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临床试验/NCT05685498
NCT05685498已完成不适用

Peer-led HIV Self-testing to Improve HIV Testing and Linkage to HIV Care Among Men in Two Fishing Communities in Rural Uganda: a Pilot Intervention

Joseph KB Matovu2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
Percentage of linked HIV-positive men who have been retained in HIV care

研究概览

简要总结

The goal of this behavioral interventional study is to assess the feasibility and acceptability of a peer-led HIV self-testing intervention among men in two fishing communities along the shores of Lake Victoria in Uganda. The main objectives of the study are: a) to assess the feasibility of implementing a peer-led HIV self-testing intervention among men in a fishing community context; b) determine the uptake of HIV self-testing among men in the fishing communities, and c) determine linkage to and retention in HIV care among newly diagnosed HIV-positive men following peer-led HIV self-testing. Participants will:

  • Be administered a baseline questionnaire to assess prior HIV testing behaviors and willingness to self-test for HIV
  • Receive two HIV self-test kits, one for them and one for someone else that they prefer to give the kit, to determine HIV testing behaviors among men and their significant others
  • Be administered follow-up questionnaires at one (1), six (6) and 12 months post-baseline to determine linkage to and retention in HIV care among those testing HIV-positive, as well as linkage to appropriate HIV prevention services among those testing HIV-negative.

详细描述

Background

In this study, investigators propose to use a social network-based, peer-led HIV self-testing model to assess uptake of HIV testing, as well as linkage to appropriate HIV prevention, care and treatment services in two high HIV prevalence island districts with limited access to HIV and other health services.

Primary aims

  1. Compare approaches for peer-leader selection in two fishing communities in order to identify suitable peer-leader selection approaches for typical fishing communities.
  2. Assess uptake of HIV testing services associated with peer-led HIV self-testing among men living in two high HIV prevalence fishing communities
  3. Assess the effect of a peer-led HIV self-testing (HIVST) model in: (i) identifying previously undiagnosed HIV infections; (ii) improving linkage to HIV care among newly identified HIV-positive individuals; and (iii) improving retention in HIV care among linked HIV-positive individuals

Study sites The intervention will be conducted in two different fishing communities (one in each district) located in two high HIV prevalence island districts of Buvuma and Kalangala, located in Lake Victoria, Uganda.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Age 15 years or older
  • Residence in the targeted fishing community (and intended to stay for 12 or more months)
  • Self-reported HIV-negative or unknown HIV status at enrolment
  • Last HIV test was done three or more months from the time of enrolment

排除标准

  • Men reporting a history of intimate partner violence in the past year preceding the survey
  • Men who did not belong to pre-identified social networks in the community
  • Men who were mentally incapacitated to understand the informed consent process
  • Unemancipated minors aged 15-17 years

结局指标

主要结局

Percentage of linked HIV-positive men who have been retained in HIV care

时间窗: Six to 12 months after linkage to HIV care

Investigators will aim to assess the percentage of linked HIV-positive results who have been retained in HIV care (i.e. percentage of linked HIV-positive men who will still be receiving their antiretroviral therapy over the study duration).

Percentage of men who have self-tested for HIV

时间窗: One month from the time of receiving the kits.

Men will receive HIV self-test kits and be trained in how to use them as well as read and interpret results by trained peer-leaders. Uptake of HIV self-testing will be defined as the percentage of those that received HIV self-test kits from their peer-leaders who actually used them to self-test for HIV.

Percentage of men with confirmed HIV-positive results who have been linked to HIV care

时间窗: One to six months after a HIV-positive self-test result

As per the manufacturer's instructions, all men with HIV-positive self-test results will be required to seek confirmatory HIV testing at the nearest health facility or at an outreach event, as case may be. For this outcome, we will aim to assess the percentage of men with confirmed HIV-positive results who have been linked to HIV care services (i.e. the percentage of men with confirmed HIV-positive results who have been started on antiretroviral therapy as per Uganda's national test and treat policy).

次要结局

  • Percentage of men with confirmed HIV-positive results who have disclosed their HIV-positive status to their peer-leaders(Six to 12 months after HIV self-testing)
  • Percentage of men with confirmed HIV-positive results who have been linked to HIV care at community-based mobile outreaches.(Six to 12 months after HIV self-testing)

研究者

发起方
Joseph KB Matovu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joseph KB Matovu

Senior Lecturer

Busitema University

研究点 (2)

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