SMS Reminders to Strengthen Demand for HPV Vaccination in Georgia
September 8, 2022 updated by: The Behavioural Insights Team
Design, Test and Evaluate Behavioural Insights Interventions to Strengthen Demand for Immunisation in Georgia
It is possible that achieving adequate HPV vaccination coverage will allow cervical cancer to be virtually eliminated. This is a priority for Georgia, where the burden of mortality and morbidity from cervical cancer is high and the yearly prevalence of cervical cancer is 14.5 per 100,000 population.
The objective of the intervention evaluated is to increase the uptake of the 1st dose of the HPV vaccination in Georgia. The intervention aims to achieve this by providing a SMS reminder informed by behavioural insights (BI) to remind caregivers of girls between 10-12 years that their daughter is due the first dose of her HPV vaccination, share information about the vaccine, and encourage them to book an appointment to receive the vaccination. Four different SMS messages will be compared to no SMS message.
The evaluation will be a 5-arm randomised controlled trial (RCT) which aims to answer the research question: Does each of the designed BI-informed SMS reminders increase the uptake of the first dose of the HPV vaccination among eligible girls in Georgia, compared to no reminder? Our hypothesis is that SMS reminders will increase the uptake of HPV vaccination.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
55176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clement Bisserbe
- Phone Number: +254711375983
- Email: clement.bisserbe@bi.team
Study Contact Backup
- Name: Zara Y Goozee
- Phone Number: +447709105143
- Email: zara.goozee@bi.team
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Girls
- Aged 10-12 years
- Not yet received any doses of the HPV vaccine
- With a caregiver's mobile phone number in the e-health system.
Exclusion Criteria:
- Boys
- Girls aged less than 10 or more than 12 years
- Girls with no caregiver phone number in the e-health system
- Girls who have received 1 or 2 doses of the HPV vaccine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No SMS reminder
This group will receive no reminder
|
|
|
Experimental: Short SMS with no additional information
Caregivers of girls eligible to receive the HPV vaccination in this group will receive an SMS reminder that states: "As per national immunization calendar your daughter is due her free human papilloma virus vaccine, which will protect her against cervical cancer.
Contact your family doctor today to arrange an appointment."
|
A BI-informed SMS reminder to remind caregivers of girls between 10-12 years that their daughter is due the first dose of her HPV vaccination and share information about the vaccine.
|
|
Experimental: Short SMS + NCDC link
Caregivers of girls eligible to receive the HPV vaccination in this group will receive an SMS reminder that states: "As per national immunization calendar your daughter is due her free human papilloma virus vaccine, which will protect her against cervical cancer.
Contact your family doctor today to arrange an appointment.
More information on the official NCDC website"
|
A BI-informed SMS reminder to remind caregivers of girls between 10-12 years that their daughter is due the first dose of her HPV vaccination and share information about the vaccine.
|
|
Experimental: SMS with "reserved for her" framing + NCDC link
Caregivers of girls eligible to receive the HPV vaccination in this group will receive an SMS reminder that states: "As per national immunization calendar your daughter is due her free human papilloma virus vaccine, which will protect her against cervical cancer.
Her vaccine is reserved at the policlinic.
Contact your family doctor today to arrange an appointment.
More information on the official NCDC website"
|
A BI-informed SMS reminder to remind caregivers of girls between 10-12 years that their daughter is due the first dose of her HPV vaccination and share information about the vaccine.
|
|
Experimental: SMS with safety information + NCDC link
Caregivers of girls eligible to receive the HPV vaccination in this group will receive an SMS reminder that states: "As per national immunization calendar your daughter is due her free human papilloma virus vaccine, which will protect her against cervical cancer.
The vaccine has been given safely to more than 118 million girls worldwide.
Contact your family doctor today to arrange an appointment.
More information on the official NCDC website"
|
A BI-informed SMS reminder to remind caregivers of girls between 10-12 years that their daughter is due the first dose of her HPV vaccination and share information about the vaccine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HPV vaccination status
Time Frame: At 60 days after receiving the SMS reminder
|
1st dose HPV vaccination status of the caregiver's daughter
|
At 60 days after receiving the SMS reminder
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Hannah Behrendt, Behavioural Insights Team
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 13, 2022
Primary Completion (Anticipated)
November 12, 2022
Study Completion (Anticipated)
November 12, 2022
Study Registration Dates
First Submitted
September 8, 2022
First Submitted That Met QC Criteria
September 8, 2022
First Posted (Actual)
September 13, 2022
Study Record Updates
Last Update Posted (Actual)
September 13, 2022
Last Update Submitted That Met QC Criteria
September 8, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNICEF Georgia 2020021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No individual data will be shared from the e-health modules of the National Center for Disease Control and Public Health of Georgia and Information Technology Agency.
All data shared will be anonymised for analysis and aggregated for reporting, there is no risk of participant identification.
Data will include HPV vaccination status, the version of the SMS reminder received, and age.
The data will not include information on patients' names, addresses, location, ethnicity, phone numbers, or any information on medical conditions.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.