TreatmentNCT03974061
Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers
A study testing Brief Acceptance and Commitment Therapy and Brief Alcohol Intervention in people with Treatment, run by Syracuse University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment
- What is being tested?
- Brief Acceptance and Commitment Therapy and Brief Alcohol Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- ≥18 years of age,
- HIV-positive,
- currently prescribed ART medication,
- score of ≥4 (men) or ≥3 (women) on the AUDIT-C.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Alcohol use is a major problem in HIV care. Sixty-six percent of people living with HIV (PLWH) report using alcohol in the previous year, 8-20% report drinking at hazardous or heavy levels, and 30% report current binge drinking (>5 drinks in an occasion in the past 30 days). PLWH who are hazardous drinkers, compared to those who abstain, experience a significant increased risk for: taking ART medications off schedule, suboptimal adherence to ART, and engaging in sexual risk behavior. Hazardous alcohol consumption has been found to affect every stage of the HIV care continuum, from diagnosis, to linkage to care, to retention, and viral suppression, making it a critical factor in HIV treatment that, if unaddressed, may significantly contribute to onward transmission.
Behavioral interventions for HIV-infected drinkers have provided limited evidence of benefit. HIV-prevention interventions do not typically address alcohol use, and it is often overlooked in HIV care. While there have been several clinical trials of alcohol interventions for PLWH in the US, these trials have shown mixed results for reducing alcohol use and improving HIV-related outcomes. 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 that PLWH who are at-risk drinkers are also likely to have multiple overlapping problems. It is estimated that 38% of PLWH meet criteria for both a substance use and another psychiatric disorder and also have a myriad of behavioral health needs (e.g., treatment adherence, condom use), any one of which would benefit from intervention. In order to adequately address these issues, PLWH require innovative alcohol intervention strategies that can also have an impact on other behavioral and mental health needs, in a format that can be feasibly delivered in the context of HIV care.
Brief acceptance and commitment therapy (ACT) is a promising intervention for HIV-infected drinkers. ACT is a transdiagnostic treatment that targets experiential avoidance (repeated attempts to eliminate or avoid difficult thoughts/feelings) 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. ACT has shown efficacy for treatment of anxiety depression, and chronic pain, making it a promising approach for HIV-infected hazardous drinkers. A recently published meta-analysis also indicates that ACT is efficacious for smoking, opiate use, methamphetamine use, and polydrug abuse, showing a small to medium effect size compared to active treatment controls (e.g., Cognitive Behavioral Therapy (CBT), pharmacotherapy). ACT's unique focus on skills that increase the ability to experience and accept, rather than change and control, urges and cravings related to substance use is different from more traditional forms of addiction treatment such as CBT. Indeed, a pilot RCT of a brief, telephone-delivered ACT intervention for smoking cessation had quit rates more than double that of traditional CBT for smokers with comorbid depression. However, ACT has not been studied as an intervention for hazardous drinkers.
The overall objective of this study is to adapt an existing brief ACT intervention and pilot test its feasibility, acceptability, and preliminary efficacy for PLWH who are hazardous drinkers. We hypothesize that the resulting intervention will have a significant effect on biological and self-reported measures of alcohol use and ART adherence. Secondary analyses will also examine changes in acceptance-a known mechanism of change in ACT -symptoms of depression and anxiety, and drug use, which we expect to differ by treatment group. The specific aims are as follows:
Aim 1: Adapt an existing brief ACT intervention for HIV-infected at-risk drinkers (ACT). We will accomplish this aim by: Modifying an existing 5-session, telephone-delivered ACT intervention for smoking cessation using a theoretical framework that has been previously used to systematically adapt evidence-based HIV interventions. We will conduct iterative multidisciplinary team meetings, focus group discussions with HIV clinic patients (N = 15-20), and qualitative interviews with HIV clinic providers (N = 5-10) to inform the adaptation process, get feedback on intervention content, and develop a new treatment manual.
Aim 2: Conduct a pilot superiority trial of ACT compared to a brief alcohol intervention. We will accomplish this aim by: Randomly assigning N = 74 HIV-infected hazardous drinkers (50% women) to the intervention developed in Aim 1 (n = 30) or a brief alcohol intervention previously developed for PLWH that is nearly equivalent in number and length of sessions. We will assess feasibility, acceptability, and primary trial outcomes of alcohol use and ART adherence immediately post-treatment and again at 3 and 6-months post-randomization. Secondary outcomes of changes in acceptance, symptoms of depression, symptoms of anxiety, and drug use will be assessed at all time points.
The proposed research will provide essential pilot data for an R01 application to conduct a full-scale RCT to determine the efficacy of ACT compared with the current evidence-based treatment for PLWH. If successful, this intervention will have broad implications for implementation in HIV and other integrated care settings.
- Conditions
- Treatment
- Being tested
- Brief Acceptance and Commitment Therapy, Brief Alcohol Intervention
- Keywords
- Brief Acceptance and Commitment Therapy, HIV, Alcohol, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Acceptance and Commitment TherapyBehavioural
Also called Brief ACT
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.
Brief Alcohol InterventionBehavioural
Also called BI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Brief Alcohol Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-months post baseline
Secondary outcomes (8)
Symptoms of Experiential Avoidance: Baseline (at Baseline)
Symptoms of experiential avoidance were measured with the Brief Experiential Avoidance Questionnaire (BEAQ). The BEAQ is a 15-item measures that assesses six domains of experiential avoidance using a Likert-type scale that ranges from 1 to 6. A total score was calculated to indicate general symptoms of experiential avoidance. Total scores can range from 15 to 90 with higher scores indicating higher levels of experiential avoidance (and lower levels of acceptance).
Measured: Baseline
Symptoms of Experiential Avoidance: 6-months (at 6-months Post-baseline)
Symptoms of experiential avoidance were measured with the Brief Experiential Avoidance Questionnaire (BEAQ). The BEAQ is a 15-item measures that assesses six domains of experiential avoidance using a Likert-type scale that ranges from 1 to 6. A total score was calculated to indicate general symptoms of experiential avoidance. Total scores can range from 15 to 90 with higher scores indicating higher levels of experiential avoidance (and lower levels of acceptance).
Measured: 6 months post-baseline
Symptoms of Depression: Baseline (at Baseline)
Symptoms of depression were measured using the total score obtained on Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 9-item standardized measure of depression severity with scores ranging from 0 to 27, and higher scores indicating higher levels of depression symptoms severity. Scores <5 are considered none-mild, in the 10-14 range are considered "moderate," in the 15-19 range are considered "moderately severe," and in the 20-27 range are considered "severe."
Measured: Baseline
Symptoms of Depression: 6-months (at 6-months Post-baseline)
Symptoms of depression were measured using the total score obtained on Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 9-item standardized measure of depression severity with scores ranging from 0 to 27, and higher scores indicating higher levels of depression symptoms severity. Scores <5 are considered none-mild, in the 10-14 range are considered "moderate," in the 15-19 range are considered "moderately severe," and in the 20-27 range are considered "severe."
Measured: 6 months post-baseline
Symptoms of Anxiety: Baseline (at Baseline)
Symptoms of anxiety were measured using the total score obtained via the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 is a 7-item standardized measure of anxiety severity with score ranging from 0 to 21. With regard to symptoms of anxiety, score in the 0-4 range are considered "minimal," 5-9 range are considered "mild," 10-14 range are considered "moderate," and 15+ are considered "severe."
Measured: Baseline
Symptoms of Anxiety: 6-months (at 6-months Post-baseline)
Symptoms of anxiety were measured using the total score obtained via the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 is a 7-item standardized measure of anxiety severity with score ranging from 0 to 21. With regard to symptoms of anxiety, score in the 0-4 range are considered "minimal," 5-9 range are considered "mild," 10-14 range are considered "moderate," and 15+ are considered "severe."
Measured: 6-months post-baseline
Number of Days Other Substances Used: Baseline (at Baseline)
Substance use other than alcohol was measured by retrospective self-report via the 6-week Time Line Follow Back (TLFB) interview method which yields the number of days non-prescription drugs were used over the past 42 days.
Measured: Baseline
Number of Days Other Substances Used: 6-months (6-months Post-baseline)
Substance use other than alcohol was measured by retrospective self-report via the 6-week Time Line Follow Back (TLFB) interview method which yields the number of days non-prescription drugs were used over the past 42 days.
Measured: 6-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Nov 2019
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 randomized (stratified by gender and interventionist) to a treatment condition (brief acceptance and commitment therapy or a brief alcohol intervention) and an interventionist.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sarah E Woolf-King, PhD, Principal investigator, Syracuse UniversityStephen A Maisto, PhD, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974061
- Sponsor's protocol ID
- 17-278
- Other IDs
- R34AA026246
- Status last verified
- Mar 2026
- First submitted
- 10 May 2019
- Last updated
- 1 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed pilot randomized clinical trail (RCT) will include data from approximately 74 HIV-infected hazardous drinkers recruited from a single HIV clinic. The final dataset will include self-reported demographic and behavioral data related to substance use, HIV medication adherence, and general mental health functioning as well as laboratory data from dried blood spots and hair analysis. We will be collecting identifying information in a separate database to track participants for followup appointments. Even though the final computerized dataset will be stripped of all personal identifiers, given the small sample of the study, and the sole recruitment source, there remains a possibility of deductive disclosure of research participants with unusual characteristics. We will thus make the data and associated documentation available to users only via a signed data-sharing agreement.
