An intervention to reduce unhealthy alcohol use for people living with HIV in Vietnam
IGHID 12230 - Scaling up the Brief Alcohol Intervention to Prevent HIV Infection in Vietnam: a Cluster Randomized, Implementation Trial (EBAI)
This study tests two different ways to help people living with HIV in Vietnam cut down on unhealthy drinking and see if it helps them manage their health better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 930 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT06358885 on ClinicalTrials.gov |
What this trial studies
This implementation trial evaluates two strategies to scale up a Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One group will receive facilitation support to overcome barriers to BAI implementation, while the other group will also participate in an experiential learning component to address their own alcohol-related behaviors. The trial involves 30 ART clinics and aims to assess both implementation and effectiveness outcomes, particularly focusing on viral suppression among participants. The study employs a cluster-randomized design to compare the two approaches.
Who should consider this trial
Good fit: Ideal candidates include individuals living with HIV who are currently attending ART clinics and exhibit unhealthy alcohol use.
Not a fit: Patients with psychological disturbances or cognitive impairments that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve alcohol use outcomes and viral suppression in people living with HIV.
How similar studies have performed: Other studies have shown success with similar alcohol intervention approaches, indicating potential for positive outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: PWH cohort participants * Person living with HIV at any stage of HIV infection * Currently attending the study ART clinic at any ART stage (initiating or receiving ART) * AUDIT-C score \>=4 for men or \>=3 for women * \>= 18 years of age * Willing to provide informed consent, which includes consenting to interview and collection of dried blood spots Clinic staff participants: * Work at the ART clinic as a clinic director, physician, nurse, or counselor * Willing to provide informed consent Exclusion Criteria: PWH cohort participants: * Psychological disturbance preventing participation * Cognitive impairment * Threatening behavior * Unwilling to provide locator information Note: If a participant screens positive with the AUDIT-C and is identified to be at substantial risk for alcohol withdrawal based on the Mini International Neuropsychiatric Interview (MINI) and Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) will be referred for treatment. They will not be eligible for enrollment until after alcohol withdrawal concerns are addressed. * These participants may be rescreened, consented, and enrolled after treatment. Clinic staff participants: * Psychological disturbance, cognitive impairment, or threatening behavior
Where this trial is running
Hanoi
- Hanoi Medical University — Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Vivian Go, MD — 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.