Randomized Controlled Trial of Game Changers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Controlled Trial of Game Changers: A Group Intervention to Train HIV Clients to be Change Agents for HIV Prevention in Uganda

Conditions
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HIV Prevention

Intervention / Treatment
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* Behavioral: Game Changers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years and older HIV-positive in HIV care at The Infectious DIseases Institute for at least one year Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>8-session group intervention to train participants to engage in HIV prevention advocacy. | Behavioral: Game Changers<br>* 8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy.<br>|
| No Intervention: Usual care control<br>Participants will receive HIV usual care, and no added intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV testing | Self-reported HIV testing behavior by social network members (yes/no) | Past 6 months | 
| Condom use | Self-reported consistent condom use during intercourse by social network members (always vs sometime/never) | Past 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internalized HIV stigma | Self-reported internalized HIV stigma among people living with HIV (on 1-5 scale) | Past 6 months | 
| HIV prevention advocacy | Self-reported prevention advocacy among people living with HIV (on 1-5 scale) | Past 6 months |