This study will evaluate the effect of a brief alcohol counseling intervention on PrEP and PEP adherence among adults with heavy alcohol use at high risk for HIV, while gaining insights into the facilitators, barriers, and cost-effectiveness of this approach.
Adult (≥18 years)
HIV-uninfected (by rapid HIV antibody test)
AUDIT-C score of >=4 for men and >=3 for women
Attending a clinical visit for initiation of biomedical HIV prevention with oral or injectable PrEP or oral PEP (or the dapivirine vaginal ring, if available)
Ineligible for PrEP based on MoH guidelines
Intention to move away from the study community in the coming year
Gross inebriation or inability to provide informed consent
Parallel
Healthy Living Intervention (HLI)
BehavioralThe Healthy Living Intervention (HLI) is a brief alcohol counseling intervention developed using the Information, Motivation, and Behavioral skills (IMB) model, a framework in which information, motivation, and behavioral skills are key determinants of health behavior. Participants initiating PrEP will be randomized to either HLI or standard of care alcohol counseling.
Standard of Care
BehavioralParticipants who are randomized to the control arm will receive basic alcohol counseling through the Ministry of Health if it is provided as standard of care.
Proportion of follow up time on biomedical prevention with PrEP or PEP
The proportion of time during the 24 weeks after PrEP/PEP initiation that a person is protected from HIV with PrEP/PEP, assessed by prescription refill data. Prescription refill data will be collected from MoH medical and pharmacy records, augmented by OPAL case report forms.
Proportion of follow up time on biomedical prevention with PrEP or PEP- 48 weeks
Secondary analysis of the primary outcome will measure the proportion of time that a person is protected from HIV with PrEP/PEP over 48 weeks, with integrated drug levels measured in hair samples collected at 48 weeks.
Proportion of participants with unhealthy alcohol use (defined by AUDIT-C ≥3 for women, ≥4 for men, and phosphatidylethanol (PEth) ≥50 ng/mL) at week 48
Study staff will assess AUDIT-C scores (modified to refer to the prior 3 months, with a minimum of 0, indicating no alcohol use, and a maximum of 12) with a standard drink guide adapted to local context at baseline and every 12-weeks post-baseline. Blood will also be collected, and dried blood spots prepared for phosphatidylethanol (PEth) testing (measured in ng/mL with higher levels associated with greater alcohol use) at baseline and 48-weeks for confirmation of self-reported alcohol use.
Proportion of participants with HIV seroconversion by week 48
HIV seroconversion will be measured as documented rapid HIV antibody test positivity with Geenius confirmation or documented detectable HIV viral load, with rapid HIV testing. HIV testing will occur at PrEP refill and injection visits, or completion of a course of PEP.
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University of California, San Francisco
Lead sponsor
University of California, Berkeley
Collaborator
Makerere University
Collaborator
Infectious Diseases Research Collaboration, Uganda
Collaborator
Kenya Medical Research Institute
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
