . . . . . . . . 34

Annexes
1. Dosage of NVP, AZT and Cotrimoxazole. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2. Early Infant Diagnosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
3. Standard Of Procedures Collection, storage and transportation of
DBS samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4. Algorithm for the clinical management of infants with discordant
PCR results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5. Nutritional support in PMTCT programmes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6. WHO Growth Charts – Weight/Age and Head Circumference
(Boys and Girls) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7. Therapeutic Education and Counselling in PMTCT Services . . . . . . . . . . . . . . . . 47
8. Suggested Follow up for HIV Exposed Infants. . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
9. Intra-partum procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
10. Family planning and PLWHA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

5
 Acronyms

Acronyms

• PMTCT: Prevention of Mother to Child Transmission (of HIV)

• HAART: Highly Active Antiretroviral Therapy = Triple therapy
• ARV: Antiretroviral
• MCH: Mother and Child Health
• NVP: Nevirapine
• Sd-NVP: Single dose Nevirapine
• EFV: Efavirenz
• NNRTI: Non-Nucleoside Reverse Transcriptase Inhibitors
• AZT: Zidovudine
• PI: Protease Inhibitor
• TDF: Tenofovir
• d4T: Stavudine
• 3TC: Lamivudine
• FTC: Emtricitabine
• VL: Viral load
• RDT: Rapid Diagnostic Test
• ABC: Abacavir
• Lop/r: Lopinavir/ritonavir
• PCR: Polymerase Chain Reaction
• DBS: Dried Blood Spot
• RUSF: Ready-to Use Supplementary Food

7
Introduction

HIV testing 13

Clinical staging and determination of CD4 count 14

Preparation and counselling of the patient 15

 Introduction

Introduction

An estimated 370 000 children under age 15 became infected with HIV in 20091. More
than 90% of children are infected through Mother to Child Transmission (MTCT).
Without intervention, the risk of transmission is 15-30% in non breastfeeding
populations. Breastfeeding by an infected mother adds an additional 5-20% risk for an
overall transmission rate of 20-45%.
In resource limited settings, without combined triple antiretroviral therapy (HAART)
treatment, 50% of HIV infected children die before the age of two.
The annual number of new HIV infections among children worldwide has declined
since 2002, as services to prevent mother-to-child transmission have expanded2.
In developed countries, lifelong HAART if indicated for the woman’s health, or
short–term provision of HAART during pregnancy and labour, associated with
abstinence from breastfeeding, have reduced HIV transmission to < 1 %. The systematic
implementation of these protocols has made pediatric infection an increasingly rare
problem.
In resource-limited settings, the current recommendations refer to two key approaches:
– Lifelong HAART for HIV-positive women in need of treatment
– Prophylaxis, or the short-term provision of HAART, to prevent HIV transmission
from mother to child
This provides the basis for:
– Earlier HAART for a larger group of HIV-positive pregnant women to benefit both
the health of the mother and prevent transmission to her child during pregnancy
– Longer provision of antiretroviral (ARV) prophylaxis for HIV-positive pregnant
women with relatively strong immune systems who do not need HAART for their
own health. This reduces the risk of HIV transmission from mother to child
– Provision of ARVs to the mother OR child to reduce the transmission during the
breastfeeding period.
In resource-limited settings, these recommendations make it possible to reduce mother
to child HIV transmission to less than 5%.
However the implementation of such recommendations faces several challenges:
– The majority of the women attending antenatal services are still unaware of their HIV
status;
– When testing is available, only a part of those found to be infected are ready to
disclose their status to their partner or relatives making it possibly more difficult for
them to adhere to ARVs;
– Many women attend antenatal services only once or twice during their pregnancies
and/or do not deliver in health facilities making the implementation of PMTCT
protocols difficult;
– Despite their relative simplicity, short course protocols may be difficult to implement
in weak health services. Mother and child health (MCH) services faced with a lack of
human resources or of adequate infrastructure, with poor working conditions for
professional staff etc, may face the greatest difficulties in introducing them on a large
scale;

1 UNAIDS report 2010

2 UNAIDS report 2008

11
Introduction

– The early identification in MCH services of infected pregnant women needing

HAART for their own health and the timely initiation of ART have proved difficult in
many settings;
– Referral of mainly asymptomatic pregnant women to HIV clinics usually results in
high rates of drop-out;
– The administration of Sd-NVP induces the emergence of resistant strains of the virus
in the mother although much reduced by the administration of a 7 days bi-therapy
(tail protection) afterwards. This may compromise the future virological success of a
NVP (and EFV) containing HAART regimen in the mother. The same holds true for
Sd-NVP in the infant;
– The administration of NVP syrup to the infant for weeks or months, or exposure to
maternal NNRTI’s will compromise the future virological success of a NVP (and
EFV) containing HAART in the few infected infants;
– Non suppressive levels of ARV drugs in breast milk might lead to acquired resistance
in the breastfed infant.

This document - Part 1 of the PMTCT Guideline Document - is mainly concerned with
the interventions to reduce transmission from the HIV infected mother to her child but
will also address the clinical management of HIV exposed infants including early infant
diagnosis. It is to be recalled that the prevention of unwanted pregnancies in HIV
positive women is also integrally part of the PMTCT strategies.
This document is meant to provide practical guidance to the teams in the field. As such
it does not propose all the possible alternatives for the mother, or infant prophylaxis.
Rather, it proposes the preferred choices, in consideration of:
- the usual contexts where MSF works
- the need to avoid complex protocols

This document can either be used as a ‘stand alone’ module or together with the
document’s second module: “Part 2 - Implementation Support”.

For more information, refer to the WHO PMTCT guideline in the MSF library or online
at http://www.who.int/hiv/pub/mtct/antiretroviral2010/en/index.html

12
 Introduction

HIV testing

All pregnant women of unknown HIV status should be offered HIV testing at their first
antenatal visit. Women who test negative early in pregnancy should be retested in the
third trimester as women who seroconvert during pregnancy are at especially high risk
of transmitting the virus to their infant.

Midwives and nurses in ANC services should be trained for HIV pre and post test
counselling. Depending on the set up, they could/should also be trained to perform the
HIV tests themselves. They should be trained to correctly stage HIV pregnant women
and be able to request and interpret CD4 count to inform the choice of the PMTCT
regimen.

13
Introduction

Clinical staging and determination of

CD4 count

All HIV positive pregnant women should have their clinical and immunological status
assessed as soon as possible after the HIV diagnosis or at the first contact with antenatal
services for women who know their status already. The main objective is to identify the
women who need HAART for their own health and to start treatment rapidly as this:
– is beneficial for the health of the women.
– allows enough time to reach undetectable viral load before the high risk period of
mother to child transmission (late pregnancy, labour, delivery and immediate post-
partum) and therefore reduces very significantly the risk of transmission.
– decreases the mortality also in un-infected infants by its impact on the survival of the
mother.
As for any adult an HIV+ pregnant woman needs HAART for her own health when:
• WHO Stage 3 or 4 regardless of CD4 count
• WHO Stage 1 or 2 if CD4 < 350/mm3

Table 1: if the CD4 count is not immediately available to guide the protocol

Initiate HAART as soon as possible, regardless of CD4 , and

Women in Stage 3 or 4
continue for life

If option A in Start AZT. Adapt regimen if necessary once

the project: CD4 result is known
Women in Stage 1 or 2
If option B in Start HAART for all women regardless of
the project: CD4

Pregnant women with low CD4 and high viral load are at high risk of transmitting the
virus to their baby. At program level, a strategy that ensures early HAART initiation for
them has a very significant impact on the rate of transmission.
Conversely, pregnant women not in need of HAART for their own health present a
much lower risk of intrauterine and peripartum HIV transmission. ART prophylaxis to
the pregnant woman and the infant is sufficient to achieve a low rate of transmission3.
Access to CD4 count is also important for cessation of HAART postpartum in woman
not in need of it for their own health.
For further information on how to organise the pre and post test counselling, the
testing, and the CD4 measurement, refer to Part 2 – Implementation Support.

3 Kesho Bora study

14
 Introduction

Preparation and counselling of the patient

Whatever the ARV regimen chosen, the pregnant woman has to be prepared and
counselled: refer to annex 7 and/or to the MSF HIV adult guideline4. This process has to
start as soon as the HIV status of the mother is known, and it must be “fast- tracked” since
starting an intervention in HIV infected pregnant women can be considered an ‘emergency’
especially for those who present in the 3rd trimester.

