Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load

Alcohol Drinking Clinical Trial

— F-REDART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153216
• Other study ID #: 14-0225a
• Secondary ID: 1R01DA037440-01
• Status: Completed
• Phase: N/A
• First received: May 29, 2014
• Last updated: May 18, 2016
• Start date: May 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Among ART Clients
• Alcohol Use Norms

Locations

Country	Name	City	State
Vietnam	Thai Nguyen Center for Preventive Medicine	Thai Nguyen

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of heavy drinking episodes	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	during interviews	No