NCT02316184

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

5.4 years

First QC Date

December 10, 2014

Last Update Submit

November 1, 2022

Conditions

HIVHepatitis C

Keywords

Alcohol

Outcome Measures

Primary Outcomes (1)

  • Alcohol Use questionnaire

    participants will be asked how many drinks/week they have

    up to 24 months

Study Arms (2)

Brief Advice

PLACEBO COMPARATOR

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

MI

ACTIVE COMPARATOR

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

Motivational InterviewingBEHAVIORAL

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.

MI
Brief AdviceBEHAVIORAL
Brief Advice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Miriam Hospital

Providence, Rhode Island, United States

Location

Related Publications (1)

  • 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.

    PMID: 33047258DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Motivational InterviewingCrisis Intervention

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesPsychotherapy

Study Officials

  • Michael Stein, MD

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (MPI)

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 12, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2020

Study Completion

February 1, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

US(2)