Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings

Overview

IMPAACT 2016 was a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous Youth Leaders (IYL) is associated with improved mental health outcomes and ART adherence among youth living with HIV in resource-limited settings. The intervention was adapted to the local context through advance conduct of focus groups and pilot testing.

IMPAACT 2016 was a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous Youth Leaders (IYL) is associated with improved mental health outcomes and ART adherence among youth living with HIV in resource-limited settings. The trial was preceded by an adaption of the TI-CBT Intervention at each site using the "ADAPT-ITT" model, which included focus groups and pilot tests. Participant-level data was not collected during the focus group phase, and the pilot phase consent form specified that collected data would not be analyzed. Per protocol, only data from the randomized trial were analyzed. The study was closed early due to the funding constraints. In the randomized study, youth were individually randomized to either the TI-CBT Intervention arm or the Discussion Control arm. Youth participants met as a group within their randomized arm and received multiple group sessions within an 8-week period. Each arm featured 15 groups with an average of 8.5 youth per group, or a total of 254 youth in the Randomized Trial. TI-CBT Intervention and Discussion Control groups could be mixed-gender, which required at least two participants of each gender. Caregivers (with consent and youth permission) were assigned to the same study arm as their youth. Caregiver participants met as a group within their arm for two caregiver-specific sessions on two separate weeks, separate from their youth's group sessions. Each arm featured 15 groups with an average of 7.7 caregivers per group, or a total of 230 caregivers in the Randomized Trial. Youth and caregivers completed a follow-up assessment immediately after their last group session and two additional follow-up assessments at 6 and 12 months. Youth and caregivers received 1 two-hour booster group session consistent with their assigned study arm immediately after the 6-month assessments. The booster sessions were intended to enhance treatment effects and increase sustainability. Following completion of 6-month assessments (primary timepoint), data were analyzed to determine the short-term effects of the interventions. Additional analyses to assess long-term effects of the interventions, including the effects of the booster group session, will be performed after the completion of 12-month assessments. Results are reported for youth participants in the randomized trial only, because limited sociodemographic characteristics and no primary or secondary outcome measures were collected for caregivers. As specified in the protocol and statistical analysis plan, primary outcomes were analyzed with groups as the analytic units due to the presence of intracluster correlation among participants in the same group.