Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers

NCT03974061 | Completed Results

• 2 other identifiers: 17-278R34AA026246
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol consumption at hazardous levels is associated with negative consequences on nearly every step of the HIV care continuum. It is a critical factor in HIV treatment that, if unaddressed, significantly contributes to onward transmission and poor treatment outcomes. Alcohol interventions for people living with HIV (PLWH) in the United States (US) have shown mixed results, and no alcohol intervention for PLHW has shown long-term reductions in heavy drinking or a significant impact on HIV-related outcomes. One hypothesized reason for this limited success is the failure of these interventions to address the multiple overlapping problems (e.g., comorbid mental health conditions, behavioral health needs) of PLWH who are hazardous drinkers. Innovative alcohol intervention strategies that can have an impact on these multiple behavioral health needs, in a format that can be feasibly delivered in the context of HIV care, are needed. Brief Acceptance and Commitment Therapy (ACT) is a promising intervention for HIV-infected hazardous drinkers. ACT is a transdiagnostic treatment that uses mindfulness skills and values-guided behavioral action plans to impact a broad array of psychological symptoms. ACT has shown efficacy for treatment of anxiety, depression, chronic pain, and substance use, making it a promising approach for hazardous drinkers. The overall objective of this application is to adapt an existing brief ACT intervention developed for smoking cessation, and pilot test its feasibility and acceptability for PLWH who are hazardous drinkers. We hypothesize that the resulting intervention will be preliminarily associated with decreased alcohol use, improved ART adherence, decreased symptoms of depression, anxiety, and drug use, and increased acceptance-a known mechanism of change in ACT.

Conditions

Treatment

Keywords

Brief Acceptance and Commitment Therapy; HIV; Alcohol; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (16)

• Number of Drinking Days: Baseline (at Baseline)

  Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinking days over the last 42-day period.

  Baseline

• Number of Drinking Days: Post-Treatment (at 7-weeks Post-baseline)

  Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinking days over the last 42-day period.

  Post-treatment (at 7-weeks post-baseline)

• Number of Drinking Days: 3-months (at 3-months Post-baseline)

  Alcohol consumption will be measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinking days over the last 42-day period.

  3-months post-baseline

• Number of Drinking Days: 6-months (at 6-months Post-baseline)

  Alcohol consumption will be measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinking days over the last 42-day period.

  6-months post-baseline

• Number of Drinks Per Drinking Day: Baseline (at Baseline)

  Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinks per day over the last 42-day period.

  Baseline

• Number of Drinks Per Drinking Day: Post-Treatment (at 7-weeks Post-baseline)

  Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinks per drinking day over the last 42-day period.

  Post-Treatment (7-weeks post-baseline)

• Number of Drinks Per Drinking Day: 3-months (at 3-months Post-baseline)

  Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinks per drinking day over the last 42-day period.

  3-months post-baseline

• Number of Drinks Per Drinking Day: 6-months (at 6-months Post-baseline)

  Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinks per day over the last 42-day period.

  6-months post-baseline

• Alcohol Consumption Measured by Phosphatidylethanol (PEth): Baseline (at Baseline)

  Alcohol use was assessed using the biomarker phosphatidylethanol (PEth). PEth is an abnormal phospholipid formed only in the presence of alcohol with an estimated half-life of 4-12 days and can be measured from dried blood spots. We calculated the percent of PEth positive tests (.50ng/ml) received at each study visit (out of all samples that were successfully sent back to our lab and successfully processed by the lab processing facility).

  Baseline

• Alcohol Consumption Measured by Phosphatidylethanol (PEth): 6-months (at 6-months Post-baseline)

  Alcohol use was assessed using the biomarker phosphatidylethanol (PEth). PEth is an abnormal phospholipid formed only in the presence of alcohol with an estimated half-life of 4-12 days and can be measured from dried blood spots. We calculated the percent of PEth positive tests (.50ng/ml) received at each study visit (out of all samples that were successfully sent back to our lab and successfully processed by the lab processing facility).

  6-months post-baseline

• ART Adherence Measured by Self-Report: Baseline (at Baseline)

  ART adherence was measured by self-report by asking participants to use a Likert-type scale of of 1 (very poor) to 6 (excellent) to report their ability to take all of their ART medication in past past 30 days.

  Baseline (at baseline)

• ART Adherence Measured by Self-report: Post-treatment (at 7-weeks Post-baseline)

  ART adherence was measured by self-report by asking participants to use a Likert-type scale of of 1 (very poor) to 6 (excellent) to report their ability to take all of their ART medication in past past 30 days.

  Post-treatment (at 7-weeks post-baseline)

• ART Adherence Measured by Self-report: 3-months (at 3-months Post-baseline)

  ART adherence was measured by self-report by asking participants to use a Likert-type scale of of 1 (very poor) to 6 (excellent) to report their ability to take all of their ART medication in past past 30 days.

  3-months post-baseline

• ART Adherence Measured by Self-report: 6-months (at 6-months Post-baseline)

  ART adherence was measured by self-report by asking participants to use a Likert-type scale of of 1 (very poor) to 6 (excellent) to report their ability to take all of their ART medication in past past 30 days.

