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.
- health policy
- sexual medicine
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Contributors All authors were involved in the conception and design of the research. SA is principal investigator; HBF is study manager and lead researcher; MB facilitates PPI; JF, JY and KE developed and advise on the self-consent procedures and the HPV vaccination process; MR advises on local immunisation strategy; JM advises on health inequalities and MH advises on statistical methods. SA wrote the first draft and all authors contributed to the final version of the manuscript.
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.
Competing interests None declared.
Patient consent Not required.
Ethics approval The University of Bristol Faculty of Health Sciences Research Ethics Committee and the National Health Service (NHS) Health Research Authority provided ethical approvals for the study. In addition, management permission from the Research and Development offices will be sought from each participating Clinical Commissioning Group prior to obtaining the dataset.
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.
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