Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
NCT ID: NCT01550783
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1335 participants
INTERVENTIONAL
2012-03-31
2017-11-16
Brief Summary
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Detailed Description
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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 overall 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
Cytology Specimen Collection Procedure
Undergo home-based HPV screening
Questionnaire Administration
Ancillary studies
Screening Method
Undergo home-based HPV screening
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.
Cervical Papanicolaou Test
Undergo standard of care Pap test screening
Questionnaire Administration
Ancillary studies
Screening Method
Undergo standard of care Pap test screening
Interventions
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Cervical Papanicolaou Test
Undergo standard of care Pap test screening
Cytology Specimen Collection Procedure
Undergo home-based HPV screening
Questionnaire Administration
Ancillary studies
Screening Method
Undergo standard of care Pap test screening
Screening Method
Undergo home-based HPV screening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Currently pregnant
* Received treatment of cervical dysplasia with 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
21 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Nancy Kiviat
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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Feder MA, Kulasingam SL, Kiviat NB, Mao C, Nelson EJ, Winer RL, Whitham HK, Lin J, Hawes SE. Correlates of Human Papillomavirus Vaccination and Association with HPV-16 and HPV-18 DNA Detection in Young Women. J Womens Health (Larchmt). 2019 Oct;28(10):1428-1435. doi: 10.1089/jwh.2018.7340. Epub 2019 Jul 2.
Mao C, Kulasingam SL, Whitham HK, Hawes SE, Lin J, Kiviat NB. Clinician and Patient Acceptability of Self-Collected Human Papillomavirus Testing for Cervical Cancer Screening. J Womens Health (Larchmt). 2017 Jun;26(6):609-615. doi: 10.1089/jwh.2016.5965. Epub 2017 Mar 23.
Other Identifiers
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NCI-2013-00745
Identifier Type: REGISTRY
Identifier Source: secondary_id
7489
Identifier Type: OTHER
Identifier Source: secondary_id
7489
Identifier Type: -
Identifier Source: org_study_id
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