Publications
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. 2026 Jun;30(6):1761-1776. doi: 10.1007/s10461-025-04990-7. Epub 2025 Dec 29.
PubMed 41460282
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers
- ClinicalTrials.gov ID
- NCT03974061
- Acronym / sponsor ID
- 17-278
- Conditions
- Treatment
- Keywords
- Brief Acceptance and Commitment Therapy, HIV, Alcohol, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Posted 1 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Alcohol use is a major problem in HIV care. Sixty-six percent of people living with HIV (PLWH) report using alcohol in the previous year, 8-20% report drinking at hazardous or heavy levels, and 30% report current binge drinking (>5 drinks in an occasion in the past 30 days). PLWH who are hazardous drinkers, compared to those who abstain, experience a significant increased risk for: taking ART medications off schedule, suboptimal adherence to ART, and engaging in sexual risk behavior. Hazardous alcohol consumption has been found to affect every stage of the HIV care continuum, from diagnosis, to linkage to care, to retention, and viral suppression, making it a critical factor in HIV treatment that, if unaddressed, may significantly contribute to onward transmission.
Behavioral interventions for HIV-infected drinkers have provided limited evidence of benefit. HIV-prevention interventions do not typically address alcohol use, and it is often overlooked in HIV care. While there have been several clinical trials of alcohol interventions for PLWH in the US, these trials have shown mixed results for reducing alcohol use and improving HIV-related outcomes. 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 that PLWH who are at-risk drinkers are also likely to have multiple overlapping problems. It is estimated that 38% of PLWH meet criteria for both a substance use and another psychiatric disorder and also have a myriad of behavioral health needs (e.g., treatment adherence, condom use), any one of which would benefit from intervention. In order to adequately address these issues, PLWH require innovative alcohol intervention strategies that can also have an impact on other behavioral and mental health needs, in a format that can be feasibly delivered in the context of HIV care.
Brief acceptance and commitment therapy (ACT) is a promising intervention for HIV-infected drinkers. ACT is a transdiagnostic treatment that targets experiential avoidance (repeated attempts to eliminate or avoid difficult thoughts/feelings) 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. ACT has shown efficacy for treatment of anxiety depression, and chronic pain, making it a promising approach for HIV-infected hazardous drinkers. A recently published meta-analysis also indicates that ACT is efficacious for smoking, opiate use, methamphetamine use, and polydrug abuse, showing a small to medium effect size compared to active treatment controls (e.g., Cognitive Behavioral Therapy (CBT), pharmacotherapy). ACT's unique focus on skills that increase the ability to experience and accept, rather than change and control, urges and cravings related to substance use is different from more traditional forms of addiction treatment such as CBT. Indeed, a pilot RCT of a brief, telephone-delivered ACT intervention for smoking cessation had quit rates more than double that of traditional CBT for smokers with comorbid depression. However, ACT has not been studied as an intervention for hazardous drinkers.
The overall objective of this study is to adapt an existing brief ACT intervention and pilot test its feasibility, acceptability, and preliminary efficacy for PLWH who are hazardous drinkers. We hypothesize that the resulting intervention will have a significant effect on biological and self-reported measures of alcohol use and ART adherence. Secondary analyses will also examine changes in acceptance-a known mechanism of change in ACT -symptoms of depression and anxiety, and drug use, which we expect to differ by treatment group. The specific aims are as follows:
Aim 1: Adapt an existing brief ACT intervention for HIV-infected at-risk drinkers (ACT). We will accomplish this aim by: Modifying an existing 5-session, telephone-delivered ACT intervention for smoking cessation using a theoretical framework that has been previously used to systematically adapt evidence-based HIV interventions. We will conduct iterative multidisciplinary team meetings, focus group discussions with HIV clinic patients (N = 15-20), and qualitative interviews with HIV clinic providers (N = 5-10) to inform the adaptation process, get feedback on intervention content, and develop a new treatment manual.
Aim 2: Conduct a pilot superiority trial of ACT compared to a brief alcohol intervention. We will accomplish this aim by: Randomly assigning N = 74 HIV-infected hazardous drinkers (50% women) to the intervention developed in Aim 1 (n = 30) or a brief alcohol intervention previously developed for PLWH that is nearly equivalent in number and length of sessions. We will assess feasibility, acceptability, and primary trial outcomes of alcohol use and ART adherence immediately post-treatment and again at 3 and 6-months post-randomization. Secondary outcomes of changes in acceptance, symptoms of depression, symptoms of anxiety, and drug use will be assessed at all time points.
