The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM). The main aims of the study are:

1. Determine the efficacy of C4 for increasing PrEP adherence among Black MSM.
2. Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence.
3. Describe the acceptability and feasibility of C4 implementation in community settings.

Participants in the clinical trial will be randomized to receive the intervention or standard of care for PrEP in two sites. Researchers will compare administration of C4 to standard of care to see if C4 improves adherence to PrEP. C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). The intervention pulls from the Centers for Disease Control and Prevention (CDC) Comprehensive Risk Counseling and Services (CRCS) and Self-Determination Theory (SDT) to support client-identified HIV prevention goals to promote, adopt, and maintain PrEP use. CRCS is a public health strategy to assist persons in developing behavioral goals to reduce HIV acquisition and transmission. In this intervention, the HIV prevention plan element of CRCS will be the foundation of the C4 intervention. After the initial prevention plan is developed, elements of SDT will be used to implement a client-centered care approach to assist in addressing issues which many arise which impede successful PrEP adherence.

Inclusion Criteria:

• Age of 18 years of age
• Identify as Black, African American, Black African, Afro-Caribbean, or Black-Latino
• Cisgender male
• PrEP naïve or who prematurely stopped PrEP
• No prior HIV diagnosis confirmed through HIV testing
• Self-reported high risk for acquiring HIV
• Currently not enrolled in another HIV prevention study

Exclusion Criteria:

• Black MSM who received a reactive or positive HIV test at screening or self report HIV-positive
• Identifying as transgender
• Current participation in any research study via self-report
• Use of PrEP or post-exposure prophylaxis in the last 60 days prior to anticipated enrollment

Data sharing ensures the ability of translation of research results into knowledge, research products, and interventions to improve the health of communities. The research team commits to transparency through sharing the data generated by this project. All research data will be shared as requested in accordance with federal regulations and the Freedom of Information Act. The research team anticipates dissemination of results beginning in the 4th year of the award period. Sharing of the findings will involve a primary paper describing the effectiveness of the intervention on pre-exposure prophylaxis (PrEP) use and adherence and secondary papers reporting the qualitative findings and sub-analyses. Study findings will also be shared in the form of scientific and community presentations.

The final study data set will be shared through Inter-university Consortium for Political and Social Research (ICPSR) no later than the time of acceptance of the secondary paper on the qualitative findings on feasibility and acceptability of the intervention. Based on our study timeline, we expect this to be approximately spring of 2029, although the actual date could be earlier or later depending on the time for completing data analysis.