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

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

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).

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Alcohol Use Norms; Alcohol Use Among ART Clients

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Vietnam
  • Thai Nguyen, Vietnam
    • Thai Nguyen Center for Preventive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ART clients with hazardous alcohol use; PWID in general population with hazardous alcohol use

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 29, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): May 19, 2016
• Last Update Submitted That Met QC Criteria: May 18, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 14-0225a; 1R01DA037440-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO