Reaching the Last 20%: a Targeted HIV Self-test Secondary Distribution Intervention to Engage High-risk Men in Kenya

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This cluster randomized controlled trial will test whether the provision of multiple oral fluid-based HIV self-test kits to women who sell sex (WSS) to secondarily distribute to their male partners who purchase sex can promote uptake of HIV service use by male partners. The study will recruit adult women who report exchanging sex for compensation in Kisumu and Siaya counties in Western Kenya. In clusters randomized to the intervention, WSS will be given multiple HIV self-tests and counseled to distribute them to men who purchase sex (MPS). Self-test kits will contain instructions for use and tailored information on clinic location and hours within the cluster, and pilot-tested messaging on the benefits of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP). In control clusters, standard of care HIV services will continue to be available. To objectively assess impacts of the intervention on post-HIVST linkage outcomes, the investigators will monitor use of HIV services by men at HIV clinics in both study arms on a monthly basis. Our goal will be to determine whether confirmatory testing (primary outcome), case diagnoses, ART initiation, and PrEP initiation by men in intervention clusters are higher than in control clusters. Mixed methods research will be utilized to conduct a process evaluation to assess mechanisms that may have impacted intervention effectiveness, pathways for linkage among MPS, and support for men's linkage to HIV services under a secondary distribution model. Cost-effectiveness analyses will also be undertaken.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Kenya
Impact Research and Development Organization (IRDO)
RECRUITING
Kisumu
Contact Information
Primary
Sue Napierala, PhD, MPH
snapierala@rti.org
5104188198
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-08-07
Participants
Target number of participants: 5000
Treatments
Experimental: HIV self-test secondary distribution
The investigators will provide women who sell sex enrolled in the study with multiple World Health Organization (WHO) and Kenya-approved oral fluid-based HIV self-test kits. Participants will be counseled to secondarily distribute self-tests to their male transactional sex partners. Self-test kits will contain instructions for use and tailored information on clinic locations and hours within the cluster, the benefits of early ART use, and the availability and benefits of PrEP.
Related Therapeutic Areas
Sponsors
Collaborators: University of North Carolina, Chapel Hill, Impact Research & Development Organization, University of Pennsylvania
Leads: Sue Napierala

This content was sourced from clinicaltrials.gov