Overview of HIV self-testing

Overview of HIV self-testing:
Moving to implementation and impact
L. Chitembo & C. Johnson
WHO
http://www.who.int/hiv/en/
www.hivst.org
28 March 2017
WHO Meeting – Nairobi, Kenya

Outline
• Understanding the HIV testing gap
• What is HIV self-testing?
• WHO Guidelines
– Evidence summary & Recommendations
• HIVST products (ERP-D & WHO PQ)
• Implementation & Lessons learned
– Country policy development
– Implementation & lessons learned
• What’s Next? (Strategic Framework)

Understanding the
HIV testing gap

Scale-Up of HIV Testing Services in Africa
Source: WHO 2015; WHO 2016
From 2005 – 2015, there was a sharp
increase in HIV-positive diagnoses in Africa
From 2010—2014, > 600 M people received
HTS in 122 low- and middle-income countries
– nearly half all tests were in Africa.
10%
55%
2005 2015
PLHIV Undiagnosed in Africa
PLHIV Diagnosed in Africa

0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Y1 Y2 Y3 Y4 Y5 Y6 Y7 Y8 Y9 Y10 Y11 Y12 Y13 Y14 Y15 Y16 Y17 Y18 Y19 Y20 Y21 Y22 Y23 Y24 Y25 Y26
HIV Diagnosis Over Time
Average % of PLHIV Identified for Top 30 Countries*, Yearly, Starting 2001
Projection suggests the earliest countries
could identify 90% of PLHIV is 2026.
* By size of the epidemic
Source: Courtesy Frederic Seghers, CHAI Input data via UNAIDS Aidsinfo; DHS Statcompiler – projections via CHAI NMOT modeling
Slow start:
Initial VCT
efforts
(Voluntary
Testing)
Steep increase:
Ramping up the number
of facilities and
introduction of
Provider-Initiated
testing Decelerated increase:
High hanging fruits are more
difficult to reach via traditional
strategies

Estimated progress toward the first 90 in
the African Region, 2015
Eastern & southern Africa Western & Central Africa
Source: UNAIDS, 2016
62% 54%
45%
PLHIV Diagnosed in
Africa
PLHIV on ART PLHIV on ART
Virally Supressed
36% 28%
12%
PLHIV Diagnosed in
Africa
PLHIV on ART PLHIV on ART
Virally Supressed

Innovation Needed to Close the Testing Gap
Photo Credit: http://fr.ubergizmo.com/2013/02/15/wifi-gratuit-metro-londonien-fin.html

Reactive results need confirmation by trained
tester using a validated national algorithm
What is HIV Self-Testing?
Collects Performs Interprets

WHO HIVST Strategy
• HIVST requires self-testers with
a reactive (positive) result to
receive further testing from a
trained provider using a
validated national testing
algorithm.
• All self-testers with a non-
reactive test result should retest
if they might have been exposed
to HIV in the preceding six
weeks, or are at high ongoing
HIV risk.
• HIVST is not recommended for
people taking anti-retroviral
drugs, as this may cause a false
non-reactive result.
*Any person uncertain about how their self-test result, should be
encouraged to access facility- or community-based HIV testing

Directly assisted HIV self-testing
Trained peer or health worker could
provide a brief demonstration on how to
use the kit and how to interpret results
• Provide face-to-face assistance during
self-testing (optional)
• Instruction-for-use &/or included in
the kit:
‒ Pictorial/written
‒ Including a hotline number or a link
to a video
‒ Multimedia instructions (tablet)
‒ Remote support via SMS, QR code
or mobile messaging applicationsUnassisted HIV self-testing
Instruction-for-use included in the kit:
• Pictorial/written
• Including a hotline number or a link to a video
• Multimedia instructions (tablet)
• Remote support via SMS, QR code or mobile messaging applications
• Package inserts included in the kit

Developing Evidence-based Policy
2013
2015
2014
2016
HIVST & PN
Implementation Tools &
Strategic Impact
framework
2017
Summary of clinical outcomes2012
2008

WHO Guidelines
Evidence & Recommendations

WHO Guidelines on HIVST
 5 RCTs (2012-2016) directly comparing
HIVST to HIV testing by a provider as
of July 2016
 25 studies on HIV RDT for self-testing
performance as of April 2016
• 125 studies on acceptability/feasibility
(including user values preferences) as
of July 2016
• 4 studies on cost/cost-effectiveness as
of July 2016

HIVST Doubled Uptake & Frequency
compared to standard HTS
Moderate quality evidence that
HIVST doubled HIV testing
uptake compared to standard
HTS
Study or Subgroup
Gichalgi 2016 3.08 [2.58, 3.69]
Thirumurthy 2016 1.77 [1.57, 2.00]
Wang 2016 1.77 [1.57, 2.00]
2.12 [1.51, 2.98]
Risk Ratio
M-H, Random, 95% CI
Favours standard of care Favours HIV self-testing
105210.50.2
Study or Subgroup
Katz 2015 1.70 [0.94, 2.46]
Jamil 2016 2.30 [2,27, 2.33]
2.13 [1.59, 2.66]
Mean Difference
IV, Random, 95% CI
Favours standard of care Favours HIV self-testing
1050-5-10
Low quality evidence that HIVST
resulted in 2 more tests in a 12-15
month period compared to standard HTS
Effect also shown for increase uptake of
couples testing in Gichangi et al &
Thirumurthy et al.
Jamil et al also showed HIVST increased the
frequency of testing among non-recent
testers compared to standard HTS

HIVST identified 2x’s as many
HIV-infections than only standard HTS
14%
9%
0%
2%
4%
6%
8%
10%
12%
14%
16%
Median HIVST
Positivity
Median HIV
Prevalence
Median HIV positivity
Studies in African region
Across observational studies -
HIV positivity ranged from
3–14% among the general
population in sub-Saharan
Africa
1–30% among key
populations Africa, America,
Asia, Europe

Linkage to care
50-56% in general populations in sub-Saharan Africa and 20-100% among
key populations Africa, Americas, Asia, Europe

• Studies reported HIVST was empowering.
• Social harm due to HIVST was not
identified in RCTs
• Reports from studies were limited and did not
suggest HIVST increased risk of harm
• In Malawi, two-years of implementing HIVST
found no suicides, no self-harm and no cases
of IPV.
• Reports of coercion identified were mostly
among men who also reported that they
would recommend HIVST
• In Kenya 4 cases of IPV identified - unclear if
due to HIVST. (41% of participants reported
IPV 12 months prior to intervention).
No identifiable increased risk of
social harm & adverse events

Results of HIV RDTs performed by self-tester were
similar to those performed by trained health worker
Measured using kappa statistic – 16 studies

Achieved acceptable
accuracy (sensitivity & specificity)
Sensitivity
as high as 98.8% (95% CI 96.6 – 99.5%)
Specificity
as high as 100% (95% CI 99.9 – 100 %)
Figueroa et al Poster AIDS 2016, WEPEC207; HIVST.org
n = 18 studies

• HIVST is highly acceptable across
different populations & settings, e.g. men,
young people, KP, couples
• Many users prefer oral HIVST– but
others, e.g. men in South Africa and
PWID reported a preference for
fingerprick HIVST.
• Preferences across service delivery
approaches vary.
• Young people preferred community-based
options, but key populations, reported
preferences for pharmacies, the Internet, and
over-the-counter approaches more
appealing because they are more discreet
and private
HIVST Values & Preferences in Africa

Knowledge about Programme Costs,
Cost-savings or efficiencies vary and are limited
Cost of GHTF approved HIVST Kits in private sector are ~US$ 7.50–43 &
in LMIC for research ~US$ 3–16. However, informal sales of HIVST Kits
in private sector is ~US$1-12
Cost of intensive community-based HIVST in Malawi. Mean health
provider cost per participant was US$8.78 for HIVST vs. US$ 7.53–10.57
for facility HTS. Cost per HIV-positive for HIVST had higher mean health
provider cost (US$ 97.50) than facility HTS (US$ 25.18–76.14).
Cost of HIVST for PrEP retesting in Kenya. Hypothetical costing
suggested that retesting SDC’s on PrEP using unassisted HIVST
(US$3/kit) would be less expensive than facility HTS; & with US$1/kit
assisted or unassisted HIVST would be less costly than facility HTS.

HIVST to achieve 1st 90 in Zimbabwe
Slide courtesy of Valentina Cambiano and STAR Consortium

New Recommendations
HIV self-testing should
be offered as an
additional approach to
HIV testing services
(strong recommendation,
moderate quality
evidence)

Key messages for users and implementers
• Use of approved HIV RDT for self-testing, either by national or
international authority
• Use HIVST kits with appropriate, validated, clear and concise
instructions for use – demonstrations and support tools may be
particularly useful for rural populations and those with low levels of
education and literacy
• Clearly state reactive results need further testing, provide
information on what to do after a reactive self-test result
• Make sure pre-test information and post-test counselling
messages are accessible and available to all self-testers – and
that health workers and providers are trained to deliver these
messages
• Integrate HIVST into comprehensive sexual health service
programmes and provide messages and information on
tuberculosis, STIs and viral hepatitis.

HIVST products
(ERP-D & WHO PQ)

WHO PQ: HIV RDTs for self-testing
• WHO PQ is actively accepting
applications for HIV RDTs for self-
testing
http://www.who.int/diagnostics_laborat
ory/evaluations/en/
• Technical Specifications for HIVST are
now available:
http://www.who.int/diagnostics_laborat
ory/guidance/technical_specification_s
eries/en/
• 2 HIVST products currently under
review

UNITAID - Global Fund
Expert Review Panel for Diagnostics
• ERP-D is a process where independent experts review the potential
risks and benefits associated with the use of finished diagnostic
products and make recommendations to the Global Fund. It is hosted
by the Quality and Safety of Medicines department of WHO.
• ERP-D approval enables countries to immediately procure
products through Global Fund and other donors – based on QA
standards
Key Facts:
• ERP-D requires agreement to submit for WHO PQ
• Provides an ERP-D approval for 12-months
• To date, Global Fund has issued 2 expressions of interest for HIVST
& provided approval for 2 products:
• 1 for research (Biosure HIV self-test)
• 1 for full programmatic use (OraQuick HIV self-test)

Test Kit Name Specimen
Approval
Status
Suggested Price Per Test
(US$)
Autotest VIH
(AAZ Labs, France)
Blood CE
25-28
(to consumer)
INSTI HIV Self Test
(Bioanalytical, Canada)
Blood CE
36
(to consumer)
Biosure HIV Self Test
(Biosure, UK)
Blood CE/ GF ERPD
38-43 (to consumer)
7.50–15 ( to public sector)
OraQuick In-Home HIV Test
(OraSure Technologies, USA)
Oral FDA
40
(to consumer)
OraQuick HIV Self-Test
(OraSure Technologies, USA)
Oral
GF - ERPD
Available upon request
*With approval from a founding member of the GHTF, All information is provided by manufacturers (UNITAID/WHO Landscape July 2016/ Dec
2016)
HIV RDTs for self-testing

Implementation & Lessons learned

Countries with HIVST Policies
Supportive HIVST Policy Supportive HIVST Policy
under development
Chad Rwanda Botswana
Burundi South Africa CAR
DRC Tanzania Mali
Kenya Zambia Namibia
Lesotho Zimbabwe Nigeria
Malawi Senegal
Swaziland
As of March 2017, 33 countries reported to WHO that
they have HIVST policies – 11 of which are in Africa with
other in development

5%
1%
10%
16%
33%
36%
0% 20% 40%
Multi-Region
SEAR
EUR
WPR
AMR
AFR
Region
3%
32%
32%
40%
Young people
General
Population
Other (Mixed,
HCW)
Key
Population
0% 20% 40% 60%
Population
Studies by Region, Population, Type of RDT
13%
7%
67%
13%
Null & N/A
Fingerstick
Oral fluid
Oral fluid & Fingerstick
Type of RDT

21%
17%
10%
1% 25%
11%
14%
0% 10% 20% 30% 40% 50%
Community based
Mixed
Facility-based Direct
Assistance
Both
Unassisted
Studies by Approach & Level of Assistance
• 41 studies (47%) are community based.
• Of these the majority, 22 /41 are unassisted and slightly less 18/41 use direct assistance.
• 21 (14%) are facility-based.
• 25 (28%) use both facility and community-based approaches.

Peer-led Oral HIVST experience in Kenya
Oral HIVST in Kenya appeared an acceptable
strategy to engage GBMSM for repeat HIV testing
and linkage to care: 337 Oral HIVST kits extended,
333 (99.1%) returned for confirmatory testing.
Compared to clinic-based HTS (n=690 GBMSM
with median age 27 yrs; IQR:22-33yrs), Oral HIVST
(n=333 with median age 26: IQR:23-32) found a
higher proportion of undiagnosed HIV - 8.7% vs.
3.5% (P<0.001).
High rates of re-testing, acceptance of immediate
ART treatment: 20 GBMSM (83.3%) started ART
after medium of 5 days (IQ R:3-14 days) verses
24 (83%) HIVST’ers started on the day of HIV
confirmation.
Would Oral HIVST be
acceptable and feasible
for GBMSM?
Would Oral HIVST identify
men with undiagnosed
HIV?
Would men be willing to
come forward for repeat
test and start ART?
Van der Elst et al., CROI #857 & themed discussion, 2017.

L
Linked:
• 64/101 (60%)
uncircumcised men
referred for VMMC
• 22/23 (96%) started
ART
• 132/300 (44%) never
tested before
• 3 adverse events
(Women pressured
man to self-test)
• 95% of women
report their partner
has self-tested
within 28 days
PASTAL - Linkage to Prevention & Treatment
Outcomes in ANC partner delivered HIVST in Malawi
(% male partners tested + linked for ART / VMMC in 28 days)
Choko unpublished

Community liaison
reporting system
Social Harms and
SAEs

User Cost of Accessing
Standard HTS
Costing HIVST
Cost Item Males
(USD)
Females
(USD)
Childcare 0.06 0.01
Transport 0.25 0.16
Consultation 0.03 0.03
Meal 0.18 0.13
Other 0.05 0.02
Work lost 3.24 1.48
Total Cost 3.81 1.84
User cost of
HTS for men
in Malawi is
154% more
than daily
wage
WTP= 1 X GDP per capita
WTP= 3 X GDP per capita
0
50
100
150
200
250
300
0 0.2 0.4 0.6 0.8 1
IncrementalCosts(2014USDollars)
Incremental Effectiveness (QALYs)
Health provider perspective: HIVST + Facility HTS v
Facility HTS
Cost-effectiveness analysis
found implementing HIVST in
Malawi was cost-effective
(US$ 230/QALY gained

Key Results: STAR Phase 1
Increased Access
Over 200K tests distributed as of January 31, 2017; 7
distribution models launched and evaluated across the three
countries; models were implemented in facilities and at
community level.
Informed Demand
Identification of barriers and facilitators of HIVST uptake and
consumer preferences for delivery. Launch of a regional
marketing campaign targeting barriers to testing and the
potential for HIVST to overcome these barriers.
Strategic Barriers
WHO normative guidance released in December 2016; national
HIVST policies established in all three project countries
Structural Barriers
Regulatory systems mapped in all project countries, 2 HIVST
products with ERPD, release of a global HIVST market
landscape to address asymmetry in market knowledge

What’s Next?
Strategic framework

Priorities
• Support more countries to implement & scale-up
HIVST – and including national policies,
strategies and implementation plans
• Including GF funding request & COP
• Work to negotiate lower prices, pooling
procurement
• WHO PQ HIVST kits – and additional ERP-D
round to fast-track approval of more products
(blood and oral)
• Strategic framework for implementation &
impact.

Where to Begin with HIV Self-Testing
Know your epidemic
& testing gap
Approaches
Couples & Partners
Men
Key populations
Young people
Other
At risk populations
(SDC, partners of PLHIV, migrants etc.)
Community-based
(outreach, door-to-door)
Facility-based
(PITC, drop-in centres)
VMMC programmes Workplace programmes
Pharmacies & Kiosks
Integrated in KP
Programmes
Internet & Apps
Integrated in RHS &
Contraceptive Services
Vending machines Partner-delivered
Considerations
Benefits & Risks to
Populations
Support tools
Linkage
Increased access
Increased
coverage

Linked to
Prevention
DIRECT IMPACT
Link to Treatment
Triaged out of
Health System
Health for PLHIV: Reduced
Morbidity & Mortality
Reduced HIV Transmission
& Infections Averted
Cost and Time Savings
(Health System & Users)
Efficiency
Expanded Coverage
Equity of Health
Health Systems
Social & Economic
Population
Productivity &
Growth
Social Benefit
Social Harm
+
-
ADDITIONAL IMPACTDIRECT
ACTION
DIFFERENT
POPULATIONS
DIFFERENT
CONTEXTS
DIFFERENT
GEOGRAPHIES
HIVST
PREP
Acceptability
Usability
Willingness
to Pay
*Adapted framework based on BMGF &
UNITAID HIVST Meeting in January 2017
Disclosure / Shared
Knowledge of HIV
status
Measuring Impact of HIVST

Rachel Baggaley, Carmen Figueroa, Shona Dalal, Caitlin Kennedy, Virginia
Fonner, Nandi Siegfried, Anita Sands, Buhle Ncube, Simba Mabaya, Brian
Chirombo, Christine Kisia, Robyn Meurant, Caitlin Payne, Nathan Ford,
Michel Beusenberg, Theresa Babovic, Daniel Low-Beer, Keith Sabin, Wale
Ajose, Heather Ingold, Tanya Schewchuk, Karin Hatzold, Liz Corbett & the
STAR Consortium.
Special thanks to meeting organizers and everyone who assisted with
developing this recommendation: Steering Committee, Guideline
Development Group, HIVST Technical Working Group, 75+ peer reviewers,
all contributors of case examples, editors, designers, administrative,
communications and technical support teams.
Funding of the guidelines provided by UNITAID and Bill, Melinda Gates
Foundation and the United States Agency for International Development
and the President’s Emergency Plan for AIDS Relief.
Acknowledgements

Overview of HIV self-testing

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