CONNECT-A: A Multicomponent Intervention to Reduce HIV Vulnerability by Addressing Alcohol Use and Co-Occurring Mental Health and Economic Risks Among Young Men - ABSTRACT Unhealthy alcohol use is a modifiable driver of HIV risk and a barrier to engagement in proven HIV prevention strategies, including preexposure prophylaxis (PrEP). Among high-risk men, alcohol use often co-occurs with depressive symptoms, self-regulation challenges, economic stress, and barriers to accessing prevention services, creating conditions that reduce PrEP uptake, adherence, and retention. Despite the availability of effective biomedical HIV prevention, few interventions integrate alcohol risk reduction with practical support for PrEP engagement among men with behavioral and contextual risk profiles associated with HIV acquisition. To address this gap, and in alignment with NIH priorities to expand HIV prevention for populations affected by alcohol use (PAS-25-161), this R34 application proposes CONNECT-A, a community-based, multicomponent intervention that integrates patient navigation (PN) with alcohol screening and brief intervention (ASBI). CONNECT-A is designed to reduce alcohol-related HIV risk, strengthen engagement across the PrEP continuum, and address co-occurring psychosocial and economic stressors that may interfere with HIV prevention. The project builds on an established partnership with a North Carolina-based organization serving individuals in high-need and high-incidence settings. This project will be implemented in three phases: adaptation, open pilot, and pilot randomized trial. In Phase 1, we will conduct qualitative interviews with 24–32 individuals from the target population, supplemented by input from 6–8 community advisory board members and 10–15 service providers working with the target population. Findings will guide adaptation of the CONNECT-A intervention manual, implementation protocol, and measurement plan. In Phase 2, we will conduct an open pilot with ~10 eligible participants to refine intervention procedures, assess participant burden, and strengthen fidelity and implementation supports. In Phase 3, we will conduct a pilot randomized trial with 60 eligible participants, randomly assigned to either the CONNECT-A or the usual care group. We will assess feasibility, acceptability, and implementation readiness. The study will also explore preliminary signals of change in unhealthy alcohol use, alcohol-related HIV risk behavior, PrEP uptake, and mechanistic targets, including self-regulation and depressive symptoms. Data will be collected at baseline, end of the program, and at 3- and 6-month follow-ups. This R34 will generate actionable evidence to support scalable, behaviorally targeted interventions to prevent HIV among alcohol impacted populations with episodic and long-term alcohol use patterns and associated behavioral and biological risks for HIV acquisition.
