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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.
 
ClinicalTrials.gov Identifier: NCT02153216
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : May 19, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date May 29, 2014
First Posted Date June 2, 2014
Last Update Posted Date May 19, 2016
Study Start Date May 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2014)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02153216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load
Official Title Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load: An RCT in ART Clinics in Vietnam
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ART clients with hazardous alcohol use; PWID in general population with hazardous alcohol use
Condition
  • Alcohol Drinking
  • Alcohol Use Norms
  • Alcohol Use Among ART Clients
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Completed
Actual Enrollment
 (submitted: May 29, 2014)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT02153216
Other Study ID Numbers 14-0225a
1R01DA037440-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor University of North Carolina, Chapel Hill
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Vivian F Go, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date May 2016