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Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?

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ClinicalTrials.gov Identifier: NCT03975127
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date June 5, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
Attendance [ Time Frame: 12 months ]
Number of women attending for cervical screening in intervention group compared to control group
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • 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)
  • HPV vaccination status [ Time Frame: 12 months ]
    Number of women attending cervical screening by HPV vaccination status (control vs intervention)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?
Official Title  ICMJE Cervical Cytology - Do SMS Reminders Increase Participation in the Cervical Screening Programme?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study arms are as follow:

  1. No intervention: women will routinely be invited to attend for cervical screening via the SCCRS application.
  2. 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)
Primary Purpose: Screening
Condition  ICMJE
  • Cervical Carcinoma
  • Cervical Dysplasia
Intervention  ICMJE Other: SMS text
A single SMS text sent to women under 30 who are eligible for the cervical screening programme and who have been invited by letter
Study Arms  ICMJE
  • 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
    Intervention: Other: SMS text
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
50000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 22 Years to 29 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975127
Other Study ID Numbers  ICMJE GN201905PH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NHS Greater Glasgow and Clyde
Study Sponsor  ICMJE NHS Greater Glasgow and Clyde
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NHS Greater Glasgow and Clyde
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP