Is Mycoplasma genitalium in women 'the new chlamydia'' Community based prevalence and prospective cohort study.

Lead Research Organisation: St George's University of London
Department Name: Community Health Sciences

Abstract

Background:
Pelvic inflammatory disease (PID) is infection of the womb and fallopian tubes. It is the most important, preventable, sexually transmitted disease in industrialized countries. PID can be devastating to women?s emotional and physical health as it can lead to infertility, chronic pelvic pain or an ectopic pregnancy in a fallopian tube which can be fatal. Although PID can be caused by chlamydia, in most cases no cause is found.
It is possible that an organism called Mycoplasma genitalium may be a cause or at least a cofactor for PID. We know it is sometimes associated with genitourinary symptoms and it has been found in some women with PID. But we do not know how common it is in normal women, nor whether it can lead to the development of symptoms such as abnormal vaginal discharge, bleeding between periods, pelvic pain and, most important, PID. This means that we do not know if we should be testing women for M.genitalium or if it should be treated.

Aims of the study:
1. To find how common M.genitalium is in young, sexually active, female students in the community.
2. To see if it is commoner in certain groups such as women with more sexual partners or with other infections such as chlamydia or bacterial vaginosis.
3. To investigate the natural history of M.genitalium in women and see if it really does lead to symptoms including PID.

Methods:
The study is unique as it is based in universities and colleges rather than health care settings. It includes 2500 female students, 40% from ethnic minorities, who provided self-taken vaginal swabs for a chlamydia screening trial in 2004-6. Participants are being followed up after 12 months by questionnaire backed by medical record search for development of symptoms including PID. We will test stored vaginal swabs for M.genitalium.

Implications:
The study will provide important new information about M.genitalium. We will find out how common it is in young women, who is more likely to be infected, and whether it can lead to disease. The study uses a relatively new, non-invasive technique of self-taken vaginal swabs; and unlike most studies of M.genitalium is community based. If future research confirms that M.genitalium is an important cause or cofactor for PID, then testing women and treating those who are infected could help to prevent PID, improve women?s reproductive health and wellbeing, and save NHS costs.

Technical Summary

Background:
Mycoplasma genitalium is associated with urethritis and cervicitis, but its natural history and role in pelvic inflammatory disease (PID) are unclear. There is a window of opportunity to provide the evidence base before consumers may demand that testing be introduced in the UK. We will use stored self-taken vaginal swabs from our ongoing trial of screening for chlamydia to prevent PID. We will also obtain follow up postal swabs from women with and without M.genitalium at baseline.
Aims:
1. To find the prevalence and predictors of M.genitalium in 2500 young, sexually active female students recruited in the community.
2. To use questionnaires backed by medical records to evaluate the development of symptoms or progression to clinical PID over 12 months in women with and without M.genitalium at baseline (n=2000).
3. To collect follow up postal self-taken vaginal swabs to look at persistence/self-resolution of infection and annual incidence over 1-3 years (n=1000).
4. To explore the role of chlamydia and/or bacterial vaginosis at baseline in the development of M.genitalium associated symptoms or PID over 12 months.
Design:
Combined prevalence and prospective cohort study.
Setting (unique, non-healthcare):
19 London Further Education colleges and universities, mainly inner city.
Participants:
2500 sexually active female students mean age 21 years (30% from black ethnic minorities) who provided self-taken vaginal swabs and completed a questionnaire in 2004-6. They are being followed up by postal, email and telephone questionnaire for incidence of symptoms or clinical PID over 12 months. Follow up: over 85%.
Methods:
Stored samples will be tested for M.genitalium using PCR. All women with M.genitalium at baseline, and all those without M.genitalium who have agreed to return them, will be sent postal follow up swabs. For incidence of clinical PID, possible cases will be identified from responses to 12 month questionnaires backed by clinical records. Confirmation of diagnosis will be done by three physicians blind to results of bacteriological tests.
Main outcome measures:
1. Prevalence and predictors of M.genitalium in 2500 women.
We will look at the relation of M.genitalium with age, ethnicity, age at first sexual intercourse, number of partners, smoking, co-infection with chlamydia or BV; and symptoms at baseline.
2. Development of symptoms or possible PID over 12 months in an estimated 60 women with and 1940 without M.genitalium at baseline.
3. Persistent infection after 1-3 years and annual incidence of infection in 40 women with and 960 without M.genitalium at baseline.
 
Description BUPA Foundation
Amount £141,658 (GBP)
Organisation BUPA 
Department BUPA Foundation
Sector Charity/Non Profit
Country United Kingdom
Start 01/2009 
End 01/2010
 
Description nihr rfpb
Amount £245,000 (GBP)
Funding ID PB-PG-1014-35007 
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start 08/2016 
End 08/2018
 
Description strategy grant
Amount £20,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2011 
End 01/2012
 
Description Mycoplasma genitalium in women 
Organisation University College London
Department Institute for Women's Health
Country United Kingdom 
Sector Academic/University 
PI Contribution This is a feasibility study funded by NIHR of screening women for M.genitalium within the National Chlamydia Screening Programme. We have conducted a pilot study recruiting 100 women aged<25 in GUM to see if they are happy for us to have their NHS numbers to follow them up.
Impact We hope to apply for a Programme Grant jointly with UCL.
Start Year 2010
 
Description Prevalence of HPV in a cohort of sexually active young women 
Organisation Public Health England
Department Centre of Infectious Disease Surveillance and Control
Country United Kingdom 
Sector Public 
PI Contribution Biobank of samples for HPV testing
Collaborator Contribution Joint paper with HPA
Impact Presentations Papers in preparation Organisation of biobank
Start Year 2009
 
Description Translating advances in diagnostic and communication technologies to reduce the burden of STIs. 
Organisation Medical Research Council (MRC)
Country United Kingdom 
Sector Public 
PI Contribution Expertise in recruitment Biobank of vaginal samples
Collaborator Contribution Funding to pilot STI testing and electronic feedback of results in a FE college
Impact Multidisciplinary, multicentre collaboration
Start Year 2010
 
Description Newsletter to participants 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Primary Audience Participants in your research and patient groups
Results and Impact Newsletter to 2500 participants with preliminary results of follow up and information about further research on their samples

About 100 participants responded with mainly positive comments about the study
Year(s) Of Engagement Activity 2007