Active — Not RecruitingNot Applicable

IGHID 12219 - A Brief Alcohol Intervention for PrEP Users

Vietnam562 participantsStarted 2024-04-03

Plain-language 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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PrEP Persistence

Timeframe: 12 months

Heavy Drinking Days (Binge drinking)

Timeframe: 12 months

Incremental Cost-Effectiveness Ratio (ICER)

Timeframe: 12 months

Acceptability of the brief alcohol intervention, as measured with mHIST

Timeframe: 3 months

Feasibility - proportion completed 4 sessions (intervention arm)

Timeframe: 17 weeks

Feasibility - proportion completed 2 sessions (intervention arm)

Timeframe: 17 weeks

Feasibility - proportion completed 4 sessions (among initiators)

Timeframe: 10 weeks

Trial details

NCT IDNCT06094634

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Unhealthy Alcohol Use trials

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

PrEP Persistence

Timeframe: 12 months

Heavy Drinking Days (Binge drinking)

Timeframe: 12 months

Incremental Cost-Effectiveness Ratio (ICER)

Timeframe: 12 months

Acceptability of the brief alcohol intervention, as measured with mHIST

Timeframe: 3 months

Feasibility - proportion completed 4 sessions (intervention arm)

Timeframe: 17 weeks

Feasibility - proportion completed 2 sessions (intervention arm)

Timeframe: 17 weeks

Feasibility - proportion completed 4 sessions (among initiators)

Timeframe: 10 weeks