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

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ClinicalTrials.gov Identifier: NCT04280068
Recruitment Status : Terminated (Due to COVID-19 recruitment and enrollment of participants was halted)
First Posted : February 21, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Montefiore Medical Center
Information provided by (Responsible Party):
Deborah Hasin, Research Foundation for Mental Hygiene, Inc.

Tracking Information
First Submitted Date  ICMJE February 17, 2020
First Posted Date  ICMJE February 21, 2020
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE March 2, 2020
Actual Primary Completion Date March 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
Change in Alcohol Consumption [ Time Frame: Baseline, 30, 60 days (end-of-treatment), 3, and 6 months ]
Assessing change over time in the total number of drinks in the past 30 days from baseline to each time point.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
  • Change in HIV Viral Load [ Time Frame: Baseline and 6 months ]
    Assessing change in viral load count between two time points.
  • Change in ART medication adherence [ Time Frame: Baseline, 30, 60 days (end-of-treatment), 3, 5 and 6 months ]
    Assessing change in ART medication usage between baseline and each time point.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
Official Title  ICMJE HealthCall-S: Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized to an evidenced-based brief behavioral intervention.
Masking: Single (Outcomes Assessor)
Masking Description:
Outcomes assessor will be blinded to arms assignments.
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Dependence
  • HIV/AIDS
Intervention  ICMJE
  • Behavioral: Clinician Guide (CG)
    An evidence-based, intervention approach to reduce heavy drinking in primary care settings.
  • Behavioral: Clinician Guide plus HealthCall
    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.
Study Arms  ICMJE
  • Active Comparator: Clinician Guide
    Clinician Guide is an evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.
    Intervention: Behavioral: Clinician Guide (CG)
  • Active Comparator: Clinician Guide plus HealthCall
    Clinician Guide plus the use of HealthCall, a smartphone application to monitor daily alcohol use, ART adherence and other health behaviors.
    Interventions:
    • Behavioral: Clinician Guide (CG)
    • Behavioral: Clinician Guide plus HealthCall
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 7, 2020)
3
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2020)
40
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date March 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04280068
Other Study ID Numbers  ICMJE AA023163-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.
Responsible Party Deborah Hasin, Research Foundation for Mental Hygiene, Inc.
Study Sponsor  ICMJE Research Foundation for Mental Hygiene, Inc.
Collaborators  ICMJE Montefiore Medical Center
Investigators  ICMJE
Principal Investigator: Deborah S Hasin, PhD New York State Psychiatric Institute & Columbia University Medical Center
PRS Account Research Foundation for Mental Hygiene, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP