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

NCT00115388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2531

Last updated 2014-11-24

No results posted yet for this study

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 There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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

Conditions

  • Pelvic Inflammatory Disease
  • Chlamydia Infections

Interventions

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

Sponsors & Collaborators

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Pippa Oakeshott, MD FRCP · St George's, University of London

  • Phillip Hay, FRCP · St George's, University of London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
27 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00115388 on ClinicalTrials.gov