Impact and acceptability of self-consent procedures for the school-based human papillomavirus vaccine: A mixed-methods study protocol

Suzanne Audrey*, Harriet Batista Ferrer, Joanne Ferrie, Karen Evans, Michael Bell, Julie Yates, Marion Roderick, John Macleod, Matthew Hickman

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    10 Citations (Scopus)

    Abstract

    Introduction The human papillomavirus (HPV) vaccine, administered in early adolescence, can substantially reduce cervical cancer incidence and mortality. However, lack of written parental consent is a key reason why some young women do not receive the vaccine. The national legal framework allows girls to be vaccinated without parental consent provided they are deemed Gillick competent, but there is some reticence about vaccinating without written parental consent. Self-consent procedures are being implemented in Bristol and South Gloucestershire. This study will examine the implementation, acceptability and impact of these new procedures. Methods and analysis Statistical analyses of routine data from Public Health England and the Child Health Information System will test if there has been an increase in HPV vaccination uptake in two ways: (a) Is there an increase when comparing before and after the change in our intervention sites? and (b) Does the percentage change in our intervention sites differ from comparison sites (similar to our intervention sites in terms of initial HPV uptake, ethnicity and deprivation levels) in England where no such intervention took place and how? For the process evaluation, we will develop a logic model and use questionnaires, observations and audio-recorded interviews with young women, school nurses, school staff and parents to examine the context, implementation of self-consent and response to the new procedures. Ethics and dissemination The University of Bristol Faculty of Health Sciences Research Ethics Committee and the National Health Service Health Research Authority provided approvals for the study. We will produce a report with recommendations about self-consent procedures in conjunction with key stakeholders. At least two papers will be written for publication in peer-reviewed journals and for conference presentations. A summary of results will be shared with participating immunisation nurses, school staff, young people and parents as requested. Trial registration number ISRCTN49086105; Pre-results.

    Original languageEnglish
    Article numbere021321
    JournalBMJ Open
    Volume8
    Issue number3
    DOIs
    Publication statusPublished - 1 Mar 2018

    Bibliographical note

    Funding Information:
    Funding This work is funded by the National Institute for Health Research's Research for Patient Benefit (NIHR RfPB) programme (project number PB-PG-0416-20013). The study is partly supported by the NIHR Health Protection Research Unit in Evaluation of Interventions at University of Bristol. The work was undertaken with the support of The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UKCRC Public Health Research Centre of Excellence. Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. disclaimer The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NIHR RfPB Programme, the Department of Health or Public Health England.

    Publisher Copyright:
    © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018.

    Keywords

    • health policy
    • sexual medicine

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