protocolSection identificationModule nctId: NCT06370923, orgStudyIdInfo id: 1R01MH133488-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01MH133488-01, briefTitle: Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention, acronym: IMPERATIVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Stellenbosch, class: OTHER, collaborators name: Biomedical Research and Training Institute, Zimbabwe, collaborators name: Imperial College London, collaborators name: University of Lincoln, collaborators name: University College London Hospitals, collaborators name: University of Copenhagen, collaborators name: University of Washington, collaborators name: Heidelberg University, descriptionModule briefSummary: 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., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster randomised trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Analysts blinded to allocation, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 3591, type: ESTIMATED, armsInterventionsModule interventions name: Peer Distribution, interventions name: Community Health Worker Distribution, outcomesModule primaryOutcomes measure: PrEP initiation, secondaryOutcomes measure: PrEP adherence, secondaryOutcomes measure: ART adherence, secondaryOutcomes measure: Confirmatory tests, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-11-07, uploadDate: 2024-04-11T04:41, filename: Prot_000.pdf, size: 766804, hasResults: False