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Alcohol Research Consortium in HIV-Intervention Research Arm (ARCH-IRA)

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ClinicalTrials.gov Identifier: NCT02938377
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham

Brief Summary:

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


Condition or disease Intervention/treatment Phase
HIV Positive Alcohol Use Behavioral: Computerized Brief Intervention (CBI) Behavioral: CBT4CBT Drug: Recommendation and Counseling for Alcohol Pharmacotherapy Phase 4

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 259 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alcohol Research Consortium in HIV-Intervention Research Arm
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Arm Intervention/treatment
Active Comparator: No dx of alcohol use disorder, panic or depre
Computerized Brief Intervention (CBI)- a video about alcohol abuse
Behavioral: 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.
Other Name: CBI

Active Comparator: 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
Behavioral: 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.
Other Name: CBI

Behavioral: CBT4CBT
9 computerized modules delivered at the participant's pace
Other Name: Cognitive Behavioral Therapy

Active Comparator: 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.
Behavioral: 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.
Other Name: CBI

Behavioral: CBT4CBT
9 computerized modules delivered at the participant's pace
Other Name: Cognitive Behavioral Therapy

Drug: 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 Name: Recommendation for APT




Primary Outcome Measures :
  1. Self-reported change in alcohol use [ Time Frame: Between baseline and 6 month follow-up ]
    Drinking days per week and number of drinks per drinking day


Secondary Outcome Measures :
  1. PEth levels [ Time Frame: Between baseline and 6 month follow-up ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years or older;
  • 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:

  • Non-English speaking;
  • Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938377


Contacts
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Contact: Karen L. Cropsey, PsyD 205-975-4204 kcropsey@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Sarah Dougherty    205-934-1284    sarahdougherty@uabmc.edu   
United States, Washington
Harborview Medical Center; 2 West Clinic; UW Center for AIDS Recruiting
Seattle, Washington, United States, 359931
Contact: Laurie Smith    206-744-5124    laursmit@u.washington.edu   
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Karen Cropsey, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02938377     History of Changes
Other Study ID Numbers: F160706007
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs