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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02720237 |
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Date of registration:
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15/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load
REDART |
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Scientific title:
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Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load: A Randomized Controlled Trial (RCT) in Antiretroviral Therapy (ART) Clinics in Vietnam |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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441 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02720237 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Vivian F Go, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Alcohol Drinking
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Intervention(s)
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Behavioral: Motivational Enhancement Therapy (MET) Intervention
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Behavioral: Brief Intervention
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Behavioral: Cognitive Behavioral Therapy (CBT) Intervention
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Primary Outcome(s)
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Alcohol use
[Time Frame: 12 months]
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HIV viral load
[Time Frame: 12 months]
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Secondary Outcome(s)
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Number of participants who report a high level of coping skills for alcohol abstinence
[Time Frame: 12 months]
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Number of participants who report a high level of readiness to change for alcohol use reduction
[Time Frame: 12 months]
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Secondary ID(s)
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14-0225b
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1R01DA037440-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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