AzTrials
AzTrials

HIV-1-infectionNCT06648629

Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers

A study testing Acceptance and Commitment Therapy (ACT) and Brief Alcohol Intervention in people with HIV-1-infection and Alcohol Drinking, run by Syracuse University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1-infection, Alcohol Drinking
What is being tested?
Acceptance and Commitment Therapy (ACT) and Brief Alcohol Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
22 Jan 2025to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sarah E Woolf-King, PhD contact

314-443-2354

sewoolf@syr.edu

Stephen A Maisto, PhD contact

samaisto@syr.edu

United States1 site, 1 recruiting
  • Syracuse University

    Syracuse, New York, 13244

    Sarah E Woolf-King, PhD, 315-443-9917, sewoolf@syr.edu

    Stephen A Maisto, PhD, 315.443.2334, samaisto@syr.edu

    Recruiting

Other trials in United States

About this study

Official title: Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers: A Randomized Clinical Trial

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.

Read the detailed description

Alcohol use has a substantial impact on HIV care. Sixty-seven percent of people with HIV (PWH) report using alcohol in the previous year, 27-40% report drinking at unhealthy levels and ~30% meet criteria for alcohol use disorder (AUD). PWH who are unhealthy drinkers, compared to those who abstain or drink relatively less, experience a significant increase in risk for: mortality, lack of viral suppression, less antiretroviral therapy (ART) utilization and sub-optimal adherence to ART. Unhealthy alcohol consumption has been found to affect nearly every stage of the HIV care continuum, making it a critical factor in HIV treatment.

Randomized clinical trials (RCTs) of alcohol interventions for PWH have had limited success, likely due to lack of attention to co-morbid mental health problems. There have been several reviews of this literature, the most recent of which identified 9 non-overlapping behavioral trials developed specifically to target alcohol use and conducted in the U.S. with adult samples of PWH. Only four of these nine trials resulted in significant effects on alcohol-related outcomes and only two trials had effects on alcohol-related outcomes that were significantly different from the control group at 12-month follow-up. One hypothesized reason for this limited success is an increasingly recognized comorbidity of co-occurring unhealthy alcohol use and other mental health-related problems among PWH. Indeed, up to 63% of PWH meet criteria for both a substance use disorder and another psychiatric disorder-necessitating a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health and substance-related problems[. One trans-diagnostic mechanism that is particularly 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) is a promising trans-diagnostic intervention for PWH.

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. A recent review of 20 meta-analyses, based on 133 studies, found ACT to be efficacious across multiple psychological and behavioral health-related outcomes including: depression, anxiety, chronic pain, stress, and trans-diagnostic combinations of conditions. Additionally, three meta- analyses have found ACT to be efficacious for smoking and other drug use and there is an emerging literature suggesting ACT is a promising approach for alcohol use. There have not, however, been any full- scale RCTs of ACT for alcohol use among any population, including PWH. Given ACT's potential to improve multiple psychological and alcohol-related problems simultaneously, it holds great promise as an intervention for PWH who are unhealthy drinkers. 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). With a multidisciplinary team, and with two rounds of input from PWH, the investigators developed a six- session, telephone-delivered ACT intervention for alcohol use and subsequently conducted a pilot feasibility/acceptability RCT. The investigators found high acceptability of the adapted ACT intervention, and evidence of feasibility for conducting a full-scale, remote, RCT.

The overall objective of this application is therefore to determine the relative efficacy of ACT, compared to a standard Brief Alcohol Intervention (BI), for reducing alcohol use and comorbid symptoms of depression, anxiety, and stress among adult PWH who are unhealthy drinkers. The application's specific aims are to:

Aim 1: Determine the relative efficacy of ACT, compared to BI, for reducing alcohol use among PWH.

To achieve this aim, the investigators will: conduct a fully remote, relative efficacy RCT. The investigators will randomly assign 300 PWH who are unhealthy drinkers 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 an objective biomarker (phosphatidylethanol) - at baseline, post-treatment (7 weeks post-baseline), and again 3-, 6-, and 12-months post-randomization. The investigators hypothesize that: the two treatments will have significant, and statistically equivalent, effects on alcohol use at post-treatment and 3-months (H1) and, consistent with a sleeper effect for ACT, the ACT condition will have superior alcohol outcomes at 6- and 12-months post- randomization (H2).

Aim 2: Determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes. To achieve this aim, the investigators will: measure EA and determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes. The investigators hypothesize that: ACT will have superior outcomes on stress, anxiety, depression, and functional outcomes at all follow-up timepoints (H3) and that EA will be a significant mediator of all treatment effects, including alcohol use (H4).

Being tested
Acceptance and Commitment Therapy (ACT), Brief Alcohol Intervention
Keywords
HIV, Alcohol, ACT, Treatment
Medical subject headings
Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment Therapy (ACT)Behavioural

    Also called 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.

  • Brief Alcohol InterventionBehavioural

    Also called BI

    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.

Study groups in NCT06648629
Study groupRoleWhat they receive
Acceptance and Commitment Therapy (ACT)ExperimentalParticipants randomized to the ACT arm will receive six, weekly, 30-45-minute ACT intervention sessions delivered via telephone.
Receives: Behavioral: Acceptance and Commitment Therapy (ACT)
Brief Alcohol Intervention (BI)Active comparatorParticipants randomized to BI will receive two 30-60 minute sessions of a brief alcohol intervention delivered via telephone, two 5-10-minute booster calls, and two 5-minute reminder phone calls.
Receives: Behavioral: Brief Alcohol Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol use - Frequency

    The Timeline Followback will be used to estimate the Number of Drinking Days 30 days prior to study visit appointment

    Measured: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

  2. Alcohol Use - Quantity

    The Timeline Followback will be used to estimate the Number of Drinks per Drinking Day 30 days prior to study visit appointment

    Measured: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

  3. Phosphatidylethanol (PEth)

    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.

    Measured: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

Secondary outcomes (5)
  1. Symptoms of Anxiety

    Symptom of anxiety will be measured using the Generalized Anxiety Questionnaire (GAD-7). There are 7 items rated on a scale of 0 (not at all) to 3 (nearly every day). The GAD-7 total score ranges from 0 (no anxiety) to 21 (severe anxiety).

    Measured: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

  2. Symptoms of Depression

    Symptoms of depression will be measured using the Patient Health Questionnaire (PHQ-9). There are 9 items rated on a scale of 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0 (no depression) to 27 (severe depression).

    Measured: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

  3. Self-reported levels of Stress

    Self-reported levels of stress will be measured using the Perceived Stress Scale (PSS). The PSS consists of 10 items rated on a scale from 0 (never) to 4 (very often). The total score ranges from 0 (indicating no stress) to 40 (indicating high levels of stress).

    Measured: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

  4. Biological levels of Stress

    Biological levels of stress will be measured by assessing levels of cortisol in samples of nails

    Measured: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

  5. Symptoms of Experiential Avoidance

    Experiential Avoidance will be measured with the Brief Experiential Avoidance Questionnaire (BEAQ). The BEAQ consists of 15 items rated on a scale from 1 (strongly disagree) to 6 (strongly agree). The total score ranges from 15 (indicating low experiential avoidance) to 90 (indicating high experiential avoidance).

    Measured: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start22 Jan 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of the following two pre-specified treatment groups: Acceptance and Commitment Therapy or Brief Alcohol Intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06648629
Sponsor's protocol ID
23-207
Other IDs
R01AA030935
Status last verified
Oct 2026
First submitted
29 Jul 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Per NOT-AA-22-011, this study will submit and share data with NIAAA Data Archive (NIAAADA), a data repository housed within the National Institute of Mental Health (NIMH) Data Archive (NDA). To this end, the study will fulfill all tasks and expectations associated with NIAAA Data Archive (NIAAADA) Data Sharing Plan (DSP)

Publications

  • Woolf-King SE, Presutti E, McKenna O, Hahn JA, Abar B, Dahne J, Gump BB, Bendinskas KG, Maisto SA. Acceptance and commitment therapy for people with HIV who drink at unhealthy levels: Protocol for the ACCEPT randomized controlled trial. Contemp Clin Trials. 2025 Dec;159:108130. doi: 10.1016/j.cct.2025.108130. Epub 2025 Oct 24.

    PubMed 41326267

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy (ACT) and Brief Alcohol Intervention in people with HIV-1-infection and Alcohol Drinking, run by Syracuse University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah E Woolf-King, PhD (314-443-2354, sewoolf@syr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol use - Frequency (time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06648629, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in