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

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

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
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• Resident in study site

Locations
Other Locations
Zimbabwe
BRTI - Manicaland Centre for Public Health Research
RECRUITING
Mutare
Contact Information
Primary
Constance Nyamukapa, PhD
nyamukapaconnie@gmail.com
+263 71 480 4050
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 3591
Treatments
Experimental: Peer Distribution
In intervention clusters 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-based risk assessment will expedite PrEP initiation at the clinic.
Active_comparator: Community Health Worker Distribution
This will be the Standard of Care, HIVST kits distributed by Community health workers in the Control clusters.
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, University of Copenhagen, University of Lincoln, Imperial College London, Heidelberg University, University College London Hospitals, Biomedical Research and Training Institute, Zimbabwe
Leads: University of Stellenbosch

This content was sourced from clinicaltrials.gov