Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention

NCT06370923 | Recruiting

• 1 other identifier: 1R01MH133488-01
• Study Type: interventional
• Target: 3,591
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV self test; HIV Pre Exposure Prophylaxis; Peer Networks

Outcome Measures

Primary Outcomes (1)

• HIV pre-exposure prophylaxis (PrEP) initiation

  A comparison between the intervention and control arms of the proportions of men aged 18 and above initiating PrEP

  Up to 6 months from the start of HIVST distribution in the local intervention clusters

Secondary Outcomes (7)

• Antiretroviral Therapy initiation

  Up to 6 months from the start of HIVST distribution in the local intervention clusters

• Antiretroviral Therapy or HIV pre-exposure prophylaxis (PrEP) initiation

  Up to 6 months from the start of HIVST distribution in the local intervention clusters

• HIV testing

  Up to 6 months from the start of HIVST distribution in the local intervention clusters

• Confirmed positive HIV test

  Up to 6 months from the start of HIVST distribution in the local intervention clusters

• HIV testing after the use of an HIV self test

  Up to 6 months from the start of HIVST distribution in the local intervention clusters

Study Arms (2)

Peer Distribution

EXPERIMENTAL

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: Peer Distribution

Community Health Worker Distribution

ACTIVE COMPARATOR

This will be the Standard of Care, HIVST kits distributed by Community health workers in the Control clusters.

Behavioral: Community Health Worker Distribution

Interventions

Peer Distribution BEHAVIORAL

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.

Peer Distribution

Community Health Worker Distribution BEHAVIORAL

Distribution of HIV self tests by community health workers

Community Health Worker Distribution

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident in study site

Sponsors & Collaborators

• University of Stellenbosch: lead
• Biomedical Research and Training Institute, Zimbabwe: collaborator
• Imperial College London: collaborator
• University of Lincoln: collaborator
• University College London Hospitals: collaborator
• University of Copenhagen: collaborator
• University of Washington: collaborator
• Heidelberg University: collaborator

Study Sites (1)

BRTI - Manicaland Centre for Public Health Research

Mutare, Manicaland Province, Zimbabwe

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Frank Tanser, PhD

  University of Stellenbosch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Constance Nyamukapa, PhD

CONTACT

+263 71 480 4050; nyamukapaconnie@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysts blinded to allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster randomised trial

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 17, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 4, 2025

Record last verified: 2025-05

Locations

ZI (1)