Summary

Eligibility
for people ages 11-17 (full criteria)
Location
at Van Nuys, California and other locations
Dates
study started
completion around
Principal Investigator
by Roshan Bastani, PhDBeth Glenn, PhD

Description

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.

Details

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.

Keywords

Human Papillomavirus Infection, Human Papillomavirus, Immunization, Oncogenic viruses, Cervical Cancer, Health Disparities, Comparative effectiveness, System-level Intervention, Federally Qualified Health Centers, Papillomavirus Infections, Multicomponent clinic-system strategies, Combined Condition, Parent Reminders

Eligibility

You can join if…

Open to people ages 11-17

  • 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

You CAN'T join if...

  • 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

Locations

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

Lead Scientists at UCLA

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT03726151
Study Type
Interventional
Participants
Expecting 17000 study participants
Last Updated