HAVLIR, DIANE V
SUMMARYDespite encouraging gains in HIV treatment outcomes among adults with HIV in Sub-Saharan Africa,adolescents and young adults(10-24 years of age) living with HIV (AYAH) are being left behind withyoung women disproportionately affected. AYAH have worse rates of HIV testing, linkage to care,retention in care, and dramatically lower rates of HIV viral suppression. Our goal is to evaluate astrategic ART combination intervention for AYAH (SATURN) in a cluster randomized controlled trial (RCT)of 1,400 AYAH in 28 clinics in rural Uganda and Kenya. SATURN is an innovative life-stage adaptedapproach to improve ART uptake, adherence, retention and virologic suppression among female and maleyouth. The life-stage adapted, combination SATURN intervention is based on premise that currentapproaches to engaging AYAH are challenged by lack of dynamic flexibility and care adaptation to thesignificant trajectories of cognitive, social, and life-stage developmental events that occur inadolescence and early adulthood. Our intervention is based on behavioral theory, implementationscience, youth/provider input, and process and outcome feasibility and pilot data from the region. InAIM 1, Phase-I (UG3), we will: a) Implement youth-led HIV testing and linkage programs using acommunity-based participatory research (CBPR) to reach AYAH who are undiagnosed or are not engaged incare b) Initiate the clustered RCT of SATURN intervention compared to standard of care among AYAH in 8of the planned 28 clinics in rural Uganda and Kenya. In AIM 2, Phase-2 (UH3) we will: Complete RCTenrollment of AYAH from 28 clinics and compare the rate of retention and virologic suppression at 2years in SATURN clinics vs control; and 2a) Identify the mechanisms of action, barriers and facilitators ofthe SATURN implementation at the community, clinic organization, provider, and patient levels using mixedmethods qualitative and quantitative assessments. 2b) Estimate the incremental costs and gains associatedwith SATURN through cost effectiveness analysis. Transition Milestones to move from UG3 to UH3: a)Enroll at least 400 youth from the first 8 clinics to the SATURN RCT; 2) Of those enrolled, 20% will be new orout-of-care diagnoses; 3) Achieve at least 70% retention with virologic suppression at 1 year in interventioncommunities. This research builds upon highly productive long-standing collaborations between Ministries ofHealth in Uganda and Kenya, African and US research organizations, and PEPFAR implementing partnerswith local community participation and substantial AYAH targeted formative work in Uganda and Kenya and isdirected at eventual dissemination and sustainability.