1. Promoting male partner and couples testing through secondary distribution of self-tests by pregnant and postpartum women: a randomized trial
Kawango Agot1, Beatrice Obonyo1, Sam Masters2, Suzanne Maman2, Sue Napierala Mavedzenge3, Harsha Thirumurthy2
1 Impact Research and Development Organization, Kenya
2 University of North Carolina at Chapel Hill, United States
3 RTI International, United States

2. Background
Inadequate HIV testing limits success of biomedical prevention and contributes to new infections
Particularly among men and couples, testing uptake and awareness of HIV infection remains low in SSA
In Kenya, 62% of men ever tested (80% women) and 53% were aware of own HIV infection (62% women; 48% men) – far from the UNAIDS 90% target
Couples testing also remains low
Novel strategies are needed to increase testing coverage
1Ng’ang’a et al. JAIDS 2014

3. Secondary distribution of self-tests
HIV self-testing (HIVST) has high acceptability1,2,3 and is already included in the National Policy on HIV Testing Services in Kenya
Secondary distribution of self-tests by individuals may help increase partner and couples testing
In 2015, pilot study in Kenya showed that FSW as well as pregnant & postpartum women can safely distribute self-tests to their partners4
We sought to test whether this approach is more effective at promoting male partner testing than conventional approaches
1Choko et al. PLOS Med 2011; 2Mavedzenge et al. CID 2013; 3Johnson et al. AIDS Behav 2014; 3Thirumurthy et al. Lancet HIV 2016

4. Methods
Randomized trial to determine whether providing multiple HIV self- tests to pregnant and postpartum women is more effective in promoting male partner testing than providing the women with an invitation for their male partner to test at a clinic
Study population and setting: pregnant and postpartum women recruited from three ANC and PPC clinics in Kisumu, Kenya

5. Eligibility criteria Women aged 18-39 years
ANC: 20 weeks gestation period
PPC: has infant aged 6 weeks-12 months
Partner HIV status unknown or known negative
Resident of Kisumu and intend to remain in area for 3 months
Did not believe violence would result from distributing self-test to partner

6. Randomization and intervention group
Following informed consent and baseline interview at clinic, women randomized to one of two groups
HIVST group: Women were given two oral fluid based HIV self-tests to take home with them
Women shown how to correctly use the self- tests at the time of enrollment
In addition, written and pictorial instructions were provided with each self-test along with encouragement to distribute self-tests to their male partner at their own discretion

7. Comparison group
Comparison group: Women given referral vouchers that invited their partner to obtain HIV testing at VCT clinics, alone or as a couple
Referral vouchers collected at each of the 3 study clinics and linked to participant
All women given information on where to seek HIV care, phone number for receiving assistance, information on where to receive services if experiencing intimate partner violence (IPV)

8. Follow-up procedures
Women contacted periodically over 3-month period to assess whether they had distributed a self-test to their sexual partner (intervention group) or if their partner had gone for clinic-based testing (control group)
All women contacted at 3 months for follow-up interview to assess
Whether partner had sought HIV testing in past 3 months
Sexual behavior and decision making (e.g., condom use)
Experienced adverse events, including IPV

9. Outcomes and analyses
Primary outcome for study was women’s report of whether their partner had an HIV test within 3 months of enrollment
Secondary outcomes:
Discussed HIV testing with partner
Tested together with partner (couples testing)
Learned partner’s HIV status
Experienced intimate partner violence (IPV)
Outcomes in the HIVST and comparison groups were compared using an unadjusted modified Poisson regression with robust standard errors …

10. Results
Between June 2015 and October 2015, a total of 1,929 women were screened for participation at 3 study facilities
614 (32%) determined to be ineligible
Reasons: no primary partner (28%), partner HIV-positive (22%), intention of leaving study area during follow-up period (15%), age (16%), fear of IPV (5%)
715 (37%) declined to participate
600 (31%) enrolled and randomized
Follow-up interviews conducted until February 15, 2016
Follow-up completed for 570 (95%)
286 (94.4%) in comparison group, 284 (95.6%) in HIVST group

11. Baseline characteristics of participants
Comparison group (N=286)
HIVST group (N=284)
Age, mean (SD)
24.2 (4.3)
24.2 (4.5)
Married
266 (93)
266 (94)
Education
Some primary or completed
138 (48)
143 (50)
Some secondary education
133 (47)
120 (42)
Completed secondary or greater
15 (5)
21 (7)
Self-reported HIV-positive
10 (3.5)
13 (4.6)
Has your partner ever tested for HIV
Yes
220 (77)
216 (76) No
19 (7)
Don't know
47 (16)
47 (17)
Notes: For all variables frequencies are presented with percentages in parentheses except where noted

