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

A New Approach to Controlling Chlamydia Transmission in Young People

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03098329
Enrollment
1907
Registered
2017-03-31
Start date
2017-05-22
Completion date
2021-05-28
Last updated
2021-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia Trachomatis Infection, Gonorrhea

Keywords

Screening, men, expedited treatment

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.

Interventions

OTHERCt/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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Tulane University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Community based screening of young men for chlamydia and gonorrhea, expedited treatment for positive subjects and their sexual partners

Eligibility

Sex/Gender
MALE
Age
15 Years to 26 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of chlamydia in womenup to 60 monthsprimary outcome

Secondary

MeasureTime frameDescription
Rate of gonorrhea in womenup to 60 monthssecondary outcome

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026