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

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.

Conditions

• HIV-1-infection

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group

  lead NETWORK

Principal Investigators

• Dorothy Dow, MD, MSc · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-06

Primary Completion

2025-03-27

Completion

2025-06-05

Countries

• Botswana
• Malawi
• South Africa
• Zimbabwe

Study Locations