Title: The practicality, acceptability and impact of self-consent procedures for the schools-based HPV vaccination programme
Funder: Department of Health and Social Care

Abstract: BACKGROUND. High coverage of Human Papillomavirus vaccination (HPV) programmes, administered in early adolescence, can substantially reduce cervical cancer incidence and mortality. However, research suggests lower socio-economic status (SES), some ethnic groups, and not attending mainstream school are all associated with lower uptake of HPV vaccination. 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 Fraser competent, but there is some reticence about vaccinating without written parental consent. AIM. To examine the implementation, acceptability and impact of self-consent procedures for HPV vaccination. PLAN OF INVESTGATION. The study comprises: a systematic review; process evaluation, and; statistical analyses of routine data concerning HPV vaccination uptake in two local authorities with low uptake (Bristol and South Gloucestershire). 1] The systematic review will include quantitative and qualitative studies relating to adolescent self-consent for vaccines. A comprehensive search strategy will be implemented across all relevant databases from inception to the present. Two reviewers will independently screen titles and abstracts, assess relevant full texts, and extract information about study characteristics, methodology and findings. For quantitative studies, meta-analysis will be undertaken if appropriate, but if heterogeneity is strong the studies will be presented as a narrative review. For qualitative studies, results from individual studies will be extracted, interpreted and combined through identifying key themes across the studies. 2] For the process evaluation, a logic model will be developed, in consultation with relevant stakeholders, to show the links between inputs (self-consent procedures) and short- and medium-term outcomes (HPV vaccine implementation and uptake) that may lead to desired longer-term outcomes (increased uptake, reduced health inequalities). Context will be examined through stakeholder questionnaires, observations and field notes. The implementation of self-consent, and response to it, will be explored through observations and audio-recorded interviews/focus groups with young people, school nurses, school staff and parents in eight schools purposively selected in relation to the SES and ethnicity of students, and type of school. Thematic analysis of the qualitative data will employ the Framework method. 3] We will examine routine Public Health England (PHE) data on HPV vaccination uptake by geographical area, and data from the Child Health Information System (CHIS). Data fields extracted will include: ethnicity, postcode (to assign area deprivation score), and school. We will test whether there has been an increase in HPV vaccination uptake in two ways. First, is there an increase when comparing before and after the change in our intervention sites? Second, is there evidence that the % change in our intervention sites is different 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? DISSEMINATION. We will produce a report with findings and recommendations about self-consent to present at events/workshops with healthcare professionals. Two papers will be written for peer-reviewed journals, and conference presentations. A summary of results will be shared with school nurses, school staff, young people and parents/carers as requested. School nurses will be encouraged to contribute to dissemination activities. Findings will also be disseminated through appropriate websites and social media. POTENTIAL BENEFITS TO PATIENTS AND THE NHS. Increasing uptake of HPV vaccination has the potential to reduce cervical cancer incidence, saving lives and reducing costs to the health service. The research results will be shared with NHS and Public Health England colleagues as well as the wider healthcare community. An important benefit will be clarification of barriers and faciltiators to self-consent, and whether self-consent is feasible and acceptable to key stakeholders.

Lay abstract: AIM: To examine whether it is practical and acceptable for young people to consent for themselves to have the HPV vaccination, rather than their parents giving written consent. We will also look at the impact of self-consent on the number of young people receiving the vaccine . BACKGROUND: HPV vaccination can reduce cervical cancer in women. However, girls from lower socio-economic groups, some ethnic groups, and those not attending mainstream schools are less likely to receive the vaccine. It is recommended that HPV vaccination takes place aged 12/13 years. Because this seems quite young, written parental consent is asked for but it can be difficult for some girls to provide. The law allows girls to consent for themselves if they understand what the vaccine is for and what the side effects might be. DESIGN AND METHODS: We will summarise all the available evidence about adolescents self-consenting for vaccination. We will observe new self-consent procedures in Bristol and South Gloucestershire, and conduct interviews and focus groups with girls, parents, school nurses and school staff. We will also look at the uptake rates of HPV vaccination before and after the new self-consent procedures to see if uptake increases overall and in relation to socio-economic status, ethnicity and type of school. PATIENT AND PUBLIC INVOLVEMENT: We have discussed self-consent with a group of young people at the Bristol Royal Hospital for Sick Children. We will consult them again about the design of the study and the forms and paperwork we use with people who take part. DISSEMINATION: We will make recommendations about self-consent and present our findings at events for healthcare practitioners and academic conferences. Two papers will be written for peer-reviewed journals. We will summarise the results to share with school nurses, school staff, young people and their parents who request it.

Research activity codes: 3.4 VACCINES
Health categories: INFECTION;CANCER AND NEOPLASMS