Educational Intervention for HPV Vaccination

(PARENT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Non-English speakers, Outside Ohio Appalachia, others

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

Compensation: Varies

Number of Visits: 4

624 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial studies an educational intervention for parents and providers in increasing human papillomavirus (HPV) vaccination rates in younger girls in Ohio Appalachia. Educational interventions may be effective in increasing the number of participants whose daughters receive HPV vaccination.

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications.

Is the Educational Intervention for HPV Vaccination safe for humans?

The Educational Intervention, which uses patient navigators to help increase HPV vaccination rates, has been implemented in pediatric clinics without any reported safety concerns related to the intervention itself. ^{1 2 3 4 5}

How does the educational intervention for HPV vaccination differ from other treatments?

This educational intervention is unique because it uses patient navigators to educate families about HPV vaccination and provide personalized reminders, which significantly increases vaccine completion rates compared to standard practices. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Educational Intervention, PRE-ACT Model, Patient Navigator Model for HPV vaccination?

Research shows that using patient navigators (people who guide patients through the healthcare system) significantly increased HPV vaccine completion rates in pediatric clinics. In one study, 93% of adolescents who started the vaccine series completed it after receiving guidance from patient navigators, demonstrating the effectiveness of this approach in improving vaccination rates. ^{1 3 6 9 10}

Who Is on the Research Team?

Electra Paskett

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking parents in Ohio Appalachia with daughters aged 9-17 who haven't received the HPV vaccine, and healthcare providers involved in vaccinations at participating locations. Parents of vaccinated children or those outside the specified counties are excluded.

Inclusion Criteria

I am a parent or guardian of an unvaccinated girl aged 9 to 17.

Parents: Not have a child who has received the HPV vaccine

Health care providers: Practicing in a participating public health department or provider office in Ohio Appalachia

Exclusion Criteria

Parents: Not able to speak, read, and write English

Parents: Does not have a daughter who receives care from or lives in one of 12 Ohio Appalachia counties

I am not a parent or guardian of an unvaccinated girl aged 9 to 17.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents and health care providers receive educational materials about HPV or influenza vaccination by mail or in-person review with project staff

3 months

1 visit (in-person or virtual)

Follow-up

Participants are monitored for the vaccination status of their daughters

6 months

Follow-up at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention

Trial Overview The study tests an educational program aimed at parents and healthcare providers to see if it increases HPV vaccination rates among young girls in Ohio Appalachia.

How Is the Trial Designed?

Group I: Arm I-HPV vaccine education Experimental Treatment 1 Intervention

The educational intervention is that parents and providers receive materials about HPV by mail including HPV/ cervical cancer videos and brochures, fact sheets, HPV/cervical cancer resource lists. Clinics receive posters, brochures, tabletop/reminder cards, resource lists, newsletters, and "invitation to be vaccinated" letters for parents.

Group II: Arm II- Flu vaccine education Active Control 1 Intervention

The educational intervention is that parents and providers receive materials about Flu by mail including Flu brochures, fact sheets, Flu resource lists. Clinics receive posters and brochures.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

An educational program focused on quality improvement (QI) significantly increased HPV vaccine completion rates from 45% to 65% in a pilot initiative involving five pediatric practices over six months.

In a second phase with eight additional practices, the program led to an increase in HPV vaccine initiation from 46% to 61% and completion from 62% to 94%, demonstrating the effectiveness of combining QI education with workflow strategies to enhance vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement education initiative to increase adolescent human papillomavirus (HPV) vaccine completion rates. Bonville, CA., Domachowske, JB., Suryadevara, M.[2020]

A stepwise evidence-based practice model significantly increased HPV vaccination rates among youth and adolescents, with all 24 eligible participants receiving the vaccine in 2019 compared to only 4 in the same period in 2018.

The model included strong provider recommendations and targeted education to address parental hesitancy, highlighting the importance of proactive communication in improving vaccination uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Practice Model to Increase Human Papillomavirus Vaccine Uptake: A Stepwise Approach. Beck, A., Bianchi, A., Showalter, D.[2022]

There are three licensed HPV vaccines: bivalent, quadrivalent, and nonavalent, with the nonavalent vaccine introduced in 2014, yet vaccination coverage remains low in many developed countries due to safety concerns.

This review aims to clarify the safety profiles of all three HPV vaccines by summarizing data from both pre- and post-licensure studies, particularly focusing on the newer nonavalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. Quattrone, F., Canale, A., Filippetti, E., et al.[2018]

A total of 3174 adverse events (AEs) were reported in children and adolescents aged 6-17 after receiving the HPV vaccine, with 191 (6%) classified as serious.

While these serious AEs raise concerns, further research is necessary to establish a direct link between these events and the HPV vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. Borja-Hart, NL., Benavides, S., Christensen, C.[2019]

Citations

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

A quality improvement education initiative to increase adolescent human papillomavirus (HPV) vaccine completion rates. [2020]

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

Achieving high HPV vaccine completion rates in a pediatric clinic population. [2020]

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

Use of patient navigators to increase HPV vaccination rates in a pediatric clinical population. [2020]

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

A Learning Collaborative Model to Improve Human Papillomavirus Vaccination Rates in Primary Care. [2022]

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

Evidence-Based Practice Model to Increase Human Papillomavirus Vaccine Uptake: A Stepwise Approach. [2022]

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

Investigating safety profiles of human papillomavirus vaccine across group differences using VAERS data and MedDRA. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. [2018]

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

Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. [2019]

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

Interventions to increase HPV vaccination coverage: A systematic review. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Human Papillomavirus Educational Intervention among Oral Health Professionals. [2022]