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

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ClinicalTrials.gov Identifier: NCT03726151
Recruitment Status : Enrolling by invitation
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Roshan Bastani, University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Behavioral: Parent Reminders Behavioral: Multicomponent clinic-system strategies Behavioral: Combined Condition Not Applicable

Detailed Description:

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 five 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 and Group B will crossover to the combined condition.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Arm Intervention/treatment
No Intervention: Usual Care
Experimental: Parent Reminders Behavioral: Parent Reminders
Automated, system-generated mailed or text message reminders

Experimental: Multicomponent clinic-system strategies Behavioral: Multicomponent clinic-system strategies
  1. Workflow modifications to reduce missed opportunities for vaccination
  2. Provider- and clinic-level audit and feedback
  3. Provider & staff training on workflow modifications and communication strategies

Experimental: Combined Condition Behavioral: Combined Condition
Parent reminders and multicomponent clinic-system strategies




Primary Outcome Measures :
  1. HPV vaccine series completion based on electronic health record data [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726151


Locations
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United States, California
Northeast Valley Health Corporation- Canoga Park
Canoga Park, California, United States, 91303
Northeast Valley Health Corporation- Pacoima
Pacoima, California, United States, 91331
Northeast Valley Health Corporation- San Fernando
San Fernando, California, United States, 91340
Northeast Valley Health Corporation- Santa Clarita
Santa Clarita, California, United States, 91351
Northeast Valley Health Corporation- Sun Valley
Sun Valley, California, United States, 91352
Northeast Valley Health Corporation- Valencia
Valencia, California, United States, 91355
Northeast Valley Health Corporation- Van Nuys
Van Nuys, California, United States, 91405
Sponsors and Collaborators
University of California, Los Angeles
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Roshan Bastani, PhD Professor, Health Policy and Management, UCLA Fielding School of Public Health
Principal Investigator: Beth Glenn, PhD Professor, Health Policy and Management, UCLA Fielding School of Public Health

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Responsible Party: Roshan Bastani, Professor, Health Policy and Management, UCLA Fielding School of Public Health, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03726151     History of Changes
Other Study ID Numbers: PCS-2017C1-6482
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roshan Bastani, University of California, Los Angeles:
Human Papillomavirus
Immunization
Oncogenic viruses
Cervical Cancer
Health Disparities
Comparative effectiveness
System-level Intervention
Federally Qualified Health Centers
Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs