Nearly half of HIV-infected individuals in sub-Saharan Africa (SSA) are unaware of their serostatus. Increasing awareness of serostatus is the first of the UNAIDS “90-90-90” targets and a critical step in ensuring the success of HIV treatment as prevention. HIV self-testing (HIVST) is a promising approach for increasing knowledge of HIV status. With the development of simple, oral fluid-based tests, a number of countries are scaling-up HIV self-testing.
This NIH-funded study seeks to increase HIV testing and reduce high-risk sexual behaviors through ‘secondary distribution’ of HIV self-tests, whereby an individual is given multiple self-tests for distribution in social and sexual networks. The study is a cluster-randomized clinical trial among 2,000 high-risk, HIV-negative women in Kenya’s Nyanza region. Over an 18-month follow-up period, the study will examine outcomes of HIV incidence, identification of HIV positive partners, and unprotected sexual encounters with partners whose status is positive or unknown.
The study enrolled 2,090 women in 66 study clusters (1,033 women from 33 intervention group clusters and 1,057 women from 33 comparison group clusters). Retention at 18 months was 90.1% (N=949) within the intervention group and 87.2% (N=891) in the comparison group.
The baseline characteristics of participants in the two study groups were similar. Participants’ median age was 25 years and 65% were married. The median number of sexual partners in the past month was two and sex work was an income source for 66% of participants.
Participants in the intervention group reported receiving an average of 16.8 self-tests during the study, whereas participants in the comparison group reported receiving an average of 16.3 HIV testing services referral cards. The availability of self-tests had no significant effect on rates of HIV incidence.
While 19 participants in the intervention group acquired HIV compared to 15 in the comparison group, the risk of HIV infection was not significantly different between the intervention groups and comparison groups (1.18 per 100 person-years in the intervention group and 0.98 per 100 person-years in the comparison group, p=0.64).
However, the study found that providing self-tests to women did make it more likely that participants’ primary partners tested for HIV. Nearly 90% of women in the intervention group reported their primary partner tested for HIV in the past 6 months. Couples testing every 6 months and identification of male partners who were HIV positive was also substantially higher because of the self-testing intervention.
These findings underscore the potential for self-tests, when combined with novel distribution strategies, to increase HIV testing coverage. Over the course of the study, the intervention resulted in nearly twice as many male partners who were identified as having HIV.
This is an important result since increasing awareness of HIV status among people living with HIV is a central part of efforts to increase HIV treatment coverage and reduce onward transmission.
Finally, the study also found no significant difference in reported intimate partner violence between the intervention and comparison groups.
Thirumurthy H, Bair EF, Ochwal P, Marcus N, Putt M, Maman S, Napierala S, Agot, K : The Effect of Providing Women Sustained Access to HIV Self-tests on Male Partner Testing, Couples Testing, and HIV Incidence in Kenya: A Cluster-randomised Trial. The Lancet HIV 8(12): e736-e746, Dec 2021.