4 Recommendation integration HIV care and treatment, November 2007, AWG. Under revision.

15
PMTCT antiretroviral
protocols
HIV-1

A. Women already on HAART when getting pregnant,

or planning a pregnancy 19

B. HAART for HIV-infected pregnant women

who need treatment for their own health 21

C. ARV prophylaxis for HIV infected women

who do not need immediate treatment for their own health 24

D. Special situations 28
 PMCT antiretroviral protocols – HIV-1

A. Women already on HAART when

getting pregnant, or planning a pregnancy

Table 2: Women already on HAART when getting pregnant or planning a pregnancy

Post partum
Pregnancy Labour & Delivery
Mother Infant

Continue HAART
Replace EFV by Irrespective of
NVP or a PI if a feeding options
pregnancy is Continue HAART Continue HAART
Daily NVP from
planned or is within birth to 6 weeks*
the first 28 days of
gestation

*WHO also gives the option of AZT BD for 6 weeks. However, NVP has several advantages: it allows a
uniform protocol to be applied for all infants, administration is once daily, it has been shown to be
efficacious in reducing the risk of HIV transmission to breastfed infants, and it avoids the risk of anaemia
associated with AZT.

Specific considerations
For women on an EFV containing regimen
– If the woman is diagnosed as pregnant after 28 days of gestation, EFV can be
continued5.
– If a pregnancy is recognized before 28 days of gestation, or if a pregnancy is planned,
EFV should be stopped and substituted with NVP or a PI.
– NVP should immediately start at 200 mg twice a day (no leading dose)6.
• Monitor the risk of hepatic toxicity: ask/look for symptoms of hepatotoxicity
(nausea, vomiting, fatigue, abdominal pain, loss of appetite, jaundice, loss of
weight) at each contact; and if feasible monitor ALAT according to the following
schedule: at baseline, D15, M1, M2, M3.7
• If NVP is started when the CD4 is > 350, ALAT monitoring is mandatory.
– There is no indication for abortion in women exposed to EFV in the first trimester of
pregnancy.

5 Since the neural tube closes at approximatively 28 days of gestation, fetal exposure to EFV during the risk period
for neural tube defects will have occurred before the recognition of pregnancy in the vast majority of women
(WHO-2010).
6 Winston, AIDS 2004
7 Recent data suggests that pregnancy itself, more than ART use, could be associated with hepatotoxicity.AIDS 2009.
Ouyang et al. Increased risk of hepatotoxicity in HIV pregnant women.

19
PMCT antiretroviral protocols – HIV-1

For women on a NVP containing regimen

– Continue the same regimen regardless of CD4 count; closely monitor the risk of
hepatic toxicity8.

For women on a TDF containing regimen

– Continue the treatment. TDF is thought to be safe in pregnancy although more data
on fetal bone toxicity are awaited. Monitor creatinine clearance as for any adult under
this ARV9.

For women on a d4T regimen

– Substitute d4T for AZT, if Hb > 7.5 g/dl.

For women on second line regimen

– Continue the treatment.

8 Recent data suggests that pregnancy itself, more than ART use, could be associated with hepatotoxicity.AIDS 2009.
Ouyang et al. Increased risk of hepatotoxicity in HIV pregnant women.
9 Ref: TDF monitoring: AWG recommendations 2010

20
 PMCT antiretroviral protocols – HIV-1

B. HAART for HIV-infected pregnant

women who need treatment for their own
health

The HAART regimens will be chosen according to the preferred first line regimen
for adults and adolescents in the country.

In HIV infected pregnant women, initiation of HAART for their own health is
recommended if CD4 count < 350 cells/mm3, irrespective of WHO clinical staging10;
and for all HIV-infected pregnant women in WHO clinical stage 3 or 4, irrespective of
CD4 cell count.

Table 3: Women in need of HAART for their own health

Post partum
Pregnancy Labour & Delivery
Mother Infant

Start HAART as Irrespective of

early as possible feeding options
Do not use EFV in Continue HAART Continue HAART
Daily NVP from
the first 28 days of birth to 6 weeks*
gestation

* WHO also gives the option of AZT BD for 6 weeks. However, NVP has several advantages: it allows a
uniform protocol to be applied for all infants, administration is once daily, it has been shown to be
efficacious in reducing the risk of HIV transmission to breastfed infants, and it avoids the risk of anaemia
associated with AZT.

During pregnancy
– Pregnant women should start HAART irrespective of gestational age and continue
throughout pregnancy, delivery and thereafter.
– The preferred first-line regimen should include an [AZT/3TC]11 or [TDF/3TC (or
FTC)] backbone depending on the national protocol used for non pregnant adults in
the country:
[AZT/3TC/NVP]12
Or [TDF/3TC (or FTC)/EFV]13. This last regimen has the convenience of
being a fixed dose combination (FDC) of one pill/day.

10 Considering the uncertain prognostic value of WHO clinical stage and some modelling and observational data
suggesting that more than 50% of HIV-infected patients with clinical stage 2 have a CD4 count of <350 cells/mm3,
the WHO panel recommended all pregnant women infected with HIV should have access to CD4 testing. Strong
recommendation.
11 Most studies were done with AZT/3TC. But WHO considers TDF/3TC (or FTC) as an alternative option.
12 Start NVP by a leading dose. See HIV adult and adolescent guidelines.
13 EFV should not be started during the first 28 days of gestation. TDF is thought to be safe in pregnancy although
more data on fetal bone toxicity are awaited.

21
PMCT antiretroviral protocols – HIV-1

Possible alternative regimens

[AZT/3TC]+ EFV
[TDF/3TC (or FTC)] + NVP
Other alternative regimens such as triple NRTI combination (only if the CD4 count is
> 200/mm3) or a PI containing regimen can be considered if one of the recommended
antiretroviral regimens is not indicated or not available.

Specific considerations
– Women starting an AZT containing regimen
Check anaemia clinically and at subsequent visits during the first 12 weeks
(laboratory monitoring if feasible at baseline, M1, M2, M3).
If Hb < 7.5 g/dl at baseline or during monitoring, choose/switch to [TDF/3TC (or
FTC)/EFV] and investigate/treat anemia.
– Women starting a NVP containing regimen with 250 CD4 < 350 ≤
Monitor the risk of hepatic toxicity: ask/look for symptoms of hepatotoxicity
(nausea, vomiting, fatigue, abdominal pain, loss of appetite, jaundice, loss of weight)
at each contact; if possible monitor ALAT according to the following schedule: at
baseline, D15, M1, M2, M3.
– Women in stage 3 or 4 starting HAART with CD4 > 350 (rare)
Choose a non NVP containing regimen, [TDF/3TC (or FTC)/EFV] is then the most
convenient.
– Women starting a TDF containing regimen
Monitor creatinin clearance14.
– Woman co-infected with TB
Choose an EFV-based ART regimen: [AZT/3TC] + EFV 15 or [TDF/3TC (or
FTC)/EFV15. [AZT/3TC/ABC] can be an option if HAART and TB treatment have to
be started very early in pregnancy (< 28 days) but will preferably be switched to an
EFV containing regimen after the first trimester of pregnancy. For women not able to
tolerate EFV, due to neuro-psychiatric disorders, a NVP based regimen or a triple
NRTI regimen can be used. In the presence of rifampicin, no NVP leading dose is
required.
– Woman co-infected with chronic hepatitis B
Choose [TDF/3TC (or FTC)/EFV], preferably after the first trimester of pregnancy.
Monitor ALAT as per the HBV-HIV co-infection recommendations15 16.

14 Ref: TDF monitoring: AWG recommendations 2010

15 EFV should not be started during the first 28 days of gestation. TDF is safe in pregnancy.
16 Co-infected patients are at higher risk of developing drug-induced (severe) hepatitis on ART. Baseline and
monitoring of liver function (ALAT) after initiation of ART is recommended when feasible (D0, D15, M1, M2,
M3, M6 and then every 6 months). If significant abnormalities occur then follow suggested hepatitis toxicity
algorithm adult guidelines. See hepatitis B and HIV co-infection, MSF-AWG recommendations 2009.

22
 PMCT antiretroviral protocols – HIV-1

– If the woman has been exposed to a PMTCT regimen with a Sd-NVP (+/- AZT)
without provision of a tail17 at stop of prophylaxis18
• Within the last 12 months,
Choose a PI containing regimen. An NNRTI containing regimen can be proposed if
a VL at 6 month can be done to confirm HAART efficacy.
• More than 12 months ago
Choose an NNRTI containing regimen
If available, check VL at 6 months and if VL is repeatedly > 5000 copies/ml in spite
of good adherence to treatment, switch to a second line PI regimen19.

During post partum

– If the woman is under an EFV containing regimen, propose birth control or substitute
EFV for NVP without a leading dose before resumption of menses.

17 A tail is the provision of 2 NRTIs, typically [AZT/3TC] for a minimum of 7 days following Sd-NVP or the
cessation of any NNRTI-based regimen with the objective of minimizing NNRTI resistance.
18 The provision of a tail prophylaxis decreases the rate of NVP resistance (0-7% at 2-6 weeks post partum): WHO
PMTCT guideline-2010.
19 Ref: WHO antiretroviral therapy for HIV infection in adults and adolescents, 2010.

