A brief alcohol intervention for people using PrEP
IGHID 12219 - A Brief Alcohol Intervention to Reduce Alcohol Use and Improve PrEP Outcomes: A Randomized Controlled Trial
NA · University of North Carolina, Chapel Hill · NCT06094634
This study is testing if a short alcohol intervention can help people who are starting or restarting PrEP stick to their medication better than standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 564 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT06094634 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a brief alcohol intervention (BAI) compared to standard care (SOC) for individuals initiating or re-initiating pre-exposure prophylaxis (PrEP) who also exhibit unhealthy alcohol use. The intervention consists of two in-person sessions and two telephone sessions, utilizing techniques from Motivational Interviewing, Cognitive Behavioral Therapy, and Motivational Enhancement Therapy. A total of 564 participants will be randomized into two groups, with follow-up assessments conducted over 12 months to measure the impact on PrEP adherence. The study aims to determine if the BAI can improve PrEP use among this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 years or older who are either newly initiating or re-initiating PrEP and have unhealthy alcohol use as indicated by specific screening scores.
Not a fit: Patients with significant psychological disturbances, cognitive impairments, or those currently involved in other alcohol-related programs or studies may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could enhance PrEP adherence among individuals with unhealthy alcohol use, potentially reducing the risk of HIV transmission.
How similar studies have performed: Other studies have shown promise in using behavioral interventions to improve adherence to PrEP, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanoi
- Hanoi Medical University — Hanoi, Vietnam (RECRUITING)
Study contacts
- Principal investigator: Vivian F Go, PhD — University of North Carolina
- Study coordinator: Teerada Sripaipan
- Email: teerada@email.unc.edu
- Phone: (919) 966 6236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Unhealthy Alcohol Use, Preexposure Prophylaxis, Alcohol Intervention, Motivational Interviewing, Cognitive Behavioral Therapy, Motivational Enhancement Therapy, Cost Analysis, Economic Evaluation