SMS Reminders to Strengthen Demand for HPV Vaccination in Georgia

Sponsor

The Behavioural Insights Team (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05536674

Collaborator

UNICEF (Other), National Center for Disease Control and Public Health, Georgia (Other), Information Technology Agency, Georgia (Other)

55,176

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HPV, Human Papillomavirus Viruses, Human Papilloma Virus Vaccine	Behavioral: SMS reminder for the HPV vaccination	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Design, Test and Evaluate Behavioural Insights Interventions to Strengthen Demand for Immunisation in Georgia

Anticipated Study Start Date :

Sep 13, 2022

Anticipated Primary Completion Date :

Nov 12, 2022

Anticipated Study Completion Date :

Nov 12, 2022

Arms and Interventions

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."	Behavioral: SMS reminder for the HPV vaccination 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"	Behavioral: SMS reminder for the HPV vaccination 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"	Behavioral: SMS reminder for the HPV vaccination 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"	Behavioral: SMS reminder for the HPV vaccination 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.

Outcome Measures

Primary Outcome Measures

HPV vaccination status [At 60 days after receiving the SMS reminder]
1st dose HPV vaccination status of the caregiver's daughter

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 12 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Behavioural Insights Team
UNICEF
National Center for Disease Control and Public Health, Georgia
Information Technology Agency, Georgia

Investigators

Study Director: Hannah Behrendt, Behavioural Insights Team

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Behavioural Insights Team

ClinicalTrials.gov Identifier:

NCT05536674

Other Study ID Numbers:

UNICEF Georgia 2020021

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Papilloma

Study Results

No Results Posted as of Sep 13, 2022