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临床试验/NCT01347164
NCT01347164已完成2 期

Development and Testing of HIV Prevention Interventions Targeting Black MSM/W

Public Health Management Corporation2 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2010年12月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
169
试验地点
2
主要终点
increased condom use

研究概览

简要总结

Black men who have sex with men (MSM) have the highest rates of HIV infection in the United States and represent a population in need of new HIV prevention interventions. Although 20 to 40% of Black MSM are estimated to have female partners, no interventions tailored to the needs of Black MSM/W have been developed and rigorously evaluated. This project will develop, implement, and evaluate an individual-level intervention (ILI), titled "RISE", that will assist Black MSM/W to reduce their risk for acquiring and transmitting HIV infection. This intervention will address the effect of individual level factors, interpersonal relationships including sexual, peer and family relationships, and socio-cultural influences on the sexual risk behaviors of MSM/W. The intervention will consist of six counseling sessions held between a trained counselor and participant, and will be guided by three theoretical perspectives: an ecological perspective of behavior, stress and coping theory, and social cognitive theory. The COLOURS Organization, the sole agency in Philadelphia dedicated to exclusively serving the Black LGBT community, will be a key collaborator in the development and implementation of the intervention. The evaluation design utilizes a randomized controlled trial to test the effectiveness of the proposed intervention. Chain referral, based on principles of respondent-driven sampling, will be used to recruit 250 HIV-positive and HIV-negative Black bisexually-active men into this study.

The specific aims of this research are to:

  • develop a new theoretically-based individual-level HIV prevention intervention culturally tailored to the needs of HIV-positive and HIV-negative Black MSM/W;
  • evaluate the intervention with a randomized control group design, using RDS to recruit 250 Black MSM/W who do not inject drugs and who report recent unprotected sex;
  • assess the efficacy of the intervention and test the intervention model through the collection of behavioral risk assessments and HIV and STD testing at three time points: baseline, immediately post-intervention and three-months post-intervention;
  • examine and describe individual factors, interpersonal relationships and network factors, and socio-cultural factors that may affect risk behaviors for HIV infection and transmission among Black MSM/W;
  • develop recommendations for recruiting Black bisexually-active men and providing them with targeted HIV prevention interventions.

Evaluation data collection will be conducted using ACASI. Data analysis will include Repeated Measures ANOVA to make assessments of changes over time and intervention dose effects and structural equation modeling to assess causal associations between factors in the conceptual model. This proposed study has significance for increasing our understanding various types of factors that may affect sexual risk behaviors of Black MSM/W as well as potentially providing an important new tool for HIV prevention specifically targeting the needs and risk behaviors of Black MSM/W.

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 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • male and female sex partners past 12 months

排除标准

  • 未提供

研究组 & 干预措施

Life coaching sessions

Experimental

6 2-hour counseling session with trained therapist/counselor. The sessions deal with coping and stress reduction as well as sexual health.

干预措施: RISE life coaching intervention (Behavioral)

HIV counseling session

Active Comparator

One 60-minute counseling session, based on standard HIV counseling content.

干预措施: HIV Counseling (Behavioral)

结局指标

主要结局

increased condom use

时间窗: at follow-up 3 months post-intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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