Presented by Rachel Baggaley and Cheryl Johnson, World Health Organization June 2016

1. Rachel Baggaley,
Coordinator, Key Populations and
Prevention Unit
WHO HIV Department
Global Fund
Geneva, Switzerland
2 June 2016
Realizing the potential of HIV
self-testing – a summary of
the latest evidence
Cheryl Johnson,
Technical Officer
WHO HIV Department

2. What is self-testing?
Collects Performs Interprets

3. Reactive results need confirmationby health provider
What is HIV Self-Testing (HIVST)?

4. Test for Triage
HIVST within algorithm
• A single rapid diagnostic
test
• Not a definitive test for
those who test +ve
• Emphasis on HIV diagnosis at
health facility (start at A1)
• Triage – prioritize linkage
following testing as
appropriate
Performtest for triage
A0
Link to HIV
testingfor
diagnosis, care
& treatment
A0 +
A0 –
Report HIV-
Recommend
repeattesting
as needed

5. Continuum of HIVST models

6. Outlines models, priorities, policy issues &
evidence gaps
Technical considerations for HIVST &
encourages countries to conduct
pilots/demonstration projects
• Global Fund Operational Note to support
implementation research pilots (2 June
lunchtimeseminar)
Most current information available on
HIVST.org
Current WHO guidance on HIVST
Source: WHO HTS GL 2015; UNITAID 2015

7. Prospective WHO Guidelines Timeline
• 6 June HIVST TWG Meeting
• 17-18 July GL 2016 Meeting
– Meeting in Durban to review synthesis of evidence
• 1 Dec 2016 Launch of HIVST GL
– Planned release of normative guidance and
considerations
– Critical to have HIV RDTs for self-testing available
• Q3/Q4 2017 HIVST Implementation GL
– Planned operational tool for HIVST

8. Available Formally
…& Informally
Credits: David Stanton, Vincent Wong, Cheryl Johnson, Matthew Rosenthal

9. Acceptability & Willingness
Source: 1 www.hivst.org , Evidence Map, accessed 15 Feb 2016 – 51 reporting studies
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%

10. PSI/UNITAID STAR Project
Catalysing HIVST in Southern Africa
Source: WHO, 2015 http://www.who.int/hiv/mediacentre/news/unitaid_hiv-self-testing/en/
Implementation-research Partnership Tackling Market Barriers
by:
• Multiple sites, models, & populations
• Normalizing HIVST in Southern Africa
• Providing evidence for scale-up
• Developing WHO Guidelines
• Encouraging policy change
• Enabling the regulatory environment
• Shaping market to reduce barriers & increase entry of low-cost
HIVST products available for purchase & on recommended
diagnostic commodities list

11. PSI/UNITAID STAR Project
Current HIVST implementation in Zimbabwe
• Modelling suggests HIVST is cost-effective if priced at US$3 per test
• Pilot studies show HIVST is acceptable, appealing and accurate
• Female sex worker (FSW) uptake ~50% - 2/3 HIV- FSW interested in HIVST & 2/3
HIV+ FSW said they’d prefer HIVST to health worker diagnosis alone.
• 93% users read tests correctly & 88% said it was easy to use (adults urban and
rural settings). Demonstration, videos and validated IFUs were key.
• UNITAID/PSI STAR Project started in Zimbabwe in March 2016
• Offering HIVST in rural, urban and peri-urban settings to reach 16+ people: KP,
men, VMMC, young people, 1st-time testers
• 8,095 HIVST kits were distributed between 23 March and 23 April 2016
• 61% distributed in men
• MoHCC formed HIVST TWG & is leading planning & guideline development
process.

12. Highest uptake among young
people & adolescents
• 76% in months 1-12
• 74% in months 13-24
• 44% first-time testers
• ~90% returned kits with self-
completed questionnaire
20-2916-19 30-39 40-49 50+
Age Group (years)
Months
Source: Choko et al 2015
Year 2
Year 1
Men
Women
Uptake AmongstAll Residents in Malawi
Since HIVST Made Available

13. Source: Lippman 2011; Gray2013; Venetuneac 2009; Katz2015
Increased Frequency
HIVST increased frequency of HTS
among MSM in USA
0%
10%
20%
30%
40%
50%
60%
70%
80%
HIVST Standard HTS
In Brazil, MSM who were less
frequent testers and considered
testing but failed to test were more
likely to prefer HIVST.
In Australia 2/3 HIV-negative MSM
said they’d test more frequently if
HIVST was available.
Models suggest increases in
frequency using HIVST among
MSM, especially in settings with low
testing coverage, could have a
public health impact.

14. Linkage
Source: 1 MacPherson 2014; 2 Choko 2015; 3.
Thirmuthy 2016; 3. Figueroa et al. 2015
Evidenceis limited, but promising1,2,3
•Especially when coupled with a proactive
approach (e.g. home-based assessment, ART
initiation)
•80-100% of MSM report they would link to
further testing and care, if they had a reactive
self-test result4
Higher ART among Home Self-test
Clusters than Facility-based
MacPherson 2014(Malawi)
181 Participants
initiatingART
63 Participants
initiatingART
8,403 Participantsnot
initiatingART
8,013 Participantsnot
initiatingART
Home-Based Test
Home Group
or HomeOption
(8,194)
Facility-Based Test
FacilityGroup
or Facility-Based
(8,466)
Parent Trial
Participants

15. Adverse Events
HIVST can be empowering.
• A 2014 lit review reportedno seriousadverseeventsas a result of
self-testing for multiple diseases and conditions, including HIV1.
• No suicideor self-harm & in Malawi trial showed no intimate-partner
violence2,3,4
• As with all HTS, clear messages,monitoring & reporting systems
are important to identify and address issues when and if they occur.
Information and messages for communities, particularly for vulnerable
populations.
• Tools include: Hotlines, Mobile phones & SMS, Community-
based monitoring systems, post-market surveillance systems,
etc.
Source: 1 Brown et al 2014; 2 Desmond 2014: 3. Kumwenda 2014; 4Choko 2015; 5. Thirmurthy 2016

16. Performance Can be Good
Table 2a. Calculatedsensitivity andspecificity of RDTs usedforself-testingwithassistedapproach
(n=12)
Table 2b. Calculatedsensitivity andspecificity of RDTs usedforself-testingwithunassistedapproach(n=18)
*HIV prevalence for sensitivity and specificity calculations.
n/a: not available, a: One participant was on ART, this person testednegative via self-test andpositive
in confirmatory testing.
*HIV prevalence for sensitivity and specificity calculations.
FWB: fingerstick/whole blood, a: four participants were on ART, they tested negative via self-test and
positive in confirmatory testing.
Sensitivity as high as 98.6% (95% CI 96.6 – 99.5%) & Specificity as high as 100% (95% CI
99.9 – 100 %)

17. Clinical utility risk-benefit HIVST
HIV prevalence 1%

18. Clinical utility risk-benefit HIVST
HIV prevalence 5%

19. Clinical utility risk-benefit HIVST
HIV prevalence 10%

20. Clinical utility risk-benefit HIVST
HIV prevalence 60% - FSW in SouthAfrica

21. Clinical utility risk-benefit HIVST
Analysis suggests HIV RDTs for self-testing have more benefit than risk
– particularly when utilized to reach people at high risk, w/ low HTS
coverage & who may not otherwise test.
Risk of false reactive/false non-reactive self-test results can be mitigated
easily through clear messaging & quality systems, such as:
• Clear messages that HIVST does not provide an HIV+ diagnosis
• Clear messages on importance of frequent retesting, as
recommended by WHO for people at high on-going risk (e.g. every 3 to 6
mo.).
• Use of evidence-based strategies to facilitate linkage to further
testing, prevention, treatment and care
• Clear and concise IFUs &/or videos designed for HIVST to guide users
on how to perform the test and interpret the results.

22. Current Policy Environment
Policies &
Product(s)
Approved for
HIVST
Policies
Explicitly
Allowing HIVST
Policies Under
Development
HIVST Available
Informally
USA 2012 Australia Namibia Namibia
UK 2015 Kenya Peru Russian Federation
France 2015 China Thailand United Republic of
Tanzania
Brazil 2015* Hong Kong SAR Zambia Nigeria
Macau SAR Zimbabwe Peru
Malawi* Belgium Uganda
Rwanda Ukraine
South Africa* Malaysia
NEW
NEW
In Brazil itHIVSTnot yet availablein pharmacies,anticipated for later in 2016.In South Africa HIVSTis availablein pharmaciesbutMoH is in processof setting
regulatory standards.

23. WHO/UNITAID landscape (Dec 2015)
• Currently being updated in collaboration with PSI
& BMGF
• 15 RDTs for HIVST identified, 3 approved by founding
member of GHTF, none WHO PQed yet (1 product
submitted dossier for PQ)
• Sales volumes increasing, but are relatively small
• Costs range from:
• US$ 28-40 (sale in high-income countries)
• US$ 3.50 – US$ 16 (for research low- & middle-income
countries)
• US$ 4-10 (sale informally in low- and middle-income
countries)

24. Preliminary estimate for demand for HIVST could be
at least 4.8 M & as high as 88 M RDTs in 2018

25. HIV RDTs for HIVST in the market
All information is provided by manufacturers (UNITAID/WHOLandscape Dec 2015)
Manufacturer Assay name SENS SPEC Specimen Approval Status Price Per Test
(US$)
AutotestVIH
(AAZ Labs, France)
100% 99.8% Whole
blood
CE marked 25-28 (to
consumer)
Biosure HIV Self Test
(Biosure, UK)
99.7% 99.9% Whole
blood
CE marked 38-43 (to
consumer)
OraQuick In-Home HIV Test
(OraSureTechnologies,
USA)
100% 99.8% Oral fluid CE marked NA
OraQuick In-Home HIV Test
(OraSureTechnologies,
USA)
91.7% 99.9% Oral fluid FDA 40 (to
consumer)

26. Current implementation of HTS not enough to get to 90.
Strategic and efficient approaches are needed to expand HTS and increase
coverage among high risk populations who may not otherwise test
Public health response lags behind public demand—and we need to catch up.
Self-testing is not new. But it is an additional tool to create demand for, not
substitute, HIV testing services.
WHO guidance on HIVST on the way, and implementation research underway
Get going. Use what we have today and urgently work toward quality assured, ERP-D
and WHO PQed, low cost products for resource limited settings & pops who can benefit
most.
Think big. We need visionaries & champions; we need to stimulate technological
advances, better tests & innovations in implementation
Conclusions

27. Rachel Baggaley, Carmen Figueroa, ShonaDalal,Michel Beusenberg and Theresa
Babovic,WHO HIV Dept, Geneva
Anita Sands, Robyn Meurant,Willy Urassa and Irena Prat WHO EMP, Geneva
Carmen Perez Casas and Wale Ajose, UNITAID
Karin Hatzold and Petra Stankard, PSI
Elizabeth Corbett andAugustine Choko, London School of Hygiene and Tropical
Medicine, MLW, Wellcome Trust, Blantyre, Malawi
Acknowledgments