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TERMINATED
NCT04024488
NA

Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings

Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

View on ClinicalTrials.gov

Summary

IMPAACT 2016 was a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous Youth Leaders (IYL) is associated with improved mental health outcomes and ART adherence among youth living with HIV in resource-limited settings. The intervention was adapted to the local context through advance conduct of focus groups and pilot testing.

Official title: IMPAACT 2016 - Evaluating a Group-Based Intervention to Improve Mental Health and Antiretroviral Therapy (ART) Adherence Among Youth Living With HIV in Low Resource Settings

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

484

Start Date

2024-04-06

Completion Date

2025-06-05

Last Updated

2026-05-22

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Youth TI-CBT Intervention Arm

For youth, each TI-CBT group session was led by IYL. TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence. Finally, the relaxation training teaches youth strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Youth Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.

BEHAVIORAL

Youth Discussion Control Arm

For youth, each discussion group session was led by IYL. Discussion topics were selected by youth in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately.

BEHAVIORAL

Caregiver TI-CBT Intervention Arm

For caregivers, each TI-CBT group session was led by adult study staff. TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and "mastery of trauma", which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender-based violence. Finally, the relaxation training teaches strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Caregiver Intervention Manuals were distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial.

BEHAVIORAL

Caregiver Discussion Control Arm

For caregivers, each discussion group session was led by adult study staff. Discussion topics were selected by caregivers in the group. Discussion Control sessions took place at a separate time from TI-CBT Intervention sessions to minimize contamination. Youth and caregiver group sessions were also held separately.

Locations (8)

Gaborone Prevention/Treatment Trials CRS 12701

Gaborone, Botswana

Molepolole Prevention/Treatment Trials CRS 12702

Molepolole, Botswana

College of Medicine CRS 30301

Blantyre, Malawi

University of North Carolina Lilongwe CRS 12001

Lilongwe, Malawi

Soweto IMPAACT CRS 8052

Soweto, South Africa

St. Mary's CRS 30303

Chitungwiza, Zimbabwe

Harare Family Care CRS 31890

Harare, Zimbabwe

Seke North CRS 30306

Harare, Zimbabwe