Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?
Primary Purpose
Cervical Carcinoma, Cervical Dysplasia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMS text
Sponsored by
About this trial
This is an interventional screening trial for Cervical Carcinoma focused on measuring population screening
Eligibility Criteria
Inclusion Criteria:
- All women aged under 30 years who are eligible for cervical screening with a CHI number and registered with a GP in the NHS Greater Glasgow and Clyde area.
Exclusion Criteria:
- Women have do not have a cervix
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine
SMS
Arm Description
women will routinely be invited to attend for cervical screening via the SCCRS application.
Women aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast
Outcomes
Primary Outcome Measures
Attendance
Number of women attending for cervical screening in intervention group compared to control group
Secondary Outcome Measures
Scottish Index of Multiple Deprivation
Number of women attending cervical screening by level of deprivation (Scottish Index of Multiple Deprivation) (control vs intervention)
HPV vaccination status
Number of women attending cervical screening by HPV vaccination status (control vs intervention)
Full Information
NCT ID
NCT03975127
First Posted
May 22, 2019
Last Updated
June 4, 2019
Sponsor
NHS Greater Glasgow and Clyde
1. Study Identification
Unique Protocol Identification Number
NCT03975127
Brief Title
Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?
Official Title
Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will pilot production and evaluate the use of reminder information in women invited for cervical screening for the first time within the GGC eligible population for cervical screening. Women aged under 30 years will be identified to receive an SMS text message following their cervical screening invitation using information from the CHI Broadcast.
Detailed Description
Cervical cancer is the commonest cancer among women aged less than 35 years. A change to the age range and frequency for cervical screening was implemented on the 6th June 2016. This increased the younger eligible age for screening from 20 to 25. Uptake of cervical screening among women in the youngest eligible age range has historically been low. Research by Scott Porter has shown that cervical screening is not on young women's radar and additionally there is scope for confusion amongst women in this cohort about the requirement to attend for cervical screening if they have been previously immunised against HPV (human papilloma virus) generally in secondary school in year 2, some 12 years earlier.
The HPV vaccine was introduced in 2008 and is designed to protect against the two types of high risk HPV which cause approximately 75% of all cervical cancer. Advice to all eligible women who have been vaccinated remains that participation in cervical screening is necessary to provide the most comprehensive protection against cervical cancer, as the current vaccine does not provide protection against all high risk cancer causing strains of HPV.
Research from other screening programmes has also shown that where individuals engage with a screening programme from the start, they are more likely to continue to participate in screening for as long as they are eligible.
"Intending to, but not getting round to it", is the reason most associated with non-response to cervical cancer screening invitations.
GGC serves approximately 40% of the total Scottish population and therefore testing the reminder in the GGC population provides an opportunity to compare the impact of the SMS text reminder in this cohort with management as usual within the remainder of the Scottish eligible population. This should enable us to identify whether use of a reminder SMS text message is in fact likely to add value and increase participation in cervical screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Carcinoma, Cervical Dysplasia
Keywords
population screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study arms are as follow:
No intervention: women will routinely be invited to attend for cervical screening via the SCCRS application.
Experimental: Women aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine
Arm Type
No Intervention
Arm Description
women will routinely be invited to attend for cervical screening via the SCCRS application.
Arm Title
SMS
Arm Type
Experimental
Arm Description
Women aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast
Intervention Type
Other
Intervention Name(s)
SMS text
Intervention Description
A single SMS text sent to women under 30 who are eligible for the cervical screening programme and who have been invited by letter
Primary Outcome Measure Information:
Title
Attendance
Description
Number of women attending for cervical screening in intervention group compared to control group
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Scottish Index of Multiple Deprivation
Description
Number of women attending cervical screening by level of deprivation (Scottish Index of Multiple Deprivation) (control vs intervention)
Time Frame
12 months
Title
HPV vaccination status
Description
Number of women attending cervical screening by HPV vaccination status (control vs intervention)
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All women aged under 30 years who are eligible for cervical screening with a CHI number and registered with a GP in the NHS Greater Glasgow and Clyde area.
Exclusion Criteria:
Women have do not have a cervix
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?
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