23
PMCT antiretroviral protocols – HIV-1

C. ARV prophylaxis for HIV infected

women who do not need immediate
treatment for their own health

– All HIV-infected pregnant women who are not in need of HAART for their own
health20 require an effective ARV prophylaxis strategy to prevent HIV transmission to
the infant. ARV prophylaxis should be started from as early as 14 weeks gestation
(beginning of second trimester) or as soon as possible when women present later in
pregnancy, in labour or at delivery.
– There are 2 options (A and B) which seem to be of equal efficacy in reducing HIV
transmission to the infant21. They mainly differ by the choice of protocol to cover the
breastfeeding period and will depend on national recommendations and/or the
feasibility within a given context.

Table 4: Issues relating to choice of infant versus maternal postnatal

antiretroviral prophylaxis for preventing breast milk HIV transmission for women
with CD4 >350 cells/mm3 and clinical stage 1 or 2,
who do not require treatment for their own health22

Infant Antiretroviral Maternal Triple Antiretroviral

Factor Prophylaxis Prophylaxis
(part of Option A Protocol) (part of Option B Protocol)
Comparative Similar effectiveness of infant ARV prophylaxis to maternal triple ARV
Efficacy prophylaxis for prevention of in utero infection in women with high CD4
count (Kesho Bora trial in women with CD4 200-500, transmission at birth
2.2% with AZT/single-dose NVP regimen vs 1.8% with maternal triple drug
regimen).
No study with adequate power to provide comparative efficacy of infant vs
maternal postnatal prophylaxis in women with CD4 >350, although
available data suggest at minimum similar efficacy.

Cost Inexpensive More expensive

Pregnancy No indication of adverse effect Potential increase in preterm delivery or

outcome safety on pregnancy outcome. low birth weight with maternal triple drug
regimen seen in some studies in resource-
limited and resource-rich countries.

20 In places where no CD4 is available, women in stage 1 and 2 will not be considered as in immediate need of
HAART for their own health.
21 Although these 2 options have never been compared in a clinical trial.
22 Ref: With the courtesy of Lynne Mofenson

24
 PMCT antiretroviral protocols – HIV-1

Infant Antiretroviral Maternal Triple Antiretroviral

Factor Prophylaxis Prophylaxis
(part of Option A Protocol) (part of Option B Protocol)

Maternal safety Use of intrapartum single-dose May be higher rates of hematologic

NVP can be associated with toxicity.
NVP resistance in mother, hence Impact on maternal health of interruption
need for AZT/3TC (or other of drugs after prolonged use during
drug) “tail” to limit resistance. pregnancy and breastfeeding and of
repeated courses with subsequent
pregnancies is a concern.
No maternal drugs postpartum No data on prophylaxis extended past 6
month.

Infant safety Up to 6 months of daily NVP Infant exposed to subtherapeutic levels of

prophylaxis is safe; no data on antiretroviral drugs in maternal milk,
more prolonged prophylaxis although BAN trials suggests similar
yet. safety between infant and maternal
prophylaxis.

Resistance If infant is receiving prophylaxis If mother is receiving triple drug during

during breastfeeding and breastfeeding and infant becomes
becomes infected, drug infected, drug resistance likely.
resistance likely.

Choice of drug Extended prophylaxis with More complicated: NVP hepatotoxicity a

infant NVP as effective as concern; in resource-rich countries,
NVP/AZT (PEPI-Malawi study). protease inhibitor-based regimens used
for prophylaxis; use of EFV for prolonged
periods postpartum a concern regarding
risk for teratogenicity should woman
become pregnant again.

Complexity Use of AZT/single-dose NVP Use of single regimen during pregnancy

and “tail” is more complex. and postpartum may be easier to
implement.

Need to assess CD4 count prior to initiation CD4 count prior to initiation important as
mother for important to determine which maternal drugs are stopped after infection
treatment need women require treatment for risk ceases (would not stop drugs if
(e.g., do CD4 own health. CD4 count could be maternal CD4 <350).
count) obtained and antepartum AZT Regimen likely to be different for women
(or postnatal NVP) initiated with CD4>350 where NVP cannot be
while waiting for result; women safely used.
with CD4 <350 can then be
switched to HAART for own
health which also provides
postnatal prophylaxis.

25
PMCT antiretroviral protocols – HIV-1

C-1 Option A
Table 5: Women who do not need HAART for their own health
OPTION A – MATERNAL AZT23

Post partum
Pregnancy Labour & Delivery
Mother Infant

Breastfed infant
Daily NVP from
birth until one week
SD-NVP 24 after all exposure to
AZT 300 mg BD [AZT/3TC] BD breast milk has
+ [AZT /3TC]
(from as early as for 7 days ended
300/150 mg BD
14 weeks gestation) post partum*
at onset of labour* Non-breastfed
infant
Daily NVP from
birth to 6 weeks**

* WHO recommend that Sd-NVP and AZT/3TC intrapartum and postpartum can be omitted if the
mother received > 4 weeks of AZT during pregnancy. However, due to limited evidence, and the
importance of avoiding complex protocols, it is preferable to give Sd-NVP and [AZT/3TC] during labour
and post partum to all women, regardless of AZT duration during pregnancy.
** WHO also gives the option of Sd-NVP + AZT BD for 6 weeks for non breast fed infants as part of
option A. However, NVP has several advantages: it allows a uniform protocol to be applied for all
infants, administration is once daily and it avoids the risk of anaemia associated with AZT.

Specific considerations
– Women starting AZT
AZT should be started even if the woman is seen late in pregnancy.
Check anaemia clinically and at subsequent visits during the first 12 weeks
(laboratory monitoring if feasible at baseline, M1, M2, M3).
If Hb < 7.5 g/dl at baseline or during monitoring, give maternal triple ARV
prophylaxis using [TDF/3TC (or FTC)/EFV] and investigate/treat anaemia
- Infant has moderate to severe side effects to NVP
Switch to maternal triple ARV prophylaxis

C-2 Option B
Maternal Triple ARV prophylaxis consists of HAART provided to pregnant women
starting from as early as 14 weeks of gestation until one week after all exposure to
breast milk has ended.

26
 PMCT antiretroviral protocols – HIV-1

Table 6: Women who do not need HAART for their own health
OPTION B - MATERNAL TRIPLE ARV PROPHYLAXIS

Post partum
Pregnancy Labour & Delivery
Mother Infant

Continue HAART Irrespective of

HAART
until one week after feeding options
(from as early as 14 Continue HAART
breastfeeding Daily NVP from
weeks of gestation)
cessation birth to 6 weeks*

* WHO also gives the option of AZT BD for 6 weeks. However, NVP has several advantages: it allows a
uniform protocol to be applied for all infants, administration is once daily, it has better evidence in
breastfed infants and it avoids the risk of anaemia associated with AZT.

Specific considerations
– Because of the higher risk of hepatic toxicity for pregnant women newly started on
HAART with CD4 > 350, NVP is not recommended.
- The preferred HAART regimen is a Fixed Dose Combination regimen having the
convenience of the lowest pill burden.
[TDF/3TC (or FTC)/EFV] particularly in projects where this is the first line for
adults
or [AZT/3TC/ABC]25.
- As EFV is thought to be teratogenic in the first 28 days of pregnancy, women under
this regimen should accept to use a family planning method after delivery until one
week after cessation of breastfeeding, in order to prevent a new early pregnancy
occurring under EFV exposure26.
If the mother is not willing to opt for family planning:
[AZT/3TC/ABC] is a valid and simple option (1 tab BD).
[AZT/3TC] + Lop/r is also a valid option, but its high pill burden (3 tabs BD)
and poor gastro-intestinal tolerance needs to be seriously balanced against
much simpler options.
- Check CD4 count again at cessation of breastfeeding. If CD4 > 500, these regimens
will be stopped one week after breastfeeding cessation. Otherwise, continue HAART
for life.
- When stopping the EFV containing regimens, continue the [AZT/3TC] or [TDF/3TC
(or FTC)] for one week more, to limit the risk of NNRTI resistance in the mother
(“tail” protection).
- If the infant has moderate to severe side effect to NVP, switch to AZT to complete 6
weeks.

25 [AZT/3TC/ABC] is virologically less potent, although it remains an option in non immunosuppressed pregnant
women (CD4>200). Cf Mma Bana study.
26 Birth spacing is also considered to have a positive impact on children’s health.

27
PMCT antiretroviral protocols – HIV-1

D. Special situations

D-1 Women/infants for whom an intervention can only

be started at the time of labour/delivery or within
6 weeks postpartum

All women in clinical stage 3 or 4 should start HAART as soon as possible.

