Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load

Completed

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

• Registration Number: NCT02153216
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-06-02
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of heavy drinking episodes	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

Trial Locations

Locations (1)

Thai Nguyen Center for Preventive Medicine; 🇻🇳 Thai Nguyen, Vietnam