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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
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Carcinoma focused on measuring population screening

Eligibility Criteria

22 Years - 29 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    May 22, 2019
    Last Updated
    June 4, 2019
    Sponsor
    NHS Greater Glasgow and Clyde
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    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

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