IGHID 12219 - A Brief Alcohol Intervention for PrEP Users

IGHID 12219 - A Brief Alcohol Intervention to Reduce Alcohol Use and Improve PrEP Outcomes: A Randomized Controlled Trial

The purpose of this study is to evaluate the effectiveness of a brief alcohol intervention (BAI) vs. standard of care (SOC) to improve pre-exposure prophylaxis (PrEP) use among PrEP initiators and re-initiators.

This is a two-arm effectiveness randomized controlled trial (RCT) to compare the brief alcohol intervention (BAI) to the standard of care (SOC) among PrEP initiators and re-initiators with unhealthy alcohol use who are initiating or reinitiating oral, event-driven, or injectable PrEP.

The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and includes 2 in-person sessions and 2 telephone sessions.

Eligible participants (n=564) will be randomized 1:1 to each arm (282 per arm). Additional assessments among a subset of participants in the BAI arm will assess acceptability of the intervention (n=48).

Study activities will span 5 years. Individual PrEP initiators and re-initiators will be followed-up for 12 months with assessment visits at 3, 6, 9, and 12 months after enrollment.

Inclusion Criteria:

• Newly initiating PrEP or re-initiating PrEP after at least 3 months from a missed PrEP appointment, based on local PrEP guidelines
• AUDIT-C score ≥ 4 or CRAFFT score ≥ 2 (for those ≤21 years old)
• 16 years of age or older
• Intention to receive PrEP care in Hanoi for 12 months
• Willingness to provide informed consent

Exclusion Criteria:

• Psychological disturbance, cognitive impairment, or threatening behavior
• Unwilling to provide locator information
• Current participation in alcohol programs or studies
• Current participation in other research studies (including HIV and PrEP studies)
• Ever enrolled in an HIV vaccine study
• Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) ≥ 10, indicating risk for alcohol withdrawal