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

May 8, 2023 updated by: Roshan Bastani, University of California, Los Angeles
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

17000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Canoga Park, California, United States, 91303
        • Northeast Valley Health Corporation- Canoga Park
      • Pacoima, California, United States, 91331
        • Northeast Valley Health Corporation- Pacoima
      • San Fernando, California, United States, 91340
        • Northeast Valley Health Corporation- San Fernando
      • Santa Clarita, California, United States, 91351
        • Northeast Valley Health Corporation- Santa Clarita
      • Sun Valley, California, United States, 91352
        • Northeast Valley Health Corporation- Sun Valley
      • Valencia, California, United States, 91355
        • Northeast Valley Health Corporation- Valencia
      • Van Nuys, California, United States, 91405
        • Northeast Valley Health Corporation- Van Nuys

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCS-2017C1-6482

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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