Check it: A New Approach to Controlling Chlamydia Transmission in Young People
Primary Purpose
Chlamydia Trachomatis Infection, Gonorrhea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ct/GC screening
Sponsored by
About this trial
This is an interventional screening trial for Chlamydia Trachomatis Infection focused on measuring Screening, men, expedited treatment
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unwilling or unable to provide informed consent
- Unable to speak or understand English
- Previously enrolled in the study by self-report
Sites / Locations
- Tulane University School of Public Health and Tropical Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ct/GC screening
Arm Description
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
Outcomes
Primary Outcome Measures
Rate of chlamydia in women
primary outcome
Secondary Outcome Measures
Rate of gonorrhea in women
secondary outcome
Full Information
NCT ID
NCT03098329
First Posted
March 14, 2017
Last Updated
November 15, 2021
Sponsor
Tulane University
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03098329
Brief Title
Check it: A New Approach to Controlling Chlamydia Transmission in Young People
Official Title
A New Approach to Controlling Chlamydia Transmission in Young People
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis Infection, Gonorrhea
Keywords
Screening, men, expedited treatment
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
1907 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ct/GC screening
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Ct/GC screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of chlamydia in women
Description
primary outcome
Time Frame
up to 60 months
Secondary Outcome Measure Information:
Title
Rate of gonorrhea in women
Description
secondary outcome
Time Frame
up to 60 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Identifies as male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Unwilling or unable to provide informed consent
Unable to speak or understand English
Previously enrolled in the study by self-report
Facility Information:
Facility Name
Tulane University School of Public Health and Tropical Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Check it: A New Approach to Controlling Chlamydia Transmission in Young People
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