HPV, Human Papillomavirus Viruses, Human Papilloma Virus VaccineNCT05536674
SMS Reminders to Strengthen Demand for HPV Vaccination in Georgia
A study testing SMS reminder for the HPV vaccination in people with HPV, Human Papillomavirus Viruses, Human Papilloma Virus Vaccine, run by The Behavioural Insights Team.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, Human Papillomavirus Viruses, Human Papilloma Virus Vaccine
- What is being tested?
- SMS reminder for the HPV vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55,176 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2022to 12 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Being tested
- SMS reminder for the HPV vaccination
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS reminder for the HPV vaccinationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: 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" Receives: 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" Receives: 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" Receives: Behavioral: SMS reminder for the HPV vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination status
1st dose HPV vaccination status of the caregiver's daughter
Measured: At 60 days after receiving the SMS reminder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start13 Sep 2022 (estimated)
- Primary completion12 Nov 2022 (estimated)
- Study completion12 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV, Human Papillomavirus Viruses, Human Papilloma Virus VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55,176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Behavioural Insights Team
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, National Center for Disease control and Public Health, Information Technology Agency, Georgia
- Responsible party
- Sponsor
- Investigators
- Hannah Behrendt, Study director, Behavioural Insights Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536674
- Sponsor's protocol ID
- UNICEF Georgia 2020021
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41248345
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Test and Evaluate Behavioural Insights Interventions to Strengthen Demand for Immunisation in Georgia
- ClinicalTrials.gov ID
- NCT05536674
- Acronym / sponsor ID
- UNICEF Georgia 2020021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55,176 participants (estimated)
- Lead sponsor
- The Behavioural Insights TeamUniversity, hospital or other
- Collaborators
- UNICEF, National Center for Disease control and Public Health, Information Technology Agency, Georgia
- Study start
- 13 Sep 2022 (estimated)
- Primary completion
- 12 Nov 2022 (estimated)
- Study completion
- 12 Nov 2022 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No SMS reminder | No intervention | –This group will receive no reminder |
| Short SMS with no additional information | Experimental | Behavioral: SMS reminder for the HPV vaccinationCaregivers 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." |
| Short SMS + NCDC link | Experimental | Behavioral: SMS reminder for the HPV vaccinationCaregivers 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" |
| SMS with "reserved for her" framing + NCDC link | Experimental | Behavioral: SMS reminder for the HPV vaccinationCaregivers 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" |
| SMS with safety information + NCDC link | Experimental | Behavioral: SMS reminder for the HPV vaccinationCaregivers 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" |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS reminder for the HPV vaccinationA 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. | Behavioural | SMS with "reserved for her" framing + NCDC link, SMS with safety information + NCDC link, Short SMS + NCDC link, Short SMS with no additional information |
Primary outcome
HPV vaccination status
Time frame: At 60 days after receiving the SMS reminder
1st dose HPV vaccination status of the caregiver's daughter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Derived from this study: PubMed 41248345Daly 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.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Behrendt study director
Behavioural Insights Team
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminder for the HPV vaccination in people with HPV, Human Papillomavirus Viruses, Human Papilloma Virus Vaccine, run by The Behavioural Insights Team.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clement Bisserbe (+254711375983, clement.bisserbe@bi.team), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccination status (time frame: At 60 days after receiving the SMS reminder). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05536674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.