VaccinesNCT03294551
HPV Centralized R/R RCT #2 - New York State
A study testing HPV Vaccine Reminder Recall - Autodialer and HPV Vaccine Reminder Recall - Texting in people with Vaccines, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Vaccines
- What is being tested?
- HPV Vaccine Reminder Recall - Autodialer and HPV Vaccine Reminder Recall - Texting
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37,003 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2017to 5 Nov 2019
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 11 to 14 years of age
- patient of a participating practice in New York State (practices were randomly selected)
- is due for an HPV dose at baseline, or
- has initiated but not yet completed the HPV series at baseline
- immunization record within the New York State Immunization Information System (NYSIIS) database
Who cannot join
- is not a patient of a participating practice that was randomly selected in New York State
- has completed the HPV vaccination series
- does not have a valid record within the NYSIIS database
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Enhancing HPV Vaccination Rates for 11-14 Year Old Adolescents Using New York State's Immunization Information System
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.
Read more
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.
Read the detailed 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.
- Conditions
- Vaccines
- Being tested
- HPV Vaccine Reminder Recall - Autodialer, HPV Vaccine Reminder Recall - Texting
- Keywords
- HPV Vaccine, immunization registry, Reminder recall (R/R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Vaccine Reminder Recall - AutodialerBehavioural
Investigators will send out HPV vaccine reminder recall notices via autodialer message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders)
HPV Vaccine Reminder Recall - TextingBehavioural
Investigators will send out HPV vaccine reminder recall notices via text message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders)
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Control | No intervention | Usual source of care |
| HPV Vaccine Reminder Recall - Autodialer | Experimental | HPV Vaccine Reminder Recall - Autodialer: Receive up to 4 reminders via telephone (live call or voicemail) - includes brief educational message + providers name + providers telephone number Receives: Behavioral: HPV Vaccine Reminder Recall - Autodialer |
| HPV Vaccine Reminder Recall - Texting | Experimental | HPV Vaccine Reminder Recall - Texting: Receive up to 4 reminders via text message - includes brief educational message + providers name + providers telephone number Receives: Behavioral: HPV Vaccine Reminder Recall - Texting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of the HPV 2-dose series
Receipt and documentation of the initial dose of the vaccine within the series as recorded in the NYSIIS database. Investigators are allowing 5 months after the initial reminder recall was sent as the timeline of attributing vaccination status to the intervention
Measured: 5 months from the first reminder received for the first dose of HPV vaccine
Completion of the HPV 2-dose series
Receipt and documentation of the final dose of the vaccine series as recorded within the NYSIIS database. Investigators are allowing up to 5 months after the first reminder recall for the second dose was received. If vaccination is received after that 5 month period, investigators will not attribute change in vaccination status to the reminder.
Measured: 5 months from the first reminder received for the last dose of HPV vaccine
Secondary outcomes (1)
Cost of the R/R intervention - autodialers and texting
A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer or text message) is the most cost-effective in relation to improving HPV vaccination rates among 11-14 year old adolescents as compared to the control, as well as comparing the two interventions arms to one another.
Measured: 17 months - entirety of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start27 Oct 2017
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaccinesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Colorado, Denver, New York State Department of Health
- Responsible party
- Principal investigator, Peter G Szilagyi, MD MPH, University of California, Los Angeles
- Investigators
- Peter Szilagyi, MD MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294551
- Sponsor's protocol ID
- 17-001559
- Other IDs
- 5R01CA187707-02
- Status last verified
- May 2021
- First submitted
- 22 Sep 2017
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The aggregate results will be published in a peer reviewed journal.
Publications
Gurfinkel D, Kempe A, Albertin C, Breck A, Zhou X, Vangala S, Beaty B, Rice J, Tseng CH, Campbell JD, Valderrama R, Rand C, Humiston SG, Roth H, Arora S, Szilagyi P. Centralized Reminder/Recall for Human Papillomavirus Vaccination: Findings From Two States-A Randomized Clinical Trial. J Adolesc Health. 2021 Oct;69(4):579-587. doi: 10.1016/j.jadohealth.2021.02.023. Epub 2021 Apr 10.
PubMed 33846054
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing HPV Vaccination Rates for 11-14 Year Old Adolescents Using New York State's Immunization Information System
- ClinicalTrials.gov ID
- NCT03294551
- Acronym / sponsor ID
- 17-001559
- Conditions
- Vaccines
- Keywords
- HPV Vaccine, immunization registry, Reminder recall (R/R)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37,003 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Colorado, Denver, New York State Department of Health
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 27 Sep 2017 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Control | No intervention | –Usual source of care |
| HPV Vaccine Reminder Recall - Autodialer | Experimental | Behavioral: HPV Vaccine Reminder Recall - AutodialerHPV Vaccine Reminder Recall - Autodialer: Receive up to 4 reminders via telephone (live call or voicemail) - includes brief educational message + providers name + providers telephone number |
| HPV Vaccine Reminder Recall - Texting | Experimental | Behavioral: HPV Vaccine Reminder Recall - TextingHPV Vaccine Reminder Recall - Texting: Receive up to 4 reminders via text message - includes brief educational message + providers name + providers telephone number |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 11 to 14 years of age
- patient of a participating practice in New York State (practices were randomly selected)
- is due for an HPV dose at baseline, or
- has initiated but not yet completed the HPV series at baseline
- immunization record within the New York State Immunization Information System (NYSIIS) database
Key exclusion criteria (3 listed)
- is not a patient of a participating practice that was randomly selected in New York State
- has completed the HPV vaccination series
- does not have a valid record within the NYSIIS database
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 |
|---|---|---|
| HPV Vaccine Reminder Recall - AutodialerInvestigators will send out HPV vaccine reminder recall notices via autodialer message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders) | Behavioural | HPV Vaccine Reminder Recall - Autodialer |
| HPV Vaccine Reminder Recall - TextingInvestigators will send out HPV vaccine reminder recall notices via text message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders) | Behavioural | HPV Vaccine Reminder Recall - Texting |
Primary outcome
Initiation of the HPV 2-dose series
Time frame: 5 months from the first reminder received for the first dose of HPV vaccine
Receipt and documentation of the initial dose of the vaccine within the series as recorded in the NYSIIS database. Investigators are allowing 5 months after the initial reminder recall was sent as the timeline of attributing vaccination status to the intervention
Completion of the HPV 2-dose series
Time frame: 5 months from the first reminder received for the last dose of HPV vaccine
Receipt and documentation of the final dose of the vaccine series as recorded within the NYSIIS database. Investigators are allowing up to 5 months after the first reminder recall for the second dose was received. If vaccination is received after that 5 month period, investigators will not attribute change in vaccination status to the reminder.
1 secondary outcome
Cost of the R/R intervention - autodialers and texting
Time frame: 17 months - entirety of the trial
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 27 May 2021.
- Derived from this study: PubMed 33846054Gurfinkel D, Kempe A, Albertin C, Breck A, Zhou X, Vangala S, Beaty B, Rice J, Tseng CH, Campbell JD, Valderrama R, Rand C, Humiston SG, Roth H, Arora S, Szilagyi P. Centralized Reminder/Recall for Human Papillomavirus Vaccination: Findings From Two States-A Randomized Clinical Trial. J Adolesc Health. 2021 Oct;69(4):579-587. doi: 10.1016/j.jadohealth.2021.02.023. Epub 2021 Apr 10.
- Individual participant dataSharing planned: No. The aggregate results will be published in a peer reviewed journal.
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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.
Peter Szilagyi, MD MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Vaccine Reminder Recall - Autodialer and HPV Vaccine Reminder Recall - Texting in people with Vaccines, run by University of California, Los Angeles at 1 site 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 5 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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Initiation of the HPV 2-dose series (time frame: 5 months from the first reminder received for the first dose of HPV vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294551, which also lists 1 linked publication.
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 27 May 2021.