Randomized Controlled Trial of Game Changers

April 4, 2024 updated by: RAND

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

885

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Infectious Diseases Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
8-session group intervention to train participants to engage in HIV prevention advocacy.
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.
No Intervention: Usual care control
Participants will receive HIV usual care, and no added intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV testing
Time Frame: Past 6 months
Self-reported HIV testing behavior by social network members (yes/no)
Past 6 months
Condom use
Time Frame: Past 6 months
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
Time Frame: Past 6 months
Self-reported internalized HIV stigma among people living with HIV (on 1-5 scale)
Past 6 months
HIV prevention advocacy
Time Frame: Past 6 months
Self-reported prevention advocacy among people living with HIV (on 1-5 scale)
Past 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Collaborators

Indiana University
Makerere University
Infectious Diseases Institute, Uganda

Investigators

  • Principal Investigator: Glenn Wagner, RAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2022

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-N0155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified dataset will be made available upon review of requests from outside researchers

IPD Sharing Time Frame

Following publication of primary results of the study (approximately August 2026).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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