Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
University of North Carolina, Chapel Hill

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

Information provided by (Responsible Party)
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier
NCT02720237

First received: March 15, 2016
Last updated: June 14, 2017
Last Verified: June 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
Alcohol Drinking
HIV

Behavioral : Brief Intervention
Behavioral : Motivational Enhancement Therapy (MET) Intervention
Behavioral : Cognitive Behavioral Therapy (CBT) Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load: A Randomized Controlled Trial (RCT) in Antiretroviral Therapy (ART) Clinics in Vietnam

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures

  • Alcohol use [ Time Frame: 12 months ]
    Percent days abstinent from alcohol
  • HIV viral load [ Time Frame: 12 months ]
    Percent HIV viral suppression
Secondary Outcome Measures:
  • 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.
  • 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.
Other Outcome Measures:
  • 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
  • Health utility of the alcohol reduction interventions [ Time Frame: 12 months ]
    Assessed using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) instrument

Enrollment: 441
Study Start Date: March 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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 Name: 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 Name: CBT
No Intervention: Assessment-Only Control
Study assessment visits and standard of care from providers at the ART clinic

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02720237

Locations

Vietnam
Thai Nguyen Center for Preventive Medicine
Thai Nguyen, Vietnam

Sponsors and Collaborators

University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
Thai Nguyen Center for Preventive Medicine
Johns Hopkins University

Investigators

Principal Investigator: Vivian F Go, PhD University of North Carolina, Chapel Hill
More Information

More Information


Responsible Party: University of North Carolina, Chapel Hill  
ClinicalTrials.gov Identifier: NCT02720237   History of Changes  
Other Study ID Numbers: 14-0225b  
  1R01DA037440-01  
Study First Received: March 15, 2016  
Last Updated: June 14, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Keywords provided by University of North Carolina, Chapel Hill:

Alcohol use
HIV
Viral Load
ART

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Alcohol Drinking
Ethanol

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.