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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• HIV Prevention

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