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?

This trial aims to determine if certain strategies can help doctors and clinics increase HPV vaccination rates. The strategies involve educating and supporting healthcare providers to encourage more HPV vaccine recommendations. Researchers will test these strategies in various clinics over time to identify the most effective approach. Clinics with historically low HPV vaccine rates, particularly those serving a large Latino adolescent population, are ideal for participation. As an unphased trial, this study allows participants to contribute to significant public health research that could enhance vaccination rates and community health.

Will I have to stop taking my current medications?

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

What prior data suggests that these implementation strategies are safe?

Previous studies have used facilitator-led strategies to increase HPV vaccination rates in health centers. These strategies train and support health providers to enhance their vaccine recommendations. Research has shown these strategies to be generally safe, as they emphasize education and organization rather than new drugs or medical procedures. No reports of physical harm or negative effects have emerged from these strategies. The goal is to boost vaccination rates by helping health providers communicate more effectively about the importance of the HPV vaccine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the implementation strategies for HPV vaccination because they focus on enhancing how healthcare providers and practices deliver the vaccine, rather than introducing a new drug. Unlike traditional approaches that rely on patient awareness and individual healthcare provider decisions, this method uses facilitator-driven strategies to improve vaccination rates at the clinic level. By tailoring these interventions to the specific needs and workflows of different clinics, the approach has the potential to boost vaccination rates more effectively and sustainably. This trial aims to uncover the best ways to implement these strategies, potentially leading to higher adoption rates and better protection against HPV-related diseases.

What evidence suggests that these implementation strategies are effective for increasing HPV vaccination rates?

This trial will evaluate facilitator-driven provider- and practice-level implementation strategies to increase HPV vaccination rates. Research has shown that a guided process can boost HPV vaccination rates. One study demonstrated that strategies at both the provider and practice levels increased vaccinations over two years. Practices that tailored their methods to local needs outperformed those using standard methods. Another review found that incorporating behavior change theories can enhance communication and encourage vaccinations. These findings suggest that a facilitator can effectively boost HPV vaccination rates. ^{1 2 3 4 6}

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11983866/

a stepped-wedge cluster randomized trial to reduce HPV- ... Combining provider- and practice-level strategies using practice facilitation [63, 64], over a two-year implementation period, HPV vaccine ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05365048

Provider Recommendation and HPV Vaccination The study goal is to evaluate the effectiveness of three implementation strategies (local-tailored, prescribed strategy, and usual care) to improve HPV ...

3. trialx.com trialx.com/clinical-trials/listings/296827/investigating-facilitator-driven-multi-level-implementation-strategies-in-federally-qualified-health-centers-to-improve-provider-recommendation-and-hpv-vaccination-rates-among-latinoa-adolescents/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

Investigating Facilitator-driven, Multi-level Implementation ... Overview. The purpose of this study is to determine the provider- and practice-level characteristics that influence the impact of ...

4. repositories.lib.utexas.edu repositories.lib.utexas.edu/bitstreams/c0863ca2-9234-4bf0-9b94-db7fca8b68e4/download

Facilitator driven Implementation strategies to improve ... •HPV causal agent for cervical cancer (CC)1 and other HPV- related cancers. •CC incidence and mortality rates higher for Hispanic women in Texas,2-3 greater.

5. sciencedirect.com sciencedirect.com/science/article/pii/S009174352500091X

A scoping review of pediatric healthcare provider HPV ... The aim was to systematically analyze scientific literature assessing the use of implementation outcomes and behavior change theories to evaluate communication ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405852117300472

Barriers, facilitators, and potential strategies for increasing ... Facilitators included momentum for improving HPV vaccination, school-entry Tdap requirement, pharmacy-based HPV vaccination, state immunization registry, HEDIS ...