Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents

Обзор

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

Вмешательства

• Другое 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

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: From baseline to end of study ( about 60 months from baseline)]

Вторичные конечные точки (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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: From baseline to end of study ( about 60 months from baseline)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

-FQHCs that participated in the pilot study were excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Публикации

• 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

Идентификаторы

NCT: NCT06598475 · HSC-SPH-24-0335

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