HIV Counseling and TestingNCT00218881
An Effective Alternative to the Standard Referral System for HIV Testing in the Emergency Department During Off Hour Tours: A Randomized Trial
A study testing HIV educational video in people with HIV Counseling and Testing and HIV Infections, run by North Bronx Healthcare Network at 1 site in United States.
Trial summary
To compare HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Counseling and Testing, HIV Infections
- What is being tested?
- HIV educational video
- Type of treatment
- Surgery or procedure
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jul 2004
- 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
- All patients 18 years and older were approached while waiting for ED provider.
Who cannot join
- Patients who were clinically unstable
- Unable to understand the consent process
- Had been HIV tested within 6 months and were informed of the result, or had a confirmed diagnosis of HIV were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Effective Alternative to the Standard Referral System for HIV Testing in the ED
To compare HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.
Read the detailed description
ED-based HIV counseling and testing (C\&T) is in its early stages of development. Most urban ED patients requesting or requiring HIV testing are referred to C\&T sites that are usually available only during regular business hours. Patient compliance with these referrals has been disappointing.
To improve ED access to HIV testing, we developed a video alternative to in-person pre-test counseling to provide the fundamental elements of the counseling. The video was based on the educational elements required by the New York State Department of Health (DOH) for HIV pre-test counseling. In a previous study, we demonstrated that the educational video performed as well as live counselors in conveying the information needed for inner city ED patients to consent to HIV testing. The present study was designed to compare HIV testing rates in ED patients offered video-assisted informed consent for HIV testing versus the standard referral for live C\&T the next business day.
- Conditions
- HIV Counseling and Testing, HIV Infections
- Being tested
- HIV educational video
- Keywords
- HIV prevention, HIV screening, Emergency Medicine, HIV counseling and Testing, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV educational videoProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.
Secondary outcomes (1)
Comparing return rates for HIV results in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Counseling and TestingStudies 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 408 participants
Sponsor and investigators
- Lead sponsor
- North Bronx Healthcare Network
- Sponsor type
- University, hospital or other
- Investigators
- Yvette Calderon, MD<MS, Principal investigator, North Bronx Healthcare Network, Jacobi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218881
- Sponsor's protocol ID
- 03-090
- Status last verified
- Sep 2005
- First submitted
- 19 Sep 2005
- Last updated
- 25 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effective Alternative to the Standard Referral System for HIV Testing in the ED
- ClinicalTrials.gov ID
- NCT00218881
- Acronym / sponsor ID
- 03-090
- Conditions
- HIV Counseling and Testing, HIV Infections
- Keywords
- HIV prevention, HIV screening, Emergency Medicine, HIV counseling and Testing, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants
- Lead sponsor
- North Bronx Healthcare NetworkUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Jul 2004
- First posted
- 22 Sep 2005 (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.
To compare HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.
Detailed description
ED-based HIV counseling and testing (C\&T) is in its early stages of development. Most urban ED patients requesting or requiring HIV testing are referred to C\&T sites that are usually available only during regular business hours. Patient compliance with these referrals has been disappointing.
To improve ED access to HIV testing, we developed a video alternative to in-person pre-test counseling to provide the fundamental elements of the counseling. The video was based on the educational elements required by the New York State Department of Health (DOH) for HIV pre-test counseling. In a previous study, we demonstrated that the educational video performed as well as live counselors in conveying the information needed for inner city ED patients to consent to HIV testing. The present study was designed to compare HIV testing rates in ED patients offered video-assisted informed consent for HIV testing versus the standard referral for live C\&T the next business day.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients 18 years and older were approached while waiting for ED provider.
Key exclusion criteria (3 listed)
- Patients who were clinically unstable
- Unable to understand the consent process
- Had been HIV tested within 6 months and were informed of the result, or had a confirmed diagnosis of HIV were excluded from the study.
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 |
|---|---|---|
| HIV educational video | Procedure or surgery | – |
Primary outcome
HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.
1 secondary outcome
Comparing return rates for HIV results in both groups.
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 25 Oct 2005.
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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.
Yvette Calderon, MD<MS principal investigator
North Bronx Healthcare Network, Jacobi 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 HIV educational video in people with HIV Counseling and Testing and HIV Infections, run by North Bronx Healthcare Network 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 1 inclusion and 3 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 25 Oct 2005. 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?
HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.. 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 25 Oct 2005.