HPV-PROTECT Intervention for Increasing HPV Vaccine Uptake in Young Cancer Survivors

Not currently recruiting at 5 trial locations

Overseen By Lindsey Hageman, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase HPV vaccine uptake in young cancer survivors, who face a higher risk for HPV-related cancers, such as cervical and anal cancer. The trial will test an intervention designed for healthcare providers in pediatric oncology clinics to promote vaccination. Participants will either begin the intervention immediately or after a delay to determine the most effective approach. Young cancer survivors who have been off therapy for at least one year and receive follow-up care at participating clinics may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance vaccination strategies for young cancer survivors.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on increasing HPV vaccine uptake in young cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the HPV-PROTECT intervention is safe for increasing HPV vaccine uptake in young cancer survivors?

Research has shown that the HPV vaccine is very safe. Large studies and health organizations like the CDC and WHO have thoroughly evaluated the vaccine's safety, finding no serious concerns. Most side effects are mild, such as a sore arm or a slight fever.

The HPV vaccine is widely used to prevent cancers caused by the human papillomavirus, such as cervical cancer. Approval in many countries further supports confidence in its safety. Importantly, the vaccine maintains a strong safety record even for young cancer survivors, who may have special health needs.

Overall, existing evidence strongly supports the safety of the HPV vaccine, making it a reliable choice for preventing HPV-related cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HPV-PROTECT intervention because it aims to boost HPV vaccine uptake among young cancer survivors, a group that may be at increased risk for HPV-related complications. Unlike traditional approaches that might focus solely on general HPV vaccination programs, this intervention tailors its strategy specifically for young cancer survivors, potentially addressing unique barriers they face. By testing both early and delayed intervention methods across different sites, HPV-PROTECT might reveal the most effective timing and strategies for increasing vaccine uptake in this vulnerable population. The findings could lead to more personalized and effective vaccination campaigns, ultimately improving health outcomes for young cancer survivors.

What evidence suggests that the HPV-PROTECT intervention could be effective for increasing HPV vaccine uptake in young cancer survivors?

Research has shown that the HPV vaccine helps prevent infections that can lead to cancers such as cervical and anal cancer. One study found that even a single dose of the HPV vaccine was 54% effective against these infections. The HPV-PROTECT program aims to increase the number of young cancer survivors who receive this vaccine, as they have a higher risk of developing new cancers from HPV. By encouraging these young survivors to start and complete the vaccine series, the program seeks to better protect them from future cancer risks. Participants will join either the Early Intervention or Delayed Intervention arms, receiving the HPV-PROTECT intervention at different times. ^{6 7 8 9 10}

Who Is on the Research Team?

Wendy Landier, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for young cancer survivors aged 9-17 who are at least one year post-cancer therapy, live in the state where the clinic is located, and receive follow-up care there. Healthcare providers involved must be licensed to order vaccines and willing to complete surveys or interviews.

Inclusion Criteria

This screening criteria is intended for healthcare providers such as oncologists and advanced practice providers.

I am between 9 and 17 years old.

You have finished your cancer treatment at least one year ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Condition

Sites are assigned to the control condition to establish baseline HPV vaccine uptake rates

12 months

Intervention

Implementation of the HPV-PROTECT intervention to increase HPV vaccine uptake among young cancer survivors

12 months

Clinic visits (in-person or via telehealth)

Sustainability

Assessment of the sustainability of increased HPV vaccine uptake rates post-intervention

24 months

Follow-up

Participants are monitored for the completion of the HPV vaccine series and long-term vaccine uptake

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HPV-PROTECT

Trial Overview

The HPV-PROTECT intervention aims to increase HPV vaccine uptake among young cancer survivors. It's an evidence-based program adapted for pediatric oncology clinics, testing whether it effectively boosts vaccination rates in this high-risk group.

How Is the Trial Designed?

