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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to encourage HPV vaccination among parents and caregivers of children aged 9-17 in rural communities. The study explores automated reminders, some with additional follow-ups, to boost vaccine rates and reduce cancer risks linked to HPV in these areas. Participants will join one of three groups: automated reminders, automated reminders with additional prompts, or usual care with standard reminders. This trial is ideal for English or Spanish-speaking parents or caregivers whose children are eligible for HPV vaccination and have visited a participating clinic in the past year. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies that could enhance public health in rural communities.

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 prior data suggests that the PREVENT intervention is safe for increasing HPV vaccination?

Research has shown that methods like those in the PREVENT study have been used safely in the past. For instance, sending reminders through automated calls, texts, or emails has increased vaccination rates without causing harm. Studies have found these methods to be well-tolerated, with no negative effects reported.

The HPV vaccine has been monitored for over 15 years and is proven safe and effective. Most side effects are mild, such as a sore arm at the injection site.

In this trial, both the Automated Intervention and the Automated Intervention Plus employ similar reminder methods. These approaches are neither new nor risky and aim to increase vaccination rates by keeping families informed and engaged. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PREVENT intervention for increasing HPV vaccination because it employs innovative communication strategies that standard care typically doesn't use. The "Automated Intervention" arm uses automated messages via phone, text, or email, incorporating engaging elements like text-linked videos and patient narratives to motivate vaccination. The "Automated Intervention Plus" arm builds on this by adding live phone calls or patient navigation for those who don't get vaccinated promptly, using tailored materials from trusted health organizations. These proactive and personalized approaches aim to significantly boost vaccination rates compared to the usual care, which relies on passive reminders during clinic visits or electronic health records.

What evidence suggests that the PREVENT intervention could be effective for increasing HPV vaccination rates?

Research has shown that automated strategies can significantly increase HPV vaccination rates. One study found a 28% rise in starting the HPV vaccine series among participants using these methods. Additionally, about 70% of studies employing these strategies reported noticeable increases in vaccination rates, ranging from 12.5% to 65.5%. In this trial, participants in the Automated Intervention arm will receive automated reminders, while those in the Automated Intervention Plus arm will receive both automated reminders and personal prompts. The Automated Intervention Plus approach, which combines automated reminders with personal prompts, is considered a promising way to boost vaccine uptake, especially when healthcare providers strongly recommend it. These findings suggest that both automated and enhanced communication strategies can effectively encourage HPV vaccination in various communities. ^{1 3 6 7 8}

Who Is on the Research Team?

Deanna Kepka, PhD, MPH

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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. Activities selected from a list of possible options from the National HPV Vaccination Roundtable 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. Automated outreach may also include innovative communication strategies, such as text-linked videos, P/C, or patient narratives. 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

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8310215/

A Systematic Review of Interventions to Improve HPV ... The study showed that the intervention improved the initiation of the HPV vaccine series (RR 1.28, 95% CI 1.02 to 1.60; 1624 participants) [31]. We judged the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25006565

Review Effective strategies in human papillomavirus (HPV) ... Around 70 % of these studies (n = 7) yielded statistically significant results with an increase in HPV vaccination from 12.5 to 65.5 % [33,40,42 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06738355

NCT06738355 | PREVENT Pilot HPV - Related Cancers Trial The proposed study will assess the feasibility of an RCT for clinic-based outreach to increase vaccination rates for HPV at community clinics in rural counties.

4. research.kpchr.org research.kpchr.org/preventhpvcancers/Research

Prevent HPV Cancers PREVENT is a National Cancer Institute funded study that incorporates formative patient- and clinic-informed research to design and evaluate an automated data- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4862306/

and Community-Based Interventions to Increase Human ... Most practice- and community-based interventions significantly increased HPV vaccination rates using varied approaches across diverse populations.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/06/NCT06290206/Prot_SAP_000.pdf

Practice-based Approaches to Promote HPV Vaccination in ... ... HPV Vaccination in the Safety Net (PREVENT), incorporates formative patient- and clinic-informed research to design and evaluate an automated data-driven.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0277953625004113

Combating vaccine hesitancy: The case of HPV vaccination HPV vaccine uptake increased by 34% to 55% with SMS-based nudges. •. Behavioral SMS interventions achieved high cost-effectiveness (USD 3.6–5.75 per $1 spent).

8. cdc.gov cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html

HPV Vaccine Safety and Effectiveness Data More than 15 years of monitoring and research have accumulated reassuring evidence that HPV vaccination provides safe, effective, and long-lasting protection.