Educational Intervention for HPV Vaccine Uptake

Overseen By Sindy Gonzalez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Non-English/Spanish speakers, Cognitive impairment, Vulnerable populations, others

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

Compensation: Varies

Number of Visits: 3

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The educational intervention to be delivered by the CHE(Community Health Educator) consists of "toolkit education materials" developed by the National Cancer Institute (NCI) and a small media intervention (i.e., video) that our research team has developed. The NCI-produced toolkit education materials consist of Power Point presentations, flyers, and posters that contain information about HPV(Human Papilloma Virus), HPV-related cancers, and the importance of the HPV vaccine series for adolescents (9-17 years old) and young adults (18-26 year old) who are eligible for the vaccine.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational materials about the HPV vaccine, so it's unlikely that your medications will be affected.

Is the HPV Educational Intervention safe for humans?

The HPV vaccines, which are part of the educational intervention, have been studied extensively for safety. Research shows that while there are some adverse events (unwanted effects) reported, they are generally considered safe for use in humans. ^{1 2 3 4 5}

How is the HPV Educational Intervention treatment different from other treatments for increasing HPV vaccine uptake?

The HPV Educational Intervention is unique because it focuses on educating health professional students and young people to increase their knowledge and acceptance of the HPV vaccine, rather than directly administering a vaccine or medication. This approach aims to improve vaccine uptake by addressing knowledge gaps and leveraging educational strategies tailored to specific groups, such as schools with low vaccination rates. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment HPV Educational Intervention for increasing HPV vaccine uptake?

Research shows that educational programs combined with strategies to improve healthcare practices can significantly increase HPV vaccine completion rates. For example, one study found that after implementing an educational program, HPV vaccine completion rates increased from 45% to 65% in a pilot program and from 62% to 94% in a follow-up phase. ^{2 8 10 11 12}

Who Is on the Research Team?

Evelinn Borrayo

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for parents of Denver Health patients aged 9-17 who haven't started or completed the HPV vaccine series, and Denver Health patients themselves aged 18-26 in the same situation. Participants must speak English or Spanish and be willing to follow study procedures.

Inclusion Criteria

Stated willingness to comply with all study procedures and be available for the duration of the study

Denver Health patients will be identified from one of the following clinics; Denver Health Clinics Eastside Adult Clinic, Eastside Women's Care Clinic, Westside Adult Clinic, Westside Women's Care Clinic, Pavilion C: Women's Care Clinic, La Casa-Quigg Newton Family Health Center, Lowry Family Health Center, Montbello Family Health Center, Westwood Family Health Center, Parkhill Family Health Center, Webb Center For Primary Care, Pena Southwest Clinic

I am 18-26 years old, a Denver Health patient, and have not completed the HPV vaccine series.

Exclusion Criteria

I am under 18 years old.

I am able to make decisions for myself and am not impaired by substances or cognitive issues.

Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and those with auditory impairment) [at the discretion of the CHE or PN upon recruitment]

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants receive educational workshops delivered by a Community Health Educator using toolkit education materials and a small media intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for vaccine uptake and completion through follow-up surveys conducted over the phone

6 months

2 follow-up calls (3 and 6 months post-intervention)

What Are the Treatments Tested in This Trial?

Interventions

• HPV Educational Intervention

Trial Overview The trial tests an educational program about HPV and its vaccine, using NCI toolkit materials like presentations, flyers, posters, plus a video developed by researchers. It aims to increase awareness and vaccination rates among eligible adolescents and young adults.

How Is the Trial Designed?

Group I: Patients Eligible for HPV Vaccine Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

An evidence-based educational brochure and reminder system significantly increased HPV vaccine uptake among parents of preteen girls, with a 9.4 times higher likelihood of vaccination compared to a historical control group.

The intervention also led to a remarkable 22.5 times increase in dose completion rates, highlighting the effectiveness of structured educational and reminder strategies in improving vaccination outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. Cassidy, B., Braxter, B., Charron-Prochownik, D., et al.[2015]

A stepwise evidence-based practice model significantly increased HPV vaccination rates among youth and adolescents, with all 24 eligible participants receiving the vaccine in 2019 compared to only 4 in the same period in 2018.

The model included strong provider recommendations and targeted education to address parental hesitancy, highlighting the importance of proactive communication in improving vaccination uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Practice Model to Increase Human Papillomavirus Vaccine Uptake: A Stepwise Approach. Beck, A., Bianchi, A., Showalter, D.[2022]

An educational program focused on quality improvement (QI) significantly increased HPV vaccine completion rates from 45% to 65% in a pilot initiative involving five pediatric practices over six months.

In a second phase with eight additional practices, the program led to an increase in HPV vaccine initiation from 46% to 61% and completion from 62% to 94%, demonstrating the effectiveness of combining QI education with workflow strategies to enhance vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement education initiative to increase adolescent human papillomavirus (HPV) vaccine completion rates. Bonville, CA., Domachowske, JB., Suryadevara, M.[2020]

A systematic review of 21 studies found that while 99% of health professional students (HPS) knew HPV causes cervical cancer, only 40-47% were aware it also causes head and neck cancers, highlighting significant gaps in HPV knowledge.

HPV vaccination uptake among HPS ranged from 34.6% to 70.3%, indicating a need for improved educational interventions, as those who received education were more likely to recommend vaccination, which could help reduce preventable cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging teachable moments in cancer prevention by improving HPV vaccination in health professional students (HPS): A systematic review. Levy, MS., Finch, L., Lindsay, KA., et al.[2022]

A quality improvement project in a pediatric practice led to a significant increase in HPV vaccine uptake among 11- and 12-year-olds, rising from 17.8% to 63.6% after implementing three targeted strategies.

The strategies included integrating the HPV vaccine into routine adolescent vaccinations, sending pre-visit informational emails to parents, and ensuring consistent communication from healthcare providers, highlighting the importance of structured approaches in improving vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Strategies to Increase HPV Vaccination in the Pediatric Primary Care Setting. Bernstein, TA., Broome, M., Millman, 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]

This systematic review and network meta-analysis aims to evaluate adverse events following HPV vaccine injections, focusing on topical pain as the primary outcome, by analyzing data from various studies published between January 2000 and September 2019.

The study will compare the HPV vaccine with placebo, adjuvants, and other vaccines to identify which components may cause adverse events, providing valuable insights into vaccine safety for female adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with human papillomavirus vaccines: a protocol for systematic review with network meta-analysis incorporating all randomised controlled trials comparing with placebo, adjuvants and other vaccines. Takeuchi, J., Noma, H., Sakanishi, Y., et al.[2023]

The reporting rate of adverse events following the quadrivalent human papillomavirus vaccine (4vHPV) was found to be 2.7 per 10,000 doses, with common events including fever, redness, and induration, indicating that while some adverse events occur, they are relatively rare.

Serious adverse events such as anaphylactic shock and Guillain-Barré Syndrome were reported, but the analysis did not reveal any new or unexpected safety concerns, suggesting that 4vHPV is generally safe based on the data from 238 reports over a period from 2018 to 2020.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine using the national adverse event following immunization surveillance system from Zhejiang province, 2018-2020. Hu, Y., Pan, X., Shen, L., et al.[2022]

From 2007 to 2011, the HPV4 vaccination program in Ontario reported 133 confirmed adverse events following immunization (AEFIs) out of 691,994 doses distributed, resulting in a low overall reporting rate of 19.2 AEFIs per 100,000 doses, which is consistent with the vaccine's safety profile.

The study found no new safety signals for the HPV4 vaccine, with serious AEFIs being rare and primarily linked to preexisting conditions, reinforcing the vaccine's safety as established in earlier trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events following immunization in Ontario's female school-based HPV program. Harris, T., Williams, DM., Fediurek, J., et al.[2015]

The study aims to create an educational package about the HPV vaccine co-produced with young people to address information gaps and increase vaccine uptake in schools with historically lower rates.

The research will involve a three-phase approach, including a review of existing materials, co-production of communication strategies with adolescents, and testing the educational package in four schools, ensuring that the intervention is tailored to the needs of the target population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-production of an educational package for the universal human papillomavirus (HPV) vaccination programme tailored for schools with low uptake: a participatory study protocol. Fisher, H., Audrey, S., Chantler, T., et al.[2021]

A randomized controlled trial involving 256 young women showed that an educational video significantly increased HPV vaccine acceptability to 51.7%, compared to 33.3% for an educational handout and 28.2% for a control group (P<.01).

Both educational interventions improved HPV vaccine knowledge, with participants in the video arm scoring higher on knowledge assessments and reporting the video as more helpful in making vaccination decisions (86.2% vs 70.2%, P<.01).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. Cory, L., Cha, B., Ellenberg, S., et al.[2021]

Parents have significant concerns about the HPV vaccine, including the young age of their children, potential side effects, and the rationale for vaccinating boys, which have persisted even after the COVID-19 pandemic.

School nurses emphasized the need for better communication tools, such as decision aids and social media campaigns, to improve understanding and acceptance of the HPV vaccine among parents, indicating that current information is not effectively reaching them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"The problem is not lack of information": A qualitative study of parents and school nurses' perceptions of barriers and potential solutions for HPV vaccination in schools. Dionne, M., Sauvageau, C., Kiely, M., et al.[2023]

Citations

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

A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. [2015]

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

Evidence-Based Practice Model to Increase Human Papillomavirus Vaccine Uptake: A Stepwise Approach. [2022]

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

A quality improvement education initiative to increase adolescent human papillomavirus (HPV) vaccine completion rates. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Leveraging teachable moments in cancer prevention by improving HPV vaccination in health professional students (HPS): A systematic review. [2022]

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

Promoting Strategies to Increase HPV Vaccination in the Pediatric Primary Care Setting. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with human papillomavirus vaccines: a protocol for systematic review with network meta-analysis incorporating all randomised controlled trials comparing with placebo, adjuvants and other vaccines. [2023]

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

Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine using the national adverse event following immunization surveillance system from Zhejiang province, 2018-2020. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events following immunization in Ontario's female school-based HPV program. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Co-production of an educational package for the universal human papillomavirus (HPV) vaccination programme tailored for schools with low uptake: a participatory study protocol. [2021]

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

Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

"The problem is not lack of information": A qualitative study of parents and school nurses' perceptions of barriers and potential solutions for HPV vaccination in schools. [2023]