ARCH Research Protocol for Provider Alcohol Pharmacotherapy Training and Assessment

NCT02610517 | Completed

• 1 other identifier: F121009007
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 3

Brief Summary

Phase 1: To train providers to offer alcohol pharmacotherapy to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care. Phase 2: To determine the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous drinking in the HIV clinical care setting.

Conditions

HIV; Alcoholism

Keywords

Hazardous alcohol use; Computer based intervention (CBI); Pharmacotherapy

Outcome Measures

Primary Outcomes (2)

• Drinks per week

  The Alcohol Use Disorders Identification Test (AUDIT) instrument will be used to assess drinks per week. This is a self-reported instrument.

  up to 1 year after enrollment

• Binge drinking episodes

  The Mini-International Neuropsychiatric Interview (MINI) instrument will be used to assess binge drinking episodes. This is a self-reported instrument.

  up to 1 year after enrollment

Secondary Outcomes (5)

• Number of participants that initiate/request alcohol pharmacotherapy

  at enrollment and after visit 2 (3 - 6 months after enrollment)

• Number of participants that complete a CNICS Patient Reported Outcome (PRO)

  every 3 - 6 months after enrollment and at 12 months after enrollment

• Number of participants that initiate antiretroviral therapy (ART)

  every 3 - 6 months after enrollment and at 12 months after enrollment

• Mean number of participants that adhere to HIV clinic visits

  for 1 year after enrollment

• Number of subjects with HIV-RNA level (viral loads) < 20 copies/ml

  1 year post enrollment

Study Arms (2)

Provider Training

OTHER

Training providers to offer alcohol pharmacotherapy to at-risk drinkers interested in quitting or reducing their drinking as part of overall HIV care could be an important strategy to reduce hazardous alcohol use in this medically-ill population.

Behavioral: Provider Training

Patient Intervention

OTHER

Determine the effectiveness of a computer-delivered brief intervention (CBI) for reducing hazardous drinking in the HIV clinical care setting at two intervention clinics: University of Alabama at Birmingham (UAB) and the University of Washington (UW).

Behavioral: Patient Intervention

Interventions

Provider Training BEHAVIORAL

All providers will receive an online survey about alcohol pharmacotherapy, and an on-site training on alcohol pharmacotherapy will be offered at UAB and UW. The training will cover the most commonly prescribed alcohol pharmacotherapy. Some medications (ex: Zofran) have been used clinically for alcohol pharmacotherapy but have not yet received FDA approval for this indication. Research has shown these medications are beneficial as alcohol pharmacotherapy and are more frequently used by doctors due to the more favorable side effects. Providers in this study will use their clinical judgment in prescribing alcohol medications per their normal standard of care and using any new information gained from the alcohol pharmacotherapy training.

Provider Training

Patient Intervention BEHAVIORAL

Eligible participants will be screened using the Audit and Mini instruments that are routinely asked during regular clinic visits. Once a participant consents, they will be shown 2 computerized brief interventions (CBIs) - one after enrollment (visit 1) and one 3-6 months after enrollment (visit 2). Participants will interact with the touch-screen computer via Peedy the Parrot, a three dimensional animated character. The intervention emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. At the end of both visits, patients will complete a patient satisfaction survey with questions related to ease of use of CBI and satisfaction with program content. Providers will have the opportunity to prescribe pharmacotherapy at visit 1 and 2.

Patient Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years or older
• Receiving HIV care at The UAB 1917 Clinic
• Hazardous drinkers as defined by an at-risk alcohol use score on the alcohol related, self-report data collected through the CNICS PRO.
• English speaking
• Willing to participate and provide informed consent

You may not qualify if:

• Pregnant or nursing women will be referred to social work for more intensive intervention per standard of care.
• Cognitive impairment such as they cannot provide informed consent
• Non-English speaker
• A visibly intoxicated person will be deferred for consent by the research assistant but will remain eligible for the study
• Patients who previously declined to participate in the project

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Washington: collaborator
• Johns Hopkins University: collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-2050, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael S Saag, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2015
• First Posted: November 20, 2015
• Study Start: June 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

US (3)