Clinical trial NCT02316184: Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons
Official title: Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Hepatitis C
Keywords: Alcohol
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol Use questionnaire
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Michael Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.