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OpenTrials
Completed

NCT Number: NCT03726151

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

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.

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Key information

Conditions

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

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeast Valley Health Corporation- Canoga Park, Canoga Park, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parent Reminders

Behavioral

Automated, system-generated mailed or text message reminders

Multicomponent clinic-system strategies

Behavioral
  • Workflow modifications to reduce missed opportunities for vaccination
  • Provider- and clinic-level audit and feedback
  • Provider & staff training on workflow modifications and communication strategies

Combined Condition

Behavioral

Parent reminders and multicomponent clinic-system strategies

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2018
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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