Providing HIV self-test kits to women who sell sex for distribution to their male partners
Reaching the Last 20%: a Targeted HIV Self-test Secondary Distribution Intervention to Engage High-risk Men in Kenya
This study is testing if giving HIV self-test kits to women who sell sex can help them share these kits with their male partners to encourage more men to get tested and access treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | RTI International Academic / other |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT05882916 on ClinicalTrials.gov |
What this trial studies
This cluster randomized controlled trial aims to evaluate the effectiveness of distributing multiple oral fluid-based HIV self-test kits to women who sell sex, enabling them to share these kits with their male partners who purchase sex. The study will take place in Kisumu and Siaya counties in Western Kenya, targeting high-risk populations to enhance HIV service uptake. Participants will receive counseling on the use of self-test kits, which include tailored information about local clinic services and the benefits of antiretroviral therapy and pre-exposure prophylaxis. The intervention's impact on male partners' engagement with HIV services will be monitored to assess its effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who exchange sex for compensation and are willing to distribute HIV self-test kits to their male partners.
Not a fit: Patients who do not engage in sex for compensation or are unwilling to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase HIV testing and service uptake among high-risk male populations.
How similar studies have performed: Preliminary data suggest that secondary distribution of HIV self-tests is feasible and acceptable, indicating potential for success in this innovative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age ≥18 years * Reports exchanging sex for compensation with ≥2 men in the past month * Engages in sex for compensation in the intervention cluster catchment area * Willing to participate in a brief questionnaire 6 weeks after enrollment * Plan to remain in the area of study recruitment for the next 8 weeks Exclusion Criteria: * Unwilling or unable to provide informed consent for participation
Where this trial is running
Kisumu
- Impact Research and Development Organization (IRDO) — Kisumu, Kenya (Recruiting)
Study contacts
- Principal investigator: Sue Napierala, PhD, MPH — RTI International
- Study coordinator: Sue Napierala, PhD, MPH
- Email: snapierala@rti.org
- Phone: 5104188198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.