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

NCT ID: NCT03098329

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1907 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2021-05-28

Brief Summary

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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

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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.

Conditions

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Chlamydia Trachomatis Infection Gonorrhea

Keywords

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Screening men expedited treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ct/GC screening

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

26 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Tulane University

OTHER

Sponsor Role lead

Responsible Party

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Patricia Kissinger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tulane University School of Public Health and Tropical Medicine

New Orleans, Louisiana, United States

Site Status

Countries

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United States

References

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Campbell MB, Ratnayake A, Gomes G, Stoecker C, Kissinger PJ. Effectiveness of Incentivized Peer Referral to Increase Enrollment in a Community-Based Chlamydia Screening and Treatment Study Among Young Black Men. J Racial Ethn Health Disparities. 2024 Jun;11(3):1173-1181. doi: 10.1007/s40615-023-01595-5. Epub 2023 Apr 24.

Reference Type DERIVED
PMID: 37095285 (View on PubMed)

Other Identifiers

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1R01HD086794-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-964337

Identifier Type: -

Identifier Source: org_study_id