Vaccine Administration RatesNCT03123419
Gardasil Administration
A study testing Appointment reminders in people with Vaccine Administration Rates, run by St. Louis University at 1 site in United States.
Trial summary
The purpose of the Gardasil study is to increase the rates of Gardasil vaccination at a maternal fetal Care Center. This will be done by reminding patients via text to come for follow up vaccine appointments. Read more about this study
- Who is it for?
- Ages 9 to 26 years, women only
- Conditions the study is for
- Vaccine Administration Rates
- What is being tested?
- Appointment reminders
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Apr 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 9 to 26 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient receiving gynecological or postpartum care at the Maternal Fetal Care Center
- Females age 9-26 years per manufacturer's recommendation
- Having a cell phone that will allow texting
- Willing to accept any texting charges that may occur for receiving the reminder text.
Who cannot join
- Allergy to HPV-4 or HPV-9 vaccine
- Prior completion of the HPV-4/9 series,
- Pregnancy
- Patients older than 26 years old
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the Gardasil study is to increase the rates of Gardasil vaccination at a maternal fetal Care Center. This will be done by reminding patients via text to come for follow up vaccine appointments.
Read the detailed description
Patients will be screened in center for history of Gardasil vaccination. If the patient has not received the vaccination series they will be counseled/educated (standard of care [SOC }) and offered the vaccine series. If the patient agrees to the vaccination, they will then be offered participation in this study, (consent will be reviewed and signed) and they will receive the first vaccination at this visit, administered according to standard protocol. The patient will then be scheduled for two follow up vaccination appointments. The second vaccination will be given 2 months after the first vaccine and the third will be given 4 months after the second vaccination in accordance with the Gardasil vaccine guidelines. -SOC
The patients will receive a total of two texts during the study entirety. The two texts will be appointment reminders for the second and third vaccination, sent 1 week prior to the next appointment. This is study related.
Data collection Data will be collected using a data collection sheet. The investigators will record date of first vaccine administration and adherence to follow up.vaccinations.
- Conditions
- Vaccine Administration Rates
- Being tested
- Appointment reminders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appointment remindersBehavioural
The purpose of the Gardasil study is to increase the rates of Gardasil vaccination in the Maternal Fetal Care Center. This will be done by reminding patients via text to come for their follow up vaccine appointments.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Other | All patients who consent to be in the study will receive Appointment reminders. Receives: Behavioral: Appointment reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase HPV-9 vaccine administration rates
The text reminder messages will increase HPV-9 vaccine administration rates
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Feb 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Why it stopped: Departmental research hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Administration RatesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Hostetter, MD, St. Louis University
- Investigators
- Sarah Hostetter, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123419
- Sponsor's protocol ID
- 27734
- Status last verified
- Mar 2018
- First submitted
- 10 Apr 2017
- Last updated
- 7 Mar 2018
- 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 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gardasil Administration
- ClinicalTrials.gov ID
- NCT03123419
- Acronym / sponsor ID
- 27734
- Conditions
- Vaccine Administration Rates
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Departmental research hold
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 21 Apr 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 purpose of the Gardasil study is to increase the rates of Gardasil vaccination at a maternal fetal Care Center. This will be done by reminding patients via text to come for follow up vaccine appointments.
Detailed description
Patients will be screened in center for history of Gardasil vaccination. If the patient has not received the vaccination series they will be counseled/educated (standard of care [SOC }) and offered the vaccine series. If the patient agrees to the vaccination, they will then be offered participation in this study, (consent will be reviewed and signed) and they will receive the first vaccination at this visit, administered according to standard protocol. The patient will then be scheduled for two follow up vaccination appointments. The second vaccination will be given 2 months after the first vaccine and the third will be given 4 months after the second vaccination in accordance with the Gardasil vaccine guidelines. -SOC
The patients will receive a total of two texts during the study entirety. The two texts will be appointment reminders for the second and third vaccination, sent 1 week prior to the next appointment. This is study related.
Data collection Data will be collected using a data collection sheet. The investigators will record date of first vaccine administration and adherence to follow up.vaccinations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Other | Behavioral: Appointment remindersAll patients who consent to be in the study will receive Appointment reminders. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient receiving gynecological or postpartum care at the Maternal Fetal Care Center
- Females age 9-26 years per manufacturer's recommendation
- Having a cell phone that will allow texting
- Willing to accept any texting charges that may occur for receiving the reminder text.
Key exclusion criteria (4 listed)
- Allergy to HPV-4 or HPV-9 vaccine
- Prior completion of the HPV-4/9 series,
- Pregnancy
- Patients older than 26 years old
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 |
|---|---|---|
| Appointment remindersThe purpose of the Gardasil study is to increase the rates of Gardasil vaccination in the Maternal Fetal Care Center. This will be done by reminding patients via text to come for their follow up vaccine appointments. | Behavioural | Vaccine |
Primary outcome
Increase HPV-9 vaccine administration rates
Time frame: through study completion, an average of 1 year
The text reminder messages will increase HPV-9 vaccine administration rates
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: No
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.
Sarah Hostetter, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appointment reminders in people with Vaccine Administration Rates, run by St. Louis University 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 7 Mar 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Increase HPV-9 vaccine administration rates (time frame: through study completion, an average of 1 year). 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 7 Mar 2018.