Addressing mental health and HIV medication adherence among high-risk men in a resource-limited setting

Emory University, Atlanta GA

Investigators

Linked publications, trials & patents

Abstract

This R34 application, submitted under PAR-23-060 (“Formative and Pilot Intervention Research to Optimize HIV Prevention and Care Continuum Outcomes”), proposes to develop and pilot test WeCare—a novel, integrated intervention addressing the dual and interconnected challenges of mental health and HIV medication adherence among high-risk men in resource-limited settings. Despite the proven efficacy of daily PrEP and antiretroviral therapy (ART), adherence to these biomedical strategies remains suboptimal, particularly among men facing socioeconomic and psychological stressors. Depression and other untreated mental health conditions are well-documented barriers to sustained PrEP and ART adherence, underscoring the need for integrated, scalable solutions. WeCare will combine principles of problem-solving therapy, stress and coping theory, and a status-neutral framework to engage men across the HIV continuum without reinforcing stigma. The project will proceed in three phases: (1) formative qualitative research to inform intervention development tailored to the target population; (2) an open pilot to refine the intervention manual and implementation protocol; and (3) a pilot randomized controlled trial comparing WeCare to an enhanced standard of care. Participants will be assessed at baseline, 3-, and 6-months post-enrollment. Primary outcomes include improvements in mental health and biologically confirmed medication adherence; secondary outcomes include self-reported adherence, PrEP persistence, and interest in long-acting PrEP/ART. Post-intervention qualitative data will inform future implementation and scale-up. This pilot will lay the foundation for a fully powered clinical trial to evaluate the efficacy of this integrated, community-relevant intervention model.