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Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care

Primary Purpose

Alcohol Dependence, HIV/AIDS

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinician Guide (CG)
Clinician Guide plus HealthCall
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Human Immunodeficiency Virus, Unsafe Drinking, Antiretroviral Therapy (ART), Clinician Guide (CG)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 and older
  • Patient had 4 or more drinks on any day in prior 30 days
  • Patient meets criteria for DSM5 current alcohol dependence
  • HIV+
  • Non-virally suppressed (HIV RNA > 200 last check)
  • Able to give informed consent

Exclusion Criteria:

  • Multi-drug resistant HIV and no fully suppressive treatment regimen is available
  • Unwilling to take ART medications
  • Patient is psychotic, suicidal, or homicidal
  • Patient has gross cognitive impairment
  • Patient does not speak English or Spanish
  • Patient has definite plans to leave the greater New York metropolitan area within the study period
  • Patient has vision/hearing impairment that would preclude participation

Sites / Locations

  • Montefiore Hospital Infectious Disease clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clinician Guide

Clinician Guide plus HealthCall

Arm Description

Clinician Guide is an evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.

Clinician Guide plus the use of HealthCall, a smartphone application to monitor daily alcohol use, ART adherence and other health behaviors.

Outcomes

Primary Outcome Measures

Change in Alcohol Consumption
Assessing change over time in the total number of drinks in the past 30 days from baseline to each time point.

Secondary Outcome Measures

Change in HIV Viral Load
Assessing change in viral load count between two time points.
Change in ART medication adherence
Assessing change in ART medication usage between baseline and each time point.

Full Information

First Posted
February 17, 2020
Last Updated
October 7, 2020
Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04280068
Brief Title
Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
Official Title
HealthCall-S: Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 recruitment and enrollment of participants was halted
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed pilot study is a randomized feasibility trial of technology-enhanced brief intervention for drinking reduction and antiretroviral therapy (ART) adherence in 60 non-virally suppressed HIV participants who meet criteria for DSM-5 Alcohol Use Disorder (AUD) in a Primary Care clinic. Study sample will be recruited from a large urban HIV primary care clinic at Montefiore Hospital where the investigators previously successfully enrolled, randomized and treated study participants The interventions consist of brief meetings to discuss drinking and ART adherence enhanced with daily self-monitoring through the use of a smartphone application that tracks drinking and other aspects of health. These meetings will be based on the Clinician's Guide, a brief intervention for heavy drinking in primary care settings advocated by the National Institute on Alcohol Abuse and Alcoholism. Participants will be assessed at baseline, 30, 60, 90 days, and 6 months after baseline. By the end of treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest among participants who receive the Clinician's Guide alone, and lowest among participants who receive the Clinician's Guide plus the smartphone application.
Detailed Description
HIV infection is a widespread health problem in the U.S. Antiretroviral (ART) therapy has increased longevity and changed the nature of risk factors for morbidity and mortality. Alcohol consumption has become an increasingly serious health issue among HIV primary care patients. Drinking is a key factor in progression to severe liver damage (especially those co-infected with hepatitis), and liver disease is now one of the most common causes of death among those with HIV. Excess drinking is also associated with medication noncompliance, reduces the effect of antiretroviral treatment, and is linked to other health problems. Therefore, helping HIV patients reduce unsafe drinking is crucial to their long-term health. This study aims to evaluate an evidence-based approach, the Clinician Guide, when combined with an innovative smartphone application designed to help users track drinking and ART adherence and other aspects of health. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics to help prevent or slow the progress of some medical problems in HIV-infected individuals, improve ART medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, HIV/AIDS
Keywords
Human Immunodeficiency Virus, Unsafe Drinking, Antiretroviral Therapy (ART), Clinician Guide (CG)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to an evidenced-based brief behavioral intervention.
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be blinded to arms assignments.
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinician Guide
Arm Type
Active Comparator
Arm Description
Clinician Guide is an evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.
Arm Title
Clinician Guide plus HealthCall
Arm Type
Active Comparator
Arm Description
Clinician Guide plus the use of HealthCall, a smartphone application to monitor daily alcohol use, ART adherence and other health behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Clinician Guide (CG)
Intervention Description
An evidence-based, intervention approach to reduce heavy drinking in primary care settings.
Intervention Type
Behavioral
Intervention Name(s)
Clinician Guide plus HealthCall
Intervention Description
HealthCall is a smartphone application designed to help participants keep track of their daily alcohol use, medication adherence and a few other health behaviors through brief daily use.
Primary Outcome Measure Information:
Title
Change in Alcohol Consumption
Description
Assessing change over time in the total number of drinks in the past 30 days from baseline to each time point.
Time Frame
Baseline, 30, 60 days (end-of-treatment), 3, and 6 months
Secondary Outcome Measure Information:
Title
Change in HIV Viral Load
Description
Assessing change in viral load count between two time points.
Time Frame
Baseline and 6 months
Title
Change in ART medication adherence
Description
Assessing change in ART medication usage between baseline and each time point.
Time Frame
Baseline, 30, 60 days (end-of-treatment), 3, 5 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 and older Patient had 4 or more drinks on any day in prior 30 days Patient meets criteria for DSM5 current alcohol dependence HIV+ Non-virally suppressed (HIV RNA > 200 last check) Able to give informed consent Exclusion Criteria: Multi-drug resistant HIV and no fully suppressive treatment regimen is available Unwilling to take ART medications Patient is psychotic, suicidal, or homicidal Patient has gross cognitive impairment Patient does not speak English or Spanish Patient has definite plans to leave the greater New York metropolitan area within the study period Patient has vision/hearing impairment that would preclude participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah S Hasin, PhD
Organizational Affiliation
New York State Psychiatric Institute & Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Hospital Infectious Disease clinic
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available to other researchers.

Learn more about this trial

Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care

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