ClinicalTrials.gg
CompletedNCT02316184REACHUpdated Nov 3, 2022

Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons

An interventional study of Motivational Interviewing and Brief Advice in HIV and Hepatitis C, sponsored by Butler Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.

Sponsored by Butler Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected participants will receive BA delivered by their HIV PCP during a regular HIV visit and will then be randomized to either a 30-minute Motivational Interviewing Intervention with a Behavioral Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting, drinking "check-in" (MI or BA) sessions will then be provided telephonically every three months for 18 months, with a final assessment at 24 months. Our primary outcome is drinks per week.

Read the detailed description

Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected participants will receive BA delivered by their HIV PCP during a regular HIV visit and will then be randomized to either a 30-minute Motivational Interviewing Intervention with a Behavioral Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting, drinking "check-in" (MI or BA) sessions will then be provided telephonically every three months for 18 months. Research assessments will also be done every three months, with a final assessment at 24 months. Our primary outcome is drinks per week.

02

Conditions studied

  • HIV
  • Hepatitis C

Browse trials for

Keywords

  • Alcohol
03

In context

Hepatitis C

2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.

This study's planned enrollment of 300 is above the median of 79 across 1,660 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Butler Hospital is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • HIV+
  • HCV RNA positive
  • consuming on average at least 4 alcoholic drinks per week in the last month
  • 18 years or older

Exclusion criteria

Exclusion Criteria:

  • current, severe psychiatric symptoms requiring immediate clinical attention (e.g., suicidal ideation, current mania, psychosis)
  • inability to understand English
  • cognitive impairment severe enough to interfere with ability to actively participate
  • hepatocellular carcinoma or life expectancy less than 24 months
  • plan to move from Providence area in the next 24 months
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Placebo comparator
    Brief Advice

    Participants in this arm will receive brief advice about alcohol use. Sessions will occur at the baseline interview and every three months for 18 months.

    Behavioral: Brief Advice

  • Active comparator
    MI

    Participants in this arm will receive a talking intervention designed to explore their interest in reducing/eliminating alcohol use. Sessions will occur at the baseline interview and every three months for 18 months.

    Behavioral: Motivational Interviewing

Interventions

  • BehavioralMotivational Interviewing

    Motivational Interviewing is a client-centered method of exploring individual's interest in making behavioral changes. In this study, the targeted behavior is alcohol use.

  • BehavioralBrief Advice
06

What researchers measure

Primary outcomes

  1. Alcohol Use questionnaire

    participants will be asked how many drinks/week they have

    Time frame: up to 24 months

07

Study locations

2 sites
  • Butler Hospital
    Providence, Rhode Island 02906, United States
  • Miriam Hospital
    Providence, Rhode Island, United States
08

References and documents

Publications

  • Stein MD, Herman DS, Kim HN, Howell A, Lambert A, Madden S, Moitra E, Blevins CE, Anderson BJ, Taylor LE, Pinkston MM. A Randomized Trial Comparing Brief Advice and Motivational Interviewing for Persons with HIV-HCV Co-infection Who Drink Alcohol. AIDS Behav. 2021 Apr;25(4):1013-1025. doi: 10.1007/s10461-020-03062-2. Epub 2020 Oct 12. PubMed 33047258 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02316184
Lead sponsor
Butler Hospital
Responsible party
Michael Stein, MD (Principal Investigator (MPI), Butler Hospital) — Principal investigator
First posted
Dec 12, 2014
Start date
Jan 2015
Primary completion
Jun 2020
Completion
Feb 2022
Last update
Nov 3, 2022

Study contacts

Michael Stein, MD
principal investigator · Butler Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion