Although HIV pre-exposure prophylaxis (PrEP) constitutes a highly effective biomedical HIV prevention
strategy, its effectiveness has been shown to be dependent on treatment adherence, retention in care, and the
continued use of condoms. Identifying and addressing factors that detract from these PrEP-relevant behaviors
is therefore imperative for maximizing the HIV preventive benefits of PrEP. Hazardous alcohol consumption,
and concurrent conditions such as substance use and depression, have been shown to adversely impact a
variety of health behaviors, and although these concerns are prevalent among PrEP-prescribed men who have
sex with men (MSM), little work has been conducted to investigate their role in PrEP treatment. The present
study involves a two-phased approach designed to 1) gain a better understanding of the associations among
alcohol use, concurrent substance use and depression, and PrEP-related behaviors among PrEP-prescribed
MSM (UH2 phase); and 2) explore whether addressing hazardous drinking and concurrent conditions can
potentially lead to improvements in MSM’s PrEP-related behaviors (UH3 phase). The recently completed first
phase of this research (UH2) involved 1) five focus groups with PrEP-prescribed MSM (N=35) to explore
barriers to PrEP adherence, retention in PrEP-related care, and condom use; with an emphasis on alcohol
consumption and concurrent conditions; 2) surveys with 141 PrEP-prescribed MSM to identify rates of, and
associations among, PrEP adherence, condomless sex, hazardous drinking, and concurrent conditions; and 3)
chart extraction of 501 PrEP-prescribed MSM to ascertain clinically-identified rates of, and associations
among, hazardous drinking and concurrent conditions; PrEP adherence; retention in PrEP-related care; and
sexually transmitted infections. Building on this initial work, the second phase of this research (UH3) will entail
a pilot randomized controlled trial in which 120 hazardous drinking, PrEP-prescribed MSM will be randomly
assigned to receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual.
Participants assigned to the former condition for whom substance use- and/or depression-related concerns are
identified will be provided with links to relevant resources. All trial participants will complete biomarker testing
and self-report assessments at baseline, 3-months, and 6-months to assess the preliminary impact of the
intervention on alcohol use, PrEP adherence, retention in care, and condomless sex. Feasibility and
acceptability of the intervention will also be examined. Taken together, findings from both phases of this
research will not only provide much needed insight into the possible impact of hazardous alcohol use and
concurrent conditions on PrEP treatment, but they will also have the potential to guide future initiatives aimed
at enhancing PrEP treatment effectiveness.