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

Human Papillomavirus Infection Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

• NCT number: NCT03726151
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2018
• Completion date: October 31, 2023