Therapy for HIV-positive individuals with hazardous drinking
Official title: Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers: A Randomized Clinical Trial
Run by Syracuse University · NCT06648629 · Data updated 2026-11-12
This study is testing if a new therapy combined with a short alcohol intervention can help people with HIV who drink too much to reduce their alcohol use and improve their overall health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Syracuse University Academic / other |
| Locations | 1 site (Syracuse, New York) |
| Status | Recruiting |
| Started | January 22, 2025 |
| Main results expected | May 2028 |
| Study ends | August 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT06648629 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults living with HIV who report unhealthy alcohol consumption but do not have severe depression or anxiety.
✕Probably not a fit
Patients with severe depression or anxiety, as indicated by high scores on screening tools, may not benefit from this study and will be referred for mental health treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of Acceptance and Commitment Therapy (ACT) combined with a brief alcohol intervention for individuals living with HIV who engage in hazardous drinking. The study aims to address the co-occurring issues of unhealthy alcohol use and mental health problems, which can significantly impact HIV treatment outcomes. Participants will be randomly assigned to receive ACT or a control intervention, with the goal of reducing alcohol consumption and improving overall health. The trial will include assessments of alcohol use and mental health symptoms throughout the intervention period.
Why it matters
Potential benefit: If successful, this approach could lead to improved health outcomes for HIV-positive individuals by reducing hazardous drinking and enhancing adherence to HIV treatment.
How similar studies have gone: Previous studies have shown limited success with alcohol interventions for people with HIV, making this approach novel in its focus on experiential avoidance and co-occurring mental health issues.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Living with HIV * Drink at unhealthy levels based on self-reported answers to the AUDIT-C, referencing drinking over the previous 3 months \[score of ≥4 (men) or ≥3 (women) will be used to identify eligible participants\] * on HIV treatment and are * 18 years or older. * Read at an 8th grade level * Can provide a physical address * Able to provide informed consent Exclusion Criteria: * Anyone with a score = 12 on the AUDIT-C will be excluded. * Anyone with a score ≥20 on the PHQ-9, indicative of severe depression, will be excluded. * Anyone with a score of ≥15 on the GAD-7, indicative of severe anxiety, will be excluded. Referrals for mental health treatment will be given to all participants who screen out.
Where it's running
-
Syracuse University
Syracuse, New York, United States Recruiting
Study contacts
- Study coordinator: Sarah E Woolf-King, PhD
- Email: sewoolf@syr.edu
- Phone: 314-443-2354
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.