NCT05536674

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55,176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 13, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

September 8, 2022

Last Update Submit

September 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • HPV vaccination status

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

    At 60 days after receiving the SMS reminder

Study Arms (5)

No SMS reminder

NO INTERVENTION

This group will receive no reminder

Short SMS with no additional information

EXPERIMENTAL

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."

Behavioral: SMS reminder for the HPV vaccination

Short SMS + NCDC link

EXPERIMENTAL

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"

Behavioral: SMS reminder for the HPV vaccination

SMS with "reserved for her" framing + NCDC link

EXPERIMENTAL

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"

Behavioral: SMS reminder for the HPV vaccination

SMS with safety information + NCDC link

EXPERIMENTAL

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"

Behavioral: SMS reminder for the HPV vaccination

Interventions

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.

SMS with "reserved for her" framing + NCDC linkSMS with safety information + NCDC linkShort SMS + NCDC linkShort SMS with no additional information

Eligibility Criteria

Age10 Years - 12 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Daly N, Merriam S, Tagliaferri G, Tomsa S, Bianco VM, Gamgebeli L, Lortkipanidze N. Effectiveness of SMS reminders to increase demand for HPV immunisation: a randomised controlled trial in Georgia. BMJ Open. 2025 Nov 13;15(11):e087080. doi: 10.1136/bmjopen-2024-087080.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hannah Behrendt

    Behavioural Insights Team

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 13, 2022

Study Start

September 13, 2022

Primary Completion

November 12, 2022

Study Completion

November 12, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

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.