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

(Edtech-HPV Trial)

Recruiting at 3 trial locations

Overseen By Francesca Gany, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Serious psychiatric, cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

672 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment HPV Vaccine, Gardasil 9, Human Papillomavirus 9-valent Vaccine, Recombinant, HPV Vaccine, HPV Vaccine Education, Text Messaging Reminder?

Research shows that the Gardasil 9 vaccine is highly effective in preventing infections and conditions caused by HPV, such as cervical cancer. Additionally, using educational materials and reminder systems has been shown to increase vaccine uptake and completion rates. ^{1 2 3 4 5}

Is the HPV vaccine, including Gardasil 9, generally safe for humans?

The HPV vaccines, including Gardasil 9, have been studied for safety and are generally considered safe for humans. Some adverse events (unwanted effects) have been reported, but these are typically mild and similar to those seen with other vaccines. ^{2 3 6 7 8}

How is the HPV Vaccine treatment unique compared to other treatments for HPV-related conditions?

The HPV Vaccine, specifically Gardasil 9, is unique because it is a 9-valent vaccine that covers 90% of cancers attributed to HPV in the US, and it can be administered in two doses if started before age 15, unlike other vaccines that may require three doses. ^{3 9 10 11 12}

What is the purpose of this trial?

This study is a two-arm randomized controlled trial, implemented to assess the effectiveness of a community-based educational program with and without a text messaging reminder system, in increasing the rate of HPV vaccination completion among children of Mexican Americans. The investigator's have extended the duration that participants are followed in assessing their child's uptake of the HPV vaccine to coincide with the COVID-19 related clinic closures and/or allow flexibility for participants who decide to delay their child's vaccination for fear of exposure to the COVID-19 infection. A survey will also assess the participants concerns regarding the impact COVID-19 has had in their daily life, such as financial insecurity, food access, housing insecurity and among other most common concerns during this unprecedented time. Additional navigation, referrals and interviewer notes will also be captured. Participants may be called by site or MSK staff to complete study surveys and will be informed verbally or by a mailed letter.

Research Team

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

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

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

Treatment Details

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.

Participant Groups

Group I: Parental Education + Text Messaging Experimental Treatment 2 Interventions

Participants will receive parental education on HPV vaccine and the vaccine's benefits plus text messaging reminder.

Group II: Parental Education Active Control 1 Intervention

Participants will receive parental education on HPV vaccine and the vaccine's benefits.

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

Approved in United States as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Approved in European Union as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Approved in Canada as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

Approved in Switzerland as Gardasil 9 for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
• Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

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+

Findings from Research

An evidence-based educational brochure and reminder system significantly increased HPV vaccine uptake among parents of preteen girls, with a 9.4 times higher likelihood of vaccination compared to a historical control group.

The intervention also led to a remarkable 22.5 times increase in dose completion rates, highlighting the effectiveness of structured educational and reminder strategies in improving vaccination outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. Cassidy, B., Braxter, B., Charron-Prochownik, D., et al.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. Fait, T., Dvořák, V., Pilka, R.[2018]

A study involving 215,965 individuals who received the nine-valent HPV vaccine (HPV9) found no new safety concerns, confirming its established safety profile from previous research.

While some elevated event categories were noted, such as skin disorders and ill-defined conditions, most were either previously known or had other causes, and no deaths were linked to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. Hansen, J., Yee, A., Lewis, N., et al.[2023]

The introduction of the quadrivalent vaccine Gardasil and the bivalent vaccine Cervarix has significantly advanced the prevention of HPV-related diseases, including various cancers and benign conditions like genital warts.

A new multivalent vaccine, Gardasil 9, has been approved and shows promise in providing broader protection against nine HPV subtypes, with ongoing efforts to improve vaccine accessibility and reduce production costs, especially in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-generation prophylactic HPV vaccines: current options and future strategies for vaccines development. Fruscalzo, A., Londero, AP., Bertozzi, S., et al.[2016]

A comprehensive analysis of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) identified 3,112 AEs for Cervarix, 31,606 for Gardasil, and 6,872 for Gardasil 9, highlighting the need for ongoing monitoring of vaccine safety.

The study found 46 unique serious adverse events (SAEs) associated with the HPV vaccines, clustered around behavioral, neurological, immune, nervous, and reproductive systems, indicating that while the vaccines are effective, further research is needed to understand the cause-and-effect relationships of these AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. Zi, W., Yang, Q., Su, J., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. Spila-Alegiani, S., Da Cas, R., Giambi, C., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. [2015]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cervical cancer vaccination indications, efficacy, and side effects. [2015]

5. Italy pubmed.ncbi.nlm.nih.gov

Second-generation prophylactic HPV vaccines: current options and future strategies for vaccines development. [2016]

6. England pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. [2015]

8. Italy pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Public Education Interventions and Uptake of Human Papillomavirus Vaccine: A Systematic Review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Factors influencing familial decision-making regarding human papillomavirus vaccination. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

HPV Vaccine in Adolescents. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

National Trends in Parental Human Papillomavirus Vaccination Intentions and Reasons for Hesitancy, 2010-2015. [2019]