Pelvic Inflammatory DiseasePOPINCT00115388
Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease
A study testing Screening for chlamydia using self-taken vaginal swabs in people with Pelvic Inflammatory Disease and Chlamydia Infections, run by St George's, University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 27 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Inflammatory Disease, Chlamydia Infections
- What is being tested?
- Screening for chlamydia using self-taken vaginal swabs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,531 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2004to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 27 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Sexually active
Who cannot join
- Never been sexually active
- Tested for chlamydia in past 3 months and no new sexual partner since then
- Pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's Hospital Medical School
London, Sw17 ORE
About this study
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 There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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
Read the 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.
- Conditions
- Pelvic Inflammatory Disease, Chlamydia Infections
- Being tested
- Screening for chlamydia using self-taken vaginal swabs
- Keywords
- Pelvic inflammatory disease, Chlamydia trachomatis, Screening
- Medical subject headings
- Pelvic Inflammatory Disease, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for chlamydia using self-taken vaginal swabsProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Deferred screening control group | Other | Samples from women in the control group were stored and tested at the end of the trial Receives: Procedure: Screening for chlamydia using self-taken vaginal swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.
Measured: 12 months
Secondary outcomes (6)
Secondary outcome measures after 12 months in women with chlamydial infection at baseline:
Measured: 12 months
Control group (untreated):
Measured: 12 months
Incidence of PID.
Measured: 12 months
Percentage with spontaneous clearance of genital infection.
Measured: 12 months
Relative risk of PID in women with and without BV
Measured: 12 months
3. Intervention group (treated): Reinfection rate.
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,531 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Pippa Oakeshott, St George's, University of London
- Investigators
- Pippa Oakeshott, MD FRCP, Principal investigator, St George's, University of LondonPhillip Hay, FRCP, Study chair, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115388
- Sponsor's protocol ID
- COHSR4PG
- Acronym
- POPI
- Status last verified
- Nov 2014
- First submitted
- 21 Jun 2005
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26082320Oakeshott 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.
PubMed 20378636Oakeshott 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.
PubMed 19077198Atherton 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.
PubMed 18053199
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease
- ClinicalTrials.gov ID
- NCT00115388
- Acronym / sponsor ID
- POPI / COHSR4PG
- Conditions
- Pelvic Inflammatory Disease, Chlamydia Infections
- Keywords
- Pelvic inflammatory disease, Chlamydia trachomatis, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,531 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deferred screening control group | Other | Procedure: Screening for chlamydia using self-taken vaginal swabsSamples from women in the control group were stored and tested at the end of the trial |
Who may qualify
- Ages
- 16 to 27 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Sexually active
Key exclusion criteria (3 listed)
- Never been sexually active
- Tested for chlamydia in past 3 months and no new sexual partner since then
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for chlamydia using self-taken vaginal swabsWomen in the intervention group will be tested for chlamydia and those found to be infected will be referred for treatment and partner notification | Procedure or surgery | Deferred screening control group |
Primary outcome
Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.
Time frame: 12 months
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Derived from this study: PubMed 26082320Hay 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.
- Derived from this study: PubMed 20378636Oakeshott 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.
- Derived from this study: PubMed 19077198Oakeshott 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.
- Derived from this study: PubMed 18053199Atherton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pippa Oakeshott, MD FRCP principal investigator
St George's, University of London
Phillip Hay, FRCP study chair
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for chlamydia using self-taken vaginal swabs in people with Pelvic Inflammatory Disease and Chlamydia Infections, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00115388, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.