IMPAACT 2016

IMPAACT 2016 was 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 proceeded 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, was 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 was evaluated for 15-19 year-olds living with HIV and their caregivers. This study prioritized 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.

To contact the clinical research managers for this study, please email impaact.crm2016@fstrf.org.