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Human Papilloma VirusHPV AcceptanceNCT00730704

Acceptance of Human Papillomavirus Vaccination in Postpartum Women

An observational study of Human Papilloma Virus and HPV, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Worldwide cervical cancer remains a major cause mortality among women. It is estimated that each year over 490,000 women are diagnosed with cervical cancer and more than 270,000 die from the disease. Read more about this study

Who is it for?
Ages 18 to 26 years, women only
Conditions the study is for
Human Papilloma Virus, HPV, Post Partum
How many people
150 participants
Where
1 siteUnited States
Study dates
May 2009to Oct 2012
Phase
Observational
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
  • No healthy volunteers
  • Adult

Study population: Women, aged 18-26, hospitalized during the postpartum period after a normal spontaneous vaginal delivery, assisted vaginal delivery or Cesarean section.

Who may be able to join

  • Age 18-26 years.
  • Patients hospitalized during the postpartum period after a normal spontaneous vaginal delivery, assisted vaginal delivery or Cesarean section.
  • Patients who delivered a singleton fetus or multiple gestations are eligible for participation.
  • Patients may have delivered at gestational ages 32-44 weeks.
  • Patients must have signed informed consent.
  • Patients must meet pre-entry criteria.
  • Patients who are breast feeding are eligible for participation.
  • Patients must have an obstetrician whom they have seen for obstetric care and plan to follow-up with in the postpartum period.

Who cannot join

  • Age < 18 or > 26 years.
  • Patients with hemophilia, other bleeding disorders or thrombocytopenia (platelets < 100,000/ul).
  • Patients receiving active anticoagulant therapy with warfarin, heparin or low molecular weight heparin.
  • Pregnancy or planning pregnancy within the next 6 months.
  • Ongoing bacteremia, endomyometritis or other serious febrile illness.
  • Hypersensitivity to yeast, aluminum or other vaccine components.
Show all 10Show fewer
  • Prior vaccination with a prophylactic HPV vaccine (single or multiple doses).
  • Patients who delivered a non-viable infant or an infant with severe congenital malformations.
  • Patients who do not plan on following up postpartum with their local obstetrician or maternal fetal medicine specialist.
  • Patients who are unwilling to receive subsequent doses of the HPV vaccine.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Worldwide cervical cancer remains a major cause mortality among women. It is estimated that each year over 490,000 women are diagnosed with cervical cancer and more than 270,000 die from the disease. While the implementation of widespread screening programs has reduced the burden of cervical cancer, a large percentage of the population still remains unscreened or is underscreened. It is now recognized that human papillomavirus (HPV) is a necessary precursor for the development of cervical cancer. The first vaccine to prevent HPV was recently approved by the Food and Drug Administration and is now available at doctors offices. Despite the availability of a safe and effective means for the prevention of cervical cancer, widespread implementation of vaccination has been extremely difficult. Several potential issues have limited the development of widespread HPV vaccination programs, including cultural and religious beliefs, and limitations in the practicality of administering the vaccine. The overall goals of our work are to improve access to preventive strategies for cervical cancer. In this proposal we will examine the strategy of HPV vaccination for women who have just given birth. We believe that HPV vaccination of these women will be associated with a high level of patient satisfaction and acceptance. If successful, this strategy could play a major role in advancing the acceptance and implementation of HPV vaccination in the United States.

Read the detailed description

Primary Objective

  1. To estimate compliance with the HPV vaccine series when initiated in postpartum women.

Secondary Objectives

  1. To determine patient acceptance and satisfaction with HPV vaccination administered in the postpartum period.
  2. To determine predictors of compliance with the HPV vaccination series.
Keywords
Human Papilloma Virus vaccines, HPV, Gardasil, Post partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2008 (estimated)
  2. Study startMay 2009
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00730704
Sponsor's protocol ID
AAAD1877
Acronym
HPV Acceptance
Status last verified
Nov 2012
First submitted
4 Aug 2008
Last updated
5 Nov 2012
Results posted
No
Data monitoring committee
No

Publications

  • Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.

    PubMed 15761078

  • Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9. doi: 10.1002/(SICI)1096-9896(199909)189:13.0.CO;2-F.

    PubMed 10451482

  • Schiffman M, Castle PE, Jeronimo J, Rodriguez AC, Wacholder S. Human papillomavirus and cervical cancer. Lancet. 2007 Sep 8;370(9590):890-907. doi: 10.1016/S0140-6736(07)61416-0.

    PubMed 17826171

  • FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741.

    PubMed 17494925

  • Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Steben M, Bryan J, Taddeo FJ, Railkar R, Esser MT, Sings HL, Nelson M, Boslego J, Sattler C, Barr E, Koutsky LA; Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007 May 10;356(19):1928-43. doi: 10.1056/NEJMoa061760.

    PubMed 17494926

  • Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702. doi: 10.1016/S0140-6736(07)60777-6.

    PubMed 17512854

  • Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271-8. doi: 10.1016/S1470-2045(05)70101-7.

    PubMed 15863374

  • Koutsky LA, Ault KA, Wheeler CM, Brown DR, Barr E, Alvarez FB, Chiacchierini LM, Jansen KU; Proof of Principle Study Investigators. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002 Nov 21;347(21):1645-51. doi: 10.1056/NEJMoa020586.

    PubMed 12444178

  • Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007 Mar 23;56(RR-2):1-24.

    PubMed 17380109

  • Davis K, Dickman ED, Ferris D, Dias JK. Human papillomavirus vaccine acceptability among parents of 10- to 15-year-old adolescents. J Low Genit Tract Dis. 2004 Jul;8(3):188-94. doi: 10.1097/00128360-200407000-00005.

    PubMed 15874862

  • Lazcano-Ponce E, Rivera L, Arillo-Santillan E, Salmeron J, Hernandez-Avila M, Munoz N. Acceptability of a human papillomavirus (HPV) trial vaccine among mothers of adolescents in Cuernavaca, Mexico. Arch Med Res. 2001 May-Jun;32(3):243-7. doi: 10.1016/s0188-4409(01)00277-6.

    PubMed 11395192

  • Slomovitz BM, Sun CC, Frumovitz M, Soliman PT, Schmeler KM, Pearson HC, Berenson A, Ramirez PT, Lu KH, Bodurka DC. Are women ready for the HPV vaccine? Gynecol Oncol. 2006 Oct;103(1):151-4. doi: 10.1016/j.ygyno.2006.02.003. Epub 2006 Mar 21.

    PubMed 16551476

  • Taylor JA, Darden PM, Brooks DA, Hendricks JW, Wasserman RC, Bocian AB; Pediatric Research in Office Settings; National Medical Association. Association between parents' preferences and perceptions of barriers to vaccination and the immunization status of their children: a study from Pediatric Research in Office Settings and the National Medical Association. Pediatrics. 2002 Dec;110(6):1110-6. doi: 10.1542/peds.110.6.1110.

    PubMed 12456907

  • Tissot AM, Zimet GD, Rosenthal SL, Bernstein DI, Wetzel C, Kahn JA. Effective strategies for HPV vaccine delivery: the views of pediatricians. J Adolesc Health. 2007 Aug;41(2):119-25. doi: 10.1016/j.jadohealth.2007.05.007.

    PubMed 17659214

  • Kahn JA, Zimet GD, Bernstein DI, Riedesel JM, Lan D, Huang B, Rosenthal SL. Pediatricians' intention to administer human papillomavirus vaccine: the role of practice characteristics, knowledge, and attitudes. J Adolesc Health. 2005 Dec;37(6):502-10. doi: 10.1016/j.jadohealth.2005.07.014.

    PubMed 16310128

Questions about this trial

What is this clinical trial studying?

An observational study of Human Papilloma Virus and HPV, run by Columbia 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 8 inclusion and 10 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 5 Nov 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?

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00730704, which also lists 16 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 5 Nov 2012.

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