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IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Apr 8, 2024

Trial Information

Current as of August 27, 2025

Recruiting

Keywords

Alcohol Intervention Cluster Randomized Controlled Implementation Trial Implementation Science Hiv/Aids Antiretroviral Therapy Cognitive Behavioral Therapy Motivational Interviewing Motivational Enhancement Therapy Cost Analysis Economic Evaluation Vietnam

ClinConnect Summary

The IGHID 12230 trial is studying how to effectively implement a Brief Alcohol Intervention (BAI) in clinics that treat HIV in Vietnam. The goal is to help reduce unhealthy alcohol use among people living with HIV, which can improve their health and support their treatment. The study will compare two groups: one group of clinics will receive support to implement the BAI, while the other group will receive that support plus the opportunity for clinic staff to personally experience the BAI themselves. This approach helps staff understand the intervention better and improve their ability to help patients.

To be eligible for this trial, participants must be at least 18 years old, living with HIV, and attending the study clinic. They should also show signs of unhealthy alcohol use based on a screening questionnaire. Clinic staff, like doctors and counselors, can also join if they work at the clinic and are willing to participate. Participants can expect to share their experiences and may also provide some health information. Importantly, anyone with serious mental health issues or who poses a risk to themselves or others will not be able to participate until those concerns are addressed. This trial aims to create effective support systems for both patients and clinic staff to improve health outcomes.

Gender

ALL

Eligibility 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

About University Of North Carolina, Chapel Hill

The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.

Locations

Hanoi, , Vietnam

Patients applied

0 patients applied

Trial Officials

Vivian Go, MD

Principal Investigator

University of North Carolina

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported