Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,175
- 试验地点
- 1
- 主要终点
- HIV injecting risk behavior
研究概览
简要总结
The purpose of this study is to determine whether a combined individual and structural level stigma reduction intervention is effective in reducing high risk injecting and sexual behaviors among HIV positive injecting drug users.
详细描述
This study is a randomized controlled trial among HIV-positive injecting drug users (IDUs) to reduce high risk injecting and sexual behaviors in Thai Nguyen, Vietnam. We will be conducting this study in collaboration with the Thai Nguyen Centre for Preventive Medicine (CPM). We will compare standard HIV voluntary counseling and testing (VCT) to an intervention that adds a continuum of psychosocial support for HIV-positive IDUs. The intervention consists of a two-tiered approach that addresses structural and individual level barriers to risk reduction: 1) The structural level of the intervention consists of community-based programs and targets HIV stigma that is a primary obstacle to risk reduction for HIV-positive individuals; 2) The individual level of the intervention consists of 2 HIV posttest counseling sessions and 2 skill-building support groups for HIV-positive IDUs. Our research questions for the overall project are:
- What is the impact of perceived HIV-related stigma on disclosure, social support, and coping among IDUs?
- What roles do disclosure, social support, and coping play in facilitating the reduction of HIV-risk behaviors
- Are combined individual and structural level interventions more effective in reducing injecting and sexual behaviors among HIV-positive IDUs than individual or structural interventions alone and more effective than the standard HIV VCT?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, 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
- 否
入选标准
- •laboratory confirmed HIV positive diagnosis
- •able and wiling to bring an injecting network member for screening
- •injected drugs in previous 6 months
- •planned residence in Thai Nguyen for next 24 months
排除标准
- •unwilling to provide locator information
- •unable to participate in group counseling sessions due to psychological disturbance, cognitive impairment or threatening behavior
- •currently participating in other HIV or drug use intervention activities
- •Network member participant
- •Inclusion Criteria:
- •laboratory confirmed HIV negative diagnosis
- •injected or shared drug paraphernalia in past 6 months
- •interacts at least once a week with index participant
- •Exclusion Criteria:
- •unwilling to provide locator information
- •having psychological or cognitive impairment
- •currently participating in other HIV intervention
研究组 & 干预措施
Individual level
干预措施: Individual level (Behavioral)
Combined individual & structural level
干预措施: Structural level (Behavioral)
Standard of Care
干预措施: Individual level standard of care (Behavioral)
Individual level
干预措施: Structural level standard of care (Behavioral)
Structural level
干预措施: Structural level (Behavioral)
Structural level
干预措施: Individual level standard of care (Behavioral)
Combined individual & structural level
干预措施: Individual level (Behavioral)
Standard of Care
干预措施: Structural level standard of care (Behavioral)
结局指标
主要结局
HIV injecting risk behavior
时间窗: 2 years
Change in self-reported use of new injecting equipment
HIV sexual risk behavior
时间窗: 2 years
Change in self-reported condom use during sexual intercourse
次要结局
- HIV incidence(2 years)
