Clinical trial NCT06094634: IGHID 12219 - A Brief Alcohol Intervention for PrEP Users
Official title: IGHID 12219 - A Brief Alcohol Intervention to Reduce Alcohol Use and Improve PrEP Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unhealthy Alcohol Use
Keywords: Preexposure Prophylaxis (PrEP)
Alcohol Intervention
Motivational Interviewing
Cognitive Behavioral Therapy
Motivational Enhancement Therapy
Cost Analysis
Economic Evaluation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Institutes of Health (NIH)
name: Hanoi Medical University
name: Johns Hopkins University
name: University of Washington
First posted: 2023-10-23
Enrollment: 564
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP Persistence
timeFrame: 12 months
measure: Heavy Drinking Days (Binge drinking)
timeFrame: 12 months
measure: Incremental Cost-Effectiveness Ratio (ICER)
timeFrame: 12 months
measure: Acceptability of the brief alcohol intervention, as measured with mHIST
timeFrame: 3 months
measure: Feasibility - proportion completed 4 sessions (intervention arm)
timeFrame: 17 weeks
measure: Feasibility - proportion completed 2 sessions (intervention arm)
timeFrame: 17 weeks
measure: Feasibility - proportion completed 4 sessions (among initiators)
timeFrame: 10 weeks
Secondary outcomes:
measure: PrEP Adherence
timeFrame: Up to 12 months
measure: Risk-aligned PrEP use
timeFrame: Up to 12 months
measure: Number of Drinking Days
timeFrame: Up to 12 months
measure: Number of Drinks Per Drinking Day
timeFrame: Up to 12 months
measure: Penetration
timeFrame: Up to 7 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
Study officials:
affiliation: University of North Carolina
name: Vivian F Go, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: William C Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanoi Medical University
name: Le Minh Giang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: