Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,531
- 试验地点
- 2
- 主要终点
- Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.
研究概览
简要总结
Chlamydial infection is a common, sexually transmitted disease which women can have without knowing. Untreated, it can lead to an infection of the womb and fallopian tubes called pelvic inflammatory disease (PID), which can cause infertility. There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests. We now need to see if screening using modern tests and self-taken swabs works in a high risk, young, multiethnic female population in the United Kingdom (UK).
The study is a randomised trial. It will involve asking women students in college bars to complete confidential questionnaires on sexual health and to provide self-administered vaginal swabs. We have successfully done this in a small pilot study. Participants will be told that the tests are for research purposes only and that if they think they may have been at risk of a sexually transmitted infection they should get checked at a clinic. If the trial shows that chlamydia screening using these new methods prevents PID, extending this community-based intervention nationwide could improve women's reproductive health and wellbeing and might prevent some women from becoming infertile
详细描述
Background: Pelvic inflammatory disease (PID) is common and can lead to infertility, ectopic pregnancy or chronic pelvic pain.
Objectives: To see if screening and treatment of chlamydial infection reduces the incidence of PID over 12 months, and to investigate the natural history of chlamydial infection and the role of bacterial vaginosis (BV) in the development of chlamydia associated PID.
Design: Randomised trial over one year
Setting: Common rooms, bars and lecture theatres at universities and colleges in London, UK.
Participants: 2500 sexually active female students aged <28 years will be asked to complete a questionnaire on sexual health and to provide a self-administered vaginal swab and smear with follow up after a year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 27 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active
排除标准
- •Never been sexually active
- •Tested for chlamydia in past 3 months and no new sexual partner since then
结局指标
主要结局
Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.
时间窗: 12 months
次要结局
- 3. Intervention group (treated): Reinfection rate.(1-3 years)
- Secondary outcome measures after 12 months in women with chlamydial infection at baseline:(12 months)
- Control group (untreated):(12 months)
- Incidence of PID.(12 months)
- Percentage with spontaneous clearance of genital infection.(12 months)
- Relative risk of PID in women with and without BV(12 months)
研究者
Dr Pippa Oakeshott
Professor of General Practice
St George's, University of London
