Human Papilloma VirusNCT04208269
A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
A study testing postcard campaign and Health Information Technology system in people with Human Papilloma Virus, run by University of Florida at 1 site in United States.
Trial summary
Our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP. The investigators will use two intervention components: postcards and an iPad survey system. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- postcard campaign and Health Information Technology system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,663 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2013to 30 Mar 2015
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in Florida Medicaid
- Not initiated the HPV vaccine series at the start of the study period.
Who cannot join
- Anyone who has a severe (life threatening) allergy to any component of HPV vaccine, esp yeast
- Pregnant
- Not enrolled in Florida Medicaid
Trial locations and contacts
1 site in 1 country.
About this study
Our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP. The investigators will use two intervention components: postcards and an iPad survey system. To estimate efficacy the investigators will select potential participants from Florida Medicaid and CHIP. The investigators will assess their claims for the HPV vaccine before and after the intervention.
- Conditions
- Human Papilloma Virus
- Being tested
- postcard campaign, Health Information Technology system
- Keywords
- preventative, postcard, vaccinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postcard campaignOther
Post card sent to parent only
Health Information Technology systemOther
Accessed by adolescent and provider only
| Study group | Role | What they receive |
|---|---|---|
| Postcard campaign | Active comparator | Not described Receives: Other: postcard campaign |
| Provider-only intervention | Active comparator | Not described Receives: Other: Health Information Technology system |
| Patient and provider intervention | Active comparator | Not described Receives: Other: postcard campaign; Other: Health Information Technology system |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants receiving HPV vaccine
The percent age eligible participants who initiate HPV vaccination.
Measured: Up to 5 months
Number of preventive care visits
The percent age eligible participants received a preventive care visit
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Aug 2013
- Primary completion1 Apr 2014
- Study completion30 Mar 2015
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 Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,663 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Staras, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208269
- Sponsor's protocol ID
- IRB201200143
- Status last verified
- May 2020
- First submitted
- 19 Dec 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staras SAS, Vadaparampil ST, Thompson LA, Scherr C, Gurka MJ, Filipp SL, Shenkman EA. Postcard reminders for HPV vaccination mainly primed parents for providers' recommendations. Prev Med Rep. 2020 Aug 26;20:101188. doi: 10.1016/j.pmedr.2020.101188. eCollection 2020 Dec.
PubMed 32953426
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
- ClinicalTrials.gov ID
- NCT04208269
- Acronym / sponsor ID
- IRB201200143
- Conditions
- Human Papilloma Virus
- Keywords
- preventative, postcard, vaccinate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,663 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 30 Mar 2015 (actual)
- First posted
- 23 Dec 2019 (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.
Our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP. The investigators will use two intervention components: postcards and an iPad survey system. To estimate efficacy the investigators will select potential participants from Florida Medicaid and CHIP. The investigators will assess their claims for the HPV vaccine before and after the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Postcard campaign | Active comparator | Other: postcard campaign |
| Provider-only intervention | Active comparator | Other: Health Information Technology system |
| Patient and provider intervention | Active comparator | Other: postcard campaign, Other: Health Information Technology system |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Enrolled in Florida Medicaid
- Not initiated the HPV vaccine series at the start of the study period.
Key exclusion criteria (3 listed)
- Anyone who has a severe (life threatening) allergy to any component of HPV vaccine, esp yeast
- Pregnant
- Not enrolled in Florida Medicaid
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 |
|---|---|---|
| postcard campaignPost card sent to parent only | Other | Patient and provider intervention, Postcard campaign |
| Health Information Technology systemAccessed by adolescent and provider only | Other | Patient and provider intervention, Provider-only intervention |
Primary outcome
The number of participants receiving HPV vaccine
Time frame: Up to 5 months
The percent age eligible participants who initiate HPV vaccination.
Number of preventive care visits
Time frame: Up to 3 months
The percent age eligible participants received a preventive care visit
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 19 May 2020.
- Derived from this study: PubMed 32953426Staras SAS, Vadaparampil ST, Thompson LA, Scherr C, Gurka MJ, Filipp SL, Shenkman EA. Postcard reminders for HPV vaccination mainly primed parents for providers' recommendations. Prev Med Rep. 2020 Aug 26;20:101188. doi: 10.1016/j.pmedr.2020.101188. eCollection 2020 Dec.
- Individual participant dataSharing planned: No
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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.
Stephanie Staras, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postcard campaign and Health Information Technology system in people with Human Papilloma Virus, run by University of Florida 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 2 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 19 May 2020. 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?
The number of participants receiving HPV vaccine (time frame: Up to 5 months). 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 NCT04208269, 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 19 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.