Educational Program for HPV Vaccination Confidence

Recruiting in Lexington (>99 mi)

Overseen By Anne E Ray, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Anne E Ray

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

Compensation: Varies

Number of Visits: 4

58 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Provider Elaborated Prompts, Web Application for increasing HPV vaccination confidence?

Research shows that decision support systems, which include educational components and reminders, are acceptable to parents and can prompt them to seek information and discuss the HPV vaccine, potentially leading to informed decision-making. Additionally, educational interventions for healthcare providers have been shown to significantly improve their knowledge about the HPV vaccine, which is crucial for making strong recommendations to patients. ^{1 2 3 4 5}

Is the educational program for HPV vaccination confidence safe for humans?

The research articles provided do not contain specific safety data about the educational program for HPV vaccination confidence, but they do discuss safety concerns related to the HPV vaccine itself, which is generally considered safe with some reported adverse events. ^{4 6 7 8 9}

How is the Educational Program for HPV Vaccination Confidence different from other treatments for HPV vaccination rates?

This treatment is unique because it uses Provider Elaborated Prompts and a Web Application to educate and build confidence in HPV vaccination, focusing on improving communication between healthcare providers and patients. Unlike traditional methods, it leverages technology and personalized prompts to address concerns and increase vaccination rates. ^{10 11 12 13 14}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the feasibility of intervention implementation in two clinics in rural KY, and its preliminary efficacy with regards to increasing vaccine confidence in a sample of vaccine hesitant parents. Hypothesis: Parents will report increased vaccine confidence scores post-intervention. Data from this study will provide preliminary data for a larger scale evaluation of the intervention. Participants will be asked to complete surveys, view a web-based intervention and then visit with their child's healthcare provider.

Research Team

Anne E Ray, PhD

Principal Investigator

University of Kentucky

Aaron Kruse-Diehr, PhD

Principal Investigator

University of Kentucky

Michael Hecht, PhD

Principal Investigator

Real Prevention, LLC

Eligibility Criteria

This trial is for parents who are hesitant about the HPV vaccine and live in rural Kentucky. They must be willing to complete surveys, use a web application, and visit their child's healthcare provider.

Inclusion Criteria

Status as a U.S. resident

Self-reported ability to read English

I am a mother or female guardian of a child aged 11-17.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Intervention

Participants complete a pre-test survey, view tailored intervention content including Parents' Stories videos, and receive personalized feedback

1 week

1 visit (virtual)

Provider Interaction

During a healthcare provider visit, providers deliver elaborated prompts related to the vaccine

1 day

1 visit (in-person)

Follow-up

Participants receive a link to the post-test survey two weeks following their appointment

2 weeks

1 visit (virtual)

Treatment Details

Interventions

• Provider Elaborated Prompts
• Web Application

Trial Overview The study tests if using prompts from providers and a web app can boost parents' confidence in the HPV vaccine. It will compare confidence levels before and after the intervention.

Participant Groups

Group I: Parents' Stories Web Application + Provider Elaborated Prompts Experimental Treatment 2 Interventions

Participating parents will be asked to navigate a web application that consists of (a) brief, 90-second narrative videos that encourage parent-provider communication about the vaccine and (b) personalized feedback to parents that is tailored to provide educational content in response to their concerns and be motivational in nature. Providers will provide elaborated prompts related to the vaccine when meeting with parents tailored to their concerns.

Who Is Running the Clinical Trial?

Anne E Ray

Lead Sponsor

Trials

2

Recruited

660+

Merck Institute for Therapeutic Research

Collaborator

Trials

2

Recruited

80,100+

Real Prevention, LLC

Industry Sponsor

Trials

7

Recruited

1,900+

Findings from Research

The electronic medical record (EMR)-based HPV vaccine decision support intervention was well-received by parents, with 46% recalling the reminder call, which encouraged them to seek more information and discuss the vaccine with others.

Parents whose daughters attended practices using the clinician-focused intervention were more likely to have discussions about the HPV vaccine during preventive visits, indicating that the intervention positively influenced clinician engagement and communication about vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation and acceptability of an HPV vaccination decision support system directed at both clinicians and families. Mayne, S., Karavite, D., Grundmeier, RW., et al.[2021]

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 structured 30-minute presentation significantly improved HPV vaccine knowledge among 427 healthcare providers, including physicians, medical students, and nurses, with average scores rising from 8 to 15 out of 16 (P < .001).

Younger participants and non-physician healthcare workers showed the greatest improvement in knowledge, highlighting the effectiveness of targeted educational interventions to address knowledge gaps in HPV vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief educational intervention increases providers' human papillomavirus vaccine knowledge. Berenson, AB., Rahman, M., Hirth, JM., et al.[2022]

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]

Healthcare providers are less likely to recommend the HPV vaccine if they feel uncomfortable discussing sexual health, perceive parental hesitance, or view patients as low risk, which can negatively impact vaccination rates.

Patients, particularly younger individuals, males, and those from racial/ethnic minorities, are less likely to receive strong recommendations for the HPV vaccine, highlighting the need for clearer communication strategies from providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider communication about HPV vaccination: A systematic review. Gilkey, MB., McRee, AL.[2023]

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]

References

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

The implementation and acceptability of an HPV vaccination decision support system directed at both clinicians and families. [2021]

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

US Health Care Clinicians' Knowledge, Attitudes, and Practices Regarding Human Papillomavirus Vaccination: A Qualitative Systematic Review. [2022]

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

Evaluation of Pediatric Human Papillomavirus Vaccination Provider Counseling Written Materials: A Health Literacy Perspective. [2019]

4. 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]

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

A brief educational intervention increases providers' human papillomavirus vaccine knowledge. [2022]

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

Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. [2019]

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

"I can be the Judge of What's Serious": A Qualitative Pilot Study of Parents' Responses to Messaging About Side Effects of the HPV Vaccine. [2023]

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

Provider communication about HPV vaccination: A systematic review. [2023]

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

A content analysis of HPV vaccination messages available online. [2019]

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

Beta-test Results for an HPV Information Web site: GoHealthyGirls.org - Increasing HPV Vaccine Uptake in the United States. [2021]

11. 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]

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

Development of a community pharmacy human papillomavirus vaccine program for underinsured university students along the United States/Mexico border. [2021]

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

Cancer Prevention Education for Providers, Staff, Parents, and Teens Improves Adolescent Human Papillomavirus Immunization Rates. [2022]

14. Australia pubmed.ncbi.nlm.nih.gov

Opportunities to increase rates of human papillomavirus vaccination in the New South Wales school program through enhanced catch-up. [2018]