Implementation Strategies for HPV Vaccination

Overseen By Daisy Y Morales-Campos, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Pilot study participants

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

Compensation: Varies

Number of Visits: Unknown

2142 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine the provider- and practice-level characteristics that influence the impact of implementation strategies guided by practice facilitation in each clinical practice, to test whether the facilitator-driven provider- and practice-level implementation strategies increase provider recommendations and Human Papilloma Virus (HPV) vaccination rates and to evaluate implementation and future sustainability of the facilitator-driven implementation strategies across nine clinical practice sites

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the implementation strategy for increasing HPV vaccination rates safe for humans?

The research articles focus on strategies to increase HPV vaccination rates and do not provide specific safety data for the implementation strategies themselves. However, the HPV vaccine, which these strategies aim to promote, is described as safe and highly effective. ^{1 2 3 4 5}

How is the Facilitator-driven provider- and practice-level implementation strategy for HPV vaccination different from other treatments?

This treatment is unique because it focuses on implementing evidence-based strategies at the provider and practice level to increase HPV vaccination rates, rather than directly administering a drug. It uses tools like decision support systems to guide healthcare providers in improving vaccination practices, making it more about enhancing healthcare delivery rather than a new medication. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Facilitator-driven provider- and practice-level implementation strategies for HPV vaccination?

Research shows that using evidence-based strategies, like having vaccine champions and improving provider communication, can increase HPV vaccination rates. These strategies have been found to make the vaccination process easier and more effective in clinics. ^{1 7 8 9 10}

Who Is on the Research Team?

Daisy Y Morales Campos, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for healthcare providers and practices within Federally Qualified Health Centers aiming to improve HPV vaccination rates among Latino/a adolescents. Specific eligibility criteria are not detailed, but the focus is on provider behavior and practice-level strategies.

Inclusion Criteria

Total adolescent patient population at least 50% Latino

I am over 18 and work at a health center as part of the vaccine team.

My practice has an HPV vaccine initiation rate below 60% for 11-12 year olds.

Exclusion Criteria

FQHCs that participated in the pilot study were excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

Clinics are in a control phase to establish baseline data before intervention

15-27 months

Intervention

Implementation of facilitator-driven strategies to increase provider recommendations and HPV vaccination rates

18-30 months

Follow-up

Participants are monitored for the sustainability of implementation strategies

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Facilitator-driven provider- and practice-level implementation strategies

Trial Overview The study tests if facilitator-driven strategies at both provider and practice levels can boost recommendations for HPV vaccinations and actual vaccination rates in nine different clinical sites.

How Is the Trial Designed?

Group I: Step 3 (3 clinics)-27 months control then 18 months intervention Experimental Treatment 1 Intervention

Group II: Step 2 (3 clinics)-21 months control then 24 months intervention Experimental Treatment 1 Intervention

Group III: Step 1 (3 clinics)-15 months control then 30 months intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The HPV vaccination quality improvement (QI) program successfully trained 95% of participating physicians, demonstrating effective implementation of training and feedback strategies in a large health care system.

While the overall increase in HPV vaccination coverage was modest (8.6% in the QI arm vs. 6.4% in the control), a significant improvement of 3.3 percentage points was observed when excluding data from physicians with poor reporting, indicating potential for greater impact with refined implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Evidence-Based Strategies to Improve HPV Vaccine Delivery. Gilkey, MB., Parks, MJ., Margolis, MA., et al.[2020]

The Adolescent Vaccination Program Implementation Tool (AVP-IT) was developed to enhance HPV vaccination rates in pediatric clinics by providing tailored guidance on six evidence-based strategies, and it was positively received by healthcare providers in usability testing.

Healthcare providers found the AVP-IT to be easier and more effective for implementing vaccination strategies compared to usual practices, indicating its potential as a scalable tool to improve HPV vaccination rates in community clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation and Formative Evaluation of Online Decision Support to Implement Evidence-Based Strategies to Increase HPV Vaccination Rates in Pediatric Clinics. Shegog, R., Savas, LS., Frost, EL., et al.[2023]

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]

This trial will evaluate two ECHO-delivered interventions aimed at increasing HPV vaccination rates among adolescents aged 11-14 in 36 primary care clinics, focusing on the effectiveness of provider training and parent recall notices.

The study aims to demonstrate that these interventions can improve HPV vaccination uptake, ultimately helping to prevent HPV-related cancers by addressing communication needs for both healthcare providers and parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial. Calo, WA., Shah, PD., Fogel, BN., et al.[2023]

Citations

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

Implementing Evidence-Based Strategies to Improve HPV Vaccine Delivery. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinician knowledge, clinician barriers, and perceived parental barriers regarding human papillomavirus vaccination: Association with initiation and completion rates. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Adaptation and Formative Evaluation of Online Decision Support to Implement Evidence-Based Strategies to Increase HPV Vaccination Rates in Pediatric Clinics. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Pre-implementation evaluation for an HPV vaccine provider communication intervention among primary care clinics. [2023]

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

HPV vaccination: Pilot study assessing characteristics of high and low performing primary care offices. [2020]

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

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

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

Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial. [2023]

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

Coaching primary care clinics for HPV vaccination quality improvement: Comparing in-person and webinar implementation. [2020]

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

What affects human papillomavirus vaccination rates? A qualitative analysis of providers' perceptions. [2022]