Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs

Study Overview
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Brief Summary
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UCLA and Northeast Valley Health Center (NEVHC), a large, multi-site Federally Qualified Health Center (FQHC), are partnering to address underutilization of the prophylactic HPV vaccine among underserved, ethnic minority adolescents receiving care through FQHCs. We will use a cluster randomized 2x2 stepped-wedge factorial study design, implemented in seven NEVHC clinics, to compare the effectiveness of parent reminders (mailed and text), multi-component clinic system strategies, a combined intervention (parent reminders + clinic system strategies) and usual care on HPV vaccine series completion among NEVHC adolescent patients. FQHCs provide essential health care to underserved groups and have the infrastructure to sustain effective strategies to improve preventive care delivery. Therefore, study findings will be invaluable for informing future efforts to improve HPV vaccination at the population-level.

Detailed Description
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The primary aims of this study are to: 1) Examine the effects of two types of parent reminders (mailed, text) and multicomponent clinic system strategies on HPV vaccine completion compared to usual care, 2) Examine the comparative effectiveness of the reminders versus the clinic system strategies and 3) Examine whether combining parent reminders with the clinic system strategies produces larger effects compared to either type of intervention implemented alone. Additional aims include: Explore the relationship between child age (12-14 years versus 15-17 years) and intervention effectiveness, due to the difference in dosing schedules for the two age groups. Examine parent (e.g., language preference) and provider (e.g., specialty) characteristics that may act as moderators of intervention effectiveness. Assess parent perspectives and experiences related to the different interventions. Examine the implementation process (including adaptations) for each of the interventions. Disseminate study findings widely to a local and national audience of relevant stakeholders. The multicomponent clinic system strategies include workflow modifications to minimize missed opportunities for vaccination, provider- and clinic-level audit and feedback, establishment of clinic-level policies and protocols, and will also include provider and staff training regarding workflow modifications and patient communication strategies. The study will be implemented across six study periods of 12 months each. The seven NEVHC clinics will be randomized into three groups (A, B, C). Following a 12-month start-up and observation period (Period 1), as part of a stepped wedge design, Group A will implement the parent reminders beginning in Period 2, Group B will implement the clinic-based intervention beginning in Period 3, and Group C will implement the combined condition beginning in period 4. In Period 5, Group A will crossover to the combined condition. This change from the original protocol was approved by the study funder as of Fall 2021.

Official Title
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Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs

Conditions
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Human Papillomavirus Infection

Intervention / Treatment
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* Behavioral: Parent Reminders
* Behavioral: Multicomponent clinic-system strategies
* Behavioral: Combined Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be a patient at one of the seven Northeast Valley Health Corporation (NEVHC) clinics participating in this study Has had at least one appointment at NEVHC in the last 2 years Must be aged 11-17 Exclusion Criteria: Is not a patient at one of the seven Northeast Valley Health Corporation (NEVHC) clinics participating in this study Has not had an appointment at NEVHC in the last 2 years Is not aged 11-17

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br> | |
| Experimental: Parent Reminders<br> | Behavioral: Parent Reminders<br>* Automated, system-generated mailed or text message reminders<br>|
| Experimental: Multicomponent clinic-system strategies<br> | Behavioral: Multicomponent clinic-system strategies<br>* Workflow modifications to reduce missed opportunities for vaccination Provider- and clinic-level audit and feedback Provider & staff training on workflow modifications and communication strategies<br>|
| Experimental: Combined Condition<br> | Behavioral: Combined Condition<br>* Parent reminders and multicomponent clinic-system strategies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV vaccine series completion based on electronic health record data | We will assess completion of the HPV vaccine series based on the number and the timing of the HPV vaccine doses received according to data in NEVHC's electronic health record system. We will determine completion status based on guidelines from the CDC Advisory Committee on Immunization Practices. For adolescents who initiated the HPV vaccine series before the age of 15, completion will be defined as receiving 2 doses of the HPV vaccine a minimum of 5 months apart. For adolescents who initiated the HPV vaccine series at age 15 or older, completion will be defined as having received 3 doses with the second dose administered at least one month after the first, the third dose received at least 3 months after the second, and the first and third doses administered at least 5 months apart from each other. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus, Immunization, Oncogenic viruses, Cervical Cancer, Health Disparities, Comparative effectiveness, System-level Intervention, Federally Qualified Health Centers