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.
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.
Brief Title
Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Alcohol Dependence
HIV/AIDS
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Human Immunodeficiency Virus
Unsafe Drinking
Antiretroviral Therapy (ART)
Clinician Guide (CG)
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04280068
Org Class
Other
Org Full Name
Research Foundation for Mental Hygiene, Inc.
Org Study Id
AA023163-05
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
HealthCall-S: Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
Primary Outcomes
Outcome Description
Assessing change over time in the total number of drinks in the past 30 days from baseline to each time point.
Outcome Measure
Change in Alcohol Consumption
Outcome Time Frame
Baseline, 30, 60 days (end-of-treatment), 3, and 6 months
Secondary Outcomes
Outcome Description
Assessing change in viral load count between two time points.
Outcome Time Frame
Baseline and 6 months
Outcome Measure
Change in HIV Viral Load
Outcome Description
Assessing change in ART medication usage between baseline and each time point.
Outcome Time Frame
Baseline, 30, 60 days (end-of-treatment), 3, 5 and 6 months
Outcome Measure
Change in ART medication adherence
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Barry Zingman
Investigator Email
bzingman@montefiore.org
Investigator Phone
718-920-2647