256
Participants
Start Date
November 11, 2023
Primary Completion Date
October 15, 2025
Study Completion Date
October 15, 2025
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."
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.
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
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Mental Health (NIMH)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK