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Completed

NCT Number: NCT02153216

Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load

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).

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Thai Nguyen Center for Preventive Medicine

Thai Nguyen, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load: An RCT in ART Clinics in Vietnam

Acronym: F-REDART

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2014
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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