The proposed research will provide essential pilot data for an R01 application to conduct a full-scale RCT to determine the efficacy of ACT compared with the current evidence-based treatment for PLWH. If successful, this intervention will have broad implications for implementation in HIV and other integrated care settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brief Acceptance and Commitment Therapy | Experimental | Behavioral: Brief Acceptance and Commitment TherapyParticipants 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. |
| Brief Alcohol Intervention | Active comparator | Behavioral: Brief Alcohol InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age,
- HIV-positive,
- currently prescribed ART medication,
- score of ≥4 (men) or ≥3 (women) on the AUDIT-C.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Acceptance and Commitment TherapyAlso: Brief ACTAcceptance and Commitment Therapy utilizes mindfulness skills and values-guided behavioral action plans to decrease experiential avoidance and impact a broad array of psychological symptoms. | Behavioural | Brief Acceptance and Commitment Therapy |
| Brief Alcohol InterventionAlso: BIThe 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. | Behavioural | Brief Alcohol Intervention |
Primary outcome
Number of Drinking Days: Baseline (at Baseline)
Time frame: 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.
Number of Drinking Days: Post-Treatment (at 7-weeks Post-baseline)
Time frame: 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.
Number of Drinking Days: 3-months (at 3-months Post-baseline)
Time frame: 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.
Number of Drinking Days: 6-months (at 6-months Post-baseline)
Time frame: 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.
Number of Drinks Per Drinking Day: Baseline (at Baseline)
Time frame: 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.
Number of Drinks Per Drinking Day: Post-Treatment (at 7-weeks Post-baseline)
Time frame: Post-Treatment (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.
Number of Drinks Per Drinking Day: 3-months (at 3-months Post-baseline)
Time frame: 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.
Number of Drinks Per Drinking Day: 6-months (at 6-months Post-baseline)
Time frame: 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.
Alcohol Consumption Measured by Phosphatidylethanol (PEth): Baseline (at Baseline)
Time frame: 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).
Alcohol Consumption Measured by Phosphatidylethanol (PEth): 6-months (at 6-months Post-baseline)
Time frame: 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).
ART Adherence Measured by Self-Report: Baseline (at Baseline)
Time frame: 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.
ART Adherence Measured by Self-report: Post-treatment (at 7-weeks Post-baseline)
Time frame: 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.
ART Adherence Measured by Self-report: 3-months (at 3-months Post-baseline)
Time frame: 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.
ART Adherence Measured by Self-report: 6-months (at 6-months Post-baseline)
Time frame: 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.
ART Adherence Measured by Hair: Baseline
Time frame: At 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.
ART Adherence Measured by Hair: 6-months (6-months Post-baseline)
Time frame: 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.
8 secondary outcomes
Symptoms of Experiential Avoidance: Baseline (at Baseline)
Time frame: Baseline
Symptoms of Experiential Avoidance: 6-months (at 6-months Post-baseline)
Time frame: 6 months post-baseline
Symptoms of Depression: Baseline (at Baseline)
Time frame: Baseline
Symptoms of Depression: 6-months (at 6-months Post-baseline)
Time frame: 6 months post-baseline
Symptoms of Anxiety: Baseline (at Baseline)
Time frame: Baseline
Symptoms of Anxiety: 6-months (at 6-months Post-baseline)
Time frame: 6-months post-baseline
Number of Days Other Substances Used: Baseline (at Baseline)
Time frame: Baseline
Number of Days Other Substances Used: 6-months (6-months Post-baseline)
Time frame: 6-months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41460282Woolf-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. 2026 Jun;30(6):1761-1776. doi: 10.1007/s10461-025-04990-7. Epub 2025 Dec 29.
- Individual participant dataSharing planned: Yes. The proposed pilot randomized clinical trail (RCT) will include data from approximately 74 HIV-infected hazardous drinkers recruited from a single HIV clinic. The final dataset will include self-reported demographic and behavioral data related to substance use, HIV medication adherence, and general mental health functioning as well as laboratory data from dried blood spots and hair analysis. We will be collecting identifying information in a separate database to track participants for followup appointments. Even though the final computerized dataset will be stripped of all personal identifiers, given the small sample of the study, and the sole recruitment source, there remains a possibility of deductive disclosure of research participants with unusual characteristics. We will thus make the data and associated documentation available to users only via a signed data-sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah E Woolf-King, PhD principal investigator
Syracuse University
Stephen A Maisto, PhD principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Acceptance and Commitment Therapy and Brief Alcohol Intervention in people with Treatment, 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 1 Apr 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?
Yes. Results are posted in the registry (first posted 1 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Drinking Days: Baseline (at Baseline) (time frame: Baseline). The study lists 16 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 NCT03974061, 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 1 Apr 2026.