NCT06648629 Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers
| NCT ID | NCT06648629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Syracuse University |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-01-22 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-01-22 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes. Randomized clinical trials (RCTs) of alcohol interventions for people with HIV (PWH) have had limited success, perhaps due to an increasingly recognized co-morbitity of co-occurring hazardous alcohol use and other mental health-related problems among PWH. This has necessitated a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health-related problems. One trans-diagnostic mechanism that is relevant to alcohol and other substance use is experiential avoidance (EA)- i.e., repeated, and maladaptive, use of substances and/or other behaviors to escape or avoid unwanted thoughts, feelings, and/or urges. Acceptance and commitment therapy (ACT) targets EA and is an empirically supported treatment for multiple psychological and behavioral health-related outcomes; however there have not been any full-scale RCTs of ACT for alcohol use among any population, including PWH. The investigators recently adapted a telephone-delivered ACT intervention originally developed for smoking cessation, into an intervention for PWH who drink at unhealthy levels (NIH/NIAAA; R34AA026246). This six-session, telephone-delivered ACT intervention for alcohol use showed high feasibility and acceptability in a pilot RCT conducted by our team. The overall objective of this application is therefore to determine if ACT can significantly reduce alcohol use and comorbid symptoms of depression, anxiety, and stress among adult PWH who drink at unhealthy levels. The specific aims are: To determine the relative efficacy of ACT, compared to BI, for reducing alcohol use among PWH (Aim 1) and to determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes (Aim 2). The investigators will accomplish these aims by: conducting a remote, RCT in which the investigators randomly assign 300 PWH who drink at unhealthy levels to either the ACT intervention the investigators developed (n = 150), or a BI intervention (n = 150) previously shown to reduce alcohol use among PWH. The investigators will assess alcohol-related outcomes-via self-report and a biomarker- at baseline, post-treatment (7 weeks post-baseline), and again 3-, 6-, and 12-months post-randomization. The investigators will also measure EA to determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes, measured at all timepoints.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06648629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06648629 currently recruiting?
Yes, NCT06648629 is actively recruiting participants. Contact the research team at sewoolf@syr.edu for enrollment information.
Where is the NCT06648629 trial being conducted?
This trial is being conducted at Syracuse, United States.
Who is sponsoring the NCT06648629 clinical trial?
NCT06648629 is sponsored by Syracuse University. The trial plans to enroll 300 participants.
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