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临床试验/NCT03098329
NCT03098329已完成不适用

A New Approach to Controlling Chlamydia Transmission in Young People

Tulane University2 个研究点 分布在 1 个国家目标入组 1,907 人开始时间: 2017年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,907
试验地点
2
主要终点
Rate of chlamydia in women

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
15 Years 至 26 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • Unwilling or unable to provide informed consent
  • Unable to speak or understand English
  • Previously enrolled in the study by self-report

结局指标

主要结局

Rate of chlamydia in women

时间窗: up to 60 months

primary outcome

次要结局

  • Rate of gonorrhea in women(up to 60 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Kissinger

Principal Investigator

Tulane University

研究点 (2)

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