Randomized Controlled Trial of Game Changers

RanD

Status: Completed

Conditions: HIV Prevention

Treatments: Behavioral: Game Changers

Study type: Interventional

Funder types: Other

Identifiers

NCT05098015

2021-N0155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 809 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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809 participants in 4 patient groups

Intervention- index

Experimental group

Description:

8-session group intervention to train index participants to engage in HIV prevention advocacy.

Treatment:

Behavioral: Game Changers

Usual care control- index

No Intervention group

Description:

Participants will receive HIV usual care, and no added intervention.

Intervention- alter

No Intervention group

Description:

Enrolled alter participants recruited by index participants assigned to the intervention comprise this arm

Usual care control- alter

No Intervention group

Description:

ALter participants recruited by index participants assigned to the usual care control group comprise this arm