IMPAACT 2016: Evaluating a Group-Based Intervention to Improve Mental Health and ART Adherence in HIV-Infected Adolescents in Low Resource Settings

Study Status Study Restriction

In Development

United States

What is IMPAACT 2016?

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-induced 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.

Sites where the study is implemented:

CRS ID Site Name City Country
Site Selection in progress.

Study contacts:

Study Co-Chair: Geri Donenberg

Study Co-Chair: Dorothy Dow

DAIDS Medical Officer: Ellen Townley

NICHD Medical Officer: Sonia Lee

NIMH Medical Officer: Susannah Allison

Clinical Trials Specialist: Jennifer Libous

Clinical Trials Specialist: Jacquelyn Mountcastle

Data Manager: Linda Marillo

Data Manager: Christina Reding

Investigator: Suad Kapetanovic

Laboratory Data Manager (LDM): Katelyn Hergott

Laboratory Specialist: Dale Dayton

Laboratory Technologist: Amy James Loftis

Laboratory Technologist: Natasha Samsunder

Statistician: Meredith Warshaw

Westat Representative: Kathryn Myers


Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.