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

HIV Clinical Trial

— REACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316184
• Other study ID #: AA023726
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: February 2022

Study information

• Verified date: November 2022
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2022
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• HIV

Intervention

Behavioral:
• Motivational 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.
• Brief Advice

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island
United States	Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Use questionnaire	participants will be asked how many drinks/week they have	up to 24 months