Human Papilloma Virus (HPV)NCT03987490
Usability of HPV Vaccine Reminders
A study testing Text Message, PostCard and Motivational Interview in people with Human Papilloma Virus (HPV), run by University of Florida at 1 site in United States.
Trial summary
This study will assess the usefulness of parent-targeted strategies in improving care seeking among parents of 11-12 year old adolescents. Specifically, the study team will focus on reminders (postcard or text message) and motivational interviewing to improve adolescent vaccination. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus (HPV)
- What is being tested?
- Text Message, PostCard and Motivational Interview
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 15 Dec 2016
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of 11-12 year olds who attend the Schiebler CMS clinic at University of Florida in the previous year
Who cannot join
- Unable to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Pediatrics - Gerold L. Schiebler CMS Center
Gainesville, Florida, 32608
About this study
Official title: A Feasibility Trial of Parent-targeted Strategies to Increase HPV Vaccination
This study will assess the usefulness of parent-targeted strategies in improving care seeking among parents of 11-12 year old adolescents. Specifically, the study team will focus on reminders (postcard or text message) and motivational interviewing to improve adolescent vaccination.
Read the detailed description
Despite the impressive cancer preventing potential of human papillomavirus (HPV) vaccines, HPV vaccine coverage rates in the United States remain substantially lower than other vaccines and Healthy People 2020 targets. HPV vaccine initiation can be improved through targeted reminders that motivate parents. Our long-term goal is to maximize HPV vaccination rates among girls and boys within the United States using efficient and sustainable strategies. The objective of this protocol is to evaluate the usefulness of a tiered strategy of a parent-targeted strategies in improving care seeking and receptiveness to vaccine recommendations. Strategies include HPV vaccine reminders via postcard or text message and phone-based Motivational Interview sessions. The central hypothesis is addressing key health beliefs (e.g., perceived benefits and barriers) will increase parental acceptance and, thus, HPV vaccine initiation.
- Conditions
- Human Papilloma Virus (HPV)
- Being tested
- Text Message, PostCard, Standard of Care, Motivational Interview
- Keywords
- vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessageBehavioural
Vaccine reminder notification sent via text
PostCardBehavioural
Vaccine reminder notification sent via standard mail
Standard of CareBehavioural
No additional information given to parents
Motivational InterviewBehavioural
Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent
| Study group | Role | What they receive |
|---|---|---|
| Parents of Girls | Experimental | Parents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims. Receives: Behavioral: Text Message; Behavioral: Standard of Care; Behavioral: Motivational Interview |
| Parents of Boys | Experimental | Parents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims. Receives: Behavioral: Text Message; Behavioral: PostCard; Behavioral: Standard of Care; Behavioral: Motivational Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients with deliverable text messages
Percentage of Patients with deliverable text messages
Measured: up to 2 weeks
Percentage of phone calls where interviewer is adherent to MI
Adherence to MI
Measured: During phone interview
Secondary outcomes (1)
Percentage of adolescent who get one dose of the HPV vaccine
HPV vaccine initiation (1 dose)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Dec 2015
- Primary completion1 Aug 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus (HPV)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Staras, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987490
- Sponsor's protocol ID
- IRB201500997
- Status last verified
- May 2020
- First submitted
- 11 Jun 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
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 Feasibility Trial of Parent-targeted Strategies to Increase HPV Vaccination
- ClinicalTrials.gov ID
- NCT03987490
- Acronym / sponsor ID
- IRB201500997
- Conditions
- Human Papilloma Virus (HPV)
- Keywords
- vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 17 Jun 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.
This study will assess the usefulness of parent-targeted strategies in improving care seeking among parents of 11-12 year old adolescents. Specifically, the study team will focus on reminders (postcard or text message) and motivational interviewing to improve adolescent vaccination.
Detailed description
Despite the impressive cancer preventing potential of human papillomavirus (HPV) vaccines, HPV vaccine coverage rates in the United States remain substantially lower than other vaccines and Healthy People 2020 targets. HPV vaccine initiation can be improved through targeted reminders that motivate parents. Our long-term goal is to maximize HPV vaccination rates among girls and boys within the United States using efficient and sustainable strategies. The objective of this protocol is to evaluate the usefulness of a tiered strategy of a parent-targeted strategies in improving care seeking and receptiveness to vaccine recommendations. Strategies include HPV vaccine reminders via postcard or text message and phone-based Motivational Interview sessions. The central hypothesis is addressing key health beliefs (e.g., perceived benefits and barriers) will increase parental acceptance and, thus, HPV vaccine initiation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents of Girls | Experimental | Behavioral: Text Message, Behavioral: Standard of Care, Behavioral: Motivational InterviewParents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims. |
| Parents of Boys | Experimental | Behavioral: Text Message, Behavioral: PostCard, Behavioral: Standard of Care, Behavioral: Motivational InterviewParents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of 11-12 year olds who attend the Schiebler CMS clinic at University of Florida in the previous year
Key exclusion criteria (1 listed)
- Unable to meet inclusion criteria
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 |
|---|---|---|
| Text MessageVaccine reminder notification sent via text | Behavioural | Parents of Boys, Parents of Girls |
| PostCardVaccine reminder notification sent via standard mail | Behavioural | Parents of Boys |
| Standard of CareNo additional information given to parents | Behavioural | Parents of Boys, Parents of Girls |
| Motivational InterviewPhone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent | Behavioural | Parents of Boys, Parents of Girls |
Primary outcome
Percentage of Patients with deliverable text messages
Time frame: up to 2 weeks
Percentage of Patients with deliverable text messages
Percentage of phone calls where interviewer is adherent to MI
Time frame: During phone interview
Adherence to MI
1 secondary outcome
Percentage of adolescent who get one dose of the HPV vaccine
Time frame: Six months
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.
- 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 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 Text Message, PostCard and Motivational Interview in people with Human Papilloma Virus (HPV), 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 1 inclusion and 1 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?
Percentage of Patients with deliverable text messages (time frame: up to 2 weeks). 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?
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.