Natsal-3: further characterisation of CT and MG specimens

• Research type

  Research Study

• Full title

  The third National Survey of Sexual Attitudes and Lifestyles (Natsal-3): further characterisation of anonymised Chlamydia trachomatis and Mycoplasma genitalium specimens

• IRAS ID

  170379

• Contact name

  Anne Johnson

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Medical Research Council , G0701757; Wellcome Trust , 084840

• Duration of Study in the UK

  0 years, 10 months, 31 days

• Research summary

  As part of Natsal-3, approximately 5000 men and women aged 16-44 provided a urine sample for testing for a range of infections. The aim was to measure the population prevalence of key sexually transmitted infections (STIs) and identify associated demographic and behavioural factors and clinical symptoms, thus informing control strategies, service provision and models of STI transmission dynamics. Participants gave written informed consent to anonymised testing without the return of results. The collection, participant information sheets, full description of the anonymisation procedures, rationale for not returning results and testing procedures were approved by the Oxfordshire Research Ethics Committee A (No 09/H0604/27).

  In this application, we are requesting ethical clearance for further testing (drug resistance and sequencing) of the specimens that tested positive (or equivocal) for Chlamydia trachomatis (CT) (n=103) and Mycoplasma genitalium (MG) (n=72). Most studies on drug resistance are undertaken in clinical settings or symptomatic patients. Testing the Natsal-3 specimens for drug resistance provides a rare opportunity to determine the presence and level of drug resistance to these organisms in the general population and link these to sexual behaviour. We plan to investigate potential Azithromycin resistance in C. trachomatis specimens and Azithromycin and Quinolone resistance in M. genitalium specimens. New technological developments enable whole genome sequencing (WGS) of these organisms from the samples we have collected. This also gives the opportunity to contribute to digital archives of these organisms for the future. The Natsal samples are an important source of data on background variability of these organisms in the general population. The added benefit of being able to link these results to the detailed demographic and behavioural variables in Natsal-3, will inform our understanding of the transmission dynamics and possible interventions.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  15/SC/0055

• Date of REC Opinion

  11 Feb 2015

• REC opinion

  Favourable Opinion