Education + Text Reminders for Parenting (in HPV Vaccination Uptake)

(Edtech-HPV Trial)

Not currently recruiting at 3 trial locations
AA
Francesca Gany, MD, MPH profile photo
Overseen ByFrancesca Gany, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if educational programs, with or without text reminders, increase HPV vaccination rates among Mexican-American children. The study compares two groups: one receives only educational materials, while the other receives both education and text reminders. It seeks Mexican-American parents or caregivers who primarily speak Spanish, have a child aged 11-17 who hasn't completed the HPV vaccine series, and use text messaging. Participants will also provide information on how COVID-19 has affected their daily lives. As an unphased trial, this study offers a unique opportunity to contribute to community health by exploring effective methods to increase vaccination rates.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational program and text messaging reminder are safe for increasing HPV vaccination uptake?

Research shows that the HPV vaccine is generally safe. Many studies have examined its safety and found that most people experience only mild side effects, such as pain at the injection site or a slight fever. Serious side effects are rare.

Studies also show that education and text message reminders can increase vaccination rates. These reminders safely inform and remind parents about the benefits of the HPV vaccine, with no known safety issues associated with receiving information through text messages.

Overall, evidence supports the safety of both the HPV vaccine and the reminder system.12345

Why are researchers excited about this trial?

Researchers are excited about the Education + Text Reminders for Parenting approach because it combines parental education on the HPV vaccine with timely text message reminders to boost vaccination rates. Unlike the standard of care, which often relies solely on informational brochures or doctor recommendations, this strategy actively engages parents through digital communication. By providing ongoing reminders, it keeps the importance of the HPV vaccine top of mind, potentially leading to higher uptake and better protection against HPV-related diseases.

What evidence suggests that this trial's treatments could be effective in increasing HPV vaccination rates?

Research has shown that text message reminders can increase HPV vaccination rates. In this trial, one group of participants will receive both parental education on the HPV vaccine and text messaging reminders, while another group will receive only parental education. One study found that text messages and automated phone calls helped people receive their HPV vaccines on time. Another study showed that mobile health tools, such as text messages, improved vaccination rates. Combining digital education with text reminders also increased interest in vaccination, with various text message methods proving effective. Overall, these strategies have shown promise in helping people complete their HPV vaccinations.14678

Who Is on the Research Team?

Francesca M. Gany, MD, MS - MSK Internist

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking primary caregivers, aged 21-84, of children between 11 and 17 who haven't started or finished the HPV vaccine series. Participants must be Mexican or Mexican-American, own a cell phone with text messaging capabilities, and be willing to receive texts for the study. Those with serious psychiatric or cognitive impairments that affect consent or adherence are excluded.

Inclusion Criteria

Currently owns a cell phone and uses text messaging services and is willing to accept text messages for this study
Self-identifies as the child's main caregiver
You were either born in Mexico or you were born in the United States and identify yourself as Mexican-American.
See 3 more

Exclusion Criteria

Presence of a serious psychiatric or cognitive impairment likely to preclude meaningful informed consent and adherence to the protocol per the consenting professional's judgment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants receive parental education on HPV vaccine and the vaccine's benefits, with or without a text messaging reminder system

Ongoing during the trial

Follow-up

Participants are monitored for vaccination completion and concerns related to COVID-19 impact

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • HPV Vaccine
  • HPV Vaccine Education
  • Text Messaging Reminder
Trial Overview The Edtech-HPV trial is testing whether an educational program about the HPV vaccine can increase vaccination rates among children of Mexican Americans when combined with text message reminders. It's a two-arm study comparing education alone versus education plus reminders.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Parental Education + Text MessagingExperimental Treatment2 Interventions
Group II: Parental EducationActive Control1 Intervention

HPV Vaccine is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸
Approved in United States as Gardasil 9 for:
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Approved in European Union as Gardasil 9 for:
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Approved in Canada as Gardasil 9 for:
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Approved in Switzerland as Gardasil 9 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Hackensack Meridian Health

Collaborator

Trials
141
Recruited
42,900+

Published Research Related to This Trial

The nine-valent HPV vaccine, Gardasil9, significantly increases the efficacy against cervical cancer from 70% to 90% compared to the quadrivalent vaccine, covering a broader range of HPV types.
Gardasil9 also provides high efficacy (97%) against lesions associated with HPV types 31, 33, 45, 52, and 58, while maintaining similar effectiveness against HPV types 6, 11, 16, and 18 as the quadrivalent vaccine.
[Nine-valent HPV vaccine - new generation of HPV vaccine].Fait, T., Dvořák, V., Pilka, R.[2018]
In a study involving 12,066 women aged 9 to 26 years who received the HPV vaccines Gardasil® and Cervarix® over three years, 61% reported experiencing mild and transient adverse events after the first dose.
The high rate of reported adverse events is attributed to the study's design, which encouraged participants to document all occurrences, highlighting the importance of ongoing surveillance for vaccine safety, especially for newly marketed vaccines.
[Human papillomavirus vaccine register].Spila-Alegiani, S., Da Cas, R., Giambi, C., et al.[2013]
The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.
The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.
Postlicensure safety evaluation of human papilloma virus vaccines.Labadie, J.[2015]

Citations

Text Messages and Automated Phone Reminders for HPV ...In this novel trial, text message and automated phone vaccine reminders were effective in promoting more timely HPV vaccination. Such ...
Randomized Controlled Trial of Impact of Mobile Health ...Mobile health (mHealth) technology via short message services (SMS) has the potential to improve HPV vaccination uptake. The mHealth-HPVac study ...
Digital HPV education to increase vaccine uptake among ...Most women showed receptivity to using an on-site health kiosk, as well as QR codes linked to text messages, to receive HPV-related health information outside ...
Effectiveness of SMS reminders to increase demand for ...Our analysis shows that each version of the SMS reminder was more effective than the control at increasing uptake of the HPV vaccine, with 'reserved' framing ...
Systematic review and meta-analysis comparing ...Here we report a systematic review and meta-analysis examining the efficacy of digital interventions, comparing educational and reminder approaches, for ...
Digital HPV education to increase vaccine uptake among ...Most women showed receptivity to using an on-site health kiosk, as well as QR codes linked to text messages, to receive HPV-related health information outside ...
Parental education and text messaging reminders as ...The HPV vaccination completion rates remain low, well below the Healthy People 2020 goal. In this study we assessed the effect of parental education and a text ...
Effectiveness of Centralized Text Message Reminders on ...MCO-based text reminders are feasible and have a modest effect on HPV dose 1 vaccination rates for those parents able to receive text messages with valid phone ...
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