Human Papillomavirus InfectionNCT03726151
Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs
A study testing Parent Reminders, Multicomponent clinic-system strategies and Combined Condition in people with Human Papillomavirus Infection, run by University of California, Los Angeles at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Parent Reminders, Multicomponent clinic-system strategies and Combined Condition
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,000 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 May 2018to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Northeast Valley Health Corporation- Canoga Park
Canoga Park, California, 91303
Northeast Valley Health Corporation- Pacoima
Pacoima, California, 91331
Northeast Valley Health Corporation- San Fernando
San Fernando, California, 91340
Northeast Valley Health Corporation- Santa Clarita
Santa Clarita, California, 91351
Northeast Valley Health Corporation- Sun Valley
Sun Valley, California, 91352
Northeast Valley Health Corporation- Valencia
Valencia, California, 91355
Northeast Valley Health Corporation- Van Nuys
Van Nuys, California, 91405
About this study
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.
Read the detailed 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.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Parent Reminders, Multicomponent clinic-system strategies, Combined Condition
- Keywords
- Human Papillomavirus, Immunization, Oncogenic viruses, Cervical Cancer, Health Disparities, Comparative effectiveness, System-level Intervention, Federally Qualified Health Centers
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent RemindersBehavioural
Automated, system-generated mailed or text message reminders
Multicomponent clinic-system strategiesBehavioural
- 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 ConditionBehavioural
Parent reminders and multicomponent clinic-system strategies
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| Parent Reminders | Experimental | Not described Receives: Behavioral: Parent Reminders |
| Multicomponent clinic-system strategies | Experimental | Not described Receives: Behavioral: Multicomponent clinic-system strategies |
| Combined Condition | Experimental | Not described Receives: Behavioral: Combined Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 May 2018
- Primary completion28 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 17,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Roshan Bastani, University of California, Los Angeles
- Investigators
- Roshan Bastani, PhD, Principal investigator, Professor, Health Policy and Management, UCLA Fielding School of Public HealthBeth Glenn, PhD, Principal investigator, Professor, Health Policy and Management, UCLA Fielding School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726151
- Sponsor's protocol ID
- PCS-2017C1-6482
- Status last verified
- May 2026
- First submitted
- 26 Oct 2018
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs
- ClinicalTrials.gov ID
- NCT03726151
- Acronym / sponsor ID
- PCS-2017C1-6482
- Conditions
- Human Papillomavirus Infection
- Keywords
- Human Papillomavirus, Immunization, Oncogenic viruses, Cervical Cancer, Health Disparities, Comparative effectiveness, System-level Intervention, Federally Qualified Health Centers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,000 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 May 2018 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent RemindersAutomated, system-generated mailed or text message reminders | Behavioural | Parent Reminders |
| Multicomponent clinic-system strategies1. 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 | Behavioural | Multicomponent clinic-system strategies |
| Combined ConditionParent reminders and multicomponent clinic-system strategies | Behavioural | Combined Condition |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshan Bastani, PhD principal investigator
Professor, Health Policy and Management, UCLA Fielding School of Public Health
Beth Glenn, PhD principal investigator
Professor, Health Policy and Management, UCLA Fielding School of Public Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Reminders, Multicomponent clinic-system strategies and Combined Condition in people with Human Papillomavirus Infection, run by University of California, Los Angeles at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccine series completion based on electronic health record data (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.