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Completed

NCT Number: NCT03098329

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

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.

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Key information

Conditions

Chlamydia Trachomatis Infection Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neisseriaceae Infections Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

15 year–26 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tulane University School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ct/GC screening

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.

Primary outcomes

  1. Rate of chlamydia in women

    Time frame: up to 60 months

    primary outcome

Secondary outcomes

  1. Rate of gonorrhea in women

    Time frame: up to 60 months

    secondary outcome

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

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

Registry information

Official study title

A New Approach to Controlling Chlamydia Transmission in Young People

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2017
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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