IMPAACT 2002 was a prospective, multi-site, two-arm, cluster-randomized study that evaluated whether a health and wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention for depression demonstrated improved depression outcomes (e.g., decreased depressive symptoms and greater remission and response rates) and medical outcomes (e.g., increased cluster of differentiation 4 (CD4) T-cell count, decreased HIV RNA level) among HIV-infected youth in the US compared to enhanced standard care (ESC). Sites were randomized to either the COMB-R intervention or the ESC control arm. Youth enrolled in the study attended a Screening/Entry Visit and study visits at Weeks 1, 6, 12, and 24. They had two additional follow-up visits at Weeks 36 and 48 for the study team to evaluate if observed effects of the intervention were maintained. The intervention was a treatment for depression that included a manualized Health and Wellness Cognitive Behavioral Therapy and an algorithm-driven Medication Management designed to address the unique challenges faced by this population.
IMPAACT 2002 is a prospective, multi-site, two-arm, cluster-randomized study to evaluate whether a health and wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention for depression demonstrates improved depression and medical outcomes for HIV-infected youth in the United States (US) compared to enhanced standard care (ESC).