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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if educational materials can increase HPV vaccination rates among young girls in Ohio Appalachia. Two groups participate: one receives information about the HPV vaccine, and the other receives materials about the flu vaccine. Parents with daughters aged 9 to 17 who haven't received the HPV vaccine and live in specific Ohio counties are suitable candidates for the trial. The researchers aim to see if informing parents and healthcare providers can lead to more girls getting vaccinated. As an unphased trial, this study offers a unique opportunity to contribute to public health by potentially increasing vaccination rates in the community.

Will I have to stop taking my current medications?

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

What prior data suggests that this educational intervention is safe for increasing HPV vaccination rates?

In a previous study, educational programs about HPV (human papillomavirus) vaccines increased the completion rate of the vaccine series from 45% to 65%. Another study found that teaching students about the vaccine at school made them feel more positive about getting vaccinated, and these feelings persisted over time. This research shows that educational programs are safe and can effectively increase vaccination rates.

Educational programs provide information through videos, brochures, and other materials. They do not involve taking medicine or undergoing medical procedures, so there are no physical risks like side effects. In this trial, the program aims to help parents and healthcare providers understand the importance of the HPV vaccine. This type of program is well-received and focuses on raising awareness and acceptance of the vaccine without any direct health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique educational approach to increasing HPV vaccination rates. Unlike traditional methods that rely on standard healthcare provider recommendations, this intervention directly engages parents and clinics with tailored educational materials, such as videos, brochures, and personalized reminder cards about HPV and cervical cancer. This approach aims to empower parents with detailed information and reminders, potentially improving vaccination uptake by addressing knowledge gaps and hesitancy in a more engaging and direct way. By comparing this method to similar educational strategies for the flu vaccine, researchers hope to uncover effective ways to boost vaccine adoption through targeted education.

What evidence suggests that this educational intervention is effective for increasing HPV vaccination rates?

Research has shown that educational programs can effectively increase HPV vaccination rates. In this trial, participants in Arm I will receive an educational intervention focused on HPV, where parents and providers receive materials about HPV by mail, including HPV/cervical cancer videos and brochures. One study found that 93% of teenagers completed the vaccine series after receiving help from patient guides, demonstrating the success of these programs. A review of 33 studies found that educating both parents and teenagers about the vaccine can positively influence vaccination rates. Educational efforts have also reduced concerns about vaccines, making parents more likely to vaccinate their children. Additionally, school-based programs improved teenagers' views on the HPV vaccine, with lasting effects. These findings suggest that educating parents and healthcare providers can significantly increase HPV vaccination rates in young girls. ^{1 2 3 4 5}

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

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

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

Parents: Be able to speak, read, and write English

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

Parents: Has a child who has received the HPV vaccine

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 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]

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]

Citations

1. withpower.com withpower.com/trial/phase-papilloma-2012-6428b

Educational Intervention for HPV Vaccination (PARENT Trial) In one study, 93% of adolescents who started the vaccine series completed it after receiving guidance from patient navigators, demonstrating the effectiveness ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4285433/

Educational interventions to increase HPV vaccination ... We identified 33 studies of HPV vaccination educational interventions: 7 tested the effectiveness of interventions with parents, 8 with adolescents or young ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12513138/

Effects of an educational health promotion intervention to ... There is evidence that educational health promotion interventions could reduce vaccine hesitancy and have positive effects on HPV vaccine ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211335520301534

Use of patient navigators to increase HPV vaccination rates ... The patient navigation program resulted in an increased odds of HPV vaccination compared to clinics without this program. Abstract. A patient navigator (PN) ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2785670

Effect of a School-Based Educational Intervention About ... An HPV vaccination intervention implemented in schools improved psychosocial vaccine-related outcomes in adolescents, an effect that was maintained throughout ...