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Trial record 38 of 126 for:    "Viral Infectious Disease" | "Ethanol"

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

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ClinicalTrials.gov Identifier: NCT02316184
Recruitment Status : Active, not recruiting
First Posted : December 12, 2014
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

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.

Condition or disease Intervention/treatment Phase
HIV Hepatitis C Behavioral: Motivational Interviewing Behavioral: Brief Advice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons
Study Start Date : January 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Alcohol Use questionnaire [ Time Frame: up to 24 months ]
    participants will be asked how many drinks/week they have



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316184


Locations
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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Miriam Hospital
Providence, Rhode Island, United States
Sponsors and Collaborators
Butler Hospital
Investigators
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Principal Investigator: Michael Stein, MD Butler Hospital

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Responsible Party: Michael Stein, MD, Principal Investigator (MPI), Butler Hospital
ClinicalTrials.gov Identifier: NCT02316184     History of Changes
Other Study ID Numbers: AA023726
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by Michael Stein, MD, Butler Hospital:
Alcohol
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ethanol
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs