Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease
Condition: Pelvic Inflammatory Disease; Chlamydia Infections
MeSH terms: Chlamydia Infections; Pelvic Inflammatory Disease; Pelvic Infection
Study type: Interventional

Summary: 
      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      chlamydia screening and this was in American women in 1992 and used outdated tests.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
    

Detailed description: 
      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.

      Intervention: Following randomisation, vaginal swabs from intervention women will be tested
      for chlamydia by PCR and those infected referred for treatment. Vaginal swabs from control
      women will be stored and analysed after a year. Vaginal smears will be Gram stained and
      analysed for BV.

      Main outcome measure: Incidence of clinical PID over 12 months in intervention and control
      groups.

      Possible cases of PID will be identified from questionnaires and record searches.
      Confirmation of the diagnosis will be done by detailed review of medical records by two
      independent researchers blind to whether the woman is in the intervention or control group.
    

Intervention name(s): Screening for chlamydia using self-taken vaginal swabs
Intervention type(s): Procedure
Intervention description(s): Women in the intervention group will be tested for chlamydia and those found to be infected will be referred for treatment and partner notification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pelvic inflammatory disease; Chlamydia trachomatis; Screening