Alcohol DependenceNCT04280068
Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
A study testing Clinician Guide (CG) and Clinician Guide plus HealthCall in people with Alcohol Dependence and HIV/AIDS, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence, HIV/AIDS
- What is being tested?
- Clinician Guide (CG) and Clinician Guide plus HealthCall
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Hospital Infectious Disease clinic
The Bronx, New York, 10467
About this study
Official title: HealthCall-S: Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
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.
Read the 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.
- Conditions
- Alcohol Dependence, HIV/AIDS
- Being tested
- Clinician Guide (CG), Clinician Guide plus HealthCall
- Keywords
- Human Immunodeficiency Virus, Unsafe Drinking, Antiretroviral Therapy (ART), Clinician Guide (CG)
- Medical subject headings
- Alcoholism, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician Guide (CG)Behavioural
An evidence-based, intervention approach to reduce heavy drinking in primary care settings.
Clinician Guide plus HealthCallBehavioural
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 group | Role | What they receive |
|---|---|---|
| Clinician Guide | Active comparator | Clinician Guide is an evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings. Receives: Behavioral: Clinician Guide (CG) |
| Clinician Guide plus HealthCall | Active comparator | Clinician Guide plus the use of HealthCall, a smartphone application to monitor daily alcohol use, ART adherence and other health behaviors. Receives: Behavioral: Clinician Guide (CG); Behavioral: Clinician Guide plus HealthCall |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 30, 60 days (end-of-treatment), 3, and 6 months
Secondary outcomes (2)
Change in HIV Viral Load
Assessing change in viral load count between two time points.
Measured: Baseline and 6 months
Change in ART medication adherence
Assessing change in ART medication usage between baseline and each time point.
Measured: Baseline, 30, 60 days (end-of-treatment), 3, 5 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start2 Mar 2020
- Primary completion27 Mar 2020
- Study completion30 Jun 2020
Why it stopped: Due to COVID-19 recruitment and enrollment of participants was halted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to an evidenced-based brief behavioral intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center
- Responsible party
- Principal investigator, Deborah Hasin, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Deborah S Hasin, PhD, Principal investigator, New York State Psychiatric Institute & Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280068
- Sponsor's protocol ID
- AA023163-05
- Status last verified
- Oct 2020
- First submitted
- 17 Feb 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealthCall-S: Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care
- ClinicalTrials.gov ID
- NCT04280068
- Acronym / sponsor ID
- AA023163-05
- Conditions
- Alcohol Dependence, HIV/AIDS
- Keywords
- Human Immunodeficiency Virus, Unsafe Drinking, Antiretroviral Therapy (ART), Clinician Guide (CG)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 recruitment and enrollment of participants was halted
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- Montefiore Medical Center
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to an evidenced-based brief behavioral intervention.
| Arm | Type | Receives |
|---|---|---|
| Clinician Guide | Active comparator | Behavioral: Clinician Guide (CG)Clinician Guide is an evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings. |
| Clinician Guide plus HealthCall | Active comparator | Behavioral: Clinician Guide (CG), Behavioral: Clinician Guide plus HealthCallClinician Guide plus the use of HealthCall, a smartphone application to monitor daily alcohol use, ART adherence and other health behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician Guide (CG)An evidence-based, intervention approach to reduce heavy drinking in primary care settings. | Behavioural | Clinician Guide, Clinician Guide plus HealthCall |
| Clinician Guide plus HealthCallHealthCall 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. | Behavioural | Clinician Guide plus HealthCall |
Primary outcome
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.
2 secondary outcomes
Change in HIV Viral Load
Time frame: Baseline and 6 months
Change in ART medication adherence
Time frame: Baseline, 30, 60 days (end-of-treatment), 3, 5 and 6 months
Results and safety
The study was stopped early (reason given: Due to COVID-19 recruitment and enrollment of participants was halted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah S Hasin, PhD principal investigator
New York State Psychiatric Institute & Columbia University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician Guide (CG) and Clinician Guide plus HealthCall in people with Alcohol Dependence and HIV/AIDS, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19 recruitment and enrollment of participants was halted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Consumption (time frame: Baseline, 30, 60 days (end-of-treatment), 3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.