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 range16 Years

SexALL

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

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 range16 Years

SexALL

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