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Trial 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
NCT ID:
NCT06598475
Condition:
Human Papillomavirus Infection
Conditions: Official terms:
Papillomavirus Infections
Conditions: Keywords:
HPV vaccination
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates
Description:
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 practice in two additional modules
and encourage providers to identify strategies to increase HPV vaccination.
- Training and education for staff (Immunization Navigators): The facilitator will
train immunization navigators to implement the plan, and practice immunization
navigators will implement the plan.
- Technical assistance plus assessment and feedback: During implementation of the
plan, the facilitator will provide technical assistance, ongoing assessment and
feedback, and booster trainings.
Arm group label:
Step 1 (3 clinics)-15 months control then 30 months intervention
Arm group label:
Step 2 (3 clinics)-21 months control then 24 months intervention
Arm group label:
Step 3 (3 clinics)-27 months control then 18 months intervention
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
Criteria for 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.
Gender:
All
Minimum age:
11 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas Health Science Center at Houston
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Daisy Y Morales-Campos, PhD
Phone:
210-276-9042
Email:
Daisy.Y.MoralesCampos@uth.tmc.edu
Start date:
January 1, 2025
Completion date:
August 1, 2028
Lead sponsor:
Agency:
The University of Texas Health Science Center, Houston
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
The University of Texas Health Science Center, Houston
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06598475
