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Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms.
Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes.
Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions
Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms. Hypothesis 1A: Patients who are treated using algorithm-guided alcohol treatment will decrease drinking quantity and or frequency compared to pre-algorithm levels. Hypothesis 1B. Patients who are treated using algorithm-guided treatment will decrease current AUD symptoms compared to pre-algorithm symptoms levels.
Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes. Hypothesis 2A. Patients treated using algorithm-guided treatment will increase adherence to clinic visits and HIV medications compared to pre-algorithm levels. Hypothesis 2B. Patients who receive algorithm-guided treatment will have improved HIV biomarkers (e.g., CD4 and VL). Hypothesis 3B. There will be a positive relationship between VL and alcohol consumption measured by self-report and PEth level.
Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions (e.g., depression, anxiety, HCV, other drug use disorders). Hypothesis 3A: Persons living with HIV (PLWH) with co-morbid depression and anxiety receiving algorithm-guided treatment will have better alcohol, mental health and HIV treatment outcomes compared to similar individuals in SC. Hypothesis 3B: PLWH with comorbid HCV receiving algorithm-guided treatment will have improved FIB4 results and reduced likelihood of HCV recurrence compared to persons in SC. Hypothesis 3C: Other drug use will decrease among those receiving algorithm-guided treatment vs SC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No dx of alcohol use disorder, panic or depression | Active Comparator | Computerized Brief Intervention (CBI)- a video about alcohol abuse |
|
| Risky drinking, no dx of AUD, has panic or depression | Active Comparator | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy |
|
| Dx of AUD with or without panic or depression | Active Comparator | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Brief Intervention (CBI) | Behavioral | A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Audit-C Score on a Scale | Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. | 18 month window |
| Measure | Description | Time Frame |
|---|---|---|
| PEth Levels | PEth is a biomarker for recent alcohol use found in the blood that is specific to ethanol ingestion and can detect low-to heavy drinking levels. | Between baseline and 6 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Harborview Medical Center; 2 West Clinic; UW Center for AIDS |
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| ID | Title | Description |
|---|---|---|
| FG000 | Risky Drinking, no dx of AUD, Has Panic or Depression | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace |
| FG001 | Dx of AUD With or Without Panic or Depression | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol. Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace Recommendation and Counseling for Alcohol Pharmacotherapy: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care. |
| FG002 | No dx of Alcohol Use Disorder, Panic or Depression | This arm received standard of care services at each clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Risky Drinking, no dx of AUD, Has Panic or Depression | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Audit-C Score on a Scale | Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. | Posted | Mean | 95% Confidence Interval | score on a scale | 18 month window |
|
18 months
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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 | Risky Drinking, no dx of AUD, Has Panic or Depression | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Cropsey, Psy.D | University of Alabama at Birmingham | (205) 975-4204 | kcropsey@uab.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2019 | Oct 11, 2024 | Prot_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2019 | Apr 17, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D003376 | Counseling |
| D000431 | Ethanol |
| C071989 | APT |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D008605 | Mental Health Services |
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Participants were given varying levels of treatment depending on their alcohol use.
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|
| CBT4CBT | Behavioral | 9 computerized modules delivered at the participant's pace |
|
|
| Recommendation and Counseling for Alcohol Pharmacotherapy | Drug | The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care. |
|
|
| Seattle |
| Washington |
| 359931 |
| United States |
| BG001 | Dx of AUD With or Without Panic or Depression | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol. Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace Recommendation and Counseling for Alcohol Pharmacotherapy: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care. |
| BG002 | No dx of Alcohol Use Disorder, Panic or Depression | This arm will receive standard of care services at each clinic. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Dx of AUD With or Without Panic or Depression | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol. Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace Recommendation and Counseling for Alcohol Pharmacotherapy: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care. |
| OG002 | No dx of Alcohol Use Disorder, Panic or Depression | This arm will receive standard of care services at each clinic. |
|
|
| Secondary | PEth Levels | PEth is a biomarker for recent alcohol use found in the blood that is specific to ethanol ingestion and can detect low-to heavy drinking levels. | As a result of the COVID pandemic, sample collection was disrupted, leading to only 13 samples collected overall. This number of samples was below the 75% threshold needed to justify processing the samples. Samples were never sent for PeTH testing and will not be sent for PeTH testing. | Posted | Between baseline and 6 month follow-up |
|
|
| 0 |
| 115 |
| 0 |
| 115 |
| 0 |
| 115 |
| EG001 | Dx of AUD With or Without Panic or Depression | Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol. Computerized Brief Intervention (CBI): A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits. CBT4CBT: 9 computerized modules delivered at the participant's pace Recommendation and Counseling for Alcohol Pharmacotherapy: The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | No dx of Alcohol Use Disorder, Panic or Depression | This arm received standard of care services at each clinic. | 0 | 4,843 | 0 | 4,843 | 0 | 4,843 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |