Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- condom use
研究概览
简要总结
This grant involved the development, implementation, and assessment of the feasibility and acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was from their primary male partner (Raj et al. 2001).
Specific aims of this study are as follows:
- To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use with at-risk Indian wives.
- To determine the feasibility and acceptability of RHANI Wives with at risk wives* in India. A two-group cluster randomized trial will involve random assignment of 12 neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a control condition (n=150). Intervention effects on the more proximal and likely safer sex mediating outcome of marital communication for this feasibility trial will be assessed via surveys at baseline and 3 month follow-up.
NOTE: Only 220 participants were able to be recruited into the study.
*At risk wives are defined as having a husband at higher risk for transactional sex based on wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7 days) or partner violence perpetration
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 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •married female aged 18-40 years
- •fluency in Hindi or Marathi
- •residence with husband in the area of study for a period of 2 months or greater
- •reports that husband engaged in either heavy drinking- past 30 day drunken behavior, or frequent drinking- 3 drinking days in past 7 days, or lifetime spousal violence perpetration
- •no plans to relocate from the area in the next year.
排除标准
- •cognitive impairment indicated at recruitment
结局指标
主要结局
condom use
时间窗: 4.5 months
condom protected sex in marital relationships
次要结局
未报告次要终点
研究者
Anita Raj
Professor
University of California, San Diego
