NCT06648629 · Syracuse University
Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers
What this study is about
Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes. randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Acceptance and Commitment Therapy (ACT)
ACT is a trans-diagnostic treatment that targets experiential avoidance as an underlying factor common to mental and behavioral health problems. Mindfulness skills and values-guided behavioral action plans are used to decrease experiential avoidance and impact a broad array of psychological symptoms via improved psychological acceptance.
BEHAVIORAL
Brief Alcohol Intervention
The Brief Alcohol Intervention (BI) is a standard intervention for reducing alcohol use in PWH. The BI includes the creation of a drinking agreement, self-monitoring via drinking diary cards, discussion of risky moods/situation, and strategies for managing these moods/situations.
Primary outcome measures
Alcohol use - Frequency
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
The Timeline Followback will be used to estimate the Number of Drinking Days 30 days prior to study visit appointment
Alcohol Use - Quantity
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
The Timeline Followback will be used to estimate the Number of Drinks per Drinking Day 30 days prior to study visit appointment
Phosphatidylethanol (PEth)
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
PEth is a metabolite, formed only in the presence of alcohol use and detectable in dried blood spots for approximately 3-4 weeks. The investigators will use both absolute PEth values and a cutoff of 50 mg/ml to indicate recent unhealthy alcohol use. Based on the consideration of both prevalence of underreport in the sample, the investigators will also consider using a compound measure of PEth+ (PEth ≥50ng/ml) and/or self-reported Alcohol Quantity \& Frequency via the AUDIT-C+ (≥4, men; ≥3, women) for any unhealthy alcohol use in the last 21 days as an outcome of interest.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Syracuse, New York
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Rochester, University of California, San Francisco
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 4, 2026 · Source of record for eligibility and locations