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

Gonorrhea Clinical Trial

Official title:

A New Approach to Controlling Chlamydia Transmission in Young People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098329
• Other study ID #: 16-964337
• Secondary ID: 1R01HD086794-01A
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: May 28, 2021

Study information

• Verified date: November 2021
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.p df. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1907
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis Infection
• Gonorrhea

Intervention

Other:
• Ct/GC screening
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.

Locations

Country	Name	City	State
United States	Tulane University School of Public Health and Tropical Medicine	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Tulane University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of chlamydia in women	primary outcome	up to 60 months
Secondary	Rate of gonorrhea in women	secondary outcome	up to 60 months