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.
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.
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
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

Gender
All
Gender Based
false
Keywords
Human Immunodeficiency Virus
Unsafe Drinking
Antiretroviral Therapy (ART)
Clinician Guide (CG)
Healthy Volunteers
No
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 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
Categories Mesh Debug
Kaposi Sarcoma & AIDS-Related Cancers --- ACQUIRED IMMUNODEFICIENCY SYNDROME
HIV/AIDS --- ACQUIRED IMMUNODEFICIENCY SYNDROME
Substance Use and Addiction --- SUBSTANCE-RELATED DISORDERS
Substance Use and Addiction --- CHEMICALLY-INDUCED DISORDERS
Child Development & Autism --- MENTAL DISORDERS
Mental Health & Behavioral Research --- MENTAL DISORDERS
Psychiatry & Behavioral Sciences --- MENTAL DISORDERS
Substance Use and Addiction --- MENTAL DISORDERS
Kaposi Sarcoma & AIDS-Related Cancers --- HIV INFECTIONS
HIV/AIDS --- HIV INFECTIONS
Infectious Disease --- HIV INFECTIONS
Blood Disorders --- BLOOD-BORNE INFECTIONS
HIV/AIDS --- BLOOD-BORNE INFECTIONS
Infectious Disease --- BLOOD-BORNE INFECTIONS
Hepatitis --- COMMUNICABLE DISEASES
HIV/AIDS --- COMMUNICABLE DISEASES
Infectious Disease --- COMMUNICABLE DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES, VIRAL
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES, VIRAL
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- LENTIVIRUS INFECTIONS
Infectious Disease --- RETROVIRIDAE INFECTIONS
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
Infectious Disease --- IMMUNOLOGIC DEFICIENCY SYNDROMES
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
ALCOHOLISM
ACQUIRED IMMUNODEFICIENCY SYNDROME
ALCOHOL-RELATED DISORDERS
SUBSTANCE-RELATED DISORDERS
CHEMICALLY-INDUCED DISORDERS
MENTAL DISORDERS
HIV INFECTIONS
BLOOD-BORNE INFECTIONS
COMMUNICABLE DISEASES
INFECTIONS
SEXUALLY TRANSMITTED DISEASES, VIRAL
SEXUALLY TRANSMITTED DISEASES
LENTIVIRUS INFECTIONS
RETROVIRIDAE INFECTIONS
RNA VIRUS INFECTIONS
VIRUS DISEASES
SLOW VIRUS DISEASES
GENITAL DISEASES
UROGENITAL DISEASES
IMMUNOLOGIC DEFICIENCY SYNDROMES
IMMUNE SYSTEM DISEASES