Adaptation and implementation of a behavioral mHealth intervention to reduce anxiety and depression and end the HIV epidemic in the rural South - ABSTRACT Untreated anxiety and depression are exceedingly common in people living with HIV (PLWH) in the rural South, a population critically affected by the HIV epidemic. Addressing mental health is essential to improving the disparate HIV burden in this population. Yet outside of routine clinical care, few interventions target mental health in PLWH in the rural South. Mobile health technology (mHealth) and community health worker (CHW)- delivered care are two intervention models that address barriers unique to rural, underserved, populations. Dr. Manavalan is an assistant professor in the Division of Infectious Diseases and Global Medicine at the University of Florida. She seeks a K23 award to gain skills, experience and preliminary data needed to become an independent physician-scientist focused on developing and implementing novel and scalable interventions in underserved communities that will contribute to Ending the HIV Epidemic. Through the training and research proposal outlined in this award, Dr. Manavalan will bridge the fields of HIV and mental health by incorporating evidence-based interventions effective in other settings into existing medical systems in Florida. In this 4-year study Dr. Manavalan will adapt an evidence-based CHW-delivered counseling intervention for delivery through an existing mHealth application, as a strategy to reduce anxiety and depression and maximize viral suppression in PLWH in the rural South. In Aim 1, she will conduct robust qualitative research with diverse key stakeholders, guided by the Consolidated Framework for Implementation Research (CFIR), to discern perspectives to inform adaption and implementation of the intervention. Next, in Aim 2, she will assemble a Design Consultation Team composed of 12 members from key stakeholder groups (PLWH from the target population, HIV and mental health providers, and mHealth and behavioral scientists) to assist in adapting CHW- delivered counseling for mHealth delivery, tailored to a rural population. Adaption of the intervention will occur iteratively, be informed from data from Aim 1 and will be guided by the ADAPT-ITT framework. Lastly, in Aim 3, she will pilot the adapted intervention with a type 1 hybrid effectiveness-implementation trial and assess implementation outcomes (reach, adoptability, implementation, maintenance) and preliminary effectiveness outcomes (viral suppression, HIV care retention, ART adherence, and anxiety and depression symptoms) using the RE-AIM model. The proposed program will enable Dr. Manavalan to gain expertise in 1) adaption and evaluation of behavioral interventions, 2) mHealth science, and 3) implementation science and hybrid trial design through mentorship with leading experts, didactic coursework, professional development programs, and application of research. This study will lay the groundwork for a fully powered R01 trial to evaluate implementation and effectiveness of the adapted intervention in underserved communities throughout the state of Florida.