Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load
REDART
2 other identifiers
interventional
441
1 country
1
Brief Summary
The purpose of this study is to compare the effectiveness of two interventions \[a Brief Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy (MET+CBT) Intervention\], against each other and with an assessment-only control, in improving both alcohol- and HIV-related outcomes, among hazardous and heavy drinking HIV-infected antiretroviral therapy (ART) clinic clients in Thai Nguyen, Vietnam.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2018
CompletedOctober 12, 2018
October 1, 2018
2.3 years
March 15, 2016
October 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Alcohol use
Percent days abstinent from alcohol
12 months
HIV viral load
Percent HIV viral suppression
12 months
Secondary Outcomes (2)
Number of participants who report a high level of readiness to change for alcohol use reduction
12 months
Number of participants who report a high level of coping skills for alcohol abstinence
12 months
Other Outcomes (2)
Cost-effectiveness of the alcohol reduction interventions
3 months
Health utility of the alcohol reduction interventions
12 months
Study Arms (3)
Brief Intervention
EXPERIMENTALBrief Intervention (2 in-person sessions and 2 phone sessions), study assessment visits, and standard of care from providers at the ART clinic
MET+CBT Intervention
EXPERIMENTALMET+CBT Intervention (6 in-person sessions and 3 optional group sessions), study assessment visits, and standard of care from providers at the ART clinic
Assessment-Only Control
NO INTERVENTIONStudy assessment visits and standard of care from providers at the ART clinic
Interventions
In-person individual sessions (occurring one month apart) and booster phone sessions (occurring 2-3 weeks after each in-person session), delivered by a trained counselor.
In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.
In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.
Eligibility Criteria
You may qualify if:
- Currently a client on ART at the clinic
- Hazardous drinking, measured using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) instrument: AUDIT-C score \>= 4 for men, AUDIT-C score \>=3 for women
- Plan on residing in Thai Nguyen province for the next 24 months
You may not qualify if:
- Unwilling to provide informed consent
- Unable to participate in study activities due to psychological disturbance, cognitive impairment or threatening behavior
- Unwilling to provide locator information
- Currently participating in other HIV, drug use or alcohol programs or interventions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- National Institute on Drug Abuse (NIDA)collaborator
- Thai Nguyen Center for Preventive Medicinecollaborator
- Johns Hopkins Universitycollaborator
Study Sites (1)
Thai Nguyen Center for Preventive Medicine
Thái Nguyên, Thai Nguyen, Vietnam
Related Publications (3)
Chen JS, Hutton HE, Tran HV, Quang VN, Nguyen MX, Sripaipan T, Dowdy DW, Latkin CA, Chander G, Frangakis C, Go VF. Efficacy of Two Evidence-Based Alcohol Consumption Interventions on Positive, Negative, and Neutral Days Among Hazardous Alcohol Users Living with HIV in Vietnam. AIDS Behav. 2024 Feb;28(2):421-428. doi: 10.1007/s10461-023-04234-6. Epub 2023 Dec 12.
PMID: 38085428DERIVEDHershow RB, Reyes HLMN, Ha TV, Chander G, Mai NVT, Sripaipan T, Dowdy DW, Latkin C, Hutton HE, Pettifor A, Maman S, Frangakis C, Go VF. Evaluating the effects of two alcohol reduction counseling interventions on intimate partner violence perpetration: secondary analysis of a three-arm randomized controlled trial among Vietnamese men with HIV. Addiction. 2021 Oct;116(10):2712-2723. doi: 10.1111/add.15496. Epub 2021 Apr 27.
PMID: 33788329DERIVEDGo VF, Hutton HE, Ha TV, Chander G, Latkin CA, Mai NVT, Quynh BX, Nguyen V, Sripaipan T, Lancaster KE, Blackburn N, Hershow RB, Dowdy DW, Frangakis C. Effect of 2 Integrated Interventions on Alcohol Abstinence and Viral Suppression Among Vietnamese Adults With Hazardous Alcohol Use and HIV: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2017115. doi: 10.1001/jamanetworkopen.2020.17115.
PMID: 32945875DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vivian F Go, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
March 25, 2016
Study Start
March 1, 2016
Primary Completion
June 19, 2018
Study Completion
June 19, 2018
Last Updated
October 12, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share