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

HIV Clinical Trial

— REDART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720237
• Other study ID #: 14-0225b
• Secondary ID: 1R01DA037440-01
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: June 19, 2018

Study information

• Verified date: October 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 hazardous and heavy drinking HIV-infected antiretroviral therapy (ART) clinic clients in Thai Nguyen, Vietnam.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: June 19, 2018
• Est. primary completion date: June 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol Drinking
• HIV
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• Brief Intervention
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) Intervention
In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.
• Cognitive Behavioral Therapy (CBT) Intervention
In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Johns Hopkins University, National Institute on Drug Abuse (NIDA), Thai Nguyen Center for Preventive Medicine

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness of the alcohol reduction interventions	Assessed by the willingness-to-pay threshold of Vietnam's gross domestic product (GDP) per disability-adjusted life years (DALYs) averted	3 months
Other	Health utility of the alcohol reduction interventions	Assessed using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) instrument	12 months
Primary	Alcohol use	Percent days abstinent from alcohol	12 months
Primary	HIV viral load	Percent HIV viral suppression	12 months
Secondary	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.	12 months
Secondary	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.	12 months