12. Primary outcome: male partner testing
Comparison group
No. (%),
(N=286)
HIVST group
(N=284)
Difference,
% (95% CI)
Male partner HIV testing
148 (51.7)
258 (90.8)
39.1 (32.4 to 45.8) .
Partner testing in comparison group was 51.7% - comparable to other estimates based on partner invitation approach
Partner testing was 90.8% in HIVST group

13. Primary outcome – partner testing
Comparison group
No. (%),
(N=286)
HIVST group
(N=284)
Difference,
% (95% CI)
Male partner HIV testing
148 (51.7)
258 (90.8)
39.1 (32.4 to 45.8)
Among the eight partners who tested positive in the HIVST group, two went for confirmatory testing and were linked to care. Among the four partners who tested positive in the comparison group, three were reported to have sought HIV care at the time of the 3-month interview.
Partner testing was 39% higher in the HIVST group than in the comparison group, a difference that was statistically significant
Participants who reported their partner tested HIV-positive: 4 (1.4%) in comparison group, 8 (2.8%) in HIVST group

14. Secondary outcome – discuss testing
Comparison group
No. (%)
(N=286)
HIVST group
No. (%),
(N=284)
Difference,
% (95% CI)
Discuss HIV testing
276 (96.5)
271 (95.4)
-1.1 (-4.3 to 2.2)
Secondary outcomes provide further information on impact of the secondary distribution intervention
Outcomes examined:
Discussion of testing between the participant and partner
Couples testing, partner and participant testing at same time
Disclosure, participant learned partner’s status
Intimate partner violence associated with testing
Nearly all participants in both study groups discussed testing with their partner (>95%)

15. Secondary outcome – couples testing
Comparison group
No. (%)
(N=286)
HIVST group
No. (%),
(N=284)
Difference,
% (95% CI)
Discuss HIV testing
276 (96.5)
271 (95.4)
-1.1 (-4.3 to 2.2)
Couples testing for HIV
95 (33.2)
214 (75.4)
42.1 (34.7 to 49.6)
Couples testing was 42% more likely in the HIVST group than the comparison group
Couples testing was lower than partner testing in both groups

16. Secondary outcome - disclosure
Comparison group
No. (%)
(N=286)
HIVST group
No. (%),
(N=284)
Difference,
% (95% CI)
Discuss HIV testing
276 (96.5)
271 (95.4)
-1.1 (-4.3 to 2.2)
Couples testing for HIV
95 (33.2)
214 (75.4)
42.1 (34.7 to 49.6)
Learned partner’s HIV status
145 (50.7)
255 (89.8)
39.1 (32.3 to 45.9)
Women in HIVST group were significantly more likely to learn their partner’s HIV status

17. Secondary outcome – IPV
Comparison group
No. (%)
(N=286)
HIVST group
No. (%),
(N=284)
Difference,
% (95% CI)
Discuss HIV testing
276 (96.5)
271 (95.4)
-1.1 (-4.3 to 2.2)
Couples testing for HIV
95 (33.2)
214 (75.4)
42.1 (34.7 to 49.6)
Learned partner’s HIV status
145 (50.7)
255 (89.8)
39.1 (32.3 to 45.9)
IPV due to HIV testing
1 (0.3)
1 (0.4)
0.0 (-1.0 to 1.0)
There was no difference in IPV associated with HIV testing between the two groups

18. Subgroup analyses
In all subgroups we examined, partner testing was higher among women in HIVST group
All three study sites
Among women whose partner had and had not tested in past 12 months
Among women who did and did not report experiencing IPV at baseline
Intervention effectiveness was not significantly different between these subgroups

19. Conclusions
Secondary distribution of HIV self-tests is a safe and effective strategy for promoting male partner testing
Intervention achieved extremely high level of reported partner testing
Results suggest this is a promising way to ensure that self-tests reach people who currently have low rates of HIV testing
Distribution strategies such as the one tested here should be considered in order to maximize the effectiveness of HIVST scale-up

20. Acknowledgments Study participants and facility staff
Ministry of Health, National and Kisumu County
Kisumu CH, Lumumba HC, Rabuor HC
Research Assistants
Carolina Population Center