Check it: A New Approach to Controlling Chlamydia Transmission in Young People

Not Applicable

Completed

• Conditions: Gonorrhea; Chlamydia Trachomatis Infection
• Interventions: Other: Ct/GC screening

• Registration Number: NCT03098329
• Lead Sponsor: Tulane University

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.

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Study Start: 2017-05-22
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1907

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ct/GC screening	Ct/GC screening	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

Primary Outcome Measures

Name	Time	Method
Rate of chlamydia in women	up to 60 months	primary outcome

Secondary Outcome Measures

Name	Time	Method
Rate of gonorrhea in women	up to 60 months	secondary outcome

Trial Locations

Locations (1)

Tulane University School of Public Health and Tropical Medicine; 🇺🇸 New Orleans, Louisiana, United States