NCT06370923Recruiting
Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention
Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention: A Large-scale Cluster Randomized Trial to Increase HIV Self-testing and PrEP Uptake Among Men in Eastern Zimbabwe
Source: ClinicalTrials.gov · Last updated 4 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination. Suboptimal engagement with HIV prevention by men increases their risk of HIV acquisition, and is an important driver of new HIV infections in women. HIV self-testing (HIVST) addresses several key facility-based access barriers and HIVST distribution through leveraging male peer networks for HIV prevention is feasible, acceptable and effective in SSA. The objective of this project is to use an implementation science approach to establish the impact of HIVST distribution through male social networks, with phone-based support and improved risk perception, on PrEP (Pre-Exposure Prophylaxis) uptake among men in Eastern Zimbabwe. The project will leverage infrastructure and data associated with 20-year programme of HIV surveillance and behavioural research in a well-characterized population cohort hosted by the Manicaland Centre for Public Health Research, Zimbabwe. The study will utilise a cluster randomised design of 44 clusters (22 Intervention:22 control) comprising on average 81 men in each cluster (total N = 3591) followed for 6 months (giving \>80% power to detect a difference in PrEP initiation among men of 2% versus 8.5%). In intervention clusters the investigators will identify initial distributors who will receive an HIVST kit for personal use and HIVST kits to distribute to local peers. These peers can subsequently become distributors, allowing the intervention to propagate through peer networks. A toll-free helpline will provide pre- and post-test support and an SMS (Short Message Service) -based risk assessment will expedite PrEP initiation at the clinic. The study team will conduct a performance (process) evaluation of the intervention. to assess implementation fidelity, causal mechanisms underlying trial effectiveness including how characteristics of peer networks affect outcomes. Results of the study will be used to quantify the population level impacts and cost-effectiveness of male peer to peer HIVST distribution strategies on the uptake of PrEP in HIV hyper-endemic settings using a fully calibrated individual-based mathematical model. The envisaged long-term impact of this research is the development of a generalizable, multicomponent male peer-based HIVST and PrEP uptake model for settings where HIV incidence is high.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3591 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 21 Oct 2024
- Primary completion date
- 31 May 2028
- Lead sponsor
- University of Stellenbosch
- Diseases
- HIV
- NCT number
- NCT06370923
What you commit to
- Study type: Interventional
- Planned participants: 3591
- From 21 Oct 2024 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Resident in study site
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BRTI - Manicaland Centre for Public Health Research Coordinator of this site? Confirm its status | Mutare | Zimbabwe | Recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.