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

NAActive, not recruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

November 11, 2023

Primary Completion Date

October 15, 2025

Study Completion Date

October 15, 2025

Conditions
HIV-1-infection
Interventions
BEHAVIORAL

TI-CBT Intervention Arm

"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 and Caregiver Intervention Manuals are distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial."

BEHAVIORAL

Discussion Control Arm

Each youth discussion control group session will be led by IYL and each caregiver discussion control group will be led by adult study staff. Discussion topics will be selected by youth and caregivers in the group as applicable. Discussion Control group session will take place at a separate time from TI-CBT youth group sessions in attempt to minimize contamination. To note, participant and caregiver group sessions are always held separately.

Trial Locations (8)

Unknown

Gaborone Prevention/Treatment Trials CRS 12701, Gaborone

Molepolole Prevention/Treatment Trials CRS 12702, Molepolole

College of Medicine CRS 30301, Blantyre

University of North Carolina Lilongwe CRS 12001, Lilongwe

Soweto IMPAACT CRS 8052, Soweto

St. Mary's CRS 30303, Chitungwiza

Harare Family Care CRS 31890, Harare

Seke North CRS 30306, Harare

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

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

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

NETWORK

NCT04024488 - Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings | Biotech Hunter | Biotech Hunter