Evaluation of Long Acting Injectable (LAI) and Teen clubs in adolescents (ATTUNE)

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PROJECT SUMMARY Significance: South Africa has the highest number of adolescents living with HIV in the world with increasing numbers expected to continue. However, adolescents living with HIV in South Africa have poor outcomes along each step of the HIV continuum of care. The use of adolescent-friendly services and peer navigation can be used to optimize behavioral interventions prior to evaluating long-acting injectable antiretroviral therapy. Long- acting injectable antiretroviral therapy can overcome adherence lapses and treatment fatigue that often contribute to viral failure among adolescents living with HIV. Innovation: This study is the first study to use adolescent-friendly services and peer navigation to optimize behavioral interventions before investigating long- acting injectable antiretroviral therapy for adolescents living with HIV in sub-Saharan Africa. This is the first study to evaluate the effectiveness of long-acting injectable antiretroviral therapy in diverse real-world settings for adolescents living with HIV in a low- to middle- income country. We hypothesize that long-acting injectable antiretroviral therapy provides for more sustained retention in care and viral suppression compared to oral daily antiretroviral therapy but has higher costs and complex adoption procedures. Approach: Using a Type I hybrid effectiveness implementation design, we will evaluate the effectiveness and implementation factors associated with peer navigation and long-acting injectable antiretroviral therapy when added to baseline adolescent-friendly services. Using a stepped-wedge, delayed implementation cluster randomized clinical trial design, we will measure the effectiveness of peer navigation compared to standard of care with viral suppression and retention in care as the primary outcomes (Aim 1). Once we have potentially maximized viral suppression rates in adolescents living with HIV using behavioral interventions, we will conduct a nested individually randomized clinical trial evaluating effectiveness of long-acting antiretroviral therapy on retention in care and viral suppression among virally suppressed adolescents living with HIV. (Aim 2) Simultaneously, we will use the RE- AIM framework to measure the implementation factors associated with the implementation strategies of peer navigators as clinic champions and audit and feedback in both interventions (Aim 3). Investigators: Multiple Principal Investigators: Brian Zanoni has been working in adolescent HIV in South Africa since 2006, has received NIH funding through an R21 to develop a transition readiness assessment, a K23 to develop and pilot a mHealth intervention, and an R01 (MPI with Archary) evaluating in-person and mHealth adolescent-friendly services. Moherndran Archary is an expert in pediatric and adolescent HIV in South Africa. He and Dr. Zanoni have been working together since 2011 in developing transition readiness assessments and interventions to improve adolescent HIV care. Co-investigators: Maryam Shahmanesh is an expert in clinical trials among youth in rural KwaZulu-Natal, South Africa. Lee Fairlie is an expert in pediatric clinical trials and implementation science. Kathy Baisley is a senior statistician with expertise in clinical trials including stepped-wedge designs.