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临床试验/NCT06370923
NCT06370923招募中不适用

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

University of Stellenbosch1 个研究点 分布在 1 个国家目标入组 3,591 人开始时间: 2024年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,591
试验地点
1
主要终点
HIV pre-exposure prophylaxis (PrEP) initiation

研究概览

简要总结

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.

详细描述

The study will use a cluster-randomised trial design with clusters based on existing village boundaries, which have been utilised as part of an ongoing population-based HIV surveillance. In some cases, neighbouring villages will be aggregated to give approximately equal numbers of adult men in each cluster.

The study cohort from which participants will be recruited is located in Manicaland province, east Zimbabwe.

The intervention will proceed with the following steps:

i. Potential primary distributors will be identified by the research team following engagement with local key informants, these individuals will be contacted and screened for study enrolment. The desired characteristics of these individuals would be that they are members of their community with strong local networks of peers. If they choose to participate an informed consent procedure will be completed by the fieldworkers.

ii. If enrolled, the distributor will be given a pack containing four HIVST kits, one for their own use and three for distribution within the cluster. The study team will collect basic demographic data (name/age / cell number) for the distributor and the intended recipients. They will also record the unique ID of the pack of kits. Advice will be provided on the correct use and interpretation of the HIVST, the need for post-test confirmatory testing in a health facility and the availability of HIV prevention methods including PrEP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Analysts blinded to allocation

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Resident in study site

排除标准

  • 未提供

结局指标

主要结局

HIV pre-exposure prophylaxis (PrEP) initiation

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

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

次要结局

  • 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)
  • Attendance at first PrEP follow-up visit(Up to 8 months from the start of HIVST distribution in the local intervention clusters)
  • Attendance at first ART follow-up visit(Up to 8 months from the start of HIVST distribution in the local intervention clusters)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank Tanser

Professor

University of Stellenbosch

研究点 (1)

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