PREVENT for Cancer

Overseen By Research Assistant

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

519 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost HPV vaccination rates among children aged 9-17 in rural Washington by testing different outreach methods. The study will compare three groups: one receiving automated messages, another receiving automated messages plus extra reminders, and a third receiving usual care. Parents or caregivers who have visited participating clinics in the past year and speak English or Spanish are eligible. The goal is to develop effective strategies to reduce HPV-related cancers in rural areas. As an unphased trial, this study allows participants to contribute to important research that could enhance public health strategies 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 medications would be affected, but you should confirm with the trial organizers.

What prior data suggests that this intervention is safe for promoting HPV vaccination?

Research has shown that many community and practice-based methods have successfully increased HPV vaccination rates in various groups. These methods include automated strategies, like those tested in this trial. The HPV vaccine has been proven safe, with over 15 years of monitoring demonstrating effective and lasting protection.

For the Automated Intervention (Auto) and Automated Intervention Plus (Auto-Plus) treatments, studies have found that digital outreach methods, such as reminders via phone, text, or email, effectively boost vaccination rates. These strategies support and inform parents and caregivers, aiding their decision to vaccinate their children. No major safety issues have been reported with these outreach methods.

Overall, evidence suggests that these automated strategies are well-received and significantly promote HPV vaccination without causing negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for increasing HPV vaccination rates because they leverage automated and personalized communication strategies. The Automated Intervention (Auto) uses innovative outreach methods like text-linked videos and patient narratives to make reminders more engaging and accessible, inviting families to attend vaccination visits during convenient hours. The Automated Intervention Plus (Auto-Plus) builds on this by adding live phone calls or patient navigation for those who don't get vaccinated within three weeks, offering a tailored approach that considers language and cultural nuances, which could significantly improve vaccination uptake compared to standard care. These methods could revolutionize how we approach vaccination reminders, making them more effective and personalized.

What evidence suggests that this trial's interventions could be effective in promoting HPV vaccination among rural parents and caregivers?

Studies have shown that digital tools can help increase HPV vaccination rates. In one study, 7.1% of people who received automated reminders got vaccinated, compared to only 1.8% in a group without these reminders. Mobile health (mHealth) strategies have also successfully encouraged more people to get vaccinated. In this trial, participants in the Automated Intervention arm will receive automated reminders. Meanwhile, those in the Automated Intervention Plus arm will receive additional prompts, which research suggests might be more effective than using the Automated Intervention alone. Specifically, a review found that it increased the start of vaccination by about 4.7% in some cases. These findings suggest that using automated reminders and extra prompts can help boost HPV vaccination rates. ^{6 7 8 9 10}

Who Is on the Research Team?

Deanna Kepka, PhD, MPH

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

The PREVENT HPV trial is for parents and caregivers of children aged 9-17 living in rural areas of the Mountain West. Participants will be involved in strategies to promote HPV vaccination. Those with diverse backgrounds are encouraged to join.

Inclusion Criteria

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

I speak English or Spanish.

I have visited the clinic for my condition within the last year.

Exclusion Criteria

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

I have conditions affecting HPV vaccine advice.

I have conditions affecting HPV vaccine advice, like pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

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

13 months

Follow-up

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

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PREVENT

Trial Overview This study tests clinic-based outreach methods aimed at increasing HPV vaccination rates among rural youth. It's a randomized controlled trial where participants receive intervention timelines, aiming to develop best practices for wider implementation.

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. Working with clinic leadership and previous research, 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. 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+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

Sea Mar Community Health Centers

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12176647/

A vaccine chatbot intervention for parents to improve HPV ... In intention-to-treat analyses, 7.1% of the intervention group met this outcome versus 1.8% of the control group (P < 0.001) over a two-week ...

2. ascopubs.org ascopubs.org/doi/10.1200/GO-25-00150

Randomized Controlled Trial of Impact of Mobile Health ... The study showed that mHealth interventions significantly improve HPV vaccine uptake. Integrating mHealth strategies into routine immunization ...

3. nature.com nature.com/articles/s41746-023-00912-w

Systematic review and meta-analysis comparing ... Meta-analysis results of the effect of digital interventions on Human papillomavirus vaccination uptake across all interventions, client ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06738355

NCT06738355 | PREVENT Pilot HPV - Related Cancers 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 ...

5. 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 ...

6. 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.

7. 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.

8. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10638515&term=CA279973

Practice-based Approaches to Promote HPV Vaccination This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural patients in the ...

9. 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- ...

10. 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.