Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention

NCT06370923 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3591

Last updated 2025-05-04

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Community Health Worker Distribution

Distribution of HIV self tests by community health workers

Sponsors & Collaborators

  • Biomedical Research and Training Institute, Zimbabwe

    collaborator OTHER
  • Imperial College London

    collaborator OTHER
  • University of Lincoln

    collaborator OTHER
  • University College London Hospitals

    collaborator OTHER
  • University of Copenhagen

    collaborator OTHER
  • University of Washington

    collaborator OTHER
  • Heidelberg University

    collaborator OTHER
  • University of Stellenbosch

    lead OTHER

Principal Investigators

  • Frank Tanser, PhD · University of Stellenbosch

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • Zimbabwe

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06370923 on ClinicalTrials.gov