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

NCT03726151 | Completed

• 1 other identifier: PCS-2017C1-6482
• Study Type: interventional
• Target: 17,000
• Locations: 1 country
• Sites: 7

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.

Conditions

Human Papillomavirus Infection

Keywords

Human Papillomavirus; Immunization; Oncogenic viruses; Cervical Cancer; Health Disparities; Comparative effectiveness; System-level Intervention; Federally Qualified Health Centers

Outcome Measures

Primary Outcomes (1)

• HPV vaccine series completion based on electronic health record data

  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

Study Arms (4)

Usual Care

NO INTERVENTION

Parent Reminders

EXPERIMENTAL

Behavioral: Parent Reminders

Multicomponent clinic-system strategies

EXPERIMENTAL

Behavioral: Multicomponent clinic-system strategies

Combined Condition

EXPERIMENTAL

Behavioral: Combined Condition

Interventions

Parent Reminders BEHAVIORAL

Automated, system-generated mailed or text message reminders

Parent Reminders

Multicomponent clinic-system strategies BEHAVIORAL

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

Multicomponent clinic-system strategies

Combined Condition BEHAVIORAL

Parent reminders and multicomponent clinic-system strategies

Combined Condition

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (7)

Northeast Valley Health Corporation- Canoga Park

Canoga Park, California, 91303, United States

Location

Northeast Valley Health Corporation- Pacoima

Pacoima, California, 91331, United States

Location

Northeast Valley Health Corporation- San Fernando

San Fernando, California, 91340, United States

Location

Northeast Valley Health Corporation- Santa Clarita

Santa Clarita, California, 91351, United States

Location

Northeast Valley Health Corporation- Sun Valley

Sun Valley, California, 91352, United States

Location

Northeast Valley Health Corporation- Valencia

Valencia, California, 91355, United States

Location

Northeast Valley Health Corporation- Van Nuys

Van Nuys, California, 91405, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Health Policy and Management, UCLA Fielding School of Public Health

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 31, 2018
• Study Start: May 1, 2018
• Primary Completion: March 28, 2024
• Study Completion: May 31, 2024
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (7)