TV/MG Prevalence Study
Research type
Research Study
Full title
Point Prevalence of Trichomonas vaginalis and Mycoplasma genitalium over a Broad Geographical Area using the cobas® TV/MG for use on the cobas® 6800/8800 Systems
IRAS ID
249175
Contact name
Michael Perry
Contact email
Sponsor organisation
Roche Molecular Systems, Inc.
Clinicaltrials.gov Identifier
RD003557, Sponsors Internal Unique Study Number
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
Mycoplasma genitalium (MG) is a sexually transmitted infection (STI) that can cause non-gonococcal urethritis (NGU) in men and cervicitis and pelvic inflammatory disease (PID) in women, which can result in infertility. Data suggests that MG is present in 1.3-3% of the general population and can be asymptomatic in up to 70% of cases. Furthermore, resistance to the most commonly used antibiotics is increasing due to the use of empiric therapy and no test for cure.
Trichomonas vaginalis (TV) is an STI that causes vaginal discharge, pruritus and irritation, although it can be asymptomatic in up to 50% of women. TV is associated with an increased risk of adverse pregnancy outcomes and increased transmission of HIV. Prevalence is thought to be low in the United Kingdom at less than 1%, but very little data is available to support this.
The aim of this study is to evaluate the point prevalence of both TV and MG in Wales in both men and women from urogenital and anorectal specimens. The study will also attempt to identify co-factors, such as age, gender, ethnicity, co-infection with other STIs (chlamydia (CT), gonorrhoea (NG), HIV, Syphilis), pregnancy, symptoms, and type of health care facility accessed, that are associated with TV and MG detection.
The study will also explore the antimicrobial resistance patterns of MG and other important emerging STI antimicrobial resistance concerns such as Neisseria gonorrhoeae (NG).
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
18/EE/0334
Date of REC Opinion
10 Oct 2018
REC opinion
Favourable Opinion