Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Stellenbosch

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Resident in study site

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Community Health Worker Distribution

    Behavioral

    Distribution of HIV self tests by community health workers

Treatment groups

3,591 Participants
are divided into 2 treatment groups
Group A: Peer DistributionExperimental treatment 1 intervention
Group B: Community Health Worker DistributionActive comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Antiretroviral Therapy initiation

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

Time frame
Up to 6 months from the start of HIVST distribution in the local intervention clusters
2

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

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

Time frame
Up to 6 months from the start of HIVST distribution in the local intervention clusters
3

HIV testing

A comparison between the intervention and control arms of the proportions of men aged 18 and above taking an HIV test in the clinic.

Time frame
Up to 6 months from the start of HIVST distribution in the local intervention clusters
4

Confirmed positive HIV test

A comparison between the intervention and control arms of the proportions of men aged 18 and above taking an HIV test in the clinic who are diagnosed HIV positive.

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

Other outcomes

Sponsors and contacts

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University of Stellenbosch

Lead sponsor

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