Randomized Controlled Trial of Game Changers

RAND809 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

809

Conditions

HIV Prevention

Interventions

Game ChangersBEHAVIORAL

8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Infectious Diseases Institute

Kampala, Uganda

Outcomes

Primary Outcomes

HIV Testing

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.

Time frame: Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18)

Condom Use

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.

Time frame: Reports of always using condoms in the past 6 months, as assessed at each follow-up assessment (Month 6, Month 12, Month 18)

Secondary Outcomes

Internalized HIV Stigma

This outcome is based solely on data from the index participants. Self-reported internalized HIV stigma (on 1-5 scale, with higher scores represented greater stigma); scale score is averaged across all follow-up assessments

Time frame: Reported at each follow-up assessment (Months 6, 12, 18)

HIV Prevention Advocacy

This outcome is based solely on data from the index participants. Self-reported prevention advocacy (on 1-5 scale, with higher scores representing greater engagement in advocacy); scores are averaged across all follow-up assessments

Time frame: Past 6 months as assessed at each follow-up (Months 6, 12, 18)

Data from ClinicalTrials.gov

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