IGHID 12219 - A Brief Alcohol Intervention for PrEP Users
Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Oct 16, 2023
Trial Information
Current as of August 27, 2025
Recruiting
Keywords
ClinConnect Summary
The clinical trial titled IGHID 12219 is studying how a brief alcohol intervention can help improve the use of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in Vietnam who also have unhealthy alcohol use. PrEP is a medication that helps prevent HIV, and the trial aims to see if providing extra support around alcohol use can encourage more people to start and continue taking PrEP. The study is currently looking for participants, specifically males aged 16 and older who are either starting PrEP for the first time or returning after a break of at least three months. They should also have had receptive or penetrative anal sex with a man in the last six months and show signs of unhealthy alcohol use.
Eligible participants can expect to receive either the brief alcohol intervention or the usual care for their PrEP needs over a 12-month period in Hanoi. It's important to note that individuals with certain psychological issues, those currently enrolled in other alcohol or HIV studies, or those at risk for alcohol withdrawal are not eligible to participate. This trial represents a valuable opportunity to explore how support with alcohol use can improve health outcomes for those at risk of HIV.
Gender
ALL
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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hanoi, , Vietnam
Patients applied
Trial Officials
Vivian F Go, PhD
Principal Investigator
University of North Carolina
William C Miller, MD, PhD
Principal Investigator
University of North Carolina
Le Minh Giang, MD, PhD
Principal Investigator
Hanoi Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported