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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

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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking HIV Behavioral: Brief Intervention Behavioral: Motivational Enhancement Therapy (MET) Intervention Behavioral: Cognitive Behavioral Therapy (CBT) Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 441 participants
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

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 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



Primary Outcome Measures :
  1. Alcohol use [ Time Frame: 12 months ]
    Percent days abstinent from alcohol

  2. HIV viral load [ Time Frame: 12 months ]
    Percent HIV viral suppression


Secondary Outcome Measures :
  1. 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.

  2. 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:
  1. 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

  2. Health utility of the alcohol reduction interventions [ Time Frame: 12 months ]
    Assessed using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) instrument



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:

  • 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

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): NCT02720237


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

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02720237     History of Changes
Other Study ID Numbers: 14-0225b
1R01DA037440-01 ( U.S. NIH Grant/Contract )
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
Alcohol use
HIV
Viral Load
ART
Additional relevant MeSH terms:
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RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Ethanol
Acquired Immunodeficiency Syndrome
HIV Infections
Alcohol Drinking
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs