Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papillomavirus Infection
Keywords: HPV vaccination
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-09-19
Enrollment: 2142
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a stepwise cluster randomized control design study. There will be 3 clusters (FQHC's) having 3 practices each
Primary purpose: PREVENTION

Brief summary: 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


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.

Primary outcomes:
measure: 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.
timeFrame: From baseline to end of study ( about 60 months from baseline)
measure: 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.
timeFrame: From baseline to end of study ( about 60 months from baseline)
Secondary outcomes:
measure: 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.
timeFrame: From baseline to end of study ( about 60 months from baseline)
measure: 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
timeFrame: From baseline to end of study ( about 60 months from baseline)
measure: 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
timeFrame: From baseline to end of study ( about 60 months from baseline)
measure: 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.
timeFrame: From baseline to end of study ( about 60 months from baseline)
measure: 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
timeFrame: From baseline to end of study ( about 60 months from baseline)
measure: 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.
timeFrame: From baseline to end of study ( about 60 months from baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Daisy Y Morales Campos, PhD
role: PRINCIPAL_INVESTIGATOR
References: