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

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: Alcohol Use; HIV Positive
• Intervention / Treatment: Behavioral: Computerized Brief Intervention (CBI); Behavioral: CBT4CBT; Drug: Recommendation and Counseling for Alcohol Pharmacotherapy

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): 158
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported change in alcohol use	Drinking days per week and number of drinks per drinking day	Between baseline and 6 month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• 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