Controlled Trial of Game Changers: A Group Intervention to Train HIV Clients to be Change Agents for HIV Prevention in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 809
- 试验地点
- 1
- 主要终点
- HIV Testing
研究概览
简要总结
The study is a randomized controlled trial (RCT) of Game Changers, an 8-session peer-led group intervention that aims to empower and mobilize people living with HIV (PLWH) to be agents for HIV prevention in their social networks.
详细描述
This RCT of Game Changers, a peer-led group intervention for persons living with HIV (PLWH) in Uganda, will test intervention effects on the primary outcomes of reduced condomless sex, increased HIV testing, and decreased enacted HIV stigma among social network members. We will recruit 210 PLWH, randomizing 105 to the intervention and 105 to an attention control. Each PLWH will be asked to recruit up to 4 social network members to complete assessments (736 total, 368/arm). All participants will complete surveys at baseline and 6-, 12-, and 18-months post-baseline.
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)
盲法说明
The assessment interviewer will be blinded to study arm allocation of the participants at baseline only.
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
- •age 18 years and older
- •HIV-positive
- •in HIV care at The Infectious DIseases Institute for at least one year
排除标准
- •Participated in the prior pilot study of the intervention.
- •Has significant cognitive impairment
- •Health status is not sufficiently stable to reliably complete 18 month study.
- •Does not speak Luganda fluently (index participant); English or Luganda fluently (social network participant)
- •spouse/partner or household member are enrolled as index participant in the study
研究组 & 干预措施
Intervention- index
8-session group intervention to train index participants to engage in HIV prevention advocacy.
干预措施: Game Changers (Behavioral)
Usual care control- index
Participants will receive HIV usual care, and no added intervention.
Intervention- alter
Enrolled alter participants recruited by index participants assigned to the intervention comprise this arm
Usual care control- alter
ALter participants recruited by index participants assigned to the usual care control group comprise this arm
结局指标
主要结局
HIV Testing
时间窗: Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18)
For each index participant (PLWH), data is examined from their enrolled alters and the percent of these alters who self-reported HIV testing behavior (yes/no) at each follow-up assessment is calculated, followed by the average percent across all follow-up assessments. Therefore, data from all three follow-up timepoints (months 6, 12 18) were pooled and an average calculated across the timepoints.
Condom Use
时间窗: Reports of always using condoms in the past 6 months, as assessed at each follow-up assessment (Month 6, Month 12, Month 18)
For each index participant (PLWH), data is examined from their enrolled alters and the percent of these alters who self-reported always using condoms use during intercourse at each follow-up assessment is calculated, followed by the average percentage across all follow-up assessments. Therefore, data from all three follow-up timepoints (months 6, 12 18) were pooled and an average calculated across the timepoints.
次要结局
- Internalized HIV Stigma(Reported at each follow-up assessment (Months 6, 12, 18))
- HIV Prevention Advocacy(Past 6 months as assessed at each follow-up (Months 6, 12, 18))