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Integrated Stepped Care for Unhealthy Alcohol Use in HIV

NCT01410123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2022-12-21

No results posted yet for this study

Summary

The study is a series of 3 linked randomized clinical trials of 6 month duration, with a total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with unhealthy alcohol use.

Conditions

  • Liver Diseases, Alcoholic
  • Alcoholism
  • HIV
  • Hepatitis C

Interventions

OTHER

Integrated Stepped Care (ISC)

1. At risk drinking: Step 1: Brief negotiated interview (BNI) + booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction Physician Management + Alcohol pharmacotherapy 2. Alcohol abuse/dependence: Step 1: Addiction Physician Management + Alcohol Pharmacotherapy; Step 2: Motivational Enhancement Therapy; Step 3: Detoxification and aftercare 3. Moderate Alcohol + Liver Disease: Step 1: Brief Negotiated Interview (BNI)+ booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction physician management + alcohol pharmacotherapy.

OTHER

Treatment as Usual

The TAU arm will receive a handout with alcohol information embedded within general health-related information (exercise, smoking cessation, and flu vaccination) and standard care as provided by their treating physician. All patients will have access to a NIAAA informational website.

Sponsors & Collaborators

Principal Investigators

  • David Fiellin, MD · Yale University

  • Jennifer Edelman, M.D., MHS · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2018-07-31
Completion
2018-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410123 on ClinicalTrials.gov