Primary Objectives

• Evaluate whether a TI-CBT Intervention is associated with improved depression, anxiety, and/or traumatic stress symptoms for youth living with HIV compared to a Discussion Control at six months

Secondary Objectives

• Determine the feasibility, acceptability, and fidelity of a TI-CBT Intervention.
• Evaluate whether a TI-CBT Intervention is associated with improved depression, anxiety, and/or traumatic stress symptoms for youth living with HIV compared to a Discussion Control following the last group session and at 12 months.
• Assess whether a TI-CBT Intervention is associated with improved ART adherence (hair samples, self-report) and viral suppression (HIV RNA plasma) for youth living with HIV compared to a Discussion Control following the last group session and at six and 12 months.
• Assess whether a TI-CBT Intervention is associated with improved structural factors for youth living with HIV (HIV stigma and support for adherence; barriers to adherence; gender-based violence; gender roles) compared to a Discussion Control following the last group session and at six and 12 months.
• Assess whether a TI-CBT Intervention is associated with improved structural factors for caregivers (HIV knowledge, stigma, and support for adherence; barriers to adherence) compared to a Discussion Control following the last group session and at six and 12 months.
• Assess whether a TI-CBT Intervention is associated with improved behavioral risk outcomes for youth living with HIV (alcohol/drug use; sex-risk behaviors; caregiver report of youth behavior) compared to a Discussion Control following the last group session and at six and 12 months.
• Identify the individual, social, and structural barriers, and facilitators to implementation of a TI-CBT Intervention.
• Compare the rates of all targeted adverse events between a TI-CBT Intervention and a Discussion Control for youth living with HIV.

Study Design: Multi-site, two-arm, individually randomized controlled trial preceded by Focus Groups and Pilot Testing to adapt the intervention to the local context.

Study Population and Size

• 15-19 year old youth living with HIV and mental health distress, and their caregivers (if available and agreed to by youth participant).
• Approximately 192 - 256 youth participants (96 - 128 per arm), plus their caregivers, in the Randomized Trial. Each arm will have 12 - 16 groups with an average of eight youth participants per group (range 6 – 10). Youth participants’ caregivers will be assigned to the same arm as their youth participants.

Study duration: 22 Months

Study Results: Study is on-going and no data analyses have been done yetr:

• National Institute of Allergy and Infectious Diseases
• Eunice Kennedy Shriver
• National Institute of Child Health and Human Development National Institute of Mental Health

Principal Investigator: Dr Gaerolwe R. Masheto