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Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons (REACH)

Butler Hospital logo

Butler Hospital

Status

Completed

Conditions

Hepatitis C
HIV

Treatments

Behavioral: Brief Advice
Behavioral: Motivational Interviewing

Study type

Interventional

Funder types

Other

Identifiers

NCT02316184
AA023726

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups, including a placebo group

Brief Advice
Placebo Comparator group
Description:
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.
Treatment:
Behavioral: Brief Advice
MI
Active Comparator group
Description:
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.
Treatment:
Behavioral: Motivational Interviewing

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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