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Alcohol DrinkingREDARTNCT02720237

Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load

A study testing Brief Intervention, Motivational Enhancement Therapy (MET) Intervention and Cognitive Behavioral Therapy (CBT) Intervention in people with Alcohol Drinking and HIV, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Drinking, HIV
What is being tested?
Brief Intervention, Motivational Enhancement Therapy (MET) Intervention and Cognitive Behavioral Therapy (CBT) Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
441 participants
Where
1 siteVietnam
Study dates
Mar 2016to 19 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Thai Nguyen Center for Preventive Medicine

    Thai Nguyen, Thai Nguyen

Other trials in Vietnam

About this study

Official title: Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load: A Randomized Controlled Trial (RCT) in Antiretroviral Therapy (ART) Clinics in Vietnam

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.

Read the detailed description

This study is a three-arm randomized controlled trial among hazardous and heavy drinking HIV-infected ART clinic clients in Thai Nguyen province, Vietnam. It compares the effects of two evidence-based, culturally adapted, behavioral interventions [a Brief Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy (MET+CBT) Intervention] both against each other and compared with an assessment-only standard of care arm, in order to understand the relative effectiveness of each intervention in reducing alcohol use and suppressing HIV viral load.

The Brief Intervention (BI) consists of 2 individual sessions and 2 booster phone sessions delivered by a trained counselor and is based on Project Treat. Content of BI sessions includes review of drinking patterns, harmful effects of drinking, and alcohol use behavior change strategies. The MET+CBT Intervention consists of 6 sessions delivered by a trained counselor. The MET+CBT Intervention uses a client-centered, motivational interviewing approach and focuses on skills-building for alcohol use behavior change, including drinking refusal skills, skills to cope with and manage cravings and triggers, and developing positive thoughts and attitudes. It also includes review of drinking patterns and harmful effects of drinking.

This study will also measure the incremental cost-effectiveness of each intervention as compared to current counseling services offered in ART clinics in Vietnam.

Investigators hypothesize that: 1) Each intervention will be more effective than an assessment-only arm on percent days alcohol abstinent and percent virally suppressed at the 12-month assessment; 2) The BI will be equivalently effective to the MET+CBT Intervention on percent days alcohol abstinent; 3) The effect of each intervention on alcohol abstinence and viral suppression will be mediated by alcohol use readiness to change and/or coping skills acquisition; 4) The MET+CBT Intervention will be more effective than the BI on alcohol abstinence and viral suppression separately among participants with more severe alcohol use, people who inject drugs, and participants with depressive symptoms; 5) The alcohol reduction interventions (BI and MET+CBT Intervention) will be highly cost-effective compared to assessment-only standard of care; and 6) The BI will be highly cost-effective relative to the MET+CBT Intervention.

Understanding the relative effectiveness of each intervention in improving both alcohol- and HIV-related outcomes will provide insight into the optimal application of alcohol programs in resource-limited settings.

Being tested
Brief Intervention, Motivational Enhancement Therapy (MET) Intervention, Cognitive Behavioral Therapy (CBT) Intervention
Keywords
Alcohol use, HIV, Viral Load, ART
Medical subject headings
Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief InterventionBehavioural

    Also called BI

    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.

  • Motivational Enhancement Therapy (MET) InterventionBehavioural

    Also called MET

    In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.

  • Cognitive Behavioral Therapy (CBT) InterventionBehavioural

    Also called CBT

    In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.

Study groups in NCT02720237
Study groupRoleWhat they receive
Brief InterventionExperimentalBrief Intervention (2 in-person sessions and 2 phone sessions), study assessment visits, and standard of care from providers at the ART clinic
Receives: Behavioral: Brief Intervention
MET+CBT InterventionExperimentalMET+CBT Intervention (6 in-person sessions and 3 optional group sessions), study assessment visits, and standard of care from providers at the ART clinic
Receives: Behavioral: Motivational Enhancement Therapy (MET) Intervention; Behavioral: Cognitive Behavioral Therapy (CBT) Intervention
Assessment-Only ControlNo interventionStudy assessment visits and standard of care from providers at the ART clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol use

    Percent days abstinent from alcohol

    Measured: 12 months

  2. HIV viral load

    Percent HIV viral suppression

    Measured: 12 months

Secondary outcomes (2)

  1. Number of participants who report a high level of readiness to change for alcohol use reduction

    Readiness to change is assessed using a brief "Readiness to Change" questionnaire based on Rollnick et al. (1996), where response is captured using a 10-point Likert scale.

    Measured: 12 months

  2. Number of participants who report a high level of coping skills for alcohol abstinence

    Coping skills are assessed using the alcohol abstinence self-efficacy scale of DiClemente et al. (1994), where response is captured using a 10-point Likert scale.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion19 Jun 2018
  4. Study completion19 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02720237
Sponsor's protocol ID
14-0225b
Other IDs
1R01DA037440-01
Acronym
REDART
Status last verified
Oct 2018
First submitted
15 Mar 2016
Last updated
12 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 38085428

  • Hershow 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.

    PubMed 33788329

  • Go 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.

    PubMed 32945875

Questions about this trial

What is this clinical trial studying?

A study testing Brief Intervention, Motivational Enhancement Therapy (MET) Intervention and Cognitive Behavioral Therapy (CBT) Intervention in people with Alcohol Drinking and HIV, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol use (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02720237, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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