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

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ClinicalTrials.gov Identifier: NCT03098329
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Patricia Kissinger, 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.

Condition or disease Intervention/treatment Phase
Chlamydia Trachomatis Infection Gonorrhea Other: Ct/GC screening Not Applicable

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. Men with negative results will be contacted by Tulane study staff and will be informed of their results. Results for men who are positive will be reported to a Louisiana Office of Public Health (LA-OPH) study specific disease intervention specialist (DIS) who will notify the subject of his positive results and engage in partners services per their standard protocols. Partner services means that the subject will be asked to name and provide contact information about his female sex partners from the past 60 days. These sex partners will then be notified that they have been exposed to the infection and offered expedited treatment. The name of the subject is not mentioned. The study will cover the cost of the medications for subjects who test positive for either or both organism and their female sexual partners. Three months after treatment, male subjects who were positive will be asked to be re-screened and if positive, the DIS 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4854 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Community based screening of young men for chlamydia and gonorrhea, expedited treatment for positive subjects and their sexual partners
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A New Approach to Controlling Chlamydia Transmission in Young People
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Other: Ct/GC screening
Men aged 15-24 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.




Primary Outcome Measures :
  1. Rate of chlamydia in women [ Time Frame: up to 60 months ]
    primary outcome


Secondary Outcome Measures :
  1. Rate of gonorrhea in women [ Time Frame: up to 60 months ]
    secondary outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Identifies as male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Identifies as African American or Black
  • Identifies as male
  • 15-24 years of age
  • Lives or spends most of his time in Orleans Parish
  • Had vaginal sex with at least one woman in the past 2 months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098329


Contacts
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Contact: Patricia J Kissinger, PhD 504-988-7320 kissing@tulane.edu
Contact: Norine M Schmidt, MPH 504-988-8268 nschmid1@tulane.edu

Locations
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United States, Louisiana
Tulane University School of Public Health and Tropical Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Patricia Kissinger, Ph.D.    504-988-7320    kissing@tulane.edu   
Contact: Norine Schmidt, MPH    504-988-8268    nschmid1@tulane.edu   
Sponsors and Collaborators
Tulane University
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Responsible Party: Patricia Kissinger, Principal Investigator, Tulane University
ClinicalTrials.gov Identifier: NCT03098329     History of Changes
Other Study ID Numbers: 16-964337
1R01HD086794-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Patricia Kissinger, Tulane University:
Screening
men
expedited treatment
Additional relevant MeSH terms:
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Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Neisseriaceae Infections