  6-months post-baseline

• ART Adherence Measured by Hair: Baseline

  Adherence was intended to be measured via ARV levels in hair. Hair concentrations of ARVs have been shown to be the strongest independent predictor of virological success in prospective cohorts of HIV-infected patients.

  At Baseline

• ART Adherence Measured by Hair: 6-months (6-months Post-baseline)

  Adherence was intended to be measured via ARV levels in hair. Hair concentrations of ARVs have been shown to be the strongest independent predictor of virological success in prospective cohorts of HIV-infected patients.

  6-months post baseline

Secondary Outcomes (8)

• Symptoms of Experiential Avoidance: Baseline (at Baseline)

  Baseline

• Symptoms of Experiential Avoidance: 6-months (at 6-months Post-baseline)

  6 months post-baseline

• Symptoms of Depression: Baseline (at Baseline)

  Baseline

• Symptoms of Depression: 6-months (at 6-months Post-baseline)

  6 months post-baseline

• Symptoms of Anxiety: Baseline (at Baseline)

  Baseline

Other Outcomes (6)

• Symptoms of Chronic Pain: Baseline (at Baseline)

  Baseline

• Symptoms of Chronic Pain: 6-months (at 6-months Post-baseline)

  6 months post-baseline

• HIV Medication Adherence Self-Efficacy: Baseline (at Baseline)

  Baseline

Study Arms (2)

Brief Acceptance and Commitment Therapy

EXPERIMENTAL

Participants randomized to the Acceptance and Commitment Therapy (ACT) arm will receive one, 1-hour intervention session followed by five weekly 30-45 minute intervention sessions delivered via telephone.

Behavioral: Brief Acceptance and Commitment Therapy

Brief Alcohol Intervention

ACTIVE COMPARATOR

Participants randomized to the Brief Alcohol Intervention (BI) will receive the following telephone-based sessions over the duration of six weeks: a 30-45 minute session of a brief alcohol intervention, a 5-10 minute booster call, a reminder phone call for the next intervention session, a 30-45 minute intervention session, a 5-10 minute booster, and a reminder phone call for the post-treatment appointment.

Behavioral: Brief Alcohol Intervention

Interventions

Brief Alcohol Intervention BEHAVIORAL

The Brief Alcohol Intervention is a standard intervention that will be adapted for men and women living with HIV. The intervention will be matched in frequency and length to the brief ACT intervention.

Also known as: BI

Brief Alcohol Intervention

Brief Acceptance and Commitment Therapy BEHAVIORAL

Acceptance and Commitment Therapy utilizes mindfulness skills and values-guided behavioral action plans to decrease experiential avoidance and impact a broad array of psychological symptoms.

Also known as: Brief ACT

Brief Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age,
• HIV-positive,
• currently prescribed ART medication,
• score of ≥4 (men) or ≥3 (women) on the AUDIT-C.

You may not qualify if:

• Experiencing acute illness or declining health status when it is determined by a treatment provider that research participation is contraindicated,
• unable to understand spoken English,
• does not own a cell phone,
• a score of 12 on the AUDIT-C, indicating high risk for a severe alcohol use disorder,
• a score of ≥20 on the PHQ-9 indicating severe depressive symptoms,
• a score of ≥15 on the GAD-7, indicating severe symptoms of anxiety,
• experiencing active psychosis as judged by research staff via scores on the BSI.

Sponsors & Collaborators

• Syracuse University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

Location

Related Publications (1)

• Woolf-King SE, Dalton MR, Firkey M, Sheinfil A, Bucci V, Estrada B, Ramos J, Hahn JA, Bricker J, Gump B, Bendinskas KG, Maisto SA. A Randomized Feasibility/Acceptability Trial of Acceptance and Commitment Therapy for People with HIV Who Drink at Unhealthy Levels. AIDS Behav. 2025 Dec 29. doi: 10.1007/s10461-025-04990-7. Online ahead of print.

  PMID: 41460282 DERIVED

MeSH Terms

Interventions

Ethanol; Methods

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Limitations and Caveats

Pilot trial was transitioned from an in-person RCT to a fully remote RCT in response to the COVID-19 pandemic. Enrollment began in Fall of 2019, paused in March, 2020, and resumed in December 2020 once the study had fully transitioned to a remote RCT.

Results Point of Contact

• Title: Sarah Woolf-King, PhD, MPH, Associate Professor of Psychology
• Organization: Syracuse University

sewoolf@syr.edu

3154432354

Study Officials

• Sarah E Woolf-King, PhD

  Syracuse University

  PRINCIPAL INVESTIGATOR

• Stephen A Maisto, PhD

  Syracuse University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to which intervention is hypothesized to be superior and produce the intended effects. Outcome assessors will be blinded to which intervention participants received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized (stratified by gender and interventionist) to a treatment condition (brief acceptance and commitment therapy or a brief alcohol intervention) and an interventionist.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: June 4, 2019
• Study Start: November 1, 2019
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: April 1, 2026
• Results First Posted: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data sharing will be available upon publication of the main study findings.
• Access Criteria: We will make the data and associated documentation available to users only via a signed data-sharing agreement that stipulates a commitment to: (1) only use the data for research purposes and not to identify any individual participants, (2) securely storing the data via password-protected databases and secure servers, and (3) destroying or returning the data after analyses are completed.

Locations

US (1)