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

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

5196 Participants Needed

Trial Summary

What is the purpose of this trial?

The focus of this research is on increasing the uptake of the human papillomavirus (HPV) vaccine in young cancer survivors, a vulnerable population at high risk for developing new cancers (such as cervical and anal cancer) caused by persistent HPV infection. An effective vaccine exists that can prevent these cancers, but HPV vaccine uptake is low among young cancer survivors. This research will evaluate the effectiveness and implementation of an evidence-based intervention, adapted for use by healthcare providers in pediatric oncology clinics, to increase the uptake of HPV vaccine among young cancer survivors 9-17 years of age. Results of this research will provide important information that can be used to implement new strategies to increase the uptake of the HPV vaccine among 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 data supports the idea that HPV-PROTECT Intervention for Increasing HPV Vaccine Uptake in Young Cancer Survivors is an effective treatment?

The available research shows that the HPV-PROTECT intervention focuses on improving healthcare providers' ability to recommend the HPV vaccine to young cancer survivors. This is important because a lack of recommendation from healthcare providers is a common reason why these survivors do not start the vaccine. By enhancing provider skills and reducing barriers for patients and their families, the intervention aims to increase vaccine uptake. Although specific data on the effectiveness of HPV-PROTECT compared to other treatments is not provided, the emphasis on provider recommendation is a proven strategy in the general population. This suggests that HPV-PROTECT could be effective in increasing vaccine uptake among young cancer survivors. ^{1 2 3 4 5}

What data supports the effectiveness of the HPV-PROTECT treatment for increasing HPV vaccine uptake in young cancer survivors?

The HPV vaccine is effective in preventing infections that can lead to cancers, such as cervical and anal cancer, which are risks for childhood cancer survivors. The HPV-PROTECT intervention aims to increase vaccine uptake by improving healthcare provider recommendations, which is a proven strategy for increasing vaccination rates in the general population. ^{1 2 3 4 5}

What safety data exists for the HPV vaccine?

The HPV vaccines, Gardasil and Cervarix, have been proven to be highly effective and safe. Cervarix has shown sustained high levels of antibodies and high efficacy with no breakthrough cases in a long-term follow-up study. Both vaccines are widely licensed and have been implemented in immunization programs globally, demonstrating their safety and effectiveness in preventing HPV-related cancers. ^{1 2 5 6 7}

Is the HPV vaccine safe for humans?

The HPV vaccines, including Gardasil and Cervarix, have been proven to be highly effective and safe in preventing infections that can lead to cervical cancer. Cervarix, in particular, has shown sustained high levels of safety and efficacy over a long follow-up period, with no breakthrough cases reported in the studied population. ^{1 2 5 6 7}

Is the HPV-PROTECT treatment a promising way to increase HPV vaccine uptake in young cancer survivors?

Yes, the HPV-PROTECT treatment is promising because it focuses on improving healthcare providers' ability to recommend the HPV vaccine effectively. This approach can help increase vaccine uptake among young cancer survivors, who are at higher risk for HPV-related cancers. ^{1 2 8 9 10}

How is the HPV-PROTECT treatment different from other HPV vaccine strategies for young cancer survivors?

The HPV-PROTECT treatment is unique because it focuses on enhancing healthcare provider skills to effectively recommend the HPV vaccine to young cancer survivors, addressing the common issue of low vaccine uptake due to lack of provider recommendation. This approach is specifically adapted for use in pediatric oncology clinics, making it distinct from general population strategies. ^{1 2 8 9 10}

Research Team

Wendy Landier, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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]

References

1. England 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. [2023]

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

Implementation barriers and considerations for recommending and administering the human papillomavirus (HPV) vaccination in oncology settings. [2023]

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

Missed opportunities for concomitant HPV vaccination among childhood cancer survivors. [2022]

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

HPV vaccination coverage for pediatric, adolescent and young adult patients receiving care in a childhood cancer survivor program. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccination and the primary prevention of cancer: implications for survivors of childhood cancer. [2018]

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

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

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

Prophylactic papillomavirus vaccines. [2022]

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

Risk factors for non-initiation of the human papillomavirus vaccine among adolescent survivors of childhood cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

HPV Vaccine Experiences and Preferences Among Young Adult Cancer Survivors and Caregivers of Childhood Cancer Survivors. [2023]

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

Human papillomavirus vaccination in survivors of childhood cancer. [2021]