A Focus on the HIV Care Continuum Through the Healthy Young Men's Cohort Study: Protocol for a Mixed-Methods Study.

Background: No group is at greater risk for acquiring HIV than young men who have sex with men (YMSM), particularly black or African American (AA) and Hispanic or Latino (L) YMSM living in inner cities, who account for the largest number of new HIV infections each year. Although pre-exposure prophylaxis (PrEP), postexposure prophylaxis (PEP), and treatment as prevention hold enormous promise for changing the course of the epidemic, AA/L-YMSM are the least likely population to be receiving primary health care and HIV prevention/care and are the least likely to be using PrEP and PEP.

Objective: The overarching aim of the Healthy Young Men's (HYM) cohort study is to conduct longitudinal research with a cohort of AA/L-YMSM to prevent new HIV infections, reduce transmission, and reduce HIV/AIDS-related disparities by focusing on successful engagement in care. Findings from this research will be used to inform the development of new interventions designed to engage AA/L-YMSM in the HIV prevention and care continua.

Methods: Longitudinal research (baseline and follow-up assessments every 6 months for a total of 8 waves of data collection) is ongoing with a new cohort of 450 high-risk AA/L-YMSM in Los Angeles. Participants were recruited using a venue-based and social media sampling design. In addition to self-report surveys, the study protocol includes the collection of urine to assess recent use of illicit drugs and the collection of blood and rectal/throat swabs to test for current sexually transmitted infection (STI)/HIV infection. An additional sample of blood/plasma (10 mL for 4 aliquots and 1 pellet) is also collected and stored in the HYM cohort study biorepository for future research. By design, we recruited 400 HIV-negative participants and 50 HIV-positive (HIV+) participants. This mixed-methods study design includes collection and triangulated analysis of quantitative, qualitative, and biological measures (ie, drug use, STI/HIV testing, and adherence to antiretroviral therapy among HIV+ participants) at baseline and every 6 months. The HYM cohort study will provide a platform from which new and emerging biomedical prevention strategies (eg, PrEP, rectal microbicides, and PEP) and other HIV prevention and care engagement interventions can be developed and evaluated with AA/L-YMSM.

Results: To date, all participants in the HYM cohort study have been recruited and baseline assessment has been conducted.

Conclusions: The findings from this research will be used to inform the development of new and/or adaptation of existing evidence-based HIV prevention interventions and interventions designed to engage this population in the HIV prevention and care continua.

International Registered Report Identifier (irrid): DERR1-10.2196/10738.