Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 09/164/01
Study information
Scientific title
STRATEGIes to increase Cervical screening uptake at first invitation: a cluster randomised trial
Acronym
STRATEGIC
Study hypothesis
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
REC within Greater Manchester via IRAS - approval pending as of 05/08/2011
Study design
Cluster randomised trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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).
Secondary outcome measures
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
Overall trial start date
01/11/2011
Overall trial end date
31/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women aged 25 in Manchester and 20 in Aberdeen who are due to receive their first invitation for cervical screening
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
9,600
Total final enrolment
10126
Participant 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
Recruitment start date
01/11/2011
Recruitment end date
31/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Manchester
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
c/o Professor Nalin Thakker
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27632816
2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/28530515 (added 27/08/2019)