Alcohol ConsumptionNCT01573065
HIV Testing and Brief Alcohol Intervention for Young Drinkers in the Emergency Department
A study testing Counseling intervention with rapid HIV testing in people with Alcohol Consumption and Sexual Risk Behaviors, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study was to determine whether a brief counseling intervention coupled with rapid HIV testing was feasible and effective at decreasing alcohol consumption and sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Alcohol Consumption, Sexual Risk Behaviors
- What is being tested?
- Counseling intervention with rapid HIV testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years old;
- engaged in at least one sexual risk behavior in past 90 days;
- alcohol consumption greater than NIAAA guidelines for at-risk drinking;
- unknown or negative HIV status and willing to be tested;
- able to provide contact information for follow-up;
- able to provide written informed consent.
Who cannot join
- known HIV positive status;
- medically or psychiatrically unstable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital Emergency Deparmtment
New Haven, Connecticut, 06511
About this study
Official title: Addressing HIV Risk in Young Unhealthy Alcohol Drinkers in the Emergency Department With Rapid HIV Testing and Brief Intervention
The purpose of this study was to determine whether a brief counseling intervention coupled with rapid HIV testing was feasible and effective at decreasing alcohol consumption and sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department.
- Conditions
- Alcohol Consumption, Sexual Risk Behaviors
- Being tested
- Counseling intervention with rapid HIV testing
- Keywords
- alcohol consumption, sexual risk behaviors, young, unhealthy drinkers
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling intervention with rapid HIV testingBehavioural
Counseling intervention (modeled after Brief Negotiation Interview and Project RESPECT-2) coupled with rapid HIV testing. Telephone booster at 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Behavioral: Counseling intervention with rapid HIV testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
number of patients enrolled and retained at 2 months.
Measured: baseline and 2 month follow-up
Secondary outcomes (2)
Alcohol consumption
As assessed by the Time Line Follow Back, change in alcohol consumption.
Measured: baseline vs. 2 month follow-up
Sexual risk behaviors
As assessed by an adapted HIV Risk Behaviors Scale, change in sexual risk behaviors.
Measured: baseline vs. 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn E. Fiellin, Yale University
- Investigators
- Lynn E Fiellin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573065
- Sponsor's protocol ID
- 0906005270
- Status last verified
- Aug 2012
- First submitted
- 4 Apr 2012
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing HIV Risk in Young Unhealthy Alcohol Drinkers in the Emergency Department With Rapid HIV Testing and Brief Intervention
- ClinicalTrials.gov ID
- NCT01573065
- Acronym / sponsor ID
- 0906005270
- Conditions
- Alcohol Consumption, Sexual Risk Behaviors
- Keywords
- alcohol consumption, sexual risk behaviors, young, unhealthy drinkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Apr 2012 (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 purpose of this study was to determine whether a brief counseling intervention coupled with rapid HIV testing was feasible and effective at decreasing alcohol consumption and sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Behavioral: Counseling intervention with rapid HIV testing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-40 years old;
- engaged in at least one sexual risk behavior in past 90 days;
- alcohol consumption greater than NIAAA guidelines for at-risk drinking;
- unknown or negative HIV status and willing to be tested;
- able to provide contact information for follow-up;
Key exclusion criteria (2 listed)
- known HIV positive status;
- medically or psychiatrically unstable.
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 |
|---|---|---|
| Counseling intervention with rapid HIV testingCounseling intervention (modeled after Brief Negotiation Interview and Project RESPECT-2) coupled with rapid HIV testing. Telephone booster at 2 weeks. | Behavioural | Single arm |
Primary outcome
Feasibility
Time frame: baseline and 2 month follow-up
number of patients enrolled and retained at 2 months.
2 secondary outcomes
Alcohol consumption
Time frame: baseline vs. 2 month follow-up
Sexual risk behaviors
Time frame: baseline vs. 2 month follow-up
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 10 Aug 2012.
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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.
Lynn E Fiellin, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling intervention with rapid HIV testing in people with Alcohol Consumption and Sexual Risk Behaviors, run by Yale University 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 2 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 10 Aug 2012. 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?
Feasibility (time frame: baseline and 2 month follow-up). 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 10 Aug 2012.