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临床试验/NCT03774160
NCT03774160已完成不适用

Combination HIV Prevention, Linking Prevention and Care, for Hispanic Men

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2017年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
458
试验地点
1
主要终点
condomless anal sex

研究概览

简要总结

This project involves adapting 3 new intervention components, and then testing them, in combination with a multi-level, community-based intervention, to promote HIV prevention and sexual health among men who have sex with men and transgender women in Lima, Peru. The total intervention has a community-based intervention and a systems-level intervention at the hospital where people living with HIV get care and medications.

详细描述

Mpowerment (MP) is an evidence-based community-level, structural, social and behavioral intervention for HIV prevention for young men who have sex with men (MSM). MP targets individual and community empowerment and community mobilization, self-affirmation, sexual self-knowledge and creation of a supportive and affirming social environment. MP has been widely used in the U.S. but not in Peru, with the exception of earlier pilot research. In the earlier research, MP was adapted for the sociocultural issues facing MSM and transgender (trans) women in Peru, and only focused risk reduction and increasing HIV testing. In addition to the MP (which is called the community-based intervention), a health systems component has been added. The health systems includes (1) sensitization of hospital staff (where people living with HIV obtain their medication) to the issues facing transgender women and MSM; (2) the use of Navigators, who help MSM and trans women at the hospital navigate the system of care and remain in care; and (3) a focus on "positive prevention", in which providers talk about the positive aspects of maintaining in care and being virally suppressed instead of only talking about "avoiding death." There is a 2.5 year implementation of the intervention, called "Projecto Orgullo Plus" or Project Pride Plus, which involves a longitudinal cohort of MSM/trans in two large districts of Lima, Peru. Primary outcomes will be unprotected anal sex and HIV testing. Secondary outcomes will be self-reported visits to hospital for care and adherence to medications.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Must live in either East Lima District or South Lima District
  • identify as man who has sex with men or transgender woman who has sex with men
  • be between the ages of 18 - 40

排除标准

  • not residing in either East or South District of Lima
  • not MSM or transgender woman

结局指标

主要结局

condomless anal sex

时间窗: 37 months post-baseline

condomless anal sex with HIV+ or unknown status partners, assessed via questionnaire

HIV testing ever

时间窗: 37 months post-baseline

if have ever tested for HIV

HIV testing frequency

时间窗: 37 months post-baseline

frequency of HIV testing by report on questionnaire

次要结局

  • If virally suppressed(37 months post-baseline)
  • If enrolled in care(37 months post-baseline)
  • Taking medications adherently(37 months post-baseline)
  • Seeking regular HIV care(37 months post-baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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