SyphilisNCT00553111
Video Tool to Promote Knowledge of Syphilis as Facilitator of HIV Transmission
A study testing educational video in people with Syphilis, run by Jacobi Medical Center at 2 sites in United States.
Trial summary
During the winter of 2007, the Syphilis Advisory Group and Bureau of STD Control of the NYC Department of Health funded the Emergency Department of Jacobi Medical Center to further evaluate the effectiveness of the Syphilis and Men video in additional settings where men access STD related information and testing and… Read more about this study
- Who is it for?
- Any age, 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
- 168 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to Apr 2007
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- must speak english or spanish
Who cannot join
- excluded if hearing or visually impaired
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York University Ambulatory Care Pavilion
Manhattan, New York, 10010
Gay Men of African Descent
Manhattan, New York, 10035
About this study
During the winter of 2007, the Syphilis Advisory Group and Bureau of STD Control of the NYC Department of Health funded the Emergency Department of Jacobi Medical Center to further evaluate the effectiveness of the Syphilis and Men video in additional settings where men access STD related information and testing and where high-risk groups, such as MSM, frequent. The video was evaluated for promoting knowledge of syphilis, especially as facilitator of HIV transmission, and in encouraging concurrent testing (syphilis and HIV) among men recruited from a community-based organization, an ambulatory care setting, and a dance club.
Read the detailed description
The Solomon-four group design was applied to assess the effectiveness of the video in raising syphilis knowledge among participants, while controlling for the influence of the pre-test knowledge survey in skewing post-knowledge survey scores. Participants in Group 1 received a pre-test survey, the video intervention, and the post-test survey; Group 2 received the pre-test and post-test surveys; Group 3 received the video intervention and post-test survey; and Group 4 received the post-test survey only. A computer-generated randomization list was used to assign participants to one of the four groups.
- Conditions
- Syphilis
- Being tested
- educational video
- Keywords
- syphilis, video education, 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 videoOther
educational video
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | pre survey, intervention, post test survey Receives: Other: educational video |
| 2 | No intervention | pre test survey and post test survey |
| 3 | Experimental | video intervention 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 syphilis educational video
Measured: 20 minutes
Secondary outcomes (1)
A secondary outcome was the decision to be tested for syphilis and HIV
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 posted5 Nov 2007 (estimated)
- Study startNov 2006
- Study completionApr 2007
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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobi Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Chinazo Cunningham, MD, Principal investigator, Montefiore Medical CenterJohn Sanchez, MD, MPH, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553111
- Sponsor's protocol ID
- 06-09390
- Status last verified
- Nov 2007
- First submitted
- 2 Nov 2007
- Last updated
- 5 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Tool to Promote Knowledge of Syphilis as Facilitator of HIV Transmission
- ClinicalTrials.gov ID
- NCT00553111
- Acronym / sponsor ID
- 06-09390
- Conditions
- Syphilis
- Keywords
- syphilis, video education, knowledge, black, hispanic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Jacobi Medical CenterUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 5 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.
During the winter of 2007, the Syphilis Advisory Group and Bureau of STD Control of the NYC Department of Health funded the Emergency Department of Jacobi Medical Center to further evaluate the effectiveness of the Syphilis and Men video in additional settings where men access STD related information and testing and where high-risk groups, such as MSM, frequent. The video was evaluated for promoting knowledge of syphilis, especially as facilitator of HIV transmission, and in encouraging concurrent testing (syphilis and HIV) among men recruited from a community-based organization, an ambulatory care setting, and a dance club.
Detailed description
The Solomon-four group design was applied to assess the effectiveness of the video in raising syphilis knowledge among participants, while controlling for the influence of the pre-test knowledge survey in skewing post-knowledge survey scores. Participants in Group 1 received a pre-test survey, the video intervention, and the post-test survey; Group 2 received the pre-test and post-test surveys; Group 3 received the video intervention and post-test survey; and Group 4 received the post-test survey only. A computer-generated randomization list was used to assign participants to one of the four 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 videopre survey, intervention, post test survey |
| 2 | No intervention | –pre test survey and post test survey |
| 3 | Experimental | Other: educational videovideo intervention and post test survey |
| 4 | No intervention | –post test survey |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- must speak english or spanish
Key exclusion criteria (1 listed)
- excluded if hearing or visually impaired
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 videoeducational video | Other | 1, 3 |
Primary outcome
The primary outcome was the score on a 10-question measure designed to assess knowledge attained from the syphilis educational video
Time frame: 20 minutes
1 secondary outcome
A secondary outcome was the decision to be tested for syphilis and HIV
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 5 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.
Chinazo Cunningham, MD principal investigator
Montefiore Medical Center
John Sanchez, MD, MPH principal investigator
Montefiore Medical Center
2 sites 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 2 sites 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 5 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 2 sites 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 syphilis 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 5 Nov 2007.