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

February 21, 2025 updated by: Karen Cropsey, University of Alabama at Birmingham

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4985

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Washington
      • Seattle, Washington, United States, 359931
        • Harborview Medical Center; 2 West Clinic; UW Center for AIDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • CBI
Behavioral: CBT4CBT
9 computerized modules delivered at the participant's pace
Other Names:
  • 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 Names:
  • CBI
Behavioral: CBT4CBT
9 computerized modules delivered at the participant's pace
Other Names:
  • 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 Names:
  • Recommendation for APT
Active Comparator: No dx of alcohol use disorder, panic or depression
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 Names:
  • CBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Audit-C Score on a Scale
Time Frame: 18 month window
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between baseline and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2017

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimated)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F160706007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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