- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03975127
Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Routine
women will routinely be invited to attend for cervical screening via the SCCRS application.
|
|
|
Experimental: SMS
Women aged under 30 years will be identified to receive an SMS following cervical screening invitation using information from the CHI Broadcast
|
A single SMS text sent to women under 30 who are eligible for the cervical screening programme and who have been invited by letter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance
Time Frame: 12 months
|
Number of women attending for cervical screening in intervention group compared to control group
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scottish Index of Multiple Deprivation
Time Frame: 12 months
|
Number of women attending cervical screening by level of deprivation (Scottish Index of Multiple Deprivation) (control vs intervention)
|
12 months
|
|
HPV vaccination status
Time Frame: 12 months
|
Number of women attending cervical screening by HPV vaccination status (control vs intervention)
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN201905PH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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