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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA026246 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of Chronic Pain: Baseline (at Baseline) | Symptoms of chronic pain were measured using the total score obtained via the brief Graded Chronic Pain Scale (GCPS-PCS). Only participants who answered "yes" to question 1 (Do you currently suffer from any type of chronic pain) were asked a second question (In the last 3 months, on average, how would you rate your pain) with response options of 0 (no pain) to 100 (pain as bad as it can be) - these are the participants included in these outcome data. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah E Woolf-King, PhD | Syracuse University | Principal Investigator |
| Stephen A Maisto, PhD | Syracuse University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse University | Syracuse | New York | 13244 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41460282 | Derived | 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. |
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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.
Data sharing will be available upon publication of the main study findings.
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.
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There were two phases to this study. Phase I was the development of a treatment, and Phase II was a pilot randomized clinical trial. Only the second phase involved participants who were individually randomization to a treatment condition and to a graduate student (who was not enrolled) interventionist within that tx condition. In Phase I, individual in-depth interviews and focus groups were conducted with HIV providers (n = 10) and HIV patients (n = 13) - who were NOT enrolled in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Acceptance and Commitment Therapy | 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. Brief Acceptance and Commitment Therapy: 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. |
| FG001 | Brief Alcohol Intervention | 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. Brief Alcohol Intervention: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Acceptance and Commitment Therapy | 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. Brief Acceptance and Commitment Therapy: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Days | Baseline |
|
3 years
This was a pilot trial of a low-risk behavioral intervention. There was no risk of all-cause mortality anticipated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brief Acceptance and Commitment Therapy | 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. Brief Acceptance and Commitment Therapy: 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Woolf-King, PhD, MPH, Associate Professor of Psychology | Syracuse University | 3154432354 | sewoolf@syr.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2023 | Jan 30, 2025 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2021 | Jun 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D008722 | Methods |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008919 | Investigative Techniques |
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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.
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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.
|
| 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. |
|
|
| 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 |
| 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). | 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." | 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." | 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." | 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." | 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. | 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. | 6-months post-baseline |
| Baseline |
| Symptoms of Chronic Pain: 6-months (at 6-months Post-baseline) | Symptoms of chronic pain were measured using the total score obtained via the brief Graded Chronic Pain Scale (GCPS-PCS). Only participants who answered "yes" to question 1 (Do you currently suffer from any type of chronic pain) were asked a second question (In the last 3 months, on average, how would you rate your pain) with response options of 0 (no pain) to 100 (pain as bad as it can be) - these are the participants included in these outcome data. | 6 months post-baseline |
| HIV Medication Adherence Self-Efficacy: Baseline (at Baseline) | HIV Medication Adherence Self-Efficacy was measured using the total score obtained on the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). The HIV-ASES is a 12-item measure of one's confidence in their ability to adhere to a treatment plan. The response scale ranges from 0 (cannot do at all) to 10 (completely certain I can do) with total scores ranging from 0 to 120. Higher scores indicate higher confidence in carrying out HIV treatment-related behaviors. | Baseline |
| HIV Medication Adherence Self-Efficacy: 6-months (6-months Post-baseline) | HIV Medication Adherence Self-Efficacy was measured using the total score obtained on the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). The HIV-ASES is a 12-item measure of one's confidence in their ability to adhere to a treatment plan. The response scale ranges from 0 (cannot do at all) to 10 (completely certain I can do) with total scores ranging from 0 to 120. Higher scores indicate higher confidence in carrying out HIV treatment-related behaviors. | 6 months post-baseline |
| Alcohol-related Problems: Baseline (at Baseline) | Alcohol-related problems were measured using the total score obtained from the Short Inventory of Problems (SIP-2L). The SIP-2L is a 15-item yes/no measure that assesses negative consequences of alcohol use. Scores range from 0 to 15 with higher scores indicating higher alcohol-related problems. | Baseline |
| Alcohol-Related Problems: 6-months (at 6-months Post-baseline) | Alcohol-related problems were measured using the total score obtained from the Short Inventory of Problems (SIP-2L). The SIP-2L is a 15-item yes/no measure that assesses negative consequences of alcohol use. Scores range from 0 to 15 with higher scores indicating higher alcohol-related problems. | 6 months post-baseline |
| BG001 | Brief Alcohol Intervention | 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. Brief Alcohol Intervention: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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. Brief Alcohol Intervention: 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | Days | Post-treatment (at 7-weeks post-baseline) |
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| Primary | 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. | Posted | Mean | Standard Deviation | Days | 3-months post-baseline |
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| Primary | 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. | Posted | Mean | Standard Deviation | Days | 6-months post-baseline |
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| Primary | 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. | Posted | Mean | Standard Deviation | Drinks | Baseline |
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| Primary | 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. | Posted | Mean | Standard Deviation | Drinks | Post-Treatment (7-weeks post-baseline) |
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| Primary | 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. | Posted | Mean | Standard Deviation | Drinks | 3-months post-baseline |
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| Primary | 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. | Posted | Mean | Standard Deviation | Drinks | 6-months post-baseline |
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| Primary | 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). | Out of a total of 24 (ACT) and 25 (BI) participants who completed a baseline study visit, a total of 21 participants in the ACT condition and 20 participants in the BI condition returned their dried blood spot samples to the lab and had samples that could be successfully processed. Of these samples 71% (15/21) in the ACT condition and 70% (14/20) in the BI condition were positive - as noted in the outcome measure data table below. | Posted | Number | percentage PEth positive | Baseline |
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| Primary | 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). | Out of a total of 16 (ACT) and 20 (BI) participants who completed a 6-month study visit, a total of 11 participants in the ACT condition and 12 participants in the BI condition returned their dried blood spot samples to the lab and had samples that could be successfully processed. Of these samples 55% (6/11) in the ACT condition and 58% (7/12) in the BI condition were positive - as noted in the outcome measure data table below. | Posted | Number | percentage PEth positive | 6-months post-baseline |
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| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (at baseline) |
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| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment (at 7-weeks post-baseline) |
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| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-months post-baseline |
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| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 6-months post-baseline |
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| Primary | 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. | We found that participants were generally not willing to self-collect samples of hair feasibility/acceptability aim of the study - findings that we published (Firkey et al., 2023). We thus did not send any hair samples to the lab for biological analysis, and thus we do not have any results from the hair analysis to report on here. Samples will not ever be analyzed and no additional data will be obtained now or in the future. | Posted | At Baseline |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 6 months post-baseline |
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| Secondary | 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." | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | 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." | Posted | Mean | Standard Deviation | score on a scale | 6 months post-baseline |
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| Secondary | 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." | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | 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." | Posted | Mean | Standard Deviation | score on a scale | 6-months post-baseline |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Days | Baseline |
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| Secondary | 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. | Posted | Mean | Standard Deviation | days | 6-months post-baseline |
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| Other Pre-specified | Symptoms of Chronic Pain: Baseline (at Baseline) | Symptoms of chronic pain were measured using the total score obtained via the brief Graded Chronic Pain Scale (GCPS-PCS). Only participants who answered "yes" to question 1 (Do you currently suffer from any type of chronic pain) were asked a second question (In the last 3 months, on average, how would you rate your pain) with response options of 0 (no pain) to 100 (pain as bad as it can be) - these are the participants included in these outcome data. | As noted above, only participants who answered "yes" to question 1 on the GCPS-PCS (Do you currently suffer from any type of chronic pain) were asked a second question (In the last 3 months, on average, how would you rate your pain) with response options of 0 (no pain) to 100 (pain as bad as it can be) - were included in these outcome data. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Other Pre-specified | Symptoms of Chronic Pain: 6-months (at 6-months Post-baseline) | Symptoms of chronic pain were measured using the total score obtained via the brief Graded Chronic Pain Scale (GCPS-PCS). Only participants who answered "yes" to question 1 (Do you currently suffer from any type of chronic pain) were asked a second question (In the last 3 months, on average, how would you rate your pain) with response options of 0 (no pain) to 100 (pain as bad as it can be) - these are the participants included in these outcome data. | As noted above, only participants who answered "yes" to question 1 on the GCPS-PCS (Do you currently suffer from any type of chronic pain) were asked a second question (In the last 3 months, on average, how would you rate your pain) with response options of 0 (no pain) to 100 (pain as bad as it can be) - were included in these outcome data. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline |
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| Other Pre-specified | HIV Medication Adherence Self-Efficacy: Baseline (at Baseline) | HIV Medication Adherence Self-Efficacy was measured using the total score obtained on the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). The HIV-ASES is a 12-item measure of one's confidence in their ability to adhere to a treatment plan. The response scale ranges from 0 (cannot do at all) to 10 (completely certain I can do) with total scores ranging from 0 to 120. Higher scores indicate higher confidence in carrying out HIV treatment-related behaviors. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Other Pre-specified | HIV Medication Adherence Self-Efficacy: 6-months (6-months Post-baseline) | HIV Medication Adherence Self-Efficacy was measured using the total score obtained on the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). The HIV-ASES is a 12-item measure of one's confidence in their ability to adhere to a treatment plan. The response scale ranges from 0 (cannot do at all) to 10 (completely certain I can do) with total scores ranging from 0 to 120. Higher scores indicate higher confidence in carrying out HIV treatment-related behaviors. | Posted | Mean | Standard Deviation | score on a scale | 6 months post-baseline |
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| Other Pre-specified | Alcohol-related Problems: Baseline (at Baseline) | Alcohol-related problems were measured using the total score obtained from the Short Inventory of Problems (SIP-2L). The SIP-2L is a 15-item yes/no measure that assesses negative consequences of alcohol use. Scores range from 0 to 15 with higher scores indicating higher alcohol-related problems. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Other Pre-specified | Alcohol-Related Problems: 6-months (at 6-months Post-baseline) | Alcohol-related problems were measured using the total score obtained from the Short Inventory of Problems (SIP-2L). The SIP-2L is a 15-item yes/no measure that assesses negative consequences of alcohol use. Scores range from 0 to 15 with higher scores indicating higher alcohol-related problems. | Posted | Mean | Standard Deviation | score on a scale | 6 months post-baseline |
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| Primary | 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. | WWe found that participants were generally not willing to self-collect samples of hair feasibility/acceptability aim of the study - findings that we published (Firkey et al., 2023). We thus did not send any hair samples to the lab for biological analysis, and thus we do not have any results from the hair analysis to report on here. Samples will not ever be analyzed and no additional data will be obtained now or in the future. | Posted | 6-months post baseline |
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| 24 |
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| 24 |
| EG001 | Brief Alcohol Intervention | 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. Brief Alcohol Intervention: 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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