Alcohol Research Consortium in HIV-Intervention Research Arm

Phase 4

Completed

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

• Registration Number: NCT02938377
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-19
• Study Start: 2017-11-06
• Status Verified: 2022-11
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Risky drinking, no dx of AUD, has panic or depression	Computerized Brief Intervention (CBI)	Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy
Dx of AUD with or without panic or depression	Computerized Brief Intervention (CBI)	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.
Dx of AUD with or without panic or depression	Recommendation and Counseling for Alcohol Pharmacotherapy	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.
No dx of alcohol use disorder, panic or depre	Computerized Brief Intervention (CBI)	Computerized Brief Intervention (CBI)- a video about alcohol abuse
Risky drinking, no dx of AUD, has panic or depression	CBT4CBT	Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy
Dx of AUD with or without panic or depression	CBT4CBT	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PEth levels	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.

Trial Locations

Locations (2)

Harborview Medical Center; 2 West Clinic; UW Center for AIDS; 🇺🇸 Seattle, Washington, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States