NCT02363088

Brief Summary

Cervical cancer is the most common cancer in women under 35 years and is a major public health concern. Fortunately, the natural history of this malignancy can be beneficially improved through cytological screening. However, the success of screening programmes depends on their ability to attract the "at risk" population, as well as the analytical sensitivity and specificity of the screening test. In the UK, screening consistently falls short of the 80% national target and recent evidence shows uptake is decreasing, in part due to the introduction of HPV vaccination programmes. In the under 30s London population, average coverage only reached 50% in 2013. Given this information, the cervical screening programme is under increasing pressure to improve uptake, and need an evidence based intervention. We aim to improve the uptake of cervical screening using SMS messaging through a randomised controlled trial. The trail will evaluate both the prevalent and incident rounds of screening and within the intervention group, analyse how the content of text reminders influences their effectiveness. Specifically we will evaluate a) neutral b) messenger c) social norms d) framed gain/loss reminders. Unlike our previous trial, this SMS reminder will encourage the booking of an appointment which has never been tested, rather than simply reminding women to attend. All women being invited for cervical screening, registered at participating GPs within Hillingdon will be eligible to participate. Women will also be provided with a 2 week window during which they can opt out of the research. Given the sample sizes we predict the trial will take 9 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,597

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

February 9, 2015

Last Update Submit

October 23, 2018

Conditions

Keywords

cervical screeninguptakeSMS messagestext messagesreminder

Outcome Measures

Primary Outcomes (1)

  • Intention to treat analysis

    Analysis of the rate of cervical screening by trial arm at the end of the screening round (32 weeks)

    13 months

Secondary Outcomes (3)

  • Attendance by age (control vs interventions)

    13 months

  • Attendance by level of deprivation (control vs interventions)

    13 month

  • Per protocol analysis using SMS delivery status data to compared the rate of cervical screening in women who receive the SMS at the end of the screening round (32 weeks from screening invitation)

    13 months

Study Arms (9)

No intervention, 24-29 years

NO INTERVENTION

No intervention, group 24-29 years. Women will receive the written invitation to screening only

Messenger text message reminder, 24-29

EXPERIMENTAL

Messenger text message reminder, group 24-29 years.

Other: Messenger text message reminder

No intervention, 30-64 years

NO INTERVENTION

No intervention group 30-64 years, Women will receive the written invitation to screening only

Neutral text message reminder, 30-64

EXPERIMENTAL

Neutral Text message, group 30-64 years

Other: Neutral text message reminder

Messenger text message reminder, 30-64

EXPERIMENTAL

Messenger text message reminder, group 30-64

Other: Messenger text message reminder

Social Norms A reminder, 30-64

EXPERIMENTAL

Social Norms (population proportion) text message reminder, group 30-64 years

Other: Social Norms A reminder

Social Norms B reminder, 30-64

EXPERIMENTAL

Social Norms (population total) text message reminder, group 30-64 years

Other: Social Norms B reminder

Framed gain text reminder, 30-64

OTHER

Framed gain text message reminder, group 30-64 years

Other: Framed Gain text reminder

Framed loss text reminder, 30-64

EXPERIMENTAL

Framed loss text message reminder, group 30-64 years

Other: Framed Loss text reminder

Interventions

"Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Neutral text message reminder, 30-64

"\<GP NAME\>: Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Messenger text message reminder, 24-29Messenger text message reminder, 30-64

"Last year in Hillingdon 7 out of 10 women took part in cervical screening. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Social Norms A reminder, 30-64

"Last year 12000 women in Hillingdon took part in cervical screening. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Social Norms B reminder, 30-64

"Cervical cancer screening saves 4500 lives in England every year. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Framed gain text reminder, 30-64

"Failing to attend cervical screening could lead to 4500 avoidable deaths in England each year. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Framed loss text reminder, 30-64

Eligibility Criteria

Age24 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 24-64 years being invited for cervical screening during the course of the study. Women included in the study will be registered with a GP Practice that has agreed to participate in the trial.

You may not qualify if:

  • Patients who opt-out, Patients who have had a hysterectomy, Patients who have informed GP practices of preference to not be screened, Patients Cervical cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery and Cancer, St Mary's Campus, Praed Street, Imperial College London

London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • Huf S, Kerrison RS, King D, Chadborn T, Richmond A, Cunningham D, Friedman E, Shukla H, Tseng FM, Judah G, Darzi A, Vlaev I. Behavioral economics informed message content in text message reminders to improve cervical screening participation: Two pragmatic randomized controlled trials. Prev Med. 2020 Oct;139:106170. doi: 10.1016/j.ypmed.2020.106170. Epub 2020 Jun 29.

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Study Officials

  • Deborah Cunningham

    Imperial College Healthcare NHS Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations