Condition category
Infections and Infestations
Date applied
19/09/2017
Date assigned
12/01/2018
Last edited
11/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
HPV vaccination can reduce the risk of 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 at age 12/13. 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. The aim of this study is 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. The study also looks at the impact of self-consent on the number of young people receiving the vaccine.

Who can participate?
Young women who were involved in the new self-consent procedures for the HPV vaccination programme at a participating school, their parents/carers, healthcare professionals and key school staff

What does the study involve?
The new self-consent procedures are observed in Bristol and South Gloucestershire, and interviews and focus groups are conducted with girls, parents, school nurses and school staff. The uptake rates of HPV vaccination before and after the new self-consent procedures are compared to see if uptake increases overall and in relation to socio-economic status, ethnicity and type of school.

What are the possible benefits and risks of participating?
The researchers cannot say that taking part in this study will benefit participants directly, but it is hoped that the study will result in improvements to the consent procedures for the HPV vaccination programme. No major risks are expected. As HPV is a sexually transmitted infection, topics may arise in the interview that relate to sexual health. Some participants maybe uncomfortable talking about such topics and are free to move on to the next topic or stop the interview at any time if they wish.

Where is the study run from?
Bristol Medical School, University of Bristol (UK)

When is the study starting and how long is it expected to run for?
September 2017 to August 2019

Who is funding the study?
NIHR Research for Patient Benefit Programme (UK)

Who is the main contact?
Dr Suzanne Audrey

Trial website

Contact information

Type

Scientific

Primary contact

Dr Suzanne Audrey

ORCID ID

http://orcid.org/0000-0002-8310-2672

Contact details

Bristol Medical School
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2790

Study information

Scientific title

The practicality, acceptability and impact of self-consent procedures for the schools-based Human Papilloma Virus (HPV) vaccination programme

Acronym

Study hypothesis

The aim of the research is to examine the implementation, acceptability and impact on uptake, of self-consent procedures for the HPV vaccination programme.

Ethics approval

Faculty of Health Sciences Research Ethics Committee at the University of Bristol, 13/11/2017, ref: 57621

Study design

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)

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Self-consent for HPV vaccination programme

Intervention

Observations of the implementation of the new-self consent procedures for the HPV vaccination programme; interviews and focus groups to find out views and experiences of the new self-consent procedures for the HPV vaccination programme from the perspectives of young women, their parents/carers, school staff and healthcare professionals; analysis of routinely collected data concerning HPV vaccination uptake in two local authorities.

Intervention type

Other

Phase

Drug names

Primary outcome measure

% change of HPV vaccination programme uptake before and after implementation of self-consent procedures

Secondary outcome measures

1. % change in HPV vaccination programme uptake in intervention site in comparison to comparison sites
2. Barriers and facilitators to implementation of self-consent procedures from perspectives of young women, parents, immunisation nurses and school staff

Overall trial start date

01/09/2017

Overall trial end date

31/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Young women who were involved in the new self-consent procedures for the HPV vaccination programme at a participating school
2. Parents/carers of young women who were involved in the new self-consent procedures for the HPV vaccination programme at a participating school
3. Healthcare professionals involved in the delivery of the HPV vaccination programme at participating schools
4. Key school staff involved in the delivery of the HPV vaccination programme at participating schools

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

112

Participant exclusion criteria

1. Participants who do not have capacity to provide informed consent/assent
2. Participants who are unable to communicate in English

Recruitment start date

01/11/2017

Recruitment end date

30/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Medical School, University of Bristol
Canynge Hall 39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 331 7130
birgit.whitman@bristol.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Research for Patient Benefit Programme

Alternative name(s)

NIHR Research for Patient Benefit Programme, RfPB

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trialists will disseminate this research to the academic community, practitioners and stakeholders.

For the academic community they plan to submit at least two open-access peer reviewed publications including the systematic review of available literature on self-consent for adolescents, and the results of the study. They will also disseminate the results to at least one national and one international conference. For practitioners they will complete a report of their findings and disseminate the results through practitioner conferences and events e.g. the South West Regional public health conference.

The trialists will also hold a stakeholder event to which we will invite school nurses, school staff, parents and young people. This will be an opportunity to discuss self-consent for young people, and the potential barriers and facilitators.

School nurses will be actively encouraged to be involved in the dissemination activities, and findings from the study will also be disseminated through appropriate websites and social media. The final report of the study will also provide an opportunity for further dissemination.

IPD sharing statement
The trialists cannot share the full datasets because they are working on an NHS dataset and the interview data is of a sensitive nature. However, they will consider reasonable requests to share anonymised non-sensitive data arising from the study. Requests can be made to Dr Suzanne Audrey.

Intention to publish date

31/08/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29502095

Publication citations

Additional files

Editorial Notes

11/09/2018: Publication reference added.