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NCT05098015 Clinical Trial

Randomized Controlled Trial of Game Changers

HIV Prevention Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05098015
Other study ID # 2021-N0155
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 24, 2022
Est. completion date August 1, 2025

Study information
Verified date April 2024
Source RAND
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 885
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Uganda Infectious Diseases Institute Kampala

Sponsors (4)
Lead Sponsor Collaborator
RAND Indiana University, Infectious Diseases Institute, Uganda, Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome
Type Measure Description Time frame Safety issue
Primary HIV testing Self-reported HIV testing behavior by social network members (yes/no) Past 6 months
Primary Condom use Self-reported consistent condom use during intercourse by social network members (always vs sometime/never) Past 6 months
Secondary Internalized HIV stigma Self-reported internalized HIV stigma among people living with HIV (on 1-5 scale) Past 6 months
Secondary HIV prevention advocacy Self-reported prevention advocacy among people living with HIV (on 1-5 scale) Past 6 months
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