Self-consent for the HPV vaccine
| ISRCTN | ISRCTN49086105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49086105 |
| Protocol serial number | 2790 |
| Sponsor | University of Bristol |
| Funder | Research for Patient Benefit Programme |
- Submission date
- 19/09/2017
- Registration date
- 12/01/2018
- Last edited
- 16/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Bristol Medical School
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-8310-2672 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| 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) |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | The practicality, acceptability and impact of self-consent procedures for the schools-based Human Papilloma Virus (HPV) vaccination programme |
| Study objectives | 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(s) | Faculty of Health Sciences Research Ethics Committee at the University of Bristol, 13/11/2017, ref: 57621 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
% change of HPV vaccination programme uptake before and after implementation of self-consent procedures |
| Key secondary outcome measure(s) |
1. % change in HPV vaccination programme uptake in intervention site in comparison to comparison sites |
| Completion date | 31/01/2020 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 112 |
| Total final enrolment | 82 |
| Key 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 |
| Key exclusion criteria | 1. Participants who do not have capacity to provide informed consent/assent 2. Participants who are unable to communicate in English |
| Date of first enrolment | 01/11/2017 |
| Date of final enrolment | 31/07/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | qualitative results | 10/11/2020 | 16/02/2021 | Yes | No |
| Results article | qualitative results (2) | 03/11/2020 | 16/02/2021 | Yes | No |
| Results article | results | 26/09/2020 | 16/02/2021 | Yes | No |
| Protocol article | protocol | 03/03/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/02/2021: Publication references added.
13/08/2019: The final enrolment number has been added.
08/05/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2019 to 31/07/2019.
2. The overall end date was changed from 31/08/2019 to 31/01/2020.
3. The intention to publish date was changed from 31/08/2019 to 31/01/2021.
11/09/2018: Publication reference added.
