Study of Facilitator-led Strategies to Improve HPV Vaccination Recommendations and Rates Among Latino Adolescents at Federally Qualified Health Centers
Led by The University of Texas Health Science Center, Houston · Updated on 2026-05-04
225
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to understand how different factors at the provider and clinic levels affect the success of strategies led by facilitators to increase healthcare providers recommendations and vaccination rates for Human Papillomavirus HPV among Latinoa adolescents. The study focuses on nine Federally Qualified Health Centers FQHCs with a high Latino adolescent population, evaluating the sustainability and impact of these facilitator-driven strategies over time.
The study involves a facilitator who works with healthcare providers and immunization navigators at each clinic using four key strategies provider education modules, development of a clinical practice plan, training of immunization navigators to carry out the plan, and providing ongoing technical assistance with assessment and feedback. Clinics are randomized into three groups with staggered timing for control and intervention phases lasting from 15 to 27 months for control and 18 to 30 months for intervention periods.
Participants include providers, staff, and parents of adolescent patients at each clinic. Researchers will measure HPV vaccination rates, such as the percentage of adolescents receiving the first and second doses before specific birthday milestones, along with uptake of other vaccines like Tdap and MenACWY. Data will be collected from baseline through about 60 months to assess the effect of the implementation strategies, with regular monitoring and feedback to support adherence and sustainability.
CONDITIONS
Brief Title
Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents
Research Team
D
Daisy Y Morales-Campos, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
The University of Texas Health Science Center, Houston
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor
How This Trial Compares With Other Options
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Facilitator‑driven strategies
Usual practice (control)
What it is
A stepped‑wedge cluster crossover condition where clinics receive facilitator‑driven provider education, implementation planning, staff training, technical assistance, assessment, feedback and booster support to enhance provider recommendations and HPV vaccine delivery.
The control condition is the usual practice period before any facilitator‑driven implementation strategies are introduced.
Role in trial
Active implementation condition applied sequentially in clinics in different steps.
Baseline control condition representing the period before implementation strategies are applied.
Primary use
To improve provider recommendation of HPV vaccine and increase HPV vaccination uptake among eligible adolescents.
To serve as baseline comparator when usual practices are in place without facilitator support.
How it is given or performed
A practice facilitator conducts provider education modules, supports clinical practice planning, trains immunization navigators, and provides ongoing technical assistance, assessment, feedback and booster trainings.
Clinics continue with usual operations without introduction of facilitator‑driven strategies.
Evidence status
Evidence for this specific facilitator‑driven stepped‑wedge intervention is currently being collected in this ongoing trial; results not yet available.
Evidence reflects existing baseline vaccination rates prior to implementation; no outcome data for this period yet published.
Important risks
No safety risks identified; intervention involves education and facilitation only.
No safety risks related to continuing usual practice.
Important limitations
Results may depend on facilitator skill and clinic context; stepped‑wedge design means all sites eventually receive intervention, limiting long‑term comparative control.
Baseline period may not reflect secular trends or external influences; comparisons may be confounded by time‑dependent factors.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 11Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
FQHCs with less than 60% HPV vaccine initiation rate among 11-12 year olds
FQHCs with family medicine and/or pediatric practices
Clinics with at least 50% Latino adolescent patients
Willingness for healthcare providers and staff to receive education, training, and support
Providers aged 18 or older employed at each FQHC (4 staff per practice)
Staff aged 18 or older employed at each FQHC (5 staff per practice)
Implementation team members aged 18 or older employed at each FQHC (4 members per practice)
Parents aged 18 or older of patients aged 11-17 seeking care at each FQHC (25 per practice)
You will not qualify if you...
FQHCs that participated in the pilot study were excluded
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Control Period
Duration - 15 to 27 months depending on clinic assignment
Participants are observed during a control period without intervention to establish baseline vaccination rates.
Periodic visits as part of routine healthcare
Facilitator-driven Implementation
Duration - 18 to 30 months depending on clinic assignment
Participants experience a multi-level implementation strategy including provider education, clinical practice planning, staff training, and ongoing technical assistance to improve HPV vaccination rates.
Ongoing engagement with healthcare providers and staff throughout the intervention period
Follow-up Monitoring
Duration - Up to the end of study at about 60 months from baseline
Participants are monitored for vaccination outcomes and continued assessment after the implementation phase.
Assessments occur during routine visits as part of clinical care
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
Similar Trials
Study of Same-Day Cervical Cancer Screening Using HPV Self-Sampling and Digital Telecytology for HPV-Positive Women in Cameroon
Study of Facilitator-led Strategies to Improve HPV Vaccination Recommendations and Rates Among Latino Adolescents at Federally Qualified Health Centers
Study of HPV Vaccine Antibody Detection in First-void Urine Samples from Different Age and Gender Groups
Evaluating IRIS Device for Treating Cervical Precancer and AI-Based Visual Triage in HPV-Positive Women Ages 30 to 49
Using Liquid Biopsies to Monitor Treatment and Detect Early Recurrence in HPV-Related Cervical and Oropharyngeal Cancers
Study of Self-Collected Vaginal Samples for HPV Testing to Improve Cervical Cancer Prevention in Women 25 and Older
Improving Cervical Cancer Screening in Czech Women Using At-Home or Clinic Self-Sampling and HPV Testing
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Trusted health system implementation strategies to increase vaccination (TRUE SYNERGI): a stepped-wedge cluster randomized trial to reduce HPV-related cancers.
Daisy Y Morales-Campos, Prajakta Adsul, Yuanyuan Liang...