Funding for this research was provided by:
National Institute for Health Research (15/110/02)
Received: 6 June 2019
Accepted: 16 September 2019
First Online: 27 November 2019
Ethics approval and consent to participate
: This trial was reviewed and given a favourable ethical opinion by the London - Harrow Research Ethics Committee (Ref CitationRef removed/LO/1245). The trial will be performed in accordance with the ethical principles of the Declaration of Helsinki and subsequent amendments. The trial will be conducted in accordance with the Research Governance Framework for Health and Social Care, the applicable UK Statutory Instruments, which include the Medicines for Human Use Clinical Trials 2004 and subsequent amendments, the Data Protection Act 1998, Human Tissue Act 2008 and Human Tissue (Scotland) Act 2006 (if applicable), EU Clinical Trials Directive, Medical Devices Regulations and amendment Regulations and Guidelines for Good Clinical Practice (GCP). This trial will be carried out under a Clinical Trial Authorisation in accordance with the Medicines for Human Use Clinical Trials regulations. The protocol will be submitted to and approved by the Research Ethics Committee prior to circulation.All participants will receive oral and written information about the trial and must give their written informed consent to take part in the trial. Participants are free to withdraw at any time.
: Not applicable.
: JDCR reports personal fees from GlaxoSmithKline (GSK) Pharma, Hologic Diagnostics, Mycovia and Janssen Pharma as well as ownership of shares in GSK Pharma and Astrazeneca Pharma. He is author of the UK and European Guidelines on Pelvic Inflammatory Disease; is a Member of the European Sexually Transmitted Infections Guidelines Editorial Board; is a Member of the National Institute for Health Research (NIHR) Funding Committee (Health Technology Assessment [HTA] programme); and was previously a Member of the NIHR HTA Primary Care, Community and Preventative Interventions Panel (2013–2016). He is an NIHR Journals editor and associate editor of the journal <i>Sexually Transmitted Infections</i>. He is an officer of the British Association for Sexual Health and HIV (vice-president) and the International Union against Sexually Transmitted Infections (treasurer), and he is a charity trustee of the Sexually Transmitted Infections Research Foundation. The other authors declare that they have no competing interests.