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

Pelvic Inflammatory Disease Clinical Trial

— POPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115388
• Other study ID #: COHSR4PG
• Status: Completed
• Phase: N/A
• First received: June 21, 2005
• Last updated: November 21, 2014
• Start date: September 2004
• Est. completion date: December 2008

Study information

• Verified date: November 2014
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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 There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2531
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 27 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia Infections
• Pelvic Inflammatory Disease

Intervention

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

Locations

Country	Name	City	State
United Kingdom	St George's Hospital Medical School	London

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.		12 months	No
Secondary	Secondary outcome measures after 12 months in women with chlamydial infection at baseline:		12 months	No
Secondary	Control group (untreated):		12 months	No
Secondary	Incidence of PID.		12 months	No
Secondary	Percentage with spontaneous clearance of genital infection.		12 months	No
Secondary	Relative risk of PID in women with and without BV		12 months	No
Secondary	3. Intervention group (treated): Reinfection rate.		1-3 years	No