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Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease (POPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00115388
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Pippa Oakeshott, St George's, University of London

Tracking Information
First Submitted Date  ICMJE June 21, 2005
First Posted Date  ICMJE June 22, 2005
Last Update Posted Date November 24, 2014
Study Start Date  ICMJE September 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2008)
Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Secondary outcome measures after 12 months in women with chlamydial infection at baseline: 1. Control group (untreated): a) Incidence of PID.
  • b) Percentage with spontaneous clearance of genital infection.
  • c) Relative risk of PID in women with and without BV
  • 3. Intervention group (treated): Reinfection rate.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease
Official Title  ICMJE Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pelvic Inflammatory Disease
  • Chlamydia Infections
Intervention  ICMJE 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
Study Arms  ICMJE Deferred screening control group
Samples from women in the control group were stored and tested at the end of the trial
Intervention: Procedure: Screening for chlamydia using self-taken vaginal swabs
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2008)
2531
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sexually active

Exclusion Criteria:

  • Never been sexually active
  • Tested for chlamydia in past 3 months and no new sexual partner since then
  • Pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 27 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00115388
Other Study ID Numbers  ICMJE COHSR4PG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr Pippa Oakeshott, St George's, University of London
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE St George's, University of London
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pippa Oakeshott, MD FRCP St George's, University of London
Study Chair: Phillip Hay, FRCP St George's, University of London
PRS Account St George's, University of London
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP