Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03294551 |
| Other study ID # |
17-001559 |
| Secondary ID |
5R01CA187707-02 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 27, 2017 |
| Est. completion date |
November 5, 2019 |
Study information
| Verified date |
May 2021 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The work done in this trial builds off of the work previously conducted by this same research
group in clinicaltrials.gov ID: NCT03057379. Due to some changes in study design, protocol,
and cohort of interest, a new registration was warranted.
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness, and
sustainability of utilizing statewide immunization information systems (IISs) to conduct
centralized reminder recall (R/R) to improve human papillomavirus (HPV) vaccination rates
among adolescents 11-14 years of age.
The latest recommendations from the ACIP, as of February 2017, modified the vaccination
schedule for the HPV series for eligible adolescents ages 11-14. Adolescents who receive dose
#1 between the ages of 11 and 14 are now eligible for their second and final dose 6-12 months
after their initial dose. Despite U.S. guidelines for vaccinating all adolescents starting at
age 11 with the HPV vaccine, in 2012 only 53% of 13-17 year old females had >1 dose and 35%
had 3 doses; 21% of teen males had a vaccination. Modeling studies predict marked reduction
in HPV associated cancers and in disparities in these cancers if high HPV vaccination rates
can be achieved.
With this new dosing schedule for adolescents, the research team proposes to conduct a
randomized control trial (RCT) utilizing the capabilities of the State Immunization
Information System (IIS), and create a HPV-specific R/R autodialer and text message to be
delivered to the parents of patients ages 11-14 of randomly selected practices within New
York State (excluding NYC). Upon conclusion of this trial, researchers will develop a toolkit
for dissemination so that other state IIS systems may replicate these centralized reminder
recall procedures.
Description:
The overarching goal is to evaluate the effectiveness, cost effectiveness, and sustainability
of statewide immunization systems (IISs) to conduct reminder/recall (R/R) to improve human
papillomarvirus (HPV) vaccination rates among adolescents ages 11-14.
Each year, 6.2 million persons are newly infected with HPV and 26,000 new HPV-related
cervical, genital, and oropharyngeal cancers are diagnosed, resulting in >$4 billion in
annual medical costs. Despite U.S. guidelines for vaccinating all adolescents starting at age
11 with the HPV vaccine, in 2012 only 53% of 13-17 year old females had >1 dose and 35% had 3
doses; 21% of teen males had a vaccination.
The most effective strategy for improving vaccination rates is patient reminder/recall (R/R).
Recent literature from Melissa Stockwell found that utilization of a new R/R modality, i.e.
text messaging, positively impacted influenza vaccination rates among the adolescents
enrolled in the study. Although R/R is already considered a "best practice" for improving
vaccination rates, very few practices use reminder/recall for any vaccinations because of
costs and lack of personnel time; and even fewer use reminder/recall for HPV vaccine.
Furthermore, since the Advisory Committee on Immunization Practices (ACIP) modified the
schedule for the HPV series for adolescents' age 11-14 years, those who receive dose #1
between ages of 11 and 14 years are now eligible for their second and final dose 6-12 months
after their initial dose. This change in dosing schedule could influence HPV vaccine visit
scheduling procedures within Family Practice and/or Pediatric Clinics, and would therefore
effect timing and frequency of any R/R strategies currently in place. Therefore, the UCLA
(overseeing the work to be done in NY) and University of Colorado at Denver research teams
unite to understand how the use of centralized R/R to disseminate reminders, via text
messages and autodialer calls, to patients eligible for the 2-dose HPV vaccine could impact
vaccination rates among adolescents ages 11-14. This will be the first head-to-head RCT
comparing text message vs. autodialer reminders to standard of care control
The aim of the study is as follows:
To assess the impact and cost-effectiveness of autodialer IIS R/R versus text message based
IIS R/R versus standard-of-care control (no reminder recall) in increasing initiation and
completion of the 2-dose HPV vaccine series among adolescents 11-14 years of age. The
investigators will use a within-practice randomized control trial, randomizing patients
within 150 practices to the aforementioned intervention arms.
Hypothesis 1: All centralized IIS R/R modalities will be more effective than usual care
Hypothesis 2: Text messaging will be more cost-effective than other modalities
Upon completion of the study, the investigators will have a feasible, sustainable,
cost-effective model for HPV vaccination reminders that could be scaled up on the national
level to help prevent HPV-related cancers. Additionally, this research will be adding
significant new knowledge to the field as no such studies exist examining the impact of
educational text message R/R on HPV vaccination rates among adolescents eligible for the
2-dose series.
