IGHID 12219 - A Brief Alcohol Intervention for PrEP Users (BPrEP)

University of North Carolina (UNC)

Status: Active, not recruiting

Conditions: Unhealthy Alcohol Use

Treatments: Behavioral: The Brief Alcohol Intervention (BAI): Behavioral

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06094634

23-0256

R01AA030479 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 562 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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562 participants in 2 patient groups

Assessment-only control

No Intervention group

Description:

Participants receive study assessment visits and standard of care from providers at the PrEP clinic.

The Brief Alcohol Intervention (BAI)

Experimental group

Description:

Participants receive the Brief Alcohol Intervention (2 in-person sessions and 2 phone sessions), study assessment visits, and standard of care from providers at the PrEP clinic.

Treatment:

Behavioral: The Brief Alcohol Intervention (BAI): Behavioral