Recruiting NCT06598475
Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates.
- Who it may be relevant to
- Registry conditions: Human Papillomavirus Infection. Basic parameters: 11 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Other Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates
The practice facilitator (UTHealth research staff) will implement the following 4 strategies with providers and immunization navigators at each practice: * Facilitator-driven provider education: The practice facilitator will conduct one provider education module (5 total modules) over three months with health care providers using a booklet and resource binder. * Facilitator-driven clinical practice plan: The practice facilitator will assist the implementation team in creating their clinical pra
Primary outcome measures
- Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 13th birthday. [Time frame: From baseline to end of study ( about 60 months from baseline)]
- Percentage of vaccine-eligible males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after their first dose and before their 13th birthday. [Time frame: From baseline to end of study ( about 60 months from baseline)]
Secondary outcome measures (6)
- Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 18th birthday. [Time frame: From baseline to end of study ( about 60 months from baseline)]
- Percentage of vaccine-eligible 13-14 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after first dose and before their 15th birthday [Time frame: From baseline to end of study ( about 60 months from baseline)]
- Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 2 months after first dose and before their 18th birthday [Time frame: From baseline to end of study ( about 60 months from baseline)]
- Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the third valid dose of the HPV vaccine series 4 months after second dose and before their 18th birthday. [Time frame: From baseline to end of study ( about 60 months from baseline)]
- Percentage of non-well visits in which HPV vaccine was not administered, among all visits for active vaccine-eligible patients ages 11-17 by clinic [Time frame: From baseline to end of study ( about 60 months from baseline)]
- Percentage of males and females at each clinic who received Tdap and MenACWY at age 11 as a requirement to attend 7th grade in Texas. [Time frame: From baseline to end of study ( about 60 months from baseline)]
Eligibility criteria
Inclusion criteria
- FQHC's with less than 60% HPV vaccine initiation rate for 11-12 year old adolescents overall at their practice sites
- FQHC's that have family medicine and/or pediatric practices
- a total adolescent patient population at least 50% Latino
- be willing for Health Care Provider (HCP) and staff members to receive education, training, and support; complete standardized measurement, and agree to randomization.
- Providers, aged 18 and over, employed at each FQHC (4 staff per practice)
- Staff, aged 18 and over, employed at each FQHC (5 staff per practice)
- Implementation team members (i.e., administrative designee, health care providers, immunization navigators, and other staff), aged 18 and over, employed at each FQHC (4 members per practice)
- Parents (aged 18 and over) of patients ages 11-17 seeking care at each FQHC (25 per practice).
Exclusion criteria
-FQHCs that participated in the pilot study were excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Publications
- Morales-Campos DY, Adsul P, Liang Y, Donovan E, Moczygemba LR, Kahn JA. Trusted health system implementation strategies to increase vaccination (TRUE SYNERGI): a stepped-wedge cluster randomized trial to reduce HPV-related cancers. BMC Public Health. 2025 Apr 9;25(1):1331. doi: 10.1186/s12889-025-22273-7. PMID 40205591
Identifiers
NCT: NCT06598475 · HSC-SPH-24-0335