GARDASIL VaccinationNCT01343485
Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series
A study testing Computer reminder system in people with GARDASIL Vaccination, run by Planned Parenthood Federation of America at 9 sites in United States.
Trial summary
Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a prospective, cluster randomized trial to determine which factors influence the acquisition of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to 26. Read more about this study
- Who is it for?
- Ages 19 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GARDASIL Vaccination
- What is being tested?
- Computer reminder system
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female;
- Age 19-26;
- Fluent in English;
- Seeking services for anything except pregnancy or abortion on the day of the visit
- No previous vaccinations for HPV
- No contraindication for HPV vaccine (includes a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, and polysorbate 80.)
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- Access to phone, text, mail, email, or facebook
- Not wanting to become pregnant in the next 8 months;
- Not planning on moving from the area in the next 8 months
- Willing to be contacted for follow-up over the next 8 months.
Who cannot join
- Women below 19 or above 26.
- Male
- Women who have one or more of HPV vaccination.
- Women who have a contraindication for HPV vaccine.
- Women who do not have access by phone, mail, email, Twitter or Facebook for follow up.
- Women who are not fluent in English
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- Pregnant women or those intending on becoming pregnant during the study period.
- Women who will be moving from the area and unable to return for follow up over the course of the study (approximately 8 months).
- Severe mental impairment and unable to give Informed Consent.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Planned Parenthood of Rocky Mountains
Arvada, Colorado, 80003
Planned Parenthood of Central North Carolina
Chapel Hill, North Carolina, 27514
Planned Parenthood of North Carolina
Charlotte, North Carolina, 28205
Family Planning Clinic of the John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
Planned Parenthood of Rocky Mountains
Denver, Colorado, 80218
Planned Parenthood of Arizona
Glendale, Arizona, 85302
Planned Parenthood Association of Utah
Ogden, Utah, 84403
Planned Parenthood of Greater Northwest
Seattle, Washington, 98105
Planned Parenthood Association of Utah
South Jordan, Utah, 84095
About this study
Official title: Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool
Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a prospective, cluster randomized trial to determine which factors influence the acquisition of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to 26. This descriptive and interventional study will provide data to assess impact of a computerized tool upon HPV vaccine series completion. The interventional aspect of this study includes determination of patient assistance and provider support programs applicable to each woman's situation as well as the implementation of a computer software system for customized patient reminders.
- Conditions
- GARDASIL Vaccination
- Being tested
- Computer reminder system
- Keywords
- Human papillomavirus (HPV) vaccine, Gardasil vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer reminder systemBehavioural
Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series
| Study group | Role | What they receive |
|---|---|---|
| Control, standard care for HPV vaccine | No intervention | Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol |
| Intervention, computer reminder system | Experimental | Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine. Receives: Behavioral: Computer reminder system |
What is being measured
The primary outcome is the main question the study is designed to answer.
On-time Completion of the Human Papillomavirus Vaccine Series
Measured: 32 weeks after receipt of initial vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GARDASIL VaccinationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood Federation of America
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Johanna Morfesis, Planned Parenthood Federation of America
- Investigators
- Ashlesha Patel, MD, MPH, Principal investigator, Planned Parenthood Federation of America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343485
- Sponsor's protocol ID
- PPFA-Merck-38068
- Status last verified
- Apr 2018
- First submitted
- 26 Apr 2011
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Centers for Disease Control and Prevention (CDC). Recommended adult immunization schedule--United States, 2011. MMWR Morb Mortal Wkly Rep. 2011 Feb 4;60(4):1-4. No abstract available.
PubMed 21381442Chao C, Velicer C, Slezak JM, Jacobsen SJ. Correlates for completion of 3-dose regimen of HPV vaccine in female members of a managed care organization. Mayo Clin Proc. 2009 Oct;84(10):864-70. doi: 10.4065/84.10.864.
PubMed 19797775Dempsey A, Cohn L, Dalton V, Ruffin M. Patient and clinic factors associated with adolescent human papillomavirus vaccine utilization within a university-based health system. Vaccine. 2010 Jan 22;28(4):989-95. doi: 10.1016/j.vaccine.2009.10.133. Epub 2009 Nov 17.
PubMed 19925899Jain N, Euler GL, Shefer A, Lu P, Yankey D, Markowitz L. Human papillomavirus (HPV) awareness and vaccination initiation among women in the United States, National Immunization Survey-Adult 2007. Prev Med. 2009 May;48(5):426-31. doi: 10.1016/j.ypmed.2008.11.010. Epub 2008 Dec 6.
PubMed 19100762Neubrand TP, Breitkopf CR, Rupp R, Breitkopf D, Rosenthal SL. Factors associated with completion of the human papillomavirus vaccine series. Clin Pediatr (Phila). 2009 Nov;48(9):966-9. doi: 10.1177/0009922809337534. Epub 2009 May 29. No abstract available.
PubMed 19483128Orenstein WA, Mootrey GT, Pazol K, Hinman AR. Financing immunization of adults in the United States. Clin Pharmacol Ther. 2007 Dec;82(6):764-8. doi: 10.1038/sj.clpt.6100401. Epub 2007 Oct 31.
PubMed 17971821Sandfort JR, Pleasant A. Knowledge, attitudes, and informational behaviors of college students in regard to the human papillomavirus. J Am Coll Health. 2009 Sep-Oct;58(2):141-9. doi: 10.1080/07448480903221368.
PubMed 19892651Patel A, Stern L, Unger Z, Debevec E, Roston A, Hanover R, Morfesis J. Staying on track: a cluster randomized controlled trial of automated reminders aimed at increasing human papillomavirus vaccine completion. Vaccine. 2014 May 1;32(21):2428-33. doi: 10.1016/j.vaccine.2014.02.095. Epub 2014 Mar 13.
PubMed 24631099
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool
- ClinicalTrials.gov ID
- NCT01343485
- Acronym / sponsor ID
- PPFA-Merck-38068
- Conditions
- GARDASIL Vaccination
- Keywords
- Human papillomavirus (HPV) vaccine, Gardasil vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Planned Parenthood Federation of AmericaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Posted 2 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a prospective, cluster randomized trial to determine which factors influence the acquisition of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to 26. This descriptive and interventional study will provide data to assess impact of a computerized tool upon HPV vaccine series completion. The interventional aspect of this study includes determination of patient assistance and provider support programs applicable to each woman's situation as well as the implementation of a computer software system for customized patient reminders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control, standard care for HPV vaccine | No intervention | –Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol |
| Intervention, computer reminder system | Experimental | Behavioral: Computer reminder systemStudy participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine. |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female;
- Age 19-26;
- Fluent in English;
- Seeking services for anything except pregnancy or abortion on the day of the visit
- No previous vaccinations for HPV
Key exclusion criteria (9 listed)
- Women below 19 or above 26.
- Male
- Women who have one or more of HPV vaccination.
- Women who have a contraindication for HPV vaccine.
- Women who do not have access by phone, mail, email, Twitter or Facebook for follow up.
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 |
|---|---|---|
| Computer reminder systemIntervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series | Behavioural | Intervention, computer reminder system |
Primary outcome
On-time Completion of the Human Papillomavirus Vaccine Series
Time frame: 32 weeks after receipt of initial vaccine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21381442Centers for Disease Control and Prevention (CDC). Recommended adult immunization schedule--United States, 2011. MMWR Morb Mortal Wkly Rep. 2011 Feb 4;60(4):1-4. No abstract available.
- Background: PubMed 19797775Chao C, Velicer C, Slezak JM, Jacobsen SJ. Correlates for completion of 3-dose regimen of HPV vaccine in female members of a managed care organization. Mayo Clin Proc. 2009 Oct;84(10):864-70. doi: 10.4065/84.10.864.
- Background: PubMed 19925899Dempsey A, Cohn L, Dalton V, Ruffin M. Patient and clinic factors associated with adolescent human papillomavirus vaccine utilization within a university-based health system. Vaccine. 2010 Jan 22;28(4):989-95. doi: 10.1016/j.vaccine.2009.10.133. Epub 2009 Nov 17.
- Background: PubMed 19100762Jain N, Euler GL, Shefer A, Lu P, Yankey D, Markowitz L. Human papillomavirus (HPV) awareness and vaccination initiation among women in the United States, National Immunization Survey-Adult 2007. Prev Med. 2009 May;48(5):426-31. doi: 10.1016/j.ypmed.2008.11.010. Epub 2008 Dec 6.
- Background: PubMed 19483128Neubrand TP, Breitkopf CR, Rupp R, Breitkopf D, Rosenthal SL. Factors associated with completion of the human papillomavirus vaccine series. Clin Pediatr (Phila). 2009 Nov;48(9):966-9. doi: 10.1177/0009922809337534. Epub 2009 May 29. No abstract available.
- Background: PubMed 17971821Orenstein WA, Mootrey GT, Pazol K, Hinman AR. Financing immunization of adults in the United States. Clin Pharmacol Ther. 2007 Dec;82(6):764-8. doi: 10.1038/sj.clpt.6100401. Epub 2007 Oct 31.
- Background: PubMed 19892651Sandfort JR, Pleasant A. Knowledge, attitudes, and informational behaviors of college students in regard to the human papillomavirus. J Am Coll Health. 2009 Sep-Oct;58(2):141-9. doi: 10.1080/07448480903221368.
- Derived from this study: PubMed 24631099Patel A, Stern L, Unger Z, Debevec E, Roston A, Hanover R, Morfesis J. Staying on track: a cluster randomized controlled trial of automated reminders aimed at increasing human papillomavirus vaccine completion. Vaccine. 2014 May 1;32(21):2428-33. doi: 10.1016/j.vaccine.2014.02.095. Epub 2014 Mar 13.
- Planned Parenthood Federation of AmericaLink provided by the sponsor.
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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.
Ashlesha Patel, MD, MPH principal investigator
Planned Parenthood Federation of America, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer reminder system in people with GARDASIL Vaccination, run by Planned Parenthood Federation of America at 9 sites 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 10 inclusion and 9 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Yes. Results are posted in the registry (first posted 2 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
On-time Completion of the Human Papillomavirus Vaccine Series (time frame: 32 weeks after receipt of initial vaccine). 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 NCT01343485, which also lists 8 linked publications.
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 26 Jun 2018.