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临床试验/NCT01121692
NCT01121692已完成2 期

Venue-Based Recruitment and HIV Prevention for Alcohol and Other Drug (AOD) Using Couples in South Africa

RTI International1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
600
试验地点
1
主要终点
Reduced alcohol use

研究概览

简要总结

Couples who use alcohol and other drugs (AOD) in South Africa are at high risk for engaging in risky sex behavior within their relationships and with other sexual partners. In addition, high levels of gender-based violence (GBV) in the Cape Town area intersect with AOD abuse and sex behavior. All of these interconnections raise concern for the importance of HIV prevention strategies within or surrounding drinking venues, where many of these behaviors occur.

The specific aims of this study are as follows:

Aim 1. To characterize the types of drinking venues (e.g., licensure status, size, plumbing, type of alcohol provided), their immediate context (e.g., observed availability and use of other drugs, observable violence and sexual activity), and surrounding neighborhood characteristics (e.g., quality of streets, building structures, and availability of electricity and plumbing) in the sampled neighborhood blocks in several large Black/African and Coloured communities in Cape Town, South Africa.

Aim 2. To refine through qualitative methods the proposed interventions in relation to skills-building to address gender-role expectations, sexual partnering, gender and power, violence, and environments where drinking and sexual risk behaviors occur.

Aim 3. To conduct a randomized group trial to compare the relative efficacy of a comprehensive intervention (Condition 3: Enhanced Couples) to the gender-focused intervention (Condition 2: Gender) and to (Condition 1: Men's Control and Women's CoOp) on reducing alcohol and other drug (AOD) use, sexual risk behavior, and gender-based violence at 6 month follow-ups. Aim 4. To assess the mechanisms through which the intervention effects may occur (e.g., mediators involving self-efficacy and condom mastery, negotiation, and communication skills) and to identify groups for whom the interventions have the greatest effect (e.g., partner characteristics such as race, gender, and age and neighborhood factors such as poverty) on study outcomes of AOD use, sexual risk, and gender-based violence.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Identify as Black or Coloured
  • •Live in one of the target communities- Khayelitsha, Mitchell's Plain and Delft
  • •Have the same main heterosexual sex partner for at least one year, plan to stay with this partner for at least one year and do not plan to get this partner pregnant within the next year
  • •Report unprotected sex at least once in the past 90 days with main partner
  • •Have used alcohol in a tavern or shebeen in the past 90 days
  • •Spend time in a tavern or shebeen at least weekly
  • •Have been a part of previous Couples' Health CoOp group study activities
  • •Are currently enrolled in an HIV research study
  • •18 or older
  • •Have the same main heterosexual sex partner for at least one year and plan to stay together with this partner for at least one year and do not plan to get pregnant within the next year with this partner
  • •Report unprotected sex at least once in the past 90 days with main partner

排除标准

  • •Have been a part of previous Couples' Health CoOp group study activities
  • •Are currently enrolled in an HIV research study
  • •Have been a part of the Cape Town Pilot Study or the Western Cape Women's Health CoOp

研究组 & 干预措施

VCT/Women's CoOp

Experimental

干预措施: Women's CoOp (Behavioral)

Women's CoOp/Men's CoOp

Experimental

干预措施: Women's CoOp and Men's Intervention (Behavioral)

Couples CoOp

Experimental

干预措施: Couples Intervention (Behavioral)

结局指标

主要结局

Reduced alcohol use

时间窗: 6 month follow up

次要结局

  • reduced gender-based violence(6 month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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