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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03098329
Other study ID # 16-964337
Secondary ID 1R01HD086794-01A
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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