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

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

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

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

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

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

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)

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

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 …

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

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

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

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

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%)

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

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

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

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

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

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