Strategies to increase cervical screening uptake at first invitation

ISRCTN	ISRCTN52303479
DOI	https://doi.org/10.1186/ISRCTN52303479
Protocol serial number	HTA 09/164/01
Sponsor	University of Manchester (UK)
Funder	Health Technology Assessment Programme

Submission date: 04/08/2011
Registration date: 08/08/2011
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-ways-increasing-number-of-young-women-who-take-up-offer-of-cervical-screening-strategic

Contact information

Prof Henry Kitchener
Scientific

School of Cancer and Enabling Sciences
University of Manchester
Research Floor
St Mary's Hospital
Manchester
M13 9WL
United Kingdom

Study information

Primary study design	Interventional
Study design	Cluster randomised trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	STRATEGIes to increase Cervical screening uptake at first invitation: a cluster randomised trial
Study acronym	STRATEGIC
Study objectives	How effective, and cost effective, are complex interventions designed to increase receptivity to, and uptake of, cervical screening in women aged 25 who are receiving their first invitation to the NHS Cervical Screening Programme? More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0916401 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0005/55193/PRO-09-164-01.pdf
Ethics approval(s)	REC within Greater Manchester via IRAS - approval pending as of 05/08/2011
Health condition(s) or problem(s) studied	Cervical cancer
Intervention	1. Pre-leaflet arm (Phase 1) - Surgeries will be cluster randomised with women either receiving the pre-leaflet in combination with a standard invitation letter or the standard invitation letter alone. 2. Internet booking arm (Phase 1, Manchester only) - Surgeries will be cluster randomised to women either receiving a standard invitation and reminder letter which gives them the opportunity to book online or the standard invitation and reminder letter alone. 3. Self-sampling arm (Phase 2) - Surgeries will be cluster randomised to women receiving the offer of a self-sampling test compared with standard practice of a reminder letter. 4. Nurse navigator arm (Phase 2) - Surgeries will be cluster randomised to women receiving the offer of speaking to a specialist nurse compared with standard practice of a reminder letter. 5. Timed appointment arm (Phase 2) - Surgeries will be cluster randomised to women receiving a timed appointment from their general practitioner (GP) compared with standard practice of a reminder letter.
Intervention type	Other
Primary outcome measure(s)	1. The uptake of cervical screening: 1.1. In response to the pre-leaflet (phase 1) 1.2. In response to the offer of each of the interventions (nurse navigator, self-sampling, timed appointments) (phase 2) 2. The uptake of internet booking (phase 1) Measured at 3, 12 and 30 months after the date the woman become eligible for cervical screening (i.e. her 25th or 20th birthday).
Key secondary outcome measure(s)	1. The differences between outcomes in Aberdeen between vaccinated and unvaccinated women 2. The differences between Aberdeen and Manchester 3. Cost-effectiveness of the interventions, individually and as packages of interventions
Completion date	31/10/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	9600
Total final enrolment	10126
Key inclusion criteria	Women aged 25 in Manchester and 20 in Aberdeen who are due to receive their first invitation for cervical screening
Key exclusion criteria	1. Women who are not aged 25 (20 in Aberdeen) and receiving their first invitation for screening will not be eligible to participate 2. Women who are pregnant 3. Women who do not have a cervix 4. Women who have made an informed decision not to participate in the cervical screening programme
Date of first enrolment	01/11/2011
Date of final enrolment	31/10/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Manchester

Manchester
M13 9WL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2016		Yes	No
Results article	results	01/06/2018	27/08/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link added.
27/08/2019: Publication reference and total final enrolment added.
19/09/2016: Publication reference added.