Chlamydia Trachomatis InfectionNCT03098329
Check it: A New Approach to Controlling Chlamydia Transmission in Young People
A study testing Ct/GC screening in people with Chlamydia Trachomatis Infection and Gonorrhea, run by Tulane University at 1 site in United States.
Trial summary
This study, named "Check it," is a bundled program for African American (AA) men ages 15-24 that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects who test positive and their female sexual contacts, and rescreening for these two sexually transmitted infections. Read more about this study
- Who is it for?
- Ages 15 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis Infection, Gonorrhea
- What is being tested?
- Ct/GC screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,907 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 28 May 2021
- 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 15 to 26 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Identifies as African American or Black
- Identifies as male
- 15-26 years of age
- Lives or spends most of his time in Orleans Parish
- Had vaginal sex with at least one woman
- Has not taken azithromycin in the past 7 days
Who cannot join
- Unwilling or unable to provide informed consent
- Unable to speak or understand English
- Previously enrolled in the study by self-report
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University School of Public Health and Tropical Medicine
New Orleans, Louisiana, 70112
About this study
Official title: A New Approach to Controlling Chlamydia Transmission in Young People
This study, named "Check it," is a bundled program for African American (AA) men ages 15-24 that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects who test positive and their female sexual contacts, and rescreening for these two sexually transmitted infections.
Read the detailed description
Participants (N=4854) will be recruited through community partners, at events and using social marketing campaigns including advertisements, referrals from other participants, social media, and a web based educational website (Web-Ed). After establishing eligibility, written informed consent will be obtained. Subjects will complete a survey and provide a urine specimen for chlamydia (Ct) and gonorrhea (GC) testing and will provide their preferred contact information in order to be contacted about their test results. The testing laboratory will report positive results per LA hygiene code LAC 51:II.105: http://ldh.la.gov/assets/oph/Center-PHCH/Center-CH/infectious-epi/Surveillance/sanitarycode.pdf. Tulane study staff will contact participants to inform them of their results. If the participant tests positive for Ct and/or GC, the subject will be offered expedited treatment for the subject and the subject's recent sex partners. The subject may choose to pick up medication at a local pharmacy or medication can be mailed to the subject. Staff will also ask the participant to contact his partner(s) and provide them with the Check It staff's contact information so that staff can let the partner know that they have been exposed to an infection and offer the subject's sexual partner expedited treatment options if the participant did not already provide the subject's sexual partners with that information. No information provided by the participant will be shared with his partners. The study will cover the cost of the medications for subjects who test positive for either or both organisms and their sexual partners. Three months after treatment, male subjects who were positive will be asked to be re-screened and if positive, staff will conduct similar expedited treatment and partner services. Any subject who provides consent for annual testing reminders will be reminded using their preferred method of contact.
- Conditions
- Chlamydia Trachomatis Infection, Gonorrhea
- Being tested
- Ct/GC screening
- Keywords
- Screening, men, expedited treatment
- Medical subject headings
- Gonorrhea, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ct/GC screeningOther
Men aged 15-26 years old will be tested for chlamydia and gonorrhea at community based venues; positive men and their sexual partners will be offered expedited treatment at participating pharmacies; positive men will be asked to be rescreened for Ct/GC at 3 months post treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ct/GC screening | Experimental | Community screening of men for Ct and GC is not normally done. We are testing to see if this intervention will impact the rates of Ct and GC among women Receives: Other: Ct/GC screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of chlamydia in women
primary outcome
Measured: up to 60 months
Secondary outcomes (1)
Rate of gonorrhea in women
secondary outcome
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start22 May 2017
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chlamydia Trachomatis InfectionStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Community based screening of young men for chlamydia and gonorrhea, expedited treatment for positive subjects and their sexual partners
- Masking
- None (open label)
- Enrolment
- 1,907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Patricia Kissinger, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098329
- Sponsor's protocol ID
- 16-964337
- Other IDs
- 1R01HD086794-01A1
- Status last verified
- Nov 2021
- First submitted
- 14 Mar 2017
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Campbell MB, Ratnayake A, Gomes G, Stoecker C, Kissinger PJ. Effectiveness of Incentivized Peer Referral to Increase Enrollment in a Community-Based Chlamydia Screening and Treatment Study Among Young Black Men. J Racial Ethn Health Disparities. 2024 Jun;11(3):1173-1181. doi: 10.1007/s40615-023-01595-5. Epub 2023 Apr 24.
PubMed 37095285
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach to Controlling Chlamydia Transmission in Young People
- ClinicalTrials.gov ID
- NCT03098329
- Acronym / sponsor ID
- 16-964337
- Conditions
- Chlamydia Trachomatis Infection, Gonorrhea
- Keywords
- Screening, men, expedited treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,907 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 22 May 2017 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 31 Mar 2017 (actual)
- 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, named "Check it," is a bundled program for African American (AA) men ages 15-24 that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects who test positive and their female sexual contacts, and rescreening for these two sexually transmitted infections.
Detailed description
Participants (N=4854) will be recruited through community partners, at events and using social marketing campaigns including advertisements, referrals from other participants, social media, and a web based educational website (Web-Ed). After establishing eligibility, written informed consent will be obtained. Subjects will complete a survey and provide a urine specimen for chlamydia (Ct) and gonorrhea (GC) testing and will provide their preferred contact information in order to be contacted about their test results. The testing laboratory will report positive results per LA hygiene code LAC 51:II.105: http://ldh.la.gov/assets/oph/Center-PHCH/Center-CH/infectious-epi/Surveillance/sanitarycode.pdf. Tulane study staff will contact participants to inform them of their results. If the participant tests positive for Ct and/or GC, the subject will be offered expedited treatment for the subject and the subject's recent sex partners. The subject may choose to pick up medication at a local pharmacy or medication can be mailed to the subject. Staff will also ask the participant to contact his partner(s) and provide them with the Check It staff's contact information so that staff can let the partner know that they have been exposed to an infection and offer the subject's sexual partner expedited treatment options if the participant did not already provide the subject's sexual partners with that information. No information provided by the participant will be shared with his partners. The study will cover the cost of the medications for subjects who test positive for either or both organisms and their sexual partners. Three months after treatment, male subjects who were positive will be asked to be re-screened and if positive, staff will conduct similar expedited treatment and partner services. Any subject who provides consent for annual testing reminders will be reminded using their preferred method of contact.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Community based screening of young men for chlamydia and gonorrhea, expedited treatment for positive subjects and their sexual partners
| Arm | Type | Receives |
|---|---|---|
| Ct/GC screening | Experimental | Other: Ct/GC screeningCommunity screening of men for Ct and GC is not normally done. We are testing to see if this intervention will impact the rates of Ct and GC among women |
Who may qualify
- Ages
- 15 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Identifies as African American or Black
- Identifies as male
- 15-26 years of age
- Lives or spends most of his time in Orleans Parish
- Had vaginal sex with at least one woman
Key exclusion criteria (3 listed)
- Unwilling or unable to provide informed consent
- Unable to speak or understand English
- Previously enrolled in the study by self-report
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 |
|---|---|---|
| Ct/GC screeningMen aged 15-26 years old will be tested for chlamydia and gonorrhea at community based venues; positive men and their sexual partners will be offered expedited treatment at participating pharmacies; positive men will be asked to be rescreened for Ct/GC at 3 months post treatment. | Other | Ct/GC screening |
Primary outcome
Rate of chlamydia in women
Time frame: up to 60 months
primary outcome
1 secondary outcome
Rate of gonorrhea in women
Time frame: up to 60 months
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 23 Nov 2021.
- Derived from this study: PubMed 37095285Campbell MB, Ratnayake A, Gomes G, Stoecker C, Kissinger PJ. Effectiveness of Incentivized Peer Referral to Increase Enrollment in a Community-Based Chlamydia Screening and Treatment Study Among Young Black Men. J Racial Ethn Health Disparities. 2024 Jun;11(3):1173-1181. doi: 10.1007/s40615-023-01595-5. Epub 2023 Apr 24.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ct/GC screening in people with Chlamydia Trachomatis Infection and Gonorrhea, run by Tulane 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 6 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 23 Nov 2021. 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?
Rate of chlamydia in women (time frame: up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03098329, which also lists 1 linked publication.
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 23 Nov 2021.