Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01550783
First received: February 17, 2012
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.


Condition Intervention
Atypical Squamous Cells of Undetermined Significance
Cervical Cancer
Cervical Intraepithelial Neoplasia Grade 1
Cervical Intraepithelial Neoplasia Grade 2
Cervical Intraepithelial Neoplasia Grade 3
Health Status Unknown
Human Papilloma Virus Infection
Stage 0 Cervical Cancer
Procedure: screening method
Other: cervical Papanicolaou test
Other: cytology specimen collection procedure
Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Sensitivity and specificity for CIN 1+ of novel home-based testing [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.

  • Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.

  • Overall cost-effectiveness and acceptability [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The results from the trial (sensitivity, specificity, and costs) will be used in conjunction with a Markov model to determine cost per LY and cost per QALY. Model outcomes (per 100,000 screened) will include the expected numbers of false-positive test results, colposcopies, cases of CIN 1+, cases of cancer, cancer deaths, life expectancy and quality adjusted life-expectancy. Strategies will be compared using incremental cost-effectiveness ratios. Costs and outcomes will be discounted at 3% annually. One, 2-way and probabilistic sensitivity analyses conducted for all inputs to the models.

  • Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty

  • Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Estimates of sensitivity and specificity for detection of CIN 1 will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty

  • Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: March 2012
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I (home-based HPV screening)
Participants collect 2 vaginal specimens using polyester swabs that are then placed in a specimen tube. Specimens are then submitted to the Harborview Medical Center clinical pathology lab. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II.
Procedure: screening method
Undergo home-based HPV screening
Other: cytology specimen collection procedure
Undergo home-based HPV screening
Other Name: cytologic sampling
Other: questionnaire administration
Ancillary studies
Experimental: Group II (clinic-based standard of care screening)
Participants undergo standard of care cervical cancer screening and follow-up. That is, participants undergo Pap testing. Participants with an abnormal Pap test undergo HPV testing, colposcopy, cervical biopsy and/or ECC. Participants with cervical biopsies showing precancerous changes are offered to undergo LEEP or are referred to appropriate care.
Procedure: screening method
Undergo standard of care Pap test screening
Other: cervical Papanicolaou test
Undergo standard of care Pap test screening
Other Name: cervical Pap test
Other: questionnaire administration
Ancillary studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) of two screening approaches:

  • Novel approach: every 3 years high risk-human papillomavirus (HR-HPV) testing of (at home) self-collected samples with in-clinic cytology of HR-HPV positive women and referral to colposcopy of women with cytology > atypical squamous cells of uncertain significance (ASCUS); repeat HPV testing of HR-HPV positive but cytology negative women at one year;
  • Currently recommended approach: for women < 30: every 3 years in-clinic cytology screening, with HPV based triage of women with ASCUS and referral to colposcopy of all women with squamous intraepithelial lesion (SIL) and/or HPV+ ASCUS; for women 30+, screening by Papanicolaou (Pap) and HPV, every 2-3 year (depending on previous history) with referral to colposcopy of those who are HPV 16/18+ or with cytology > ASCUS; retesting of those who are positive for other HR-HPV at one year.

II. Compare these two approaches with respect to over all cost-effectiveness and acceptability.

III. Determine the performance and cost-effectiveness of each approach in vaccinated and unvaccinated women < 30.

OUTLINE: Participants are randomized to 1 of 2 arms.

GROUP I (home-based HPV screening): Participants collect 2 vaginal specimens using polyester swabs. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II.

GROUP II (clinic-based standard of care screening): Participants undergo Pap testing. Participants with a positive Pap test undergo standard of care, including colposcopy, HPV testing, cervical biopsy and/or endocervical curettage (ECC). Participants with cervical biopsies showing precancerous changes requiring treatment may undergo loop electrosurgical excision procedure (LEEP) or are referred to appropriate care.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to provide informed consent in English

Exclusion Criteria:

  • Have had hysterectomy
  • Currently pregnant
  • Received treatment of cervical dysplasia with loop electrosurgical excision procedure (LEEP), cone biopsy, laser procedure or cryotherapy within THREE years
  • Received colposcopy of cervix within TWO years
  • Received Pap test within ONE year
  • Immunocompromised (positive human immunodeficiency virus [HIV] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs)
  • Decisionally impaired adults requiring a legally authorized representative
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550783

Locations
United States, Minnesota
University of Minnesota Medical Center-Fairview Active, not recruiting
Minneapolis, Minnesota, United States, 55455
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Cady Stanton    206-543-3327    homehpv@uw.edu   
Principal Investigator: Nancy Kiviat         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Nancy Kiviat Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01550783     History of Changes
Other Study ID Numbers: 7489, NCI-2013-00745, 7489, P30CA015704, R01CA157469
Study First Received: February 17, 2012
Last Updated: May 28, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Cervical cancer
Atypical squamous cells of undetermined significance
Stage 0 cervical cancer
Cervical intraepithelial neoplasia grade 1
Cervical
intraepithelial neoplasia grade 2
Cervical intraepithelial neoplasia grade 3
Human papillomavirus
HPV

Additional relevant MeSH terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Neoplasms
Carcinoma in Situ
Virus Diseases
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Tumor Virus Infections
Precancerous Conditions

ClinicalTrials.gov processed this record on September 16, 2014