HIV Counseling and TestingNCT00218907
An Educational HIV Pre-Test Counseling Video Program for Off Hours Testing in the ED: A Randomized Control Trial
A study testing 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
This study compared the educational effectiveness of a ten-minute pre-test counseling video with the usual practice of a session with an HIV counselor. 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?
- Educational video
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Aug 2003
- 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 awaiting UC treatment were approached for the study.
- Patients 18 years of age and older were included
- Patients who spoke English and Spanish were included.
Who cannot join
- Clinically unstable,
- Diagnosed with HIV
- Unable to understand the consent process because such patients require unique arrangements for consenting processes.
Trial locations and contacts
1 site in 1 country.
About this study
This study compared the educational effectiveness of a ten-minute pre-test counseling video with the usual practice of a session with an HIV counselor.
Read the detailed description
HIV is increasingly affecting urban populations, making the inner city ED a prime venue for C\&T because of their unique opportunity to identify HIV positive patients. These underserved communities often use the ED for their regular health care specifically because it provides services outside of the usual weekday working hours. However, there are significant barriers to HIV C\&T in the ED, such as the lack of resources to provide prevention oriented messages, cost issues, and the feasibility of providing the required manpower for testing. The objective of this study is to determine whether an educational video, with the required pre-test counseling elements, conveys the necessary information for inner city ED patients to consent to a standard Elisa HIV test.
In order to address the HIV testing needs of the patient population presenting to the ED, innovative methods must be developed to provide HIV C\&T, while simultaneously removing the barriers to testing. Video technology may provide an opportunity to make HIV counseling feasible when counselors are not available.
- Conditions
- HIV Counseling and Testing, HIV Infections
- Being tested
- Educational video
- Keywords
- HIV prevention, HIV counseling, HIV testing, Emergency Medicine, 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.
Educational videoProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean knowledge score 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 startJun 2003
- Study completionAug 2003
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- North Bronx Healthcare Network
- Sponsor type
- University, hospital or other
- Investigators
- Yvette Calderon, MD, MS, Principal investigator, Jacobi Medical Center, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218907
- Sponsor's protocol ID
- 03-073
- 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 Educational HIV Pre-Test Counseling Video Program for Off Hours Testing in the ED: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00218907
- Acronym / sponsor ID
- 03-073
- Conditions
- HIV Counseling and Testing, HIV Infections
- Keywords
- HIV prevention, HIV counseling, HIV testing, Emergency Medicine, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 130 participants
- Lead sponsor
- North Bronx Healthcare NetworkUniversity, hospital or other
- Study start
- Jun 2003
- Study completion
- Aug 2003
- 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.
This study compared the educational effectiveness of a ten-minute pre-test counseling video with the usual practice of a session with an HIV counselor.
Detailed description
HIV is increasingly affecting urban populations, making the inner city ED a prime venue for C\&T because of their unique opportunity to identify HIV positive patients. These underserved communities often use the ED for their regular health care specifically because it provides services outside of the usual weekday working hours. However, there are significant barriers to HIV C\&T in the ED, such as the lack of resources to provide prevention oriented messages, cost issues, and the feasibility of providing the required manpower for testing. The objective of this study is to determine whether an educational video, with the required pre-test counseling elements, conveys the necessary information for inner city ED patients to consent to a standard Elisa HIV test.
In order to address the HIV testing needs of the patient population presenting to the ED, innovative methods must be developed to provide HIV C\&T, while simultaneously removing the barriers to testing. Video technology may provide an opportunity to make HIV counseling feasible when counselors are not available.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (3 listed)
- All patients awaiting UC treatment were approached for the study.
- Patients 18 years of age and older were included
- Patients who spoke English and Spanish were included.
Key exclusion criteria (3 listed)
- Clinically unstable,
- Diagnosed with HIV
- Unable to understand the consent process because such patients require unique arrangements for consenting processes.
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 |
|---|---|---|
| Educational video | Procedure or surgery | – |
Primary outcome
Comparison of mean knowledge score in both groups.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2005.
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
Jacobi Medical Center, Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 3 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: stopped early, 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 was stopped early. 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?
Comparison of mean knowledge score in both groups.. 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; AzTrials last refreshed its copy on 29 Oct 2026.