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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Alcohol Use; HIV Positive

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02938377

F160706007

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,985 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,985 participants in 3 patient groups

No dx of alcohol use disorder, panic or depression

Active Comparator group

Description:

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

Treatment:

Behavioral: Computerized Brief Intervention (CBI)

Risky drinking, no dx of AUD, has panic or depression

Active Comparator group

Description:

Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy

Treatment:

Behavioral: Computerized Brief Intervention (CBI)

Behavioral: CBT4CBT

Dx of AUD with or without panic or depression

Active Comparator group

Description:

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.

Treatment:

Drug: Recommendation and Counseling for Alcohol Pharmacotherapy

Behavioral: Computerized Brief Intervention (CBI)

Behavioral: CBT4CBT