Clinical trial NCT03098329: Check it: A New Approach to Controlling Chlamydia Transmission in Young People
Official title: A New Approach to Controlling Chlamydia Transmission in Young People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia Trachomatis Infection
Gonorrhea
Keywords: Screening
men
expedited treatment
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-03-31
Enrollment: 1907
Sex: MALE
Minimum age (years): 15
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Community based screening of young men for chlamydia and gonorrhea, expedited treatment for positive subjects and their sexual partners
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of chlamydia in women
timeFrame: up to 60 months
Secondary outcomes:
measure: Rate of gonorrhea in women
timeFrame: up to 60 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University School of Public Health and Tropical Medicine
state: Louisiana
Study officials:
References: