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

Primary Purpose

HIV Positive, Alcohol Use

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Computerized Brief Intervention (CBI)
CBT4CBT
Recommendation and Counseling for Alcohol Pharmacotherapy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Harborview Medical Center; 2 West Clinic; UW Center for AIDS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

No dx of alcohol use disorder, panic or depre

Risky drinking, no dx of AUD, has panic or depression

Dx of AUD with or without panic or depression

Arm Description

Computerized Brief Intervention (CBI)- a video about alcohol abuse

Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy

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.

Outcomes

Primary Outcome Measures

Self-reported change in alcohol use
Drinking days per week and number of drinks per drinking day

Secondary Outcome Measures

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.

Full Information

First Posted
October 17, 2016
Last Updated
November 29, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02938377
Brief Title
Alcohol Research Consortium in HIV-Intervention Research Arm
Acronym
ARCH-IRA
Official Title
Alcohol Research Consortium in HIV-Intervention Research Arm
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Positive, Alcohol Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No dx of alcohol use disorder, panic or depre
Arm Type
Active Comparator
Arm Description
Computerized Brief Intervention (CBI)- a video about alcohol abuse
Arm Title
Risky drinking, no dx of AUD, has panic or depression
Arm Type
Active Comparator
Arm Description
Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy
Arm Title
Dx of AUD with or without panic or depression
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Brief Intervention (CBI)
Other Intervention Name(s)
CBI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT4CBT
Other Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
9 computerized modules delivered at the participant's pace
Intervention Type
Drug
Intervention Name(s)
Recommendation and Counseling for Alcohol Pharmacotherapy
Other Intervention Name(s)
Recommendation for APT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported change in alcohol use
Description
Drinking days per week and number of drinks per drinking day
Time Frame
Between baseline and 6 month follow-up
Secondary Outcome Measure Information:
Title
PEth levels
Description
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.
Time Frame
Between baseline and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Harborview Medical Center; 2 West Clinic; UW Center for AIDS
City
Seattle
State/Province
Washington
ZIP/Postal Code
359931
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Alcohol Research Consortium in HIV-Intervention Research Arm

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