Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03726151 |
| Other study ID # |
PCS-2017C1-6482 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2018 |
| Est. completion date |
October 31, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
