MedTrace Logo

IGHID 12219 - A Brief Alcohol Intervention for PrEP Users

NCT06094634 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Unhealthy Alcohol Use

Interventions

BEHAVIORAL

The Brief Alcohol Intervention (BAI): Behavioral

The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and comprises 2 in-person face-to-face sessions and 2 booster telephone sessions by a trained counselor.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Hanoi Medical University

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Vivian F Go, PhD · University of North Carolina

  • William C Miller, MD, PhD · University of North Carolina

  • Le Minh Giang, MD, PhD · Hanoi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06094634 on ClinicalTrials.gov