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临床试验/NCT01722838
NCT01722838已完成不适用

An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention

Loyola University Chicago2 个研究点 分布在 1 个国家目标入组 438 人开始时间: 2012年9月1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
438
试验地点
2
主要终点
reductions in sexual risk behaviors

研究概览

简要总结

B-ME is a research intervention study designed to address the needs of African American men who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is to decrease HIV risk behaviors among African American MSM using an intervention developed by and for African American MSM.

The hypothesis guiding this study is: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group.

详细描述

The Specific Aims of this study are 1) to further explicate and develop the intervention, 2) to evaluate its efficacy in reducing HIV risk behaviors and 3) to expand the limited body of research on HIV prevention/risk reduction practices for African American men who have sex with men(AAMSM). The study will use a randomized-controlled trial design to compare receiving B-ME intervention to receiving basic men's health and wellness messaging (standard of care), hypothesizing: hypothesizing: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group. The study will utilize a pre-test/post-test design with participants randomized to intervention and comparison groups; have a strategy to retain at least 80% of participants through study completion; collect data at baseline, at 3 months post-intervention, and at 6 months post-intervention; and rigorously measure outcomes that directly impact HIV risk. Data will be collected at each assessment point to assess B-ME's ability to improve behavioral outcomes that directly impact Black MSM HIV risk: (1) number of unprotected anal and vaginal sex events; (2) number of unprotected sex events with persons of unknown HIV status; (3) frequency of HIV testing, and (4) increased communication between partners about sex and strategies for reducing the risk of HIV infection.

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
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • a) Be 18 to 55 years old b) Self identify as African American (Black national) c) Self identify as a male (because this is a study of an intervention to impact change among Black MSM, only self identified males will be included, therefore no females or transgendered identified persons will be included).
  • d) Report being sexually active in the past 30 days (ie., one or more instances of vaginal or anal sex with a male or female) e) Report at least one instance of unprotected anal or oral sex with a male identified partner in the past year f) Have not previously participated in the CTCA intervention. g) Have not received an evidence-based HIV prevention intervention in the past 180 days

排除标准

  • Men are ineligible to participate in the trial if they:
  • Identify as a transgender woman; OR
  • Plan to move before the end of the study; OR
  • Have participated in any HIV or substance use prevention studies in the last 180 days.

结局指标

主要结局

reductions in sexual risk behaviors

时间窗: baseline, 3-month, 6-month

Unprotected anal or vaginal sex and condom use during

次要结局

未报告次要终点

研究者

发起方
Loyola University Chicago
申办方类型
Other
责任方
Sponsor

研究点 (2)

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