Alcohol Research Consortium in HIV-Intervention Research Arm

Alcohol Use Clinical Trial

— ARCH-IRA  

Official title:

Alcohol Research Consortium in HIV-Intervention Research Arm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938377
• Other study ID #: F160706007
• Status: Completed
• Phase: Phase 4
• Start date: November 6, 2017
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use
• HIV Positive
• HIV Seropositivity

Intervention

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.
• CBT4CBT
9 computerized modules delivered at the participant's pace

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Harborview Medical Center; 2 West Clinic; UW Center for AIDS	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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