Clinical trial NCT03726151: Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs
Official title: Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Human Papillomavirus Infection
Keywords: Human Papillomavirus
Immunization
Oncogenic viruses
Cervical Cancer
Health Disparities
Comparative effectiveness
System-level Intervention
Federally Qualified Health Centers
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-10-31
Enrollment: 17000
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: HPV vaccine series completion based on electronic health record data
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: Northeast Valley Health Corporation- Canoga Park
state: California
city: Pacoima
country: United States
facility: Northeast Valley Health Corporation- Pacoima
state: California
city: San Fernando
country: United States
facility: Northeast Valley Health Corporation- San Fernando
state: California
city: Santa Clarita
country: United States
facility: Northeast Valley Health Corporation- Santa Clarita
state: California
city: Sun Valley
country: United States
facility: Northeast Valley Health Corporation- Sun Valley
state: California
city: Valencia
country: United States
facility: Northeast Valley Health Corporation- Valencia
state: California
city: Van Nuys
country: United States
facility: Northeast Valley Health Corporation- Van Nuys
state: California
Study officials:
affiliation: Professor, Health Policy and Management, UCLA Fielding School of Public Health
name: Roshan Bastani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, Health Policy and Management, UCLA Fielding School of Public Health
name: Beth Glenn, PhD
role: PRINCIPAL_INVESTIGATOR
References: