Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load (REDART)

October 11, 2018 updated by: University of North Carolina, Chapel Hill

Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load: A Randomized Controlled Trial (RCT) in Antiretroviral Therapy (ART) Clinics in Vietnam

The purpose of this study is to compare the effectiveness of two interventions [a Brief Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy (MET+CBT) Intervention], against each other and with an assessment-only control, in improving both alcohol- and HIV-related outcomes, among hazardous and heavy drinking HIV-infected antiretroviral therapy (ART) clinic clients in Thai Nguyen, Vietnam.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a three-arm randomized controlled trial among hazardous and heavy drinking HIV-infected ART clinic clients in Thai Nguyen province, Vietnam. It compares the effects of two evidence-based, culturally adapted, behavioral interventions [a Brief Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy (MET+CBT) Intervention] both against each other and compared with an assessment-only standard of care arm, in order to understand the relative effectiveness of each intervention in reducing alcohol use and suppressing HIV viral load.

The Brief Intervention (BI) consists of 2 individual sessions and 2 booster phone sessions delivered by a trained counselor and is based on Project Treat. Content of BI sessions includes review of drinking patterns, harmful effects of drinking, and alcohol use behavior change strategies. The MET+CBT Intervention consists of 6 sessions delivered by a trained counselor. The MET+CBT Intervention uses a client-centered, motivational interviewing approach and focuses on skills-building for alcohol use behavior change, including drinking refusal skills, skills to cope with and manage cravings and triggers, and developing positive thoughts and attitudes. It also includes review of drinking patterns and harmful effects of drinking.

This study will also measure the incremental cost-effectiveness of each intervention as compared to current counseling services offered in ART clinics in Vietnam.

Investigators hypothesize that: 1) Each intervention will be more effective than an assessment-only arm on percent days alcohol abstinent and percent virally suppressed at the 12-month assessment; 2) The BI will be equivalently effective to the MET+CBT Intervention on percent days alcohol abstinent; 3) The effect of each intervention on alcohol abstinence and viral suppression will be mediated by alcohol use readiness to change and/or coping skills acquisition; 4) The MET+CBT Intervention will be more effective than the BI on alcohol abstinence and viral suppression separately among participants with more severe alcohol use, people who inject drugs, and participants with depressive symptoms; 5) The alcohol reduction interventions (BI and MET+CBT Intervention) will be highly cost-effective compared to assessment-only standard of care; and 6) The BI will be highly cost-effective relative to the MET+CBT Intervention.

Understanding the relative effectiveness of each intervention in improving both alcohol- and HIV-related outcomes will provide insight into the optimal application of alcohol programs in resource-limited settings.

Study Type

Interventional

Enrollment (Actual)

441

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Thai Nguyen, Vietnam
        • Thai Nguyen Center for Preventive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently a client on ART at the clinic
  • Hazardous drinking, measured using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) instrument: AUDIT-C score >= 4 for men, AUDIT-C score >=3 for women
  • Plan on residing in Thai Nguyen province for the next 24 months

Exclusion Criteria:

  • Unwilling to provide informed consent
  • Unable to participate in study activities due to psychological disturbance, cognitive impairment or threatening behavior
  • Unwilling to provide locator information
  • Currently participating in other HIV, drug use or alcohol programs or interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Brief Intervention
Brief Intervention (2 in-person sessions and 2 phone sessions), study assessment visits, and standard of care from providers at the ART clinic
Behavioral: Brief Intervention
In-person individual sessions (occurring one month apart) and booster phone sessions (occurring 2-3 weeks after each in-person session), delivered by a trained counselor.
Other Names:
  • BI
EXPERIMENTAL: MET+CBT Intervention
MET+CBT Intervention (6 in-person sessions and 3 optional group sessions), study assessment visits, and standard of care from providers at the ART clinic
Behavioral: Motivational Enhancement Therapy (MET) Intervention
In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.
Other Names:
  • MET
Behavioral: Cognitive Behavioral Therapy (CBT) Intervention
In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.
Other Names:
  • CBT
NO_INTERVENTION: Assessment-Only Control
Study assessment visits and standard of care from providers at the ART clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol use
Time Frame: 12 months
Percent days abstinent from alcohol
12 months
HIV viral load
Time Frame: 12 months
Percent HIV viral suppression
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who report a high level of readiness to change for alcohol use reduction
Time Frame: 12 months
Readiness to change is assessed using a brief "Readiness to Change" questionnaire based on Rollnick et al. (1996), where response is captured using a 10-point Likert scale.
12 months
Number of participants who report a high level of coping skills for alcohol abstinence
Time Frame: 12 months
Coping skills are assessed using the alcohol abstinence self-efficacy scale of DiClemente et al. (1994), where response is captured using a 10-point Likert scale.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness of the alcohol reduction interventions
Time Frame: 3 months
Assessed by the willingness-to-pay threshold of Vietnam's gross domestic product (GDP) per disability-adjusted life years (DALYs) averted
3 months
Health utility of the alcohol reduction interventions
Time Frame: 12 months
Assessed using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) instrument
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Thai Nguyen Center for Preventive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2016

Primary Completion (ACTUAL)

June 19, 2018

Study Completion (ACTUAL)

June 19, 2018

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (ESTIMATE)

March 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0225b
  • 1R01DA037440-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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