Alcohol Research Consortium in HIV-Intervention Research Arm

NCT02938377 | Completed Phase 4 Results FDA Drug

• 1 other identifier: F160706007
• Study Type: interventional
• Target: 4,985
• Locations: 1 country
• Sites: 2

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

Conditions

HIV Positive; Alcohol Use

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• PEth Levels

  Between baseline and 6 month follow-up

Study Arms (3)

No dx of alcohol use disorder, panic or depression

ACTIVE COMPARATOR

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

Behavioral: Computerized Brief Intervention (CBI)

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

Behavioral: Computerized Brief Intervention (CBI); Behavioral: CBT4CBT

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.

Behavioral: Computerized Brief Intervention (CBI); Behavioral: CBT4CBT; Drug: Recommendation and Counseling for Alcohol Pharmacotherapy

Interventions

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.

Also known as: CBI

Dx of AUD with or without panic or depression; No dx of alcohol use disorder, panic or depression; Risky drinking, no dx of AUD, has panic or depression

CBT4CBT BEHAVIORAL

9 computerized modules delivered at the participant's pace

Also known as: Cognitive Behavioral Therapy

Dx of AUD with or without panic or depression; Risky drinking, no dx of AUD, has panic or depression

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.

Also known as: Recommendation for APT

Dx of AUD with or without panic or depression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Harborview Medical Center; 2 West Clinic; UW Center for AIDS

Seattle, Washington, 359931, United States

Location

MeSH Terms

Conditions

HIV Seropositivity; Alcohol Drinking

Interventions

Cognitive Behavioral Therapy; Counseling; Ethanol; APT

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Karen Cropsey, Psy.D
• Organization: University of Alabama at Birmingham

kcropsey@uab.edu

(205) 975-4204

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were given varying levels of treatment depending on their alcohol use.

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: November 6, 2017
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)