Genital Human Papilloma Virus InfectionNCT01133509
A Model for Implementation of Cervical Cancer Screening and HPV Vaccination the Emergency Department: a Pilot Study
A study testing Gardasil in people with Genital Human Papilloma Virus Infection, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
In this pilot study, we intend to demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV testing via ThinPrep®Pap testTM and surveillance. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genital Human Papilloma Virus Infection
- What is being tested?
- Gardasil
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Oct 2012
- 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 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 3 years of beginning sexual activity or by age 21 years whichever occur first.
- resident of the City of Norfolk, Virginia
- uninsured
Who cannot join
- Pregnant women
- Women with Hysterectomy with cervical excision
- Women who received full HPV vaccine series
- Known history of cervical cancer
- Male sex
- Loop electrocautery excision procedure(LEEP)
- Cold-Knife conization
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Alicia S Devine, MD, JD
About this study
Official title: A Model for the Implementation of the Cervical Cancer Screening and HPV Vaccination in the Emergency Department: a Pilot Study.
In this pilot study, we intend to demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV testing via ThinPrep®Pap testTM and surveillance. We intend to provide improved access to healthcare and monitoring through administration of vaccine to eligible patients and 1 year follow up for patients involved in this study.
Females meeting inclusion/exclusion criteria participating in the study (n=100) that have not had a cytology test in 2 or more years will be offered the Thin Prep® cytology test. This study will allow surveillance of disease through cytology and HPV DNA testing via collection of data using Thin Prep® cytology with reflex HPV DNA testing according to established guidelines as described below.
Provide improved access to healthcare and monitoring through administration of vaccine for eligible females as established by guidelines. Patients will receive first vaccine in the ED and will have arranged follow up for administration of the 2 month and 6 month series of the HPV vaccination. Through data collection, we intend to determine if there is a need for vaccination and determine if patients are likely to follow up..
- Conditions
- Genital Human Papilloma Virus Infection
- Being tested
- Gardasil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GardasilDrug
Also called Human Papillomarvirus, HPV vaccine, Gardisil, Silgard
0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months
| Study group | Role | What they receive |
|---|---|---|
| gardisil | Other | gardisil Receives: Drug: Gardasil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and /or cytology)are presenting to the ED,by analysis of a constructed survey,cytology/HPV testing via ThinPrep Pap test and surveillance
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Genital Human Papilloma Virus InfectionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Alicia Devine, MD, Eastern Virginia Medical School
- Investigators
- Alicia Devine, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133509
- Sponsor's protocol ID
- 33249
- Status last verified
- Aug 2012
- First submitted
- 4 Nov 2008
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bosch X, Harper D. Prevention strategies of cervical cancer in the HPV vaccine era. Gynecol Oncol. 2006 Oct;103(1):21-4. doi: 10.1016/j.ygyno.2006.07.019. Epub 2006 Aug 17. No abstract available.
PubMed 16919714Lonky NM. Risk factors related to the development and mortality from invasive cervical cancer clinical utility and impact on prevention. Obstet Gynecol Clin North Am. 2002 Dec;29(4):817-42, viii. doi: 10.1016/s0889-8545(02)00021-9.
PubMed 12509097Society of Gynecologic Oncologists Education Resource Panel Writing group; Collins Y, Einstein MH, Gostout BS, Herzog TJ, Massad LS, Rader JS, Wright J. Cervical cancer prevention in the era of prophylactic vaccines: a preview for gynecologic oncologists. Gynecol Oncol. 2006 Sep;102(3):552-62. doi: 10.1016/j.ygyno.2006.07.022.
PubMed 16979432Kinney W, Sung HY, Kearney KA, Miller M, Sawaya G, Hiatt RA. Missed opportunities for cervical cancer screening of HMO members developing invasive cervical cancer (ICC). Gynecol Oncol. 1998 Dec;71(3):428-30. doi: 10.1006/gyno.1998.5135.
PubMed 9887244Plummer M, Schiffman M, Castle PE, Maucort-Boulch D, Wheeler CM; ALTS Group. A 2-year prospective study of human papillomavirus persistence among women with a cytological diagnosis of atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion. J Infect Dis. 2007 Jun 1;195(11):1582-9. doi: 10.1086/516784. Epub 2007 Apr 16.
PubMed 17471427
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model for the Implementation of the Cervical Cancer Screening and HPV Vaccination in the Emergency Department: a Pilot Study.
- ClinicalTrials.gov ID
- NCT01133509
- Acronym / sponsor ID
- 33249
- Conditions
- Genital Human Papilloma Virus Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 31 May 2010 (estimated)
- 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.
In this pilot study, we intend to demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and/or cytology) are presenting to the ED, cytology/ HPV testing via ThinPrep®Pap testTM and surveillance. We intend to provide improved access to healthcare and monitoring through administration of vaccine to eligible patients and 1 year follow up for patients involved in this study.
Females meeting inclusion/exclusion criteria participating in the study (n=100) that have not had a cytology test in 2 or more years will be offered the Thin Prep® cytology test. This study will allow surveillance of disease through cytology and HPV DNA testing via collection of data using Thin Prep® cytology with reflex HPV DNA testing according to established guidelines as described below.
Provide improved access to healthcare and monitoring through administration of vaccine for eligible females as established by guidelines. Patients will receive first vaccine in the ED and will have arranged follow up for administration of the 2 month and 6 month series of the HPV vaccination. Through data collection, we intend to determine if there is a need for vaccination and determine if patients are likely to follow up..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gardisil | Other | Drug: Gardasilgardisil |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 3 years of beginning sexual activity or by age 21 years whichever occur first.
- resident of the City of Norfolk, Virginia
- uninsured
Key exclusion criteria (7 listed)
- Pregnant women
- Women with Hysterectomy with cervical excision
- Women who received full HPV vaccine series
- Known history of cervical cancer
- Male sex
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 |
|---|---|---|
| GardasilAlso: Human Papillomarvirus, HPV vaccine, Gardisil, Silgard0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months | Drug | gardisil |
Primary outcome
To demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and /or cytology)are presenting to the ED,by analysis of a constructed survey,cytology/HPV testing via ThinPrep Pap test and surveillance
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Background: PubMed 16919714Bosch X, Harper D. Prevention strategies of cervical cancer in the HPV vaccine era. Gynecol Oncol. 2006 Oct;103(1):21-4. doi: 10.1016/j.ygyno.2006.07.019. Epub 2006 Aug 17. No abstract available.
- Background: PubMed 12509097Lonky NM. Risk factors related to the development and mortality from invasive cervical cancer clinical utility and impact on prevention. Obstet Gynecol Clin North Am. 2002 Dec;29(4):817-42, viii. doi: 10.1016/s0889-8545(02)00021-9.
- Background: PubMed 16979432Society of Gynecologic Oncologists Education Resource Panel Writing group; Collins Y, Einstein MH, Gostout BS, Herzog TJ, Massad LS, Rader JS, Wright J. Cervical cancer prevention in the era of prophylactic vaccines: a preview for gynecologic oncologists. Gynecol Oncol. 2006 Sep;102(3):552-62. doi: 10.1016/j.ygyno.2006.07.022.
- Background: PubMed 9887244Kinney W, Sung HY, Kearney KA, Miller M, Sawaya G, Hiatt RA. Missed opportunities for cervical cancer screening of HMO members developing invasive cervical cancer (ICC). Gynecol Oncol. 1998 Dec;71(3):428-30. doi: 10.1006/gyno.1998.5135.
- Background: PubMed 17471427Plummer M, Schiffman M, Castle PE, Maucort-Boulch D, Wheeler CM; ALTS Group. A 2-year prospective study of human papillomavirus persistence among women with a cytological diagnosis of atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion. J Infect Dis. 2007 Jun 1;195(11):1582-9. doi: 10.1086/516784. Epub 2007 Apr 16.
- American Cancer SocietyLink provided by the sponsor.
- American College of Obstetrics and GynecologyLink 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.
Alicia Devine, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gardasil in people with Genital Human Papilloma Virus Infection, run by Eastern Virginia Medical School 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Aug 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alicia Devine, MD (757-388-3397, aliciadevine@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that a great portion of women at high risk (inadequate screening, HPV 16/18 and /or cytology)are presenting to the ED,by analysis of a constructed survey,cytology/HPV testing via ThinPrep Pap test and surveillance (time frame: two years). 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 NCT01133509, which also lists 5 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 23 Aug 2012.