SyphilisNCT00552539
Syphilis Video Tool to Promote Knowledge and Testing in the ED
A study testing 'educational video' in people with Syphilis, run by Jacobi Medical Center at 1 site in United States.
Trial summary
The objective of this study is to determine whether the "Syphilis and Men" educational video can be a useful tool to increase syphilis knowledge and testing among English and Spanish-speaking urgent care and emergency department patients, regardless of various self-reported characteristics that increase their risk for… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Syphilis
- What is being tested?
- 'educational video'
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 2006
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-55 years of age were eligible only if they spoke English or Spanish.
Who cannot join
- Patients were excluded if clinically unstable, unarousable, hearing impaired or visually impaired despite corrected lens.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Tool to Promote Syphilis Knowledge and Testing in the Emergency Department
The objective of this study is to determine whether the "Syphilis and Men" educational video can be a useful tool to increase syphilis knowledge and testing among English and Spanish-speaking urgent care and emergency department patients, regardless of various self-reported characteristics that increase their risk for syphilis infection.
Read the detailed description
A randomized four-group intervention-control Solomon design was implemented with Group 1 participants receiving a pre-test survey, the educational video intervention, and a post-test survey; Group 2 the pre-test and post-test surveys; Group 3 the video intervention and a post-test survey; and Group 4 the post-test survey. This design was selected to assess the effect of the video in increasing syphilis knowledge while controlling for the influence of the pre-test instrument in potentially sensitizing participants to key facts. A computer-generated randomization list was created and used to assign patients to groups.
- Conditions
- Syphilis
- Being tested
- 'educational video'
- Keywords
- syphilis, educational video, knowledge, black, Hispanic
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'educational video'Other
'educational video'
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | pre test survey, educational video, post test survey Receives: Other: 'educational video' |
| 2 | No intervention | no intervention |
| 3 | Experimental | educational video and post test survey Receives: Other: 'educational video' |
| 4 | No intervention | post test survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the score on a 10-question measure designed to assess knowledge attained from the educational video.
Measured: 20 minutes
Secondary outcomes (1)
A secondary outcome was the decision to be tested for syphilis.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startJun 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Solutions
- Investigators
- Yvette Calderon, MD, MS, Principal investigator, Jacobi Medical CenterJohn P Sanchez, MD, MPH, Principal investigator, Jacobi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552539
- Sponsor's protocol ID
- 06431
- Status last verified
- Oct 2007
- First submitted
- 31 Oct 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Tool to Promote Syphilis Knowledge and Testing in the Emergency Department
- ClinicalTrials.gov ID
- NCT00552539
- Acronym / sponsor ID
- 06431
- Conditions
- Syphilis
- Keywords
- syphilis, educational video, knowledge, black, Hispanic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Jacobi Medical CenterUniversity, hospital or other
- Collaborators
- Public Health Solutions
- Study start
- Jun 2006
- Study completion
- Aug 2006 (actual)
- First posted
- 2 Nov 2007 (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 objective of this study is to determine whether the "Syphilis and Men" educational video can be a useful tool to increase syphilis knowledge and testing among English and Spanish-speaking urgent care and emergency department patients, regardless of various self-reported characteristics that increase their risk for syphilis infection.
Detailed description
A randomized four-group intervention-control Solomon design was implemented with Group 1 participants receiving a pre-test survey, the educational video intervention, and a post-test survey; Group 2 the pre-test and post-test surveys; Group 3 the video intervention and a post-test survey; and Group 4 the post-test survey. This design was selected to assess the effect of the video in increasing syphilis knowledge while controlling for the influence of the pre-test instrument in potentially sensitizing participants to key facts. A computer-generated randomization list was created and used to assign patients to groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: 'educational video'pre test survey, educational video, post test survey |
| 2 | No intervention | –no intervention |
| 3 | Experimental | Other: 'educational video'educational video and post test survey |
| 4 | No intervention | –post test survey |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18-55 years of age were eligible only if they spoke English or Spanish.
Key exclusion criteria (1 listed)
- Patients were excluded if clinically unstable, unarousable, hearing impaired or visually impaired despite corrected lens.
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''educational video' | Other | 1, 3 |
Primary outcome
The primary outcome was the score on a 10-question measure designed to assess knowledge attained from the educational video.
Time frame: 20 minutes
1 secondary outcome
A secondary outcome was the decision to be tested for syphilis.
Time frame: 20 minutes
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 2 Nov 2007.
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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
Jacobi Medical Center
John P Sanchez, MD, MPH principal investigator
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 'educational video' in people with Syphilis, run by Jacobi Medical Center 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 1 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 2007. 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?
The primary outcome was the score on a 10-question measure designed to assess knowledge attained from the educational video. (time frame: 20 minutes). 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 2007.