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临床试验/NCT02556294
NCT02556294已完成不适用

Fostering Resilience to Psychosocial and HIV Risk in Indian MSM

Massachusetts General Hospital4 个研究点 分布在 2 个国家目标入组 608 人开始时间: 2015年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
608
试验地点
4
主要终点
Number of incident STIs from Baseline

研究概览

简要总结

India has the world's third largest HIV epidemic and men who have sex with men (MSM) are an identified high risk group. MSM in India face unique psychosocial stress underlying the context of HIV risk. To maximize the potential impact of an HIV prevention intervention, the purpose of this study is to test, in a two-arm randomized controlled efficacy trial, a behavioral intervention that addresses both psychosocial / contextual stress and reducing participant's risk for HIV.

详细描述

India has the world's third largest HIV epidemic, and MSM in India have an estimated seroprevalence of 14.7%. Many HIV prevention efforts for MSM in India are limited to condom distribution and HIV education, with no existing efficacy trials of HIV prevention interventions and therefore no evidenced based HIV prevention interventions this population. MSM in India are hidden, stigmatized, and face considerable psychosocial stressors, including pressure to marry, which potentially increases the risk for HIV transmission to their wives.

This proposal is the culmination of our ongoing, successful > 10-year community based research collaboration with two NGOs dedicated to HIV prevention among MSM, Sahodaran (Chennai) and The Humsafar Trust (Mumbai), and investigators from the India Council of Medical Research (ICMR), National Institute for Research in Tuberculosis (NIRT) in Chennai. Our work, including extensive community advisory input, has identified self-acceptance as a key resilience variable that protects against both HIV risk and psychosocial distress. A field test and pilot randomized controlled trial of our behavioral intervention that addresses both HIV risk and self-acceptance showed high participant acceptability and feasibility of study procedures, and success reducing HIV sexual risk behavior.

The current study is a two-arm randomized controlled trial to reduce HIV, STI and sexual transmission risk compared to HIV/STI counseling and testing alone.

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
Single (Outcomes Assessor)

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

  • 未提供

排除标准

  • Participant does not identify as male
  • Younger than 18
  • Is unable to understand or consent to the procedures
  • Is deemed by the local PI or study staff to be engaging in deception about the inclusion/exclusion criteria.

研究组 & 干预措施

Self-acceptance behavioral intervention

Experimental

The intervention will consist of individual and 4 group counseling sessions and 6 individual counseling sessions. The individual sessions are focused on specific individualized risk reduction plans, whereas the group sessions are focused on increasing self-acceptance and reducing HIV risk. Additionally, participants in this arm will receive HIV and STI counseling and testing.

干预措施: Self-acceptance based intervention (Behavioral)

Self-acceptance behavioral intervention

Experimental

The intervention will consist of individual and 4 group counseling sessions and 6 individual counseling sessions. The individual sessions are focused on specific individualized risk reduction plans, whereas the group sessions are focused on increasing self-acceptance and reducing HIV risk. Additionally, participants in this arm will receive HIV and STI counseling and testing.

干预措施: HIV/STI counseling and testing (Behavioral)

Comparison/Control

Other

The comparison group will receive HIV and STI counseling and testing.

干预措施: HIV/STI counseling and testing (Behavioral)

结局指标

主要结局

Number of incident STIs from Baseline

时间窗: 12 month visit

Chlamydia, gonorrhea, syphilis, and HIV

Changes in frequency of condomless sex

时间窗: 4 month visit, 8 month visit, 12, month visit

Self-reported insertive or receptive anal sex without the use of a condom.

次要结局

  • Changes in Psychosocial Mediators(Measured at baseline, 4, 8, 12 month visits)
  • Cost-effectiveness of intervention(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven A. Safren

Principle Investigator

Massachusetts General Hospital

研究点 (4)

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