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Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load (F-REDART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02153216
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : May 19, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This study is the Formative Phase of a larger study; once this phase is completed, enrollment into the randomized controlled trial (RCT Phase) will begin. The primary objective of the Formative Phase is to gain a better understanding of the context in which drinking alcohol among ART client in Vietnam occurs, in order to culturally tailor the intervention to be tested in the RCT Phase. Formative Phase activities will consist of up to 40 in-depth interviews with hazardous drinkers who are either: a) ART clients in one of the ART clinics in Thai Nguyen, or b) who are people who inject drugs (PWID) that are not recruited from the ART clinics (whom we will refer to as general population PWID).

Condition or disease
Alcohol Drinking Alcohol Use Norms Alcohol Use Among ART Clients

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load: An RCT in ART Clinics in Vietnam
Study Start Date : May 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Primary Outcome Measures :
  1. Frequency of heavy drinking episodes [ Time Frame: during interviews ]

    This will be an assessment of how and why individuals engage in heavy drinking. As part of this exploration, we will assess:

    • number of standard drinks consumed on those days that an individual drank
    • number of days on which alcohol was consumed beyond recommended levels

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ART clients with hazardous alcohol use; PWID in general population with hazardous alcohol use

Inclusion Criteria:

  • being 18-49 years of age;
  • having an AUDIT score ≥ 8 (hazardous alcohol use);
  • being a current ART client at one of the Thai Nguyen ART clinics or a general population PWID;
  • being capable of providing voluntary informed consent.

Exclusion Criteria:

  • being unable to participate in study activities due to psychological disturbance, cognitive impairment or threatening behavior;
  • currently participating in other HIV, drug use or alcohol studies.

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 identifier (NCT number): NCT02153216

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Thai Nguyen Center for Preventive Medicine
Thai Nguyen, Vietnam
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
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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 Identifier: NCT02153216    
Other Study ID Numbers: 14-0225a
1R01DA037440-01 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior