Formative research was conducted in Kenya to inform the design and implementation of HIV self-testing pilots. The research found high acceptability of HIV self-testing, especially among men and never-tested individuals. While some concerns around potential abuses were raised, little evidence of actual harms was found. Public health facilities were the preferred location for distribution and linkage to counseling and confirmatory testing. Based on these findings, 3 randomized controlled trials of HIV self-testing pilots were launched in Kenya to evaluate impacts, with the goal of expanding pilots and evaluations to Zambia and another country.

1. www.3ieimpact.orgAnna Heard
HIV SELF TESTING: MOVING
FORWARD USING EVIDENCE
Anna Heard Sc.D.
CROI Side Event
Bill and Melinda Gates Foundation
February 27, 2015

2. www.3ieimpact.orgAnna Heard
Improving lives through impact
evaluation
International Initiative for Impact Evaluation

3. www.3ieimpact.orgAnna Heard
Outline
• 3ie and our IE philosophy
• HIVST grants program
• Results of formative research for HIVST
pilots in Kenya
• Future work

4. www.3ieimpact.orgAnna Heard
3ie’s role
• Fund new studies
• Synthesize evidence
• Disseminate and broker knowledge
• Provide incentives and resources

5. www.3ieimpact.orgAnna Heard
HIV self-testing grants program
• Fund pilot programs using HIV self-tests
accompanied by impact evaluations
• Test for both intended positive outcomes
and unintended negative outcomes
• Implement country by country (3 countries)
• Start with Kenya (12/2012)
– Formative research
– Impact evaluations
• Launched in Zambia in summer 2014

6. www.3ieimpact.orgAnna Heard
Formative research Kenya
• Accuracy
• Packaging and labeling
• Potential users and messaging
• Distribution outlets
• Linkage to counseling and care
• Potential social harms and
abuses

7. www.3ieimpact.orgAnna Heard
Methods
• Five of six studies used medium to large sample
surveys, three of these used random sampling
• One study used small sample qualitative data
collection (packaging and labeling)
• Heterogeneous samples, but not population
representative samples
• Studies employed basic statistical analysis and
some qualitative analysis
• Two of six used actual self tests as part of study
• Most summary findings include evidence from
more than one formative study

8. www.3ieimpact.orgAnna Heard
Formative research findings
• Do people want it?
– Why? Why not?
– Who?
• Does it work?
• Where would people get it?
• Will people get counseling and/or care?
• What are people worried about?
• How can we address concerns?

9. www.3ieimpact.orgAnna Heard
Do people want it?
• 5/6 studies report near universal
“acceptability”: >90%
• 5/6 studies collected data on acceptability
among never tested: 80% - 99%
• FSW: 98%
• MSM: 57%

10. www.3ieimpact.orgAnna Heard
What about never tested?
• One study [6]
– Men
• Never tested would like to be tested: 70%
• Never tested would purchase and use if available: 86%
– Women
• Never tested would like to be tested: 58%
• Never tested would purchase and use if available: 80%
• Another study [4]
– Men never tested who would use a self-test: 90%
– Women never tested: 86%
• Third [1]
– Men never tested would recommend after using:
94%, women, 100%.

11. www.3ieimpact.orgAnna Heard
Uptake of HIVST among testers
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
General facility site Home-based testing Key population site Total
Uptake of HIVST by gender and testing site
Male Female
[5]

12. www.3ieimpact.orgAnna Heard
Who would use it (from surveys)?
• Ever been tested more likely [3] [6]
• Men more likely [5][6]

13. www.3ieimpact.orgAnna Heard
Why would people use self-tests?
0%
10%
20%
30%
40%
50%
60%
70%
80%
Women Men Never Tested Total Providers [4]

14. www.3ieimpact.orgAnna Heard
Why would people self-test?
Reasons why self-test Males Females
Private 70.9% 56.7%
Early treatment 20.1% 24.7%
“No worry” if negative 9.0% 19.5%
Know status 13.8% 11.1%
Easy to use 13.0% 9.9%
Convenient 12.6% 9.5%
Test is accurate 5.9% 3.4%
Protect regular partners 6.7% 1.0%
Protect other partners 1.7% 1.4%
Other 3.4% 3.6% [6]

15. www.3ieimpact.orgAnna Heard
Why not self-test?
Mombasa Siaya
Average
Total
% % % n
Afraid of finding out positive result while
alone 46.9 41.2 44.9 22
Health workers are more
knowledgeable 18.8 17.6 18.4 9
Afraid of misinterpreting results 12.5 35.3 20.4 10
Other 21.9 5.9 16.3 8
[3]

16. www.3ieimpact.orgAnna Heard
Does it work?
• Sensitivity: 92.9% (89.7%)
– Unobserved sensitivity in US: 91.7%
• Specificity: 97.8% (98.0%)
• Invalids: 15% (men and never tested more
likely)
[1]

17. www.3ieimpact.orgAnna Heard
Where would people get it?
Preferred distribution channel
Women
(%)
Men
(%)
Never
Tested
Total
(%)
Public health facility 63.2 59 53.1 61.8
Private pharmacy 7.5 5.7 8.3 6.9
Local shops/supermarkets 4.1 8.2 9.7 5.4
Private health facility 4.6 3 4.1 4.1
Local administration 6.8 11.3 13.8 8.3
Faith-based/NGO health facility 3 2.3 0.7 2.7
Mobile clinic/tent/outreach 2.1 2 0.7 2.1
Community health worker 2.9 2 2.1 2.6
Stand-alone VCT center 0.3 0 0 0.2
Community-based distributor 0.9 1.4 2.8 1
CBO/self-help group 0.3 0.2 0.7 0.3
Non-governmental organization 0 0 0 0
Social marketing events 0.2 0.7 0 0.4
Relative/Friend/Neighbor 0.1 0.2 0 0.2
Traditional birth attendant 0.2 0 0.7 0.2
Other 3.9 4.1 3.5 3.9 [4]

18. www.3ieimpact.orgAnna Heard
Where would people get it?
All distribution channels
Women
(%)
Men
(%)
Never
Tested (%)
Total
(%)
Public health facility 78 75 68 77
Private health facility 22 16 19 20
Private pharmacy 23 20 18 22
Local administration 13 15 9 14
Local shops/supermarkets 12 13 13 12
Mobile clinic/tent/outreach 13 10 6 12
Social marketing events 8 13 13 9
CHW 10 9 6 9
Faith-based/NGO health facility 9 9 7 9
School/Church/Mosque 6 7 8 7
Community-based distributor 4 4 3 4
Relative/Friend/Neighbor 4 8 10 5
VCT 5 2 1 4
CBO/self-help group 1 1 1 1
NGO 0 0 0 0
Traditional birth attendant 1 0 0 0 [4]

19. www.3ieimpact.orgAnna Heard
Where would people get it?
PSI NYU
Never
(%)
Ever
(%
Total
(%)
Total
(%)
Pharmacy 72 60 62 57
Government
Health Facility 56 70 68 42**
Private clinic 27 21 22
Supermarket 24 25 25 3
Other* 9 17 16
*Other includes primarily Community-Based Organizations and NGOs
**Does not distinguish between government and private

20. www.3ieimpact.orgAnna Heard
What are people worried about?
• 27% of people said HIV self-testing “could
be open to abuse” [3]
– Kinds of abuse were more related to
problems, not abuses
• 36% of people said that if available, it is
“possible that people could abuse it” [5]

21. www.3ieimpact.orgAnna Heard
What are people worried about?
70.7% of men and 54.9% of women feel
there are disadvantages [6]
• Might commit suicide
• Anxious or depressed (men more than women)
• Not disclose (men more than women)
• Harm others (men more than women)
• Counterfeit kits (men more than women)

22. www.3ieimpact.orgAnna Heard
What are people worried about?
66.2% of men and 54.7% of women feel that
self-testing “is open to abuse” [6]
Perceived abuses Male Female
Intentionally infecting others 70.7% 90.5%
Testing partner without consent 73.0% 59.5%
Parents testing children w/o consent 80.9% 49.5%
Testing people without consent 45.4% 52.0%
Testing potential employees 36.6% 46.9%
Schools testing children 31.7% 41.1%
Disclosing others’ HIV status 19.9% 53.9%
Don’t know 3.0% 5.0%

23. www.3ieimpact.orgAnna Heard
What would people do?
What would people do
if positive? [3]
Men Women
Seek counseling 41.4% 35.8%
Confirm results 22.0% 19.5%
Seek medication 10.7% 18.9%
Go into depression 9.0% 8.3%
Keep results secret 4.8% 2.2%
….
Commit suicide 1.9% 1.6%
Intentionally infect others 0.2% 0%

24. www.3ieimpact.orgAnna Heard
What evidence of harms?
Is there evidence of harms from self-
tests? A rapid evidence search
By Annette N. Brown, Eric W. Djimeu, and Drew B.
Cameron
“After an extensive search and broadly inclusive screening
process, we find very little evidence of any harms occurring
in practice. There is evidence that BSE is linked to anxiety,
but the evidence is not specific to receiving the test result
and the cost cited for the anxiety is resistance to BSE
rather than emotional or psychological damage.”

25. www.3ieimpact.orgAnna Heard
How to address concerns?
Ways to prevent abuses Male Female
Make non-consensual testing illegal 39.5% 22.2%
Self-testing kit used only by person who
receives
30.9% 14.4%
Provide only one self-testing kit per
person
21.5% 18.3%
Sensitization 17.7% 14.7%
Other ways 5.4% 11.1%
Don’t allow home self-testing 5.1% 10.8%
Pre-counseling 5.9% 6.2%
Restricted distribution points 3.2% 3.3%
Legal penalties for misuse 4.8% 0.3%
Age restrictions for purchase 1.3% 1.3%
[3]

26. www.3ieimpact.orgAnna Heard
Messaging
• Mass media sensitization and awareness
campaigns
– Come from MOH
– Inform: address concerns and advantages
– Educate: importance of confirmatory test,
disclosure, linkage to care, prevention
• Prior to and during roll-out
[2]

27. www.3ieimpact.orgAnna Heard
Packaging and labeling
• Packaging secure
• Small size
• Labeling—with quality
seals, informative
– Improved
instructions—simple,
explicit
– Information about
storage, expiration
• May require point of
distribution instruction
[4]

28. www.3ieimpact.orgAnna Heard
Instructions

29. www.3ieimpact.orgAnna Heard
Linkage to care
Counseling Confirmatory testing
Intent if positive 91.1% 84.3%
Intent if negative 41.4% 50.0%
Actual 31.6% 29.6%
• Those choosing HIVST as part of home-based testing more like to
express intent to seek both counseling and confirmatory testing.
• Women, those divorced, widowed, or separated, and those testing
at key population sites more likely to access confirmatory testing

30. www.3ieimpact.orgAnna Heard
Linkage to care
• Strong desire for face-to-
face counseling [3]
• Telephone hotline not
preferred [3]
• Public health facilities
strongly preferred for
counseling before and after
[1]

31. www.3ieimpact.orgAnna Heard
Main conclusions
• High acceptability and likelihood of use
• Accuracy not much different from US
• Health facilities are a desirable outlet
• Perceptions of disadvantages and abuses do
exist
• Big differences between men and women
• Mass messaging important
• Packaging and labeling important

32. www.3ieimpact.orgAnna Heard
Formative studies
[1] “Accuracy of oral HIV self-tests in Kenya” Ann E. Kurth, Abraham M.
Siika
[2] “How HIV self-testing kits should be packaged in Kenya” Olivier LeTouzé
[3] “Insights into potential users and messaging for HIV oral self-test kits in
Kenya” Rhoune Ochako, Lung Vu, Katia Peterson
[4] “Possible channels for distribution of HIV oral self-test kits in Kenya”
Jerry Okal, Francis Obare, Waimar Tun, James Matheka
[5] “Exploring potentially effective methods for counselling and linkage to
care in the context of HIV self-testing in Kenya” Wanjiru Mukoma, Miriam
Taegtmeyer, Anna Heard, Hisham Esper, Kara Ingraham, Annette N.
Brown
[6] “Understanding perceived social harms and abuses of oral HIV self-
testing in Kenya” Caroline W. Kabiru, Estelle M. Sidze, Thaddaeus Egondi,
Damar Osok, Chimaraoke O. Izugbara

33. www.3ieimpact.orgAnna Heard
What’s next?
Three pilot interventions and impact
evaluations in Kenya
• A Randomized Controlled Trial to Evaluate
Adding Self-Administered Oral HIV Testing as a
Choice in Clinic and Non-Clinic Settings to
Increase HIV Testing Uptake Among Truck
Drivers in Kenya
• Distribution of HIV Oral Self-Tests at Antenatal
Clinics in Kenya
• The Use of HIV Self-tests to Promote Partner
and Couples Testing: A Randomized Trial

34. www.3ieimpact.orgAnna Heard
What’s next?
• Feasibility Study for HIV Self-Testing in
Zambia
• Then two-three pilot interventions with
impact evaluations in Zambia
• Now looking for third country—will start
with pilot interventions and impact
evaluations

35. www.3ieimpact.orgAnna Heard
HIV Evidence Initiative
Annette Brown
Anna Heard
Eric Djimeu
Nancy Diaz