Clinical Trials Link
Primary Protocol Team Members
IMPAACT 2016 is a multi-site, two-arm, randomized, controlled study preceded by a feasibility and acceptability pilot to examine if an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) intervention demonstrates improved mental health outcomes and ART adherence for youth living with HIV. The study will proceed in two stages over approximately three and one-half years. In Stage 1, the feasibility and acceptability of the ILOM of TI-CBT program, consisting of 6 two-hour sessions, will be evaluated for 15-19 year-olds living with HIV and their caregivers using the ADAPT-ITT Model. In Stage 2, the efficacy of an ILOM of TI-CBT intervention using a 2-arm randomized controlled trial design will be evaluated for 15-19 year-olds living with HIV and their caregivers. This study will prioritize implementation in countries with high volumes of 15 - 19 year-olds living with HIV, and sites with minimal mental health care infrastructure in order to achieve the biggest impact and deliver the program in areas of greatest need.