An interventional study of Screening for chlamydia using self-taken vaginal swabs in Pelvic Inflammatory Disease and Chlamydia Infections, sponsored by St George's, University of London. Completed at 1 site in United Kingdom. Open to female participants aged 16 Years to 27 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-24.
Sponsored by St George's, University of London · Not applicable, Interventional, and Prevention
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 There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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
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.
121 studies on the registry are indexed under Chlamydia Infections; 21 are open to participants now.
This study's enrollment of 2,531 is above the median of 600 across 85 interventional studies indexed under Chlamydia Infections.
Browse Chlamydia Infections studies →St George's, University of London is the lead sponsor of 105 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Samples from women in the control group were stored and tested at the end of the trial
Procedure: Screening for chlamydia using self-taken vaginal swabs
Women in the intervention group will be tested for chlamydia and those found to be infected will be referred for treatment and partner notification
Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.
Time frame: 12 months
Secondary outcome measures after 12 months in women with chlamydial infection at baseline:
Time frame: 12 months
Control group (untreated):
Time frame: 12 months
Incidence of PID.
Time frame: 12 months
Percentage with spontaneous clearance of genital infection.
Time frame: 12 months
Relative risk of PID in women with and without BV
Time frame: 12 months
3. Intervention group (treated): Reinfection rate.
Time frame: 1-3 years
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St George's, University of London