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Clinical Trials/NCT02938377
NCT02938377
Completed
Phase 4

Alcohol Research Consortium in HIV-Intervention Research Arm

University of Alabama at Birmingham2 sites in 1 country4,985 target enrollmentNovember 6, 2017

Overview

Phase
Phase 4
Intervention
Computerized Brief Intervention (CBI)
Conditions
HIV Positive
Sponsor
University of Alabama at Birmingham
Enrollment
4985
Locations
2
Primary Endpoint
Audit-C Score on a Scale
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
November 6, 2017
End Date
November 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Cropsey

Principal Investigator

University of Alabama at Birmingham

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.

Arms & Interventions

No dx of alcohol use disorder, panic or depression

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

Intervention: Computerized Brief Intervention (CBI)

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

Intervention: Computerized Brief Intervention (CBI)

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

Intervention: CBT4CBT

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.

Intervention: Computerized Brief Intervention (CBI)

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.

Intervention: CBT4CBT

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.

Intervention: Recommendation and Counseling for Alcohol Pharmacotherapy

Outcomes

Primary Outcomes

Audit-C Score on a Scale

Time Frame: 18 month window

Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.

Secondary Outcomes

  • PEth Levels(Between baseline and 6 month follow-up)

Study Sites (2)

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