HIV InfectionsNCT00548041
Rapid HIV Testing Program in the Emergency Department
A study testing HIV test by oral swab in people with HIV Infections, run by Temple University at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the feasibility of a rapid HIV testing program in the Temple University Hospital(TUH)Emergency Department. We hypothesize that a rapid HIV testing program in the TUH Emergency Department is feasible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV test by oral swab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One of the following conditions:
- Sexually transmitted disease evaluation or prior history of sexually transmitted disease
- Pregnancy
- Clinical condition that suggests possible immunodeficiency
- History of illicit drug use
- History of chronic viral hepatitis
Show all 11Show fewer
- Patients with unexplained pneumonia or recurrent pneumonia
- Male patients who have a history of sex with men
- Abdominal pain in a sexually active woman or urethritis in a man
- Trauma.
- Age 18 years old or older.
Who cannot join
- Age less than 18 years.
- None of the above conditions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Pilot Study to Evaluate a Rapid HIV Testing Program in the Emergency Department
The purpose of the study is to evaluate the feasibility of a rapid HIV testing program in the Temple University Hospital(TUH)Emergency Department. We hypothesize that a rapid HIV testing program in the TUH Emergency Department is feasible. Patients presenting to the Adult TUH Emergency Department with certain conditions will be offered rapid HIV testing. Testing will be performed by oral swab using the OraQuick Advance test. Patients will receive post-test counseling.
- Conditions
- HIV Infections
- Being tested
- HIV test by oral swab
- Keywords
- HIV, Emergency Department, HIV Seronegativity
- Medical subject headings
- HIV Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV test by oral swabOther
Eligible subjects underwent rapid HIV testing by oral swab.
| Study group | Role | What they receive |
|---|---|---|
| Rapid HIV Tested | Other | Subjects have HIV testing by oral swab performed. Receives: Other: HIV test by oral swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Rapid HIV Testing in Emergency Department
Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Ellen Tedaldi, M.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548041
- Sponsor's protocol ID
- 11007
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2007
- Last updated
- 2 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate a Rapid HIV Testing Program in the Emergency Department
- ClinicalTrials.gov ID
- NCT00548041
- Acronym / sponsor ID
- 11007
- Conditions
- HIV Infections
- Keywords
- HIV, Emergency Department, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Apr 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Posted 2 Nov 2015
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 the study is to evaluate the feasibility of a rapid HIV testing program in the Temple University Hospital(TUH)Emergency Department. We hypothesize that a rapid HIV testing program in the TUH Emergency Department is feasible. Patients presenting to the Adult TUH Emergency Department with certain conditions will be offered rapid HIV testing. Testing will be performed by oral swab using the OraQuick Advance test. Patients will receive post-test counseling.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid HIV Tested | Other | Other: HIV test by oral swabSubjects have HIV testing by oral swab performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sexually transmitted disease evaluation or prior history of sexually transmitted disease
- Pregnancy
- Clinical condition that suggests possible immunodeficiency
- History of illicit drug use
- History of chronic viral hepatitis
Key exclusion criteria (2 listed)
- Age less than 18 years.
- None of the above conditions.
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 test by oral swabEligible subjects underwent rapid HIV testing by oral swab. | Other | Rapid HIV Tested |
Primary outcome
Feasibility of Rapid HIV Testing in Emergency Department
Time frame: 2 years
Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ellen Tedaldi, M.D. principal investigator
Temple 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 HIV test by oral swab in people with HIV Infections, run by Temple 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 11 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 2 Nov 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?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Rapid HIV Testing in Emergency Department (time frame: 2 years). 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 2 Nov 2015.