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Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention - Trial NCT06370923

Access comprehensive clinical trial information for NCT06370923 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Stellenbosch and is currently Not yet recruiting. The study focuses on HIV Infections. Target enrollment is 3591 participants.

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NCT06370923
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behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06370923
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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

Study Focus

HIV Infections

Peer Distribution

Interventional

behavioral

Sponsor & Location

University of Stellenbosch

Timeline & Enrollment

N/A

Jul 01, 2024

Dec 01, 2028

3591 participants

Primary Outcome

PrEP initiation

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.

ICD-10 Classifications

HIV disease resulting in other viral infections
HIV disease resulting in other bacterial infections
HIV disease resulting in multiple infections
Acute HIV infection syndrome
HIV disease resulting in other infectious and parasitic diseases

Data Source

ClinicalTrials.gov

NCT06370923

Non-Device Trial