Group I: Early Intervention Experimental Treatment 1 Intervention

Sites randomized to the Early Intervention Arm (Sites D, E, F) will be assigned to the control condition in Year 1, to the HPV-PROTECT intervention in Year 2, and to the sustainability condition in Years 3 and 4

Group II: Delayed Intervention Experimental Treatment 1 Intervention

Sites randomized to the Delayed Intervention Arm (Sites A, B, C) will be assigned to the control condition in Years 1 and 2, to the HPV-PROTECT intervention in Year 3, and to the sustainability condition in Year 4

HPV-PROTECT is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gardasil for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal, and penile cancers caused by HPV types 16 and 18

Approved in European Union as Gardasil for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal, and penile cancers caused by HPV types 16 and 18

Approved in European Union as Cervarix for:

• Prevention of cervical cancer caused by HPV types 16 and 18

Approved in Canada as Gardasil for:

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal, and penile cancers caused by HPV types 16 and 18

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 24 oncology providers revealed significant barriers to recommending and administering the HPV vaccine in oncology settings, including educational gaps and complicated vaccination guidelines.

Addressing these multi-level barriers could enhance HPV vaccination rates among childhood and adolescent cancer survivors, highlighting the need for effective implementation strategies in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation barriers and considerations for recommending and administering the human papillomavirus (HPV) vaccination in oncology settings. Waters, AR., Weir, C., Kramer, HS., et al.[2023]

Among adolescent and young adult cancer survivors, only 50% had received at least one dose of the HPV vaccine, highlighting a significant gap in vaccination rates compared to the general population.

Participants expressed a strong preference for receiving HPV vaccination recommendations from their oncologists and favored digital reminders for vaccination, indicating that targeted communication strategies could enhance vaccine uptake among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV Vaccine Experiences and Preferences Among Young Adult Cancer Survivors and Caregivers of Childhood Cancer Survivors. Waters, AR., Mann, K., Vaca Lopez, PL., et al.[2023]

The study aims to evaluate the effectiveness of the HPV PROTECT intervention, designed to enhance healthcare provider recommendations for the HPV vaccine among childhood cancer survivors aged 9 to 17, using a multi-state stepped-wedge cluster-randomized trial.

If successful, the HPV PROTECT intervention could significantly increase HPV vaccine uptake in pediatric oncology clinics, thereby reducing the risk of HPV-related cancers in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a provider-focused intervention for maximizing human papillomavirus (HPV) vaccine uptake in young cancer survivors receiving follow-up care in pediatric oncology practices: protocol for a cluster-randomized trial of the HPV PROTECT intervention. Landier, W., Bhatia, S., Richman, JS., et al.[2023]

Among childhood cancer survivors, only 17.9% completed the HPV vaccination series, highlighting a significant gap in vaccination despite their increased risk for HPV-related complications.

Factors influencing HPV vaccination initiation included older age and physician recommendations, while perceived barriers and non-White ethnicity were linked to lower completion rates, indicating areas for targeted intervention in vaccine promotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for non-initiation of the human papillomavirus vaccine among adolescent survivors of childhood cancer. Klosky, JL., Russell, KM., Canavera, KE., et al.[2021]

Cervarix, an HPV vaccine, has shown a 70.2% reduction in cervical precancerous lesions in HPV-naïve young girls, indicating its strong efficacy in preventing cervical cancer caused by HPV types 16, 18, 31, 33, and 45.

Cervarix induces significantly higher levels of neutralizing antibodies and memory immune cells compared to Gardasil, with sustained protection lasting over 7 years, demonstrating its long-term effectiveness and safety in preventing HPV-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical update of the AS04-adjuvanted human papillomavirus-16/18 cervical cancer vaccine, Cervarix. Schwarz, TF.[2020]

In a study of 592 patients aged 11-26 years, those in a childhood cancer survivor program (CCSP) had HPV vaccination coverage of 60.0%, which was not significantly different from the 66.3% coverage in matched controls without cancer.

Despite similar vaccination rates, only 8.0% of survivorship care plans recommended HPV vaccination, highlighting that initiation and completion of the recommended 3-dose series remain low in this high-risk population for secondary HPV-associated cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV vaccination coverage for pediatric, adolescent and young adult patients receiving care in a childhood cancer survivor program. Thomaier, L., Aase, DA., Vogel, RI., et al.[2022]

The HPV vaccine is crucial for females who are cancer survivors, as they are at higher risk for HPV-related complications due to the effects of cancer treatment, and guidelines recommend vaccination for all eligible survivors.

Despite the vaccine's approval in 2006, there is limited understanding of the factors influencing HPV vaccination uptake among cancer survivors, highlighting the need for targeted strategies to improve adherence to vaccination recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccination in survivors of childhood cancer. Klosky, JL., Gamble, HL., Spunt, SL., et al.[2021]

The HPV vaccine is crucial for females who are survivors of childhood cancer, as they are at a higher risk for HPV-related complications due to the effects of cancer treatment.

The Children's Oncology Group recommends HPV vaccination for all eligible female survivors of childhood cancer, highlighting the need for strategies to improve vaccination uptake among this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccination and the primary prevention of cancer: implications for survivors of childhood cancer. Klosky, JL., Foster, RH., Hodges, J., et al.[2018]

The Gardasil® and Cervarix® vaccines are highly effective and safe in preventing cervical cancer caused by human papillomaviruses (HPV), which is the third most common cancer in women.

Current research is focused on developing more affordable second-generation HPV vaccines using different formulations, as the high cost of existing vaccines limits their global implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic papillomavirus vaccines. Ribeiro-Müller, L., Müller, M.[2022]

Childhood cancer survivors are at a higher risk of missed opportunities for receiving the HPV vaccine compared to their peers without cancer, with 70% of survivors missing these opportunities versus 59% in the general population sample.

Factors such as higher parental education, living in rural areas, receiving chemotherapy, and younger age at first vaccination were linked to increased missed opportunities, highlighting the need for healthcare providers to actively recommend HPV vaccination during routine vaccine encounters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities for concomitant HPV vaccination among childhood cancer survivors. Ramsay, JM., Kaddas, HK., Ou, JY., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12465035/

Clinical effectiveness of HPV vaccine by age at vaccination

In this real-world study evaluating HPV vaccine effectiveness within a diverse U.S. population, we found that one or more doses provided 54% (95 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36096775/

protocol for a cluster-randomized trial of the HPV ...

HPV vaccination is effective in preventing the infections that lead to these cancers, but HPV vaccine uptake is low among young cancer survivors. Lack of a ...

3.

bmcpediatr.biomedcentral.com

bmcpediatr.biomedcentral.com/articles/10.1186/s12887-022-03562-1

protocol for a cluster-randomized trial of the HPV ...

HPV vaccination is effective in preventing the infections that lead to these cancers, but HPV vaccine uptake is low among young cancer survivors ...

4.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35857

A framework‐based guide for adapting and implementing ...

HPV PROTECT's primary effectiveness outcome is survivor HPV vaccine initiation rate; vaccine series completion rate is an exploratory outcome.

5.

withpower.com

withpower.com/trial/phase-1-2021-9b82c

HPV-PROTECT Intervention for Increasing HPV Vaccine ...

An effective vaccine exists that can prevent these cancers, but HPV vaccine uptake is low among young cancer survivors. This research will evaluate the ...

6.

cdc.gov

cdc.gov/vaccine-safety/vaccines/hpv.html

Human Papillomavirus (HPV) Vaccine Safety

HPV vaccine continues to have a strong safety record, and CDC continues to recommend that all preteen girls and boys receive three doses of this cancer- ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5662846/

Human Papillomavirus Vaccination Rates in Young Cancer ...

Among 13- to 26-year-old cancer survivors, 23.8% (95% CI, 20.6% to 27.0%) initiated HPV vaccination, compared with 40.5% (95% CI, 40.2% to 40.7%) in the general ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10283160/

Reasons for refusal of the human papillomavirus vaccine ...

Oncology providers can address concerns regarding HPV vaccine safety among young cancer survivors and their parents by using data supporting the safety and ...

9.

who.int

who.int/groups/global-advisory-committee-on-vaccine-safety/topics/human-papillomavirus-vaccines/safety

Safety of HPV vaccines

No other adverse reactions have been identified and GACVS considers HPV vaccines to be extremely safe. Further safety data have been generated recently from ...

10.

thelancet.com

thelancet.com/journals/lanchi/article/PIIS2352-4642(21)00312-6/fulltext

Human papillomavirus vaccination for young survivors of ...

Human papillomavirus (HPV) vaccine can prevent six types of cancers and has a strong safety profile. However, only 55% of US adolescents (ie, aged 13–15 years) ...