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SMS Reminders to Strengthen Demand for HPV Vaccination in Georgia

Primary Purpose

HPV, Human Papillomavirus Viruses, Human Papilloma Virus Vaccine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMS reminder for the HPV vaccination
Sponsored by
The Behavioural Insights Team
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HPV, Human Papillomavirus Viruses, Human Papilloma Virus Vaccine

Eligibility Criteria

10 Years - 12 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    No SMS reminder

    Short SMS with no additional information

    Short SMS + NCDC link

    SMS with "reserved for her" framing + NCDC link

    SMS with safety information + NCDC link

    Arm Description

    This group will receive no reminder

    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."

    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"

    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"

    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"

    Outcomes

    Primary Outcome Measures

    HPV vaccination status
    1st dose HPV vaccination status of the caregiver's daughter

    Secondary Outcome Measures

    Full Information

    First Posted
    September 8, 2022
    Last Updated
    September 8, 2022
    Sponsor
    The Behavioural Insights Team
    Collaborators
    UNICEF, National Center for Disease Control and Public Health, Georgia, Information Technology Agency, Georgia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05536674
    Brief Title
    SMS Reminders to Strengthen Demand for HPV Vaccination in Georgia
    Official Title
    Design, Test and Evaluate Behavioural Insights Interventions to Strengthen Demand for Immunisation in Georgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 13, 2022 (Anticipated)
    Primary Completion Date
    November 12, 2022 (Anticipated)
    Study Completion Date
    November 12, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Behavioural Insights Team
    Collaborators
    UNICEF, National Center for Disease Control and Public Health, Georgia, Information Technology Agency, Georgia

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HPV, Human Papillomavirus Viruses, Human Papilloma Virus Vaccine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    55176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    No SMS reminder
    Arm Type
    No Intervention
    Arm Description
    This group will receive no reminder
    Arm Title
    Short SMS with no additional information
    Arm Type
    Experimental
    Arm Description
    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."
    Arm Title
    Short SMS + NCDC link
    Arm Type
    Experimental
    Arm Description
    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"
    Arm Title
    SMS with "reserved for her" framing + NCDC link
    Arm Type
    Experimental
    Arm Description
    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"
    Arm Title
    SMS with safety information + NCDC link
    Arm Type
    Experimental
    Arm Description
    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"
    Intervention Type
    Behavioral
    Intervention Name(s)
    SMS reminder for the HPV vaccination
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    HPV vaccination status
    Description
    1st dose HPV vaccination status of the caregiver's daughter
    Time Frame
    At 60 days after receiving the SMS reminder

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clement Bisserbe
    Phone
    +254711375983
    Email
    clement.bisserbe@bi.team
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zara Y Goozee
    Phone
    +447709105143
    Email
    zara.goozee@bi.team
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hannah Behrendt
    Organizational Affiliation
    Behavioural Insights Team
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.

    Learn more about this trial

    SMS Reminders to Strengthen Demand for HPV Vaccination in Georgia

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