For women in clinical stage 1 and 2, two options are available:

Table 7: Women/infant for whom an intervention can only be started

at the time of labour/delivery/within 6 weeks postpartum

Option B
Option A
(Maternal Triple ARV prophylaxis)
(Infant ARV prophylaxis)
(relevant only if breastfeeding)
Woman Woman
Sd-NVP + [AZT/3TC] BD HAART during labour (if applicable)/just
at onset of labour (if applicable) and for after delivery until 1 week after end of
7 days postpartum breastfeeding
Breastfed infant Breastfed infant:
Daily NVP from birth until one week after Daily NVP for 6 weeks
all exposure to breast milk has ended
Non breastfed infant
Daily NVP from birth to 6 weeks*

* WHO also gives the option of Sd-NVP + AZT BD for 6 weeks in non breastfed infants. However, NVP
has several advantages: it allows a uniform protocol to be applied for all infants, administration is once
daily and it avoids the risk of anaemia associated with AZT.

Specific considerations
– CD4 count (if available) should be obtained as soon as possible to identify women in
need of HAART for their own health, but should not delay the initiation of ART
prophylaxis. If at delivery, or soon after, the mother meets the criteria for receiving
HAART for her own health (clinical stage 3 or 4, or CD4 < 350), triple ARV therapy
for life should be started as soon as possible after delivery regardless of her feeding
choice. However the mother has to be assessed for readiness as with any other HIV
patient.
– If the infant is breastfed, he will continue NVP until the mother has received at least
6 weeks of HAART.

28
 PMCT antiretroviral protocols – HIV-1

D-2 HIV positive mothers identified post partum with

breastfeeding infants > 6 weeks of age
HIV positive women may present for the first time with an infant, having not been
through any PMTCT intervention. The management of such mothers and babies
presents particular challenges. Refer to the following flow chart for guidance.

HIV positive mother identified post partum with a breastfeeding infant

> 6 weeks of age

Mother:
Do clinical staging and CD4 count.
Start HAART asap if stage 3 or 4, or if CD4 < 350.

Child:
– > 18 months
Do RDT:
• If Positive – Child is HIV infected. Start cotrimoxazole. Assess criteria for HAART
initiation (see below).
• If Negative – Wean slowly from breast milk over 1 month (see below).
– < 18 months
Start cotrimoxazole.
Start HAART asap if criteria for ‘Presumptive diagnosis of severe HIV disease’ are met.
Do RDT:
• If positive: do PCR. DO NOT START NVP prophylaxis. Continue breastfeeding. Await PCR
result.
• If negative: see below.

Child: Child:
RDT + (> 18 months) RDT –
or or
PCR + (< 18 months) PCR –

Start children < 2 years old on Child < 12 months:

HAART* asap Give option A or B as in project
If mother started on HAART, give child 6 weeks
If over 2 years, use CD4 and clinical of NVP prophylaxis
stage as initiation criteria If option A, infant should receive NVP throughout
Continue breast feeding for as long breastfeeding
as the mother wishes
Wean slowly at 12 months
Confirm HIV positive status with Stop option A or B, 1 week after last breast milk
RDT after 18 months old exposure

*or according to national guidelines Child > 12 months

Wean slowly from breast milk over one month

FOR ALL CHILDREN

Test HIV status 6 weeks after last breast milk
exposure
Repeat RDT for final status after 18 months old

29
PMTCT antiretroviral
protocol
HIV-2
or HIV-1 & 2 co-infection

A. Pregnant women in need of HAART for their own health 33

B. Pregnant women not in need of HAART for their own health 34

HIV-2 is not sensitive to the NNRTI class (NVP or EFV).

HIV-2 is much less transmissible from mother to child than HIV-1 (0-4%).
 PMCT antiretroviral protocol – HIV-2 or HIV-1 & 2 co-infection

A. Pregnant women in need of HAART

for their own health

HIV-2 alone
==> During pregnancy, labour, delivery and post delivery
– [AZT/3TC] + Lop/r
or
– [AZT/3TC/ABC]

==> PEP for the infant

– AZT BD for 6 weeks

HIV-1 & 2 co-infection

– Refer to HIV-1 protocols

33
PMCT antiretroviral protocol – HIV-2 or HIV-1 & 2 co-infection

B. Pregnant women not in need of

HAART for their own health

HIV-2 alone
==> During pregnancy, labour and delivery
– AZT twice daily from 14 weeks of gestation (or as soon as possible thereafter) and
during labour and delivery

==> PEP for the infant

– Irrespective of the feeding option: AZT BD for 6 weeks

HIV-1 & 2 co-infection

– Refer to HIV-1 protocols

34
Annexes

1. Dosage of NVP, AZT and Cotrimoxazole 37

2. Early Infant Diagnosis 38

3. Standard Of Procedures Collection, storage and

transportation of DBS samples 41

4. Algorithm for the clinical management of infants with

discordant PCR results 42

5. Nutritional support in PMTCT programmes 43

6. WHO Growth Charts – Weight/Age and Head

Circumference (Boys and Girls) 46

7. Therapeutic Education and Counselling in PMTCT Services 47

8. Suggested Follow up for HIV Exposed Infants 51

9. Intra-partum procedures 57

10. Family planning and PLWHA 58

 Annex 1

Dosage of NVP, AZT and Cotrimoxazole

ARV syrup(s) should be started as soon as possible after birth.

Extended simplified infant NVP dosing recommendations

Infant age NVP daily dosing (OD)

Birth -6 weeks

≥
• Birth Weight < 2,500 gram 10 mg/daily (1 ml/d - OD)
• Birth Weight 2,500 gram 15 mg/daily (1.5 ml/d - OD)

≥ 6 weeks to 6 months 20 mg/daily (2 ml/d - OD)

≥ 6 to 9 months 30 mg/daily (3 ml/d – OD)
≥ 9 months to end of BF 40 mg/daily (4 ml/d – OD)

Aurobindo syrup is available in 100 & 240 ml bottles (50 mg/5 ml). Shelf live, once
open is 2 months
Boerhinger Ingelheim syrup is available in 240 ml bottle (50 mg/5 ml). Shelf life once,
open is 6 months.
It is advised to give full bottle(s) to the mother with a syringe and to ask the women to
bring back the bottle with the remaining syrup (to be later discarded following waste
management recommendations)27.

AZT infant dosing

Infant age NVP daily dosing (OD)
Birth -6 weeks

≥
• Birth Weight < 2,500 gram 10 mg/dose (1 ml) twice daily
• Birth Weight 2,500 gram 15 mg/dose (1.5 ml) twice daily

Cotrimoxazole infant dosing

Cotrimoxazole daily dosing (OD)
Infant age Infant weight
Syrup (200/40 mg per 5 ml) Tablets (100/20 mg)
6 weeks – 6 mths < 5 kg 2.5 ml/d - OD 1 tab/d - OD
6 mths – 18 mths > 5 kg 5 ml/d - OD 2 tabs/d - OD

27 For the moment, NVP and AZT are only available in syrups, for infants. Dispersible forms could become
available.

37
Annex 2

Early Infant Diagnosis

Early Diagnosis of HIV Infection in Infants and Children < 18 months by DNA-PCR

Infants and children can be infected with HIV during pregnancy, delivery or post
partum through breastfeeding. Infants infected in utero usually have already detectable
HIV viral load when tested after birth. In contrast, infants infected during or around
delivery usually have undetectable HIV viral load when tested after birth because it
takes approximately 1-2 weeks following infection for the virus to be detectable by viral
assays.

For infants and children under 18 months of age, serological antibody detection assays
are not suitable because passive transfer of maternal antibodies may lead to a false
positive result. Thus, virological assays, such as HIV DNA-PCR or HIV RNA detection
are recommended for early HIV diagnosis in infants <18 months of age. For infants
older than 18 months, an antibody detection test can be used because the maternal
antibodies have been cleared from the infant's blood.
Since neither HIV DNA- nor RNA-PCR can usually be performed in MSF laboratories,
the specimens need to be sent to an external laboratory. In this document, we focus on
DNA-PCR. For RNA-PCR, please contact your lab advisor. For HIV DNA-PCR, Dried
Blood Spots (DBS) must be sent for analysis (refer to Annex 4).

There is a high risk of cross contamination from capillary blood sampling to laboratory
testing if proper procedures are not followed.

According to WHO guidelines28, MSF recommends:

A positive HIV result obtained from virological testing of an infant or child younger
than 18 months should be confirmed by a second virological test.

• The confirmation of the initial positive result is recommended in order to reduce

errors during sampling, transportation and/or testing.
• The confirmation test should be performed in the same laboratory within 4 weeks
of collection of the first specimen. This allows follow-up on consistency of the
results and investigation on discordant results.
• Data should be collected including minimum information of age of child, results of
DBS 1 and 2 and dates of blood collection.

HIV Infant Diagnosis by DNA-PCR using Dried Blood Spot (DBS)

Initial testing (DBS1) is recommended from 6 weeks of age even if the mother/child is
breastfeeding or receiving ART. The specimen for confirmation is called DBS2 and
should be collected at a different point in time but preferably within 4 weeks of DBS1.
DBS2 should be sent to the same laboratory.

28 WHO. Early detection of HIV infection in infants and children. Guidance note on the selection of technology for
the early diagnosis of HIV in infants and children. May 2007.

38
 Annex 2

Alternative:
DBS1 and DBS2 could be collected at the same time: While DBS1 is sent for HIV
DNA-PCR analysis, DBS2 is stored at MSF project site.
If the DBS1 result is positive, DBS2 can be sent for confirmation of result.

Result Interpretation

– If DBS1 is NEGATIVE: Report the result as "HIV-negative". There is no need to

confirm a negative result with a second DBS.
– If the first result (DBS1) is POSITIVE: Start HAART as soon as possible. For
confirmation of the result, a second specimen (DBS2) must be collected, if possible
within 4 weeks.
– If the second result (DBS2) is also POSITIVE: Report final result as "HIV-positive".
– If the second result (DBS2) is negative: This is a discordant result. Refer to your
laboratory advisor to follow specific strategy.

Result DBS1 Result DBS2 Final Result

negative not applicable NEGATIVE
positive Positive POSITIVE
Discordant
positive Negative
Refer to lab advisor

If DBS1 is positive, anti-retroviral treatment should be initiated

and at the same time, DBS2 should be collected for confirmation of DBS1 result.

Notes
– Ideally, all children must be re-tested using antibody-based tests (e.g. Rapid
Diagnostic Tests) to confirm the HIV infection after 18 months29.
– In projects which do not have the capacity to do so, earlier discharge between
12-15 months may be considered if a negative HIV test is obtained and the baby has
not breastfed during the past 6 weeks.
– All infants with a positive PCR test should be confirmed by RDT at 18 months
– Please keep in mind that:
• The likelihood of a false positive result decreases when clear clinical indications of
HIV infection are present.
• The likelihood of a false negative result increases when there are clear clinical
indications of an HIV infection:
- If a child is severely immunosuppressed, HIV DNA-PCR can return negative.
This is because of the lower number of lymphocytes present in advanced stage of
disease. In case of suspicion, repeat the PCR and rely on clinical judgement.
- If a child tested negative once but has new symptoms compatible with HIV
disease, testing must be repeated (and treatment started following the 2010 MSF
Pediatric HIV Handbook on when to start treatment in infants).

29 Children remain at risk of HIV infection as long as they are breastfed.

39
Annex 2

– On each site, the lab-in-charge should monitor and report quarterly the HIV DNA-
PCR discordance percentage to the medical coordinator and to the MSF section lab
advisor.

DBS1 DBS2

Number negative = a not applicable

Discordance ratio %
Number positive = b* Number positive = c
= d/b x100
b=c+d Number negative = d

* Only for those children whose DBS2 result already returned.

For discordant results, please indicate which of the following strategies has been used
during the past quarter:
Third DNA-PCR (DBS3) in the same lab (please mention lab)
Third DNA-PCR (DBS3) in another lab in the same country (please mention lab)
Third DNA-PCR (DBS3) in reference laboratory or in Antwerp AIDS laboratory if
no reliable reference laboratory can be found in the country
Viral load
Other

It is recommended to keep track of discordant results and to liaise with the medical
department. For case management of an infant with discordant result see Annexe 4
Below an example of register for tracking discordant results

MSF section: Country: Site:

DBS 1 DBS 2
DBS 3 Comments
Child file Birth pos. neg.
number date
Date Date Date Result

40
 Annex 3

Standard Of Procedures Collection,

storage and transportation of DBS
samples

1. Equipment
– Sample collection card: Protein SaverTM 903® Card Whatman
– Drying rack
– Low gas permeable zip-lock bag
– Desiccant bags
– Humidity card: Tropack Indicator B/1
– Rip-resistant envelope

2. Method: collection and storage of DBS

a. Label card with appropriate identification number and date.
b. Apply 1 drop or 50-75 µl of whole blood to each circle, and fill the 5 circles (at least 4
circles).
c. Placing the card on the drying rack, let the card completely air dry (between 2-3
hours and overnight depending of the ambient humidity), in a clean, dust-free and
insect-free area.
d. Complete patient information in the appropriate laboratory register (identification
number, age, date of blood collection)
e. Once dry, place the card in a low gas-permeable zip-lock bag with desiccant and
humidity card. The cards are either placed individually in a zip-lock bag or placed
individually in a glassine bag and packed by 5 maximum in the zip-lock bag. Press
as much as possible the air out of the bag and seal it shut.
f. Keep packed DBS (in sealed plastic bags) in a dry place at room temperature until
transportation to the external laboratory.
g. Check the humidity cards weekly: if the card is pink (humidity > 30%) remove the
desiccant bag and store with 6 packets of new desiccant bags in the sealable bag.

3. Transportation
Place zip-lock bags containing DBS in a rip-resistant envelope with the necessary
documents.
DBS are not considered infectious material regarding international regulations. It is
possible to transport them by normal post at room temperature.

41
Annex 4

Algorithm for the clinical management of

infants with discordant PCR results

DNA PCR (DBS 1)

POS NEG

Start HAART without delay For details on the follow up of these

Baseline CD4 count and % children
Collect and send 2nd sample for viral Refer to the MSF Paediatric HIV
test: DNA PCR (DBS 2) Handbook

POS NEG

Likely true infection Discordant result

Continue HAART Record the discordant result in the register
Confirm positive status with RDT and contact your lab and medical advisor
at 18 months Collect and send a 3rd sample for viral testing
at the referral laboratory: DNA PCR (DBS 3)
Repeat CD4 count and %
Continue HAART

POS NEG

Continue HAART If child is well, CD4 count and % are normal,

Confirm positive status with RDT AND field, desk and medical advisors agree:
at 18 months HAART CAN BE STOPPED
If these criteria are not met, continue HAART
and confirm final HIV status at 18 months
with an RDT

42
 Annex 5

Nutritional support in PMTCT

programmes

1. Feeding methods
These recommendations are in line with current evidence and expert opinion. However,
the final feeding option will always remain the choice of the mother based on the
information provided to her. Her choice must be respected.

A. The Breast Fed Infant

Breastfeeding, under protection from ART, is the preferred feeding method for HIV
exposed infants in most MSF settings30.

Recommendations
Exclusive breast feeding until 6 months of age
Introduce complementary foodsa after 6 months of age
Start weaning from breast milk around 12 months of age
Wean slowly over a period of one month
Desirable programmatic choice - provide Ready to Use Supplementary Food (RUSF) or local
equivalent from start of weaning until 18 months of age
HOWEVER: If an infant is determined to be HIV-infected at any point prior to
weaning, then breast-feeding should continue without time limit.

B. The Formula Fed Infant

In MSF settings, formula feeding should be exceptional31. It is usually indicated in cases
where the mother has died or is too sick to breastfeedb.

Recommendations
Exclusive infant formula until 6 months of age
Introduce complementary foodsa after 6 months of age
Transition from formula to family food diet at 12 months of age
Desirable programmatic choice - provide Ready to Use Supplementary Food (RUSF) or local
equivalent from 12 months of age until 18 months of age

a Complementary foods should include fruits, vegetables and cereals as well as animal sourced foods
such as egg, meat or fish.
b Program responsibility extends beyond the provision of infant formula; plans must be made to assure
that the mother/care-giver has access to a fuel source, thermos for storing boiled water, cups and
spoons. Formula must be fed with a cup and spoon. Infant bottles and teats should be prohibited as
they are near impossible to keep clean.

30 Ref: Mashi study, CROI 2005

31 Ref.: HIV and infant feeding, WHO rapid advice 2009

43
Annex 5

2. Growth Monitoring

Standard rates of monthly weight gain – WHO 2006

By age Low normal Mid-range High-normal

sex-combined g/month g/month g/month
0 - 5 months 500 650 900
6 - 11 months 190 300 400
12 - 24 months 135 200 300

44
 Annex 5

Recommended Growth Monitoring and Nutrition Support

for HIV Exposed or Infected Children

AT EACH VISIT
Weigh the child and document in the file
Plot weight-for-age (W/A) on the growth chart
In young children, head circumference should also be
measured and plotted on the growth chart

W/A is > –2 Z-score W/A is < –2 Z-score

and or
Child is gaining weight Child is failing to gain
or losing weight

Child is doing well

Evaluate medically for illness
Routine nutritional education +/or opportunistic infection
Nutritional supplements may be Evaluate family social situation
given for programmatic reasons

< 6 months of age

Refer to
Therapeutic Feeding Protocol
REPEAT HIV TESTING*

> 6 months of age

Measure length and calculate
W/H index, or measure MUAC

W/H > –2 Z-score –2 > W/H ≥

–3 Z-score W/H < –3 Z-score

≥
or or or
MUAC > 125 mm 125 mm > MUAC 115 mm MUAC < 115 mm

and if < 12 months old: Supplement with a RUSF or Refer to

≤
Supplement with a RUSF local equivalent Therapeutic Feeding Protocol
or local equivalent: 12 M: 500 kcal/day
300 kcal/day > 12 M: 1000 kcal/day REPEAT HIV TESTING*

until infant reaches Supplement until W/H > –2 Z-

12 months score or MUAC > 125mm
at 2 consecutive visits
At discharge
REPEAT HIV TESTING*

*Repeat HIV testing for exposed children whose status is not already known.

45
Annex 6

WHO Growth Charts – Weight/Age and

Head Circumference (Boys and Girls)

cht_wfa_girls_z_0_5.pdf

cht_wfa_boys_z_0_5.pdf

cht_hcfa_girls_z_0_5.pdf

cht_hcfa_boys_z_0_5.pdf

46
 Annex 7

Therapeutic Education and Counselling in

PMTCT Services

Pregnant women enter PMTCT services either through a HIV program, or through
antenatal consultations. In general, women who come for antenatal visits are informed
that they can take an HIV test while they wait for their consultation. Often, this is the
first time they have ever heard of HIV. It is important to remember that a positive result
in a woman who is unprepared can result in high rate of lost to follow up.
Depending on the context, patient education/counselling sessions are done by ANC
nurses/midwifes or by counsellors. Even though women generally arrive late in their
pregnancy, it is still advisable to try to have at least 2-3 sessions with HIV infected
women before delivery. After delivery, sessions should take place at least at week 6, M3
and M6, or more often according to the needs.

HIV testing
The pre-test information
This can be given individually or in a group (no more than 12-15 persons at a time), in
the waiting room.
It should not last longer than 20 min.
If done in a group, ensure that everybody can hear.
– Give information on HIV/AIDS, modes of transmission and prevention.
– Explain the risk of HIV transmission to the child if the pregnant woman is HIV
positive.
– Explain possible ways to prevent the mother to child transmission of HIV.
– Explain the testing procedure.
– Explain that the result of the test will remain confidential.
– Explain that the woman may refuse to take the test now but will be free to take it at a
subsequent consultation.

The individual testing procedure

– Repeat that the woman has the choice to refuse the test (opt out).
– Address any fears related to testing. Insist on the benefits for the woman’s own
health.

The individual post-test session

The Post-Test session is crucial. It is meant to encourage and support a woman with
HIV infection to accept her status and the PMTCT intervention that will benefit both
her health and that of her future infant.
All sessions have two components: the first is to educate and inform the woman, and
the second is to provide her with emotional and social support.

47
Annex 7

a) Educational/Informative Component
If the test is negative:
– Explain the meaning of a negative HIV test and the importance of remaining HIV
negative.
– Re-discuss methods of prevention (already explained in the pre-test information).
– Discuss risky behaviours and the need for protection particularly during pregnancy32.
– Encourage the woman to return to take a test in 3 months or before delivery.
– Give condoms, as requested.
If the test is positive:
– Explain the positive test result and provide emotional support (see below).
– Explain that she has a good chance to stay healthy and well for a long time, and that
her child has a good chance to be HIV negative if she continues to come to the clinic
and to follow the advice given.
– Explain the risk of transmission of HIV to the child if there is no intervention.
– Explain the PMTCT intervention, focusing on ARV prophylaxis and delivery in a
medical environment (hospital or health centre).
– Explain the importance of the CD4 count measure to assess the health of the woman.
– Explain the importance of regular follow-up, before and after birth.
– If she has other children, discuss issues around their health and the possibility to test
them.

b) Emotional and Social Component

– When the result is positive, help the patient to cope with emotions arising from the
test result. It is critical to provide a message of hope and to help the woman
understand that she is not alone.
– Reaffirm the confidentiality of the results.
– Discuss if the patient can identify a person she trusts to support her (not necessarily
her partner) and help her anticipate what could be the reactions of her
relatives/friends.
– Don’t force disclosure to partner. Fear of stigma and discrimination prevents many
women from disclosing their HIV status, even to their partner. Safer sex issues will be
discussed on subsequent consultations. The woman needs time to think about these
many issues.
– Reassure the patient in explaining to her the possibilities of care for herself and her
child.
– Explain that the health staff are here to help the patient through the process of
decision making.

Individual session when ART (HAART or ARV prophylaxis) is started 33

a) Educational/Informative Component
– Assess whether the information received during the post test session was well
understood and rectify if necessary. Encourage the woman to ask for clarification, if
need be.
– Address the meaning of the results of the CD4 count (if available) and the importance
of follow up visits, whatever the regimen chosen.

32 HIV MTC transmission rates are very high if HIV infection occurs during pregnancy.
33 ART can be started at the first or subsequent consultations, depending on the pregnant woman’s understanding/
willingness.

48
 Annex 7

– Explain the importance of the ARV for the mother’s own health (if relevant34) and/or
to reduce the risk of mother to child transmission.
– Explain the importance of delivery in a medical environment (hospital or health
centre, linked to the PMTCT program) for better management.
When starting the ART for the pregnant woman:
– Explain how to take and show and name the different components of her treatment
(ARV & other drugs eg cotrimoxazole and iron). Have her repeat their individual
function and their dosing instructions.
– Explain that adherence to ARV is essential to effectively reduce the amount of virus
in the body.
– Explain that ARV may cause some side effects. Many people do not get any, and
others have mild side effects. Most people tolerate ARVs well. Serious side effects
(e.g. skin rash, or symptoms of liver toxicity) may occur at the beginning of the
treatment and need to be managed by a Health Care Provider.
– Explain the schedule for the follow up visits.

b) Emotional/Social Component
– Help the woman identify adjustments that will be introduced into her life.
– Discuss possible difficulties in following regular appointments.
– Assess if the woman has someone at home to support her and share knowledge of
her status.
– Detect and give support with regards to psychological reactions (signs of depression
or anxiety).

If PMTCT support groups exist within the clinic or the community, encourage the women to
join those groups.

Follow-up during pregnancy

a) Educational/Informative Component
– Discuss adherence to HAART or ARV Prophylaxis (eg how she takes the different
drugs, any difficulties she faces such as the need to hide to take the medicines).
– Address treatment side effects.
– Check that the woman understands the risks of abandoning treatment and reinforce
the importance of good adherence.

Last consultation before delivery

a) Reinforce the following messages
– The importance of delivery in a medical environment (hospital or health centre,
linked to the PMTCT program).
– If delivery takes place at home, the importance of taking the prescribed ARV
prophylaxis for mother and infant, and coming to the hospital/health centre with the
newborn, as soon as possible after birth.
– Explain the importance of exclusive breast-feeding until 6 months.

34 If the mother is put on HAART for life.

49
Annex 7

Start to discuss issues around the health of the future infant,

– Explain that the infant will be given ARV prophylaxis starting immediately after birth.
– Explain how to administer the right dosage and demonstrate how to use the syringe.
– Explain that several HIV tests will be proposed during infancy.
– If ever the infant turns out to be positive in spite of the intervention, he will also be
looked after in the HIV program with the woman.

b) Discuss Emotional and Social issues

After delivery
a) Educational
– Discuss adherence to HAART (mother) or ARV prophylaxis (child) as per the chosen
protocol.
– Explain how the follow up visits will be planned for both mother & infant.
– Explain exclusive breastfeeding until 6 months of age and introduction of
complementary foods thereafter.
– Explain the weaning period around 12 months of age.
– Explain the process of HIV testing for the child.
– Introduce birth control methods.

b) Discuss Emotional and Social issues

– Don’t forget to look at the relationship between the mother and her infant, above all
if the baby has been tested HIV positive.

50
 Suggested Follow up for HIV Exposed Infants
Essential visits are highlighted in BOLD
a Refer to NVP and AZT PMTCT dosing table.
b Where PCR is not available, ensure close clinical follow up of the child. Start HAART if ever the criteria for ‘Presumptive Diagnosis of Severe HIV Disease’ are
met (see MSF Paediatric HIV Handbook). Confirm HIV positive status with a rapid test (RDT) at 18 months of age.
c Appropriate feeding counselling should be done at each visit. If any growth problem is detected, refer to the nutrition algorithm for guidance on management.
d Children with immune suppression at the time EPI vaccinations, should be revaccinated once they have been on HAART for 6-12 months. See Chapter 2 of
Paediatric HIV Handbook for more details on vaccination.
e http://www.who.int/wer/2009/wer8440.pdf
f For HIV exposed children found to be BCG unvaccinated before 6 weeks of age and clinically well: give BCG.
For BCG unvaccinated children older than 6 weeks of age and < 1 year: give BCG only after confirming HIV negative status.
* If signs and symptoms of HIV: start HAART if criteria for ‘Presumptive clinical diagnosis of severe HIV disease’ are met. If positive RDT: do PCR.

OI and Malaria HIV PCRb or

Age Clinical Assessment HIV PEPa Nutritionc Vaccinationd
prophylaxis serology/CD4%
Encourage exclusive
NVP for 6 weeks breastfeeding
Weigh and plot W/A OPV0 / HepB0e
Mosquito net (preferred option)
Measure and plot HC
If formula feeding is
General physical BCGf
At birth INH if maternal N/A necessary:
examination defer if maternal
active Pulmonary TB Ensure appropriate refer to
Assess possible TB active TB
maternal ART Nutritional support in
exposure
PMTCT programmes’ for
further guidance

Post natal check

Encourage exclusive
Weigh and plot W/A Ensure Mosquito net
breastfeeding Check birth
Measure and plot HC Check adherence to
1 week N/A vaccinations were
General physical INH if maternal NVP prophylaxis
Check breast health of received
examination active Pulmonary TB
mother
Assess possible TB
exposure
Annex 8

51
52
OI and Malaria HIV PCRb or
Age Clinical Assessment HIV PEPa Nutritionc Vaccinationd
Annex 8

prophylaxis serology/CD4%

If mother on HAART:
Stop PEP except if BF
Post natal check and mother < 6 weeks on
HAART
Weigh and plot W/A In these cases: continue Encourage exclusive
Measure and plot HC NVP breastfeeding OPV 1
Start
6 weeks Assess development: Ensure maternal Do PCR DPT/HepB/Hib 1
Cotrim 2.5 ml/d
- Child looks at faces? HAART supply Check breast health of PCV 1
Do TB screening mother
If child on long PEP:
Assess for signs of HIV* Prescribe NVP

Check adherence

Give PCR results

Weigh and plot W/A If mother on HAART:
Measure and plot HC Ensure maternal
If positive:
Assess development: HAART supply
Cotrim 2.5 ml/d Start HAART without Encourage exclusive OPV 2
- Child smiles?
10 weeks delay breastfeeding DTP/HepB/Hib 2
- Child holds head steady? If child on long PEP:
Check adherence Do CD4 count and % PCV 2
Do TB screening Prescribe NVP
Collect and send 2nd
sample for PCR
Assess for signs of HIV* Check adherence
confirmation

Weigh and plot W/A If mother on HAART:

Measure and plot HC Ensure maternal
Assess development: HAART supply
Cotrim 2.5 ml/d OPV 3
- Child smiles? IF signs and symptoms of Encourage exclusive
14 weeks DTP/HepB/Hib 3
- Child holds head steady? If child on long PEP: HIV: repeat testing* breastfeeding
Check adherence PCV 3
Do TB screening Prescribe NVP

Assess for signs of HIV* Check adherence

 OI and Malaria HIV PCRb or
Age Clinical Assessment HIV PEPa Nutritionc Vaccinationd
prophylaxis serology/CD4%

Weigh and plot W/A

If mother on HAART:
Measure and plot HC
Ensure maternal
Assess development:
HAART supply
4 months - Child can grab and hold Cotrim 2.5 ml/d Check if up to date
IF signs and symptoms of Encourage exclusive
and objects?
If child on long PEP: HIV: repeat testing* breastfeeding
5 months - Child can roll over? Check adherence Complete if needed
Prescribe NVP
Do TB screening
Check adherence
Assess for signs of HIV*

Give Vit A:
If mother on HAART:
100 000 IU
Weigh and plot W/A Ensure maternal Measles Vaccine 0
Measure and plot HC HAART supply
Introduce
Assess development: Cotrim 5 ml/d Check maternal CD4 Postpone if
IF signs and symptoms of complementary foods
6 months - Child can sit alone? symptomatic or known
HIV: repeat testing* 2-3 meals/day
Do TB screening Check adherence If child on long PEP: to be severely immune
(also for formula fed infants)
Prescribe NVP suppressed
Assess for signs of HIV* (%CD4 < 25%)
Encourage continued
Check adherence
breastfeeding

If mother on HAART:
Weigh and plot W/A
Ensure maternal
Measure and plot HC
HAART supply Complementary foods
7 months Assess development: Cotrim 5 ml/d Check if up to date
IF signs and symptoms of
and - Child can sit alone?
If child on long PEP: HIV: repeat testing* Encourage continued
8 months Do TB screening Check adherence Complete if needed
Prescribe NVP breastfeeding
Assess for signs of HIV*
Check adherence
Annex 8

53
54
OI and Malaria HIV PCRb or
Age Clinical Assessment HIV PEPa Nutritionc Vaccinationd
prophylaxis serology/CD4%
Annex 8

Measles Vaccine 1
Weigh and plot W/A Repeat RDT regardless Postpone if
If mother on HAART:
Measure and plot HC of symptoms: symptomatic or known
Ensure maternal
Assess development: HAART supply Complementary foods to be severely immune
- Child can stand with Cotrim 5 ml/d If positive RDT: do PCR 3-4 meals/ day suppressed
9 months help? Start HAART if criteria (%CD4 < 25%)
If child on long PEP:
- Child can make sounds? Check adherence for ‘Presumptive Encourage continued
Prescribe NVP Yellow fever
Do TB screening clinical diagnosis of breastfeeding
severe HIV disease’ are Check national
Assess for signs of HIV * Check adherence schedule. Do not give
met
if confirmed HIV
infection

Weigh and plot W/A If mother on HAART:

Measure and plot HC Complementary foods
Ensure maternal
Assess development:
10 months - Child can stand with Cotrim 5 ml/d HAART supply Encourage continued Check if up to date
IF signs and symptoms of
and help? breastfeeding
If child on long PEP: HIV: repeat testing*
11 months - Child can make sounds? Check adherence Complete if needed
Prescribe NVP
Do TB screening Start education about
weaning at 12 months
Check adherence
Assess for signs of HIV*
BREASTFED CHILDREN not HIV infected
- Start weaning from breast milk over one month
- Give nutritional supplement (RUSF or local
equivalent) 1 month supply. Explain how to use it.
- IF signs and symptoms of HIV: delay weaning and
repeat testing* Consider
If mother on HAART:
Weigh and plot W/A BREASTFED CHILDREN with confirmed HIV infection Measles Vaccine 2
Ensure maternal
Measure and plot HC - Do not stop breastfeeding (give before 2 years
Cotrim 5ml/d HAART supply
Assess development: of age)
Recheck maternal CD4 FORMULA FED CHILDREN#
12 months - Child can walk? Check adherence
- Child can say words? - Advise mother to stop formula milk Postpone if
If child on long PEP:
Do TB screening - Give nutritional supplement (RUSF or local symptomatic or known
Replace mosquito net Prescribe NVP equivalent) 1 month supply. Explain how to use it. to be severely immune
Assess for signs of HIV* - IF signs and symptoms of HIV: repeat testing* suppressed
Check adherence (%CD4 < 25%)
# Some programs may choose to discharge formula fed
infants earlier than 18 months once HIV negative status
is confirmed
ALL CHILDREN
Give Vit A: 200 000 IU
 OI and Malaria HIV PCRb or
Age Clinical Assessment HIV PEPa Nutritionc Vaccinationd
prophylaxis serology/CD4%

If mother on HAART for

own health: Do not stop
Assess the progress of
weaning
If mother on HAART as
It should now be complete
prophylaxis:
- If new CD4 < 500, do
Weigh and plot W/A Ensure adequate weight
not stop HAART
Measure and plot HC gain
- If new CD4 > 500,
Assess development:
Cotrim 5ml/d plan to stop HAART Check if up to date
- Child can walk? IF signs and symptoms of Ensure mother
13 months 1 week after last
- Child can say words? HIV: repeat testing* understands how to give
Check adherence breast milk exposure. Complete if needed
Do TB screening RUSF or local equivalent
Explain and counsel
Give 6 week supply
mother
Assess for signs of HIV*
If child on long PEP:
MAKE NEXT
Counsel mother to stop
APPOINTMENT
giving NVP one week
IN 6 WEEKS
after last breast milk
exposure

ALL CHILDREN not HIV infected

Confirm that breast feeding has ceased AND that
last breast milk exposure was > 6 weeks ago
Weigh and plot W/A If mother on HAART for If No: continue to follow up child, and test HIV
Measure and plot HC Cotrim her own health: status 6 weeks after complete breastfeeding
Assess development: 5ml/d of syrup Provide drug supply cessation Check if up to date
14.5 - 15 - Child can walk? or tablet forms if
months - Child can say words? available For other cases: If Yes: do RDT regardless of symptoms
Complete if needed
Do TB screening Ensure ART was If RDT positive:
Check adherence successfully stopped for Do PCR
Assess for signs of HIV* mother or child Start HAART IF criteria for ‘Presumptive clinical
diagnosis of severe HIV disease’ are met
Give nutritional supply (RUSF or other) until next
visit
Annex 8

55
56
OI and Malaria HIV PCRb or
Age Clinical Assessment HIV PEPa Nutritionc Vaccinationd
Annex 8

prophylaxis serology/CD4%

If PCR result is negative and the child is well

=Continue nutritional supplements and follow up.
Repeat RDT for final status at 18 months
If PCR result is positive = enrol in HIV program and
14.5 - 15 start HAART asap
months
If RDT negative
Child is likely HIV negative
Continue nutritional supplements and follow up
Repeat RDT for final status at 18 months

Do RDT for final status

Cotrim
If positive:
5ml/d of syrup
Weigh and plot W/A Child is HIV positive.
or tablet forms if
Measure and plot HC Enrol in HIV program
available
Assess development: and start HAART asap
- Child can run?
Check adherence If mother on HAART Check if up to date
- Child can say words? If negative:
18 months for own health: Give Vit A: 200 000 IU
- Child can follow simple Child is HIV negative
Provide drug supply Complete if needed
commands?
NB: Children who
Do TB screening If any child continues to
are confirmed HIV
have exposure to breast
negative and
Assess for signs of HIV* milk, follow up should
discharged, can stop
continue, and HIV testing
Cotrim
repeated 6 weeks after all
exposure ends

Annex 8: Suggested Follow up

for HIV Exposed Infants
 Annex 9

Intra-partum procedures

Universal precautions (safe needle handling and storage, protective clothes and
eyewear etc.) need always to be well implemented in all maternity wards, for all
patients regardless of their HIV status.

During labour
– Use the partograph to monitor progress in labour as recommended for all deliveries.
Particularly in HIV positive women, prolonged labour must be avoided as the risk of
transmission increases with the length of time.
– Limit the number of cervical examinations, as lesions and infections in the birth canal
will increase the risk of transmission
– Limit time between rupture of membranes and delivery. For every additional hour of
ruptured membranes, the risk of HIV transmission to the infant increases by 2%.
• Avoid artificial rupture of membranes
• Stimulate labour according to protocol 35 when spontaneous rupture occurs, to
ensure rapid progress of labour. If the stimulation fails, proceed to c-section.

During delivery
Elective C-sections are often performed in developed countries to reduce the risk of
HIV transmission during delivery. However, performing c-sections in resource limited
settings has a higher risk of complications and post-operative infections. Furthermore,
access to c-section in future pregnancies cannot be ensured therefore the potential risk
of uterine rupture with possible maternal and fetal death must be considered. For these
reasons, elective c-section for HIV positive women is not recommended in most MSF
settings.
– Avoid invasive procedures during delivery (vacuum extraction, forceps and
episiotomy) to limit the risk of HIV transmission. However, if these measures are
necessary to save the life of the baby, they should be performed.
– Avoid routine vaginal cleansing as this has not been proven to reduce the risk of HIV
transmission. However in cases of prolonged ruptured membranes (> 4 h) it is
recommended to perform a vaginal cleansing as there may be some effect in reducing
HIV transmission.

Newborn care
As universal precautions are to be applied to any woman and newborn in the maternity
ward, there are no special measures for the HIV exposed infant. All infants should be
dried well after delivery. The places where the infant is handled (eg resuscitation table)
and the used materials must be thoroughly cleaned between each infant.

35 Obstetric in remote settings – Practical guide for non-specialized health care professionals, MSF 1st ed. 2007.

57
Annex 10

Family planning and PLWHA

Preventing unintended pregnancies among women with HIV/AIDS is one of the 4

PMTCT prongs established by WHO and one way of averting infant infections caused
by mother to child transmission. However in many resource-poor countries, there is a
high unmet need for contraceptive methods. By offering a wide variety of contraceptive
methods, including long-lasting reversible methods, in combination with proper
counseling, acceptance and uptake of family planning methods improves.

Counselling
Counselling on family planning should be initiated when a woman is first diagnosed
and continued at every contact point with the woman and/or her partner.
The counselling should include information and discussion about:
– contraceptive methods and dual protection
– the risk of HIV transmission to an uninfected partner
– the risk of acquiring secondary infections
– the risk of transmission of HIV to the infant and measures that can be taken to reduce
this risk
– information on the interaction between HIV and pregnancy and the increased
possibility of certain adverse pregnancy outcomes

Contraceptive methods and dual protection

Women living with HIV/AIDS can use most methods of contraception and should, like
all women, be presented with a variety of methods, including long lasting reversible
methods. This variety enables her to choose the most suitable method for her according
to her life circumstances.

Dual protection
Dual protection refers to simultaneous protection against both unplanned pregnancy
and STIs (including HIV/AIDS) and it is achieved by using condoms together with
another effective method of contraception. Such protection can also be achieved
through safe alternatives to penetrative sex. Dual protection is of great importance for
women living with HIV/AIDS in order to:
– protect against unintended pregnancy
– prevent infection with other STIs
– prevent re-infection with other HIV strains
– prevent transmission of HIV to an uninfected partner

Condoms
Both male and female condoms are the only methods, when used consistently and
correctly, that are highly effective in protecting against pregnancy, HIV/AIDS
(including secondary infections) and other STI’s. However, the condom is not always
used correctly and many women experience situations in which negotiation on condom

58
 Annex 10

use with their sex partner is not a real option. Therefore the best way to protect against
pregnancy is to use the condom together with another type of modern contraceptive
method - dual protection.

Hormonal methods
Women living with HIV/AIDS have the same contra-indications and restrictions for
using hormonal methods as HIV negative women. They can use all hormonal methods
(combined oral contraception, progesterone only pills, depot medroxyprogesterone
acetate etc.).
However:
– For women receiving antituberculosis therapy: Rifampicin will most likely reduce the
effectiveness of hormonal contraception (mainly the combined oral contraceptive
pill).
– For women receiving ARV therapy: Some NNRTI’s and PI’s have the potential to
either decrease or increase the effectiveness of hormonal contraceptives.
This possible drug interaction is one of the reasons why women living with HIV/AIDS
should always be advised to use a hormonal method in combination with condoms -
dual protection.

Emergency contraception
Emergency contraception will reduce the possibility of a pregnancy when used within
5 days after unprotected intercourse and can be used safely and without any
restrictions for women living with HIV/AIDS.

Copper - bearing intra uterine device

The copper-bearing intra uterine device (IUD) is a long lasting contraceptive method
that will provide at least 10 years of protection against pregnancies. The device can be
safely used by all women with HIV/AIDS who are under ARV treatment or not yet
symptomatic, but is not recommended for women with more advanced HIV infection
who are not receiving ARV therapy. The intra uterine device can stay in place when the
woman develops AIDS, however a close monitoring for pelvic inflammatory infections
(PID) will be necessary, as the reduced immunity of the woman can increase the risk of
an acquired STI to develop rapidly into PID.
The IUD is not the recommended method for women who have an increased risk of
acquiring an STI and must not be inserted when a woman has a current STI. In this case
she needs to be first treated and be symptom free before insertion of the device.
However if a woman develops an STI, while already using an IUD, the device can stay
in place and STI treatment will be initiated according to the normal protocol.

Implant

The implant is a long lasting hormonal contraceptive method and will protect against
pregnancies for a period of 3 to 5 years, depending on the model inserted. This method
can be used safely by all women with HIV/AIDS. Drug interactions might exist for
women receiving ARV therapy, but this is not a contra-indication for insertion of the
implant, since dual protection will be advised at all times.

59
Annex 10

Tubal ligation and vasectomy

Women and men who are infected with HIV, including those who have AIDS, can
safely undergo tubal ligation or vasectomy, which are surgical long-lasting irreversible
family planning methods. In cases of acute AIDS-related illness, it is recommended to
wait until the condition is improved before undergoing surgery. Particular attention is
needed for young patients or patients with mental health problems, including
depressive conditions. Health care workers should ensure that they are not pressured
or coerced to undergo the procedure and that the decision is not made in a moment of
crisis.
It must be clarified to the patients that these procedures do not protect against
acquiring STI or transmitting HIV. The importance of dual protection needs to be
emphasized.

Spermicides
Women living with HIV/AIDS should not use spermicides alone or in combination with
other barrier methods (diaphragms and cervical caps) as they will increase the
possibility of vaginal irritation and ulcerations, resulting in an increased risk of
acquiring infection with other STIs, re-infection with other HIV strains and transmitting
HIV infection to sexual partners (when not using condoms).

60
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