CHAMPS+: Protocol for a Randomized Trial of a CHW-Delivered mHealth Intervention to Improve Viral Suppression in the U.S. Deep South.

Viral suppression (VS) disparities persist among persons living with HIV in the U.S. Deep South because of structural barriers and disengagement from care. Community health workers and mobile health (mHealth) interventions may address multilevel challenges, yet real-world evidence is limited. The aim of our study is to evaluate effectiveness and implementation of CHAMPS+, a CHW-delivered mHealth intervention to improve VS. CHAMPS+ is a multisite randomized controlled trial with mixed-method implementation evaluation. A total of 420 virally unsuppressed or out-of-care adults with HIV in Alabama (AL), Louisiana (LA), and Mississippi (MS) are randomized to a 6-month CHW-delivered program supported by WiseApp and electronic adherence monitoring or standard care. Implementation is assessed using RE-AIM. The primary outcome is VS at 6 months; secondary outcomes include medication adherence and psychosocial mediators. The trial will generate evidence on the clinical effectiveness and real-world implementation of a scalable CHW-mHealth intervention in Ending the HIV Epidemic priority jurisdictions.