Alcohol Research Consortium in HIV-Intervention Research Arm
NCT ID: NCT02938377
Last Updated: 2025-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
4985 participants
INTERVENTIONAL
2017-11-06
2023-11-01
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No dx of alcohol use disorder, panic or depression
Computerized Brief Intervention (CBI)- a video about alcohol abuse
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.
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving HIV care at the UAB, UW or UCSD clinics and not anticipating changing clinics over the next 12 months;
* AUDIT-C score \> 3 women or \> 4 men at time of PRO.
Exclusion Criteria
* Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent.
18 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Karen Cropsey
Principal Investigator
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Harborview Medical Center; 2 West Clinic; UW Center for AIDS
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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F160706007
Identifier Type: -
Identifier Source: org_study_id
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