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

HIV-1-infection Clinical Trial

Official title: IMPAACT 2016 - Evaluating a Group-Based Intervention to Improve Mental Health and Antiretroviral Therapy (ART) Adherence Among Youth Living With HIV in Low Resource Settings

Status Recruiting

Clinical Trial Summary

IMPAACT 2016 is 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 is adapted to the local context through advance conduct of focus groups and pilot testing.

Clinical Trial Description

IMPAACT 2016 is 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. To adapt the intervention for the local context, the trial will be preceded by an adaption of the TI-CBT intervention at each site using the "ADAPT-ITT" model, which includes focus groups and pilot tests. In the randomized study, youth will be individually randomized to either the TI-CBT Intervention Arm or the Discussion Control Arm. Participants will meet as a group within their randomized arm and receive multiple group sessions within an eight-week period. Each group will include an average of eight youth for an approximate total of 192-256 youth in the Randomized Trial (96-128 youth per arm). TI-CBT and Discussion Control groups in each arm will be mixed-gender unless it is determined necessary to have single-gender groups during the focus group. Caregivers (as available and with youth permission) will be assigned to the same study arm as their youth. Caregivers will meet as a group for two caregiver-specific sessions on two separate weeks and separate from their youth group sessions. Youth and caregivers will complete a follow-up visit immediately after their last group session and two additional follow-up visits at six and 12 months. Youth and caregivers will also receive one two-hour booster group session consistent with their assigned study arm immediately after the six-month evaluations. The booster sessions are intended to enhance treatment effects and increase sustainability. Once all participants have completed their six-month evaluations, data from these evaluations will be analyzed to determine the short-term effects of the intervention. Additional analyses to assess the longer-term effects of the intervention, including the effects of the booster group session, will be performed after the completion of follow-up. ;

Related Conditions & MeSH terms

• HIV-1-infection

• NCT number: NCT04024488
• Study type: Interventional
• Source: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Contact: Nicole Montañez, MSW
• Phone: 919-544-7040
• Email: nmontanez@fhi360.org
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2023
• Completion date: September 30, 2025