Alcohol AbuseNCT00371969
Reducing Unsafe Alcohol Use in HIV-Positive Individuals
A study testing Enhanced Motivational Interview and Standard Motivational Interview or viewing DVD in people with Alcohol Abuse, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial summary
The main aim of this study is to test an intervention to reduce unsafe drinking among HIV-positive primary care patients. The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Enhanced Motivational Interview and Standard Motivational Interview or viewing DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females 18 years of age or older.
- Participants have had 4 or more drinks on any day in the prior 30 days assessed via standardized questions.
- Participants are referred to a study MI counselor by clinic staff as needing an intervention for drinking
- Participants agree to random assignment and provide informed consent
Who cannot join
- Participants who are currently psychotic, suicidal or homicidal.
- Participants who have definite plans to leave the greater New York metropolitan area within the study period.
- Participants who demonstrate gross cognitive impairment as evidenced on the Halstead-Reitain Trails (A).
- Participants who do not speak English or Spanish, or have hearing impairments that preclude use of the telephone.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute/ St. Vincent's Hospital
New York, New York, 10032
About this study
Official title: Reducing Unsafe Drinking in HIV Primary Care
The main aim of this study is to test an intervention to reduce unsafe drinking among HIV-positive primary care patients. The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system). Subjects who receive the enhanced motivational interview are expected to show greater improvements in drinking than individuals who receive the standard motivational interview or view a DVD on HIV self-care.
Read the detailed description
HIV infection is a widespread health problem in the U.S. Antiretroviral treatment 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. The intervention combines the brief MI, an established, evidence-based counseling approach, with an innovative procedure designed to strengthen the effects of the MI. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics helping prevent or slow the progress of some medical problems in HIV-infected individuals, improve medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use.
Comparison(s): Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes), brief motivational interview, viewing a DVD on HIV self-care.
- Conditions
- Alcohol Abuse
- Being tested
- Enhanced Motivational Interview, Standard Motivational Interview or viewing DVD
- Keywords
- Unsafe drinking, Human Immunodeficiency Virus, Motivational Interviewing
- 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.
Enhanced Motivational InterviewBehavioural
The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system).
Standard Motivational Interview or viewing DVDBehavioural
Brief motivational interview, viewing a DVD on HIV self-care.
| Study group | Role | What they receive |
|---|---|---|
| 1 - enhanced MI | Active comparator | Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes) Receives: Behavioral: Enhanced Motivational Interview |
| 2- standard MI | Active comparator | The intervention consists of a standard motivational interview or viewing a DVD on HIV self-care. Receives: Behavioral: Standard Motivational Interview or viewing DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
As measured by number of drinks per drinking day and percentage of days abstinent.
Measured: Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies 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
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Hasin, Columbia University
- Investigators
- Selvija G. Marovic, PhD, Study director, New York State Psychiatric Institute (NYSPI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371969
- Sponsor's protocol ID
- NIAAA-HAS-14323
- Other IDs
- NIH Grant R01 AA14323-01A1
- Status last verified
- Oct 2015
- First submitted
- 31 Aug 2006
- Last updated
- 30 Oct 2015
- Results posted
- No
Publications
Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.
PubMed 23432593
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Unsafe Drinking in HIV Primary Care
- ClinicalTrials.gov ID
- NCT00371969
- Acronym / sponsor ID
- NIAAA-HAS-14323
- Conditions
- Alcohol Abuse
- Keywords
- Unsafe drinking, Human Immunodeficiency Virus, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Sep 2006 (estimated)
- 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 main aim of this study is to test an intervention to reduce unsafe drinking among HIV-positive primary care patients. The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system). Subjects who receive the enhanced motivational interview are expected to show greater improvements in drinking than individuals who receive the standard motivational interview or view a DVD on HIV self-care.
Detailed description
HIV infection is a widespread health problem in the U.S. Antiretroviral treatment 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. The intervention combines the brief MI, an established, evidence-based counseling approach, with an innovative procedure designed to strengthen the effects of the MI. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics helping prevent or slow the progress of some medical problems in HIV-infected individuals, improve medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use.
Comparison(s): Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes), brief motivational interview, viewing a DVD on HIV self-care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - enhanced MI | Active comparator | Behavioral: Enhanced Motivational InterviewEnhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes) |
| 2- standard MI | Active comparator | Behavioral: Standard Motivational Interview or viewing DVDThe intervention consists of a standard motivational interview or viewing a DVD on HIV self-care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and females 18 years of age or older.
- Participants have had 4 or more drinks on any day in the prior 30 days assessed via standardized questions.
- Participants are referred to a study MI counselor by clinic staff as needing an intervention for drinking
- Participants agree to random assignment and provide informed consent
Key exclusion criteria (4 listed)
- Participants who are currently psychotic, suicidal or homicidal.
- Participants who have definite plans to leave the greater New York metropolitan area within the study period.
- Participants who demonstrate gross cognitive impairment as evidenced on the Halstead-Reitain Trails (A).
- Participants who do not speak English or Spanish, or have hearing impairments that preclude use of the telephone.
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 |
|---|---|---|
| Enhanced Motivational InterviewThe intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system). | Behavioural | 1 - enhanced MI |
| Standard Motivational Interview or viewing DVDBrief motivational interview, viewing a DVD on HIV self-care. | Behavioural | 2- standard MI |
Primary outcome
Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
Time frame: Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months
As measured by number of drinks per drinking day and percentage of days abstinent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Derived from this study: PubMed 23432593Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.
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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.
Selvija G. Marovic, PhD study director
New York State Psychiatric Institute (NYSPI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Motivational Interview and Standard Motivational Interview or viewing DVD in people with Alcohol Abuse, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 30 Oct 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. (time frame: Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371969, which also lists 1 linked publication.
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 30 Oct 2015.