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  • Accelerated partner therapy (APT) partner notification for people with Chlamydia trachomatis: protocol for the Limiting Undetected Sexually Transmitted infections to RedUce Morbidity (LUSTRUM) APT cross-over cluster randomised controlled trial

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Sexual health
Protocol
Accelerated partner therapy (APT) partner notification for people with Chlamydia trachomatis: protocol for the Limiting Undetected Sexually Transmitted infections to RedUce Morbidity (LUSTRUM) APT cross-over cluster randomised controlled trial
  1. Claudia S Estcourt1,
  2. Alison R Howarth2,
  3. Andrew Copas2,
  4. Nicola Low3,
  5. Fiona Mapp2,
  6. Melvina Woode Owusu2,
  7. Paul Flowers4,
  8. Tracy Roberts5,
  9. Catherine H Mercer2,
  10. Sonali Wayal2,6,
  11. Merle Symonds7,
  12. Rak Nandwani8,
  13. John Saunders2,9,
  14. Anne M Johnson2,
  15. Maria Pothoulaki1,
  16. Christian Althaus3,
  17. Karen Pickering5,
  18. Tamsin McKinnon2,
  19. Susannah Brice10,
  20. Alex Comer10,
  21. Anna Tostevin2,
  22. Chidubem (Duby) Ogwulu5,
  23. Gabriele Vojt1,
  24. Jackie A Cassell11
  1. 1School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK
  2. 2Institute for Global Health, UCL, London, UK
  3. 3Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
  4. 4Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
  5. 5Health Economics Unit, University of Birmingham, Birmingham, UK
  6. 6Development Media International CIC, London, Greater London, UK
  7. 7Western Sussex Hospitals NHS Foundation Trust, Worthing, West Sussex, UK
  8. 8NHS Greater Glasgow and Clyde, Glasgow, UK
  9. 9Public Health England, London, UK
  10. 10All East Sexual Health, Barts Health NHS Trust, London, UK
  11. 11Brighton and Sussex Medical School, East Sussex, UK
  1. Correspondence to Dr Claudia S Estcourt; claudia.estcourt{at}gcu.ac.uk

Abstract

Introduction Partner notification (PN) is a process aiming to identify, test and treat the sex partners of people (index patients) with sexually transmitted infections (STIs). Accelerated partner therapy (APT) is a PN method whereby healthcare professionals assess sex partners, by telephone consultation, before giving the index patient antibiotics and STI self-sampling kits to deliver to their sex partner(s). The Limiting Undetected Sexually Transmitted infections to RedUce Morbidity programme aims to determine the effectiveness of APT in heterosexual women and men with chlamydia and determine whether APT could affect Chlamydia trachomatis transmission at population level.

Methods and analysis This protocol describes a cross-over cluster randomised controlled trial of APT, offered as an additional PN method, compared with standard PN. The trial is accompanied by an economic evaluation, transmission dynamic modelling and a qualitative process evaluation involving patients, partners and healthcare professionals. Clusters are 17 sexual health clinics in areas of England and Scotland with contrasting patient demographics. We will recruit 5440 heterosexual women and men with chlamydia, aged ≥16 years.

The primary outcome is the proportion of index patients testing positive for C. trachomatis 12-16 weeks after the PN consultation. Secondary outcomes include: proportion of sex partners treated; cost effectiveness; model-predicted chlamydia prevalence; experiences of APT.

The primary outcome analysis will be by intention-to-treat, fitting random effects logistic regression models that account for clustering of index patients within clinics and trial periods. The transmission dynamic model will be used to predict change in chlamydia prevalence following APT. The economic evaluation will use mathematical modelling outputs, taking a health service perspective. Qualitative data will be analysed using interpretative phenomenological analysis and framework analysis.

Ethics and dissemination This protocol received ethical approval from London—Chelsea Research Ethics Committee (18/LO/0773). Findings will be published with open access licences.

Trial registration number ISRCTN15996256.

  • partner notification
  • STIs
  • chlamydia
  • accelerated partner therapy
  • RCT
  • transmission
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2019-034806

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    Footnotes

    • Twitter @nicolamlow, @fionamapp, @tracyrobertsbham

    • Contributors CSE is chief investigator of the study. CSE, JAC, NL, TR, AnC, AMJ, CHM, JS, MS, PF, RN and SW conceived the study and secured funding. They are responsible for the planning and delivery of the study. PF leads the process evaluation; TR leads on the health economics evaluation and NL leads on the mathematical modelling. AnC is the trial statistician. ARH, FM and MWO are responsible for coordination of the study. ARH, FM, MWO, KP, C(D)O, SB, AlC, TM, MP, GV and AT are responsible for operationalisation of the study procedures. FM, MWO, KP, C(D)O, MP and GV will contribute to data collection and analysis. ARH, SB and AlC will contribute to data collection. CA and NL are responsible for the mathematical modelling. AT is responsible for trial data management and will contribute to data analysis. All authors contributed to the development of the study design and establishment of procedures. CSE led on preparing the manuscript. All authors critically reviewed and approved the final version.

    • Funding This work presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (reference number RP-PG-0614-20009).

    • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The funders had no role in study design, collection, management, analysis and interpretation of data; writing of the report and the decision to submit the report for publication.

      Trial sponsor: Noclor, Central and North West London NHS Trust. The sponsor had no role in study design, collection, management, analysis and interpretation of data; writing of the report and the decision to submit the report for publication.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Ethics approval Ethical approval from London—Chelsea Research Ethics Committee (18/LO/0773).

    • Provenance and peer review Not commissioned; externally peer reviewed.