Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03726151|
Recruitment Status : Enrolling by invitation
First Posted : October 31, 2018
Last Update Posted : November 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus Infection||Behavioral: Parent Reminders Behavioral: Multicomponent clinic-system strategies Behavioral: Combined Condition||Not Applicable|
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 five 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 and Group B will crossover to the combined condition.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17000 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2022|
|No Intervention: Usual Care|
|Experimental: Parent Reminders||
Behavioral: Parent Reminders
Automated, system-generated mailed or text message reminders
|Experimental: Multicomponent clinic-system strategies||
Behavioral: Multicomponent clinic-system strategies
|Experimental: Combined Condition||
Behavioral: Combined Condition
Parent reminders and multicomponent clinic-system strategies
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726151
|United States, California|
|Northeast Valley Health Corporation- Canoga Park|
|Canoga Park, California, United States, 91303|
|Northeast Valley Health Corporation- Pacoima|
|Pacoima, California, United States, 91331|
|Northeast Valley Health Corporation- San Fernando|
|San Fernando, California, United States, 91340|
|Northeast Valley Health Corporation- Santa Clarita|
|Santa Clarita, California, United States, 91351|
|Northeast Valley Health Corporation- Sun Valley|
|Sun Valley, California, United States, 91352|
|Northeast Valley Health Corporation- Valencia|
|Valencia, California, United States, 91355|
|Northeast Valley Health Corporation- Van Nuys|
|Van Nuys, California, United States, 91405|
|Principal Investigator:||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|