Alcohol Research Consortium in HIV-Intervention Research Arm

Study Overview
=================
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.

Official Title
-----------------
Alcohol Research Consortium in HIV-Intervention Research Arm

Conditions
-----------------
HIV Positive, Alcohol Use

Intervention / Treatment
-----------------
* Behavioral: Computerized Brief Intervention (CBI)
* Behavioral: CBT4CBT
* Drug: Recommendation and Counseling for Alcohol Pharmacotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No dx of alcohol use disorder, panic or depre<br>Computerized Brief Intervention (CBI)- a video about alcohol abuse | Behavioral: Computerized Brief Intervention (CBI)<br>* 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.<br>* Other names: CBI;|
| Active Comparator: Risky drinking, no dx of AUD, has panic or depression<br>Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy | Behavioral: Computerized Brief Intervention (CBI)<br>* 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.<br>* Other names: CBI;Behavioral: CBT4CBT<br>* 9 computerized modules delivered at the participant's pace<br>* Other names: Cognitive Behavioral Therapy;|
| Active Comparator: Dx of AUD with or without panic or depression<br>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)<br>* 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.<br>* Other names: CBI;Behavioral: CBT4CBT<br>* 9 computerized modules delivered at the participant's pace<br>* Other names: Cognitive Behavioral Therapy;Drug: Recommendation and Counseling for Alcohol Pharmacotherapy<br>* 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.<br>* 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 |