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临床试验/NCT01376895
NCT01376895已完成1 期

Developing and Testing of an HIV Prevention Intervention Targeting Black Men Who Have Sex With Men and Women (BMSM/W)

Nova Southeastern University2 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
211
试验地点
2
主要终点
unprotected sex

研究概览

简要总结

The goal of this study is to develop and test a program to help Black men who have sex with men and women reduce their chances of getting or giving HIV infection to their sex partners. The program is designed to be delivered via the internet so that it would be available to more men. Men who agree to participate in the study will be assigned by chance to receive the POWER intervention or a similar program that is focused on general health called POWER-HEALTH. They will also complete a computer administered interview when they first enroll in the study, 2 weeks following the last session of the program and 3 months after that. Participants will receive a small compensation for their time and effort.

详细描述

The purpose of this study is to examine the preliminary efficacy, feasibility and acceptability of delivering a culturally and developmentally tailored HIV risk reduction intervention via the Internet in real-time that promotes risk reduction among black men who have sex with men and women (BMSMW). During the Developmental Phase, our activities will consist of completing development (finalizing sessions, completing the manuals) of a theoretically grounded, culturally based, individual intervention, Project POWER, to reduce risk of HIV acquisition and transmission among BMSMW.

The investigators will then conduct a randomized controlled trial (RCT) to test the preliminary efficacy, acceptability, and feasibility of POWER compared to HEALTH. Using chain referral methods, the investigators will recruit 200 BMSMW (100 per arm) and assign them to 1 of 2 conditions (POWER or HEALTH). Participants will complete an assessment battery delivered via ACASI at baseline, immediate post intervention and at 3 months post intervention. The investigators will also measure uptake of HIV and STI testing. Participants will also complete acceptability/feasibility assessments after the

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Self identify as Black or African descent
  • At least 18 years of age
  • Resident of Chicago MSA
  • Sexually active with men and women

排除标准

  • Previously participated in the study
  • Identify as transgendered

结局指标

主要结局

unprotected sex

时间窗: last 3 month

Unprotected sex refers to either vaginal or anal sex

次要结局

  • number of sex partners(last 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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