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Completed

NCT Number: NCT00115388

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

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 There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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

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Key information

Conditions

Pelvic Inflammatory Disease Adnexal Diseases Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gram-Negative Bacterial Infections Infections Pelvic Infection Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

16 year–27 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St George's Hospital Medical School

London, Sw17 ORE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening for chlamydia using self-taken vaginal swabs

Procedure

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 outcomes

  1. Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.

    Time frame: 12 months

Secondary outcomes

  1. Secondary outcome measures after 12 months in women with chlamydial infection at baseline:

    Time frame: 12 months

  2. Control group (untreated):

    Time frame: 12 months

  3. Incidence of PID.

    Time frame: 12 months

  4. Percentage with spontaneous clearance of genital infection.

    Time frame: 12 months

  5. Relative risk of PID in women with and without BV

    Time frame: 12 months

  6. 3. Intervention group (treated): Reinfection rate.

    Time frame: 1-3 years

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Registry information

Acronym: POPI

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jun 22, 2005
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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