Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania

SYV incorporates components of existing evidence-based models: Trauma Focused-Cognitive Behavioral Therapy, Interpersonal Psychotherapy, and Motivational Interviewing to address the needs youth described in formative interviews. Preliminary data indicates implementation success with estimated effects towards improved MH, antiretroviral therapy adherence, and a 10% greater increase in viral suppression in the intervention arm compared to standard of care. The central hypothesis here is that the new integrated "i" SYV will be acceptable, feasible, and effective to improve virologic suppression and improve retention in care. The mechanism of change is that improved MH leads to better medication adherence, viral suppression, and care engagement. The rationale is twofold: 1) Tanzania is planning to initiate MH screening in HIV clinical visits, but the MH treatment gap persists; 2) the iSYV stepped-care package could be an effective approach to support integrated MH care for YLWH. The central hypothesis will be tested in a hybrid type-2 effectiveness-implementation trial. The first aim will leverage the Fit to Context Framework, using an iterative Designing for Dissemination and Sustainability approach. Current SYV peer-group leaders with extensive experience delivering SYV will co-design the new iSYV package. The iSYV in-person sessions will be delivered by trained peer youth leaders and be aligned to the Tanzanian differentiated care model: stable youth (those fully suppressed) attend clinic every 6 months; and unstable youth (those with HIV RNA \> 50 copies/mL) attend enhanced adherence counseling monthly. Youth with symptoms of MH difficulties on screening (PHQ9-depression, GAD7-anxiety, Trauma-related stress) will join the unstable group. To support engagement between visits, iSYV will explore use of a mHealth gamification strategy. The second aim includes a pilot and a four-arm cluster randomized trial. Two large implementing partners of PEPFAR clinics will support testing of the iSYV care package. The primary outcome is powered to show an increase in viral suppression (HIV RNA \<50 copies/mL) in the unstable group and improved retention in care among the stable group. Change in MH is measured as a secondary outcome. The third aim will evaluate implementation determinants and outcomes, including acceptability, feasibility, fidelity, and cost informed by the Consolidated Framework for Implementation Research. The proposal is significant because it is expected to help address the MH gap for YLWH with implications for HIV care in Tanzania and other low income areas.

• changes in self-reported antiretroviral therapy (ART) regarding adherence [Срок оценки: 6-months, 12-months, 18-months]
• change in self-reported mental health difficulties related to depression [Срок оценки: 6-months, 12-months, 18-months]
• change in self-reported mental health difficulties related to anxiety [Срок оценки: 6-months, 12-months, 18-months]
• change in HIV knowledge in the SOC+iSYV intervention arm compared to SOC arm at 6 month follow-up and at all timepoints in the intervention arm compared to SOC arm [Срок оценки: 6-months, 12-months, 18-months]
• viral load [Срок оценки: 12-months, 18-months as drawn per standard of care]
• retention in care [Срок оценки: 12-months and 18-months]
• change in coping and self efficacy on the Coping and Self-Efficacy Scale (CSES) [Срок оценки: 6-months, 12-months, 18-months]
• change in resilience on People Living with HIV (PLHIV) Resilience Scale [Срок оценки: 6-months, 12-months, 18-months]
• SYV risk behaviors scale [Срок оценки: 6-months, 12-months, 18-months]
• interpersonal violence on the World Health Organization intimate partner violence (WHO IPV) scale [Срок оценки: 6-months, 12-months, 18-months]