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Trial record 2 of 126 for:    "Viral Infectious Disease" | "Ethanol"

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

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ClinicalTrials.gov Identifier: NCT02720237
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
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

Tracking Information
First Submitted Date  ICMJE March 15, 2016
First Posted Date  ICMJE March 25, 2016
Last Update Posted Date October 12, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date June 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
  • Alcohol use [ Time Frame: 12 months ]
    Percent days abstinent from alcohol
  • HIV viral load [ Time Frame: 12 months ]
    Percent HIV viral suppression
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02720237 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 26, 2016)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: March 21, 2016)
  • 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 EQ-5D-5L instrument
 
Descriptive Information
Brief Title  ICMJE Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load
Official Title  ICMJE Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load: A Randomized Controlled Trial (RCT) in Antiretroviral Therapy (ART) Clinics in Vietnam
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Drinking
  • HIV
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Brief Intervention
  • 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
    Interventions:
    • Behavioral: Motivational Enhancement Therapy (MET) Intervention
    • Behavioral: Cognitive Behavioral Therapy (CBT) Intervention
  • No Intervention: Assessment-Only Control
    Study assessment visits and standard of care from providers at the ART clinic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2016)
441
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 19, 2018
Actual Primary Completion Date June 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02720237
Other Study ID Numbers  ICMJE 14-0225b
1R01DA037440-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Thai Nguyen Center for Preventive Medicine
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Vivian F Go, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP