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

NCT00115388 | Completed

• 1 other identifier: COHSR4PG
• Study Type: interventional
• Target: 2,531
• Locations: 1 country
• Sites: 1

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 There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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

Conditions

Pelvic Inflammatory Disease; Chlamydia Infections

Keywords

Pelvic inflammatory disease; Chlamydia trachomatis; Screening

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (6)

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

  12 months

• Control group (untreated):

  12 months

• Incidence of PID.

  12 months

• Percentage with spontaneous clearance of genital infection.

  12 months

• Relative risk of PID in women with and without BV

  12 months

Study Arms (1)

Deferred screening control group

OTHER

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

Interventions

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

Deferred screening control group

Eligibility Criteria

• Age: 16 Years - 27 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Sexually active

You may not qualify if:

• Never been sexually active
• Tested for chlamydia in past 3 months and no new sexual partner since then
• Pregnant

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's Hospital Medical School

London, Sw17 ORE, United Kingdom

Location

Related Publications (4)

• Hay PE, Kerry SR, Normansell R, Horner PJ, Reid F, Kerry SM, Prime K, Williams E, Simms I, Aghaizu A, Jensen J, Oakeshott P. Which sexually active young female students are most at risk of pelvic inflammatory disease? A prospective study. Sex Transm Infect. 2016 Feb;92(1):63-6. doi: 10.1136/sextrans-2015-052063. Epub 2015 Jun 16.

  PMID: 26082320 DERIVED

• Oakeshott P, Kerry S, Aghaizu A, Atherton H, Hay S, Taylor-Robinson D, Simms I, Hay P. Randomised controlled trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial. BMJ. 2010 Apr 8;340:c1642. doi: 10.1136/bmj.c1642.

  PMID: 20378636 DERIVED

• Oakeshott P, Kerry S, Atherton H, Aghaizu A, Hay S, Taylor-Robinson D, Simms I, Hay P. Community-based trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial. Trials. 2008 Dec 10;9:73. doi: 10.1186/1745-6215-9-73.

  PMID: 19077198 DERIVED

• Atherton H, Banks D, Harbit R, Long L, Chadd F, Hay P, Kerry S, Simms I, Oakeshott P. Recruitment of young women to a trial of chlamydia screening - as easy as it sounds? Trials. 2007 Dec 4;8:41. doi: 10.1186/1745-6215-8-41.

  PMID: 18053199 DERIVED

MeSH Terms

Conditions

Pelvic Inflammatory Disease; Chlamydia Infections

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Pippa Oakeshott, MD FRCP

  St George's, University of London

  PRINCIPAL INVESTIGATOR

• Phillip Hay, FRCP

  St George's, University of London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General Practice

Study Record Dates

• First Submitted: June 21, 2005
• First Posted: June 22, 2005
• Study Start: September 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

GB (1)