PREVENT Intervention for Increasing HPV Vaccination

Overseen By Kaila Christini, MsPH, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Completed vaccination, Pregnancy, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 13 months

519 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on promoting HPV vaccination, so it's unlikely that your current medications would be affected.

What data supports the effectiveness of the PREVENT treatment for increasing HPV vaccination?

Research shows that various intervention strategies can effectively increase HPV vaccination rates, especially when applied at both community and provider levels. This suggests that the PREVENT treatment, if it includes similar strategies, could be effective in increasing HPV vaccination coverage. ^{1 2 3 4 5}

Is the HPV vaccine safe for humans?

The HPV vaccines, including the newer 9-valent version, have been studied extensively for safety. Most reported side effects are mild, like injection-site reactions or headaches, and serious adverse events are rare. Overall, the vaccines are considered safe based on large-scale studies and monitoring systems. ^{6 7 8 9 10}

How does the PREVENT treatment for increasing HPV vaccination differ from other treatments?

The PREVENT treatment is unique because it focuses on increasing HPV vaccination rates through interventions like starting vaccination at age 9, which is earlier than the usual recommendation. This approach aims to improve coverage by allowing more time to complete the vaccination series and emphasizes cancer prevention messaging. ^{11 12 13 14 15}

What is the purpose of this trial?

This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States. The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. This study is a boot camp translation to tailor messaging based on patient and provider input The proposed study includes the following: (1) boot camp translation to tailor messaging based on patient and provider input; (2) PREVENT randomized controlled trial (RCT) that will assign adult parent/caregiver participants to a timeline for receiving intervention; and (3) qualitative interviews with parents/caregivers, providers, and other healthcare team members and development of best practices, implementation guides and dissemination of findings for other clinics to implement the program on a broader scale. At the end of the trial, personal interviews with parents/caregivers, clinical staff, and providers will be conducted to understand reactions to the program and persistent barriers to initiating and completing HPV vaccination.

Research Team

Deanna Kepka, PhD, MPH

Principal Investigator

Study Principal Investigator

Eligibility Criteria

This trial is for parents and caregivers of children aged 9-17 living in rural areas of the Mountain West who are hesitant about or have refused HPV vaccination. Participants will help test strategies to increase vaccine uptake.

Inclusion Criteria

I am the parent or caregiver of a child aged 9-17.

P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 months)

Exclusion Criteria

I have a condition affecting my cervical cancer or HPV vaccine recommendations.

I have conditions affecting HPV vaccine advice, like pregnancy.

P/C of C/A with previous excluding HPV vaccination history (e.g., completed vaccination, or not due)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Boot Camp Translation

Boot camp translation to tailor messaging based on patient and provider input

4-6 weeks

Treatment

Participants receive automated reminders, live reminders, or usual care to promote HPV vaccination

13 months

Follow-up

Participants are monitored for completion of the HPV vaccination series and effectiveness of interventions

4 weeks

Treatment Details

Interventions

• PREVENT

Trial Overview The PREVENT program aims to boost HPV vaccination rates through tailored clinic-based outreach. It involves a randomized controlled trial where participants receive interventions at different times, plus interviews for feedback.

Participant Groups

Group I: Automated Intervention Plus (Auto-Plus) Experimental Treatment 1 Intervention

Auto-Plus intervention participants will be eligible for automated reminders, plus additional P/C prompts for patients who do not undergo vaccination within three weeks. These prompts may be delivered via live phone call outreach or patient navigation. Working with clinic leadership and using the findings of BCT, activities will be selected from a list of possible options from the National HPV Vaccination Roundtable (previously chaired by Dr. Brewer) and our ranking of the effectiveness of language- and culturally- tailored intervention materials.

Group II: Automated Intervention (Auto) Experimental Treatment 1 Intervention

Auto intervention participants will be eligible for outreach delivered using automated phone calls, text, or email messages with the mode, frequency, timing of reminders, and message content refined using BCT. Automated outreach may also include innovative communication strategies, such as text-linked videos, P/C, or patient narratives (based on BCT). Auto outreach to P/C will invite P/Cs to attend free HPV vaccination visits and emphasize family-friendly hours.

Group III: Usual Care (UC) Active Control 1 Intervention

The UC group will not receive tailored reminders but will only receive opportunistic vaccine reminders that are delivered during clinic visits or MyChart EHR-based patient portal reminders.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

Sea Mar Community Health Centers

Collaborator

Trials

4

Recruited

1,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Sea Mar Community Health Centers

Collaborator

Findings from Research

Expanding HPV vaccination to adults, particularly at cervical cancer screening visits for women and during STI consultations for both sexes, could lead to significant reductions in HPV infection rates, with reductions of about 20% for women and even greater reductions (63% for HPV-16 and 84% for HPV-18) when including male vaccination.

The study suggests that while the impact of vaccinating adult women alone is modest, combining vaccination strategies for both genders during key health consultations is a highly efficient approach to improve HPV prevention and reduce the incidence of related cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public Health Benefits of Routine Human Papillomavirus Vaccination for Adults in the Netherlands: A Mathematical Modeling Study. Matthijsse, SM., Hontelez, JA., Naber, SK., et al.[2018]

All three HPV vaccines (bivalent, quadrivalent, and 9vHPV) show high efficacy in preventing infections from specific HPV types and associated high-grade cervical dysplasia in women who have not been previously exposed to HPV.

While the bivalent and quadrivalent vaccines have demonstrated early clinical effectiveness in reducing HPV 16 and 18 prevalence, the overall benefits of HPV vaccination in reducing cervical cancer are still largely theoretical, highlighting the need for large-scale studies to confirm long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of 2-, 4- and 9-valent HPV vaccines on morbidity and mortality from cervical cancer. Luckett, R., Feldman, S.[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]

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]

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]

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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Perspectives for preventive and therapeutic HPV vaccines. [2022]

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

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

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

Public Health Benefits of Routine Human Papillomavirus Vaccination for Adults in the Netherlands: A Mathematical Modeling Study. [2018]

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

Impact of 2-, 4- and 9-valent HPV vaccines on morbidity and mortality from cervical cancer. [2018]

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

Population-Based Incidence Rates of Cervical Intraepithelial Neoplasia in the Human Papillomavirus Vaccine Era. [2022]

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

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

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

A Broad Safety Assessment of the 9-Valent Human Papillomavirus Vaccine. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Italy pubmed.ncbi.nlm.nih.gov

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

An overview on the implementation of HPV vaccination in Europe. [2022]

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

Implementing a Multipartner HPV Vaccination Assessment and Feedback Intervention in an Integrated Health System. [2018]

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

Implementing interventions to start HPV vaccination at age 9: Using the evidence we have. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Risk compensation and vaccination: can getting vaccinated cause people to engage in risky behaviors? [2022]

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

Lessons learned from HPV vaccine delivery in low-resource settings and opportunities for HIV prevention, treatment, and care among adolescents. [2022]