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

Primary Purpose

Atypical Squamous Cell of Undetermined Significance, Cervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical Papanicolaou Test
Cytology Specimen Collection Procedure
Questionnaire Administration
Screening Method
Screening Method
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atypical Squamous Cell of Undetermined Significance focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to provide informed consent in English

Exclusion Criteria:

  • Have had hysterectomy
  • 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

Sites / Locations

  • University of Minnesota/Masonic Cancer Center
  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (home-based HPV screening)

Group II (clinic-based standard of care screening)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old
Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old
Overall cost-effectiveness and acceptability
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 for CIN 1+ of currently recommended in-clinic cytology screening
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 novel home-based testing
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 of the novel approach in vaccinated women less than 30 years old
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
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

Secondary Outcome Measures

Full Information

First Posted
February 17, 2012
Last Updated
July 29, 2020
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01550783
Brief Title
Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
Official Title
Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 16, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Squamous Cell of Undetermined Significance, Cervical Carcinoma, Cervical Intraepithelial Neoplasia Grade 2/3, Health Status Unknown, Human Papillomavirus Infection, Low Grade Cervical Squamous Intraepithelial Neoplasia, Stage 0 Cervical Cancer
Keywords
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (home-based HPV screening)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (clinic-based standard of care screening)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cervical Papanicolaou Test
Other Intervention Name(s)
Cervical Pap Test
Intervention Description
Undergo standard of care Pap test screening
Intervention Type
Other
Intervention Name(s)
Cytology Specimen Collection Procedure
Other Intervention Name(s)
Cytologic Sampling
Intervention Description
Undergo home-based HPV screening
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Screening Method
Intervention Description
Undergo standard of care Pap test screening
Intervention Type
Procedure
Intervention Name(s)
Screening Method
Intervention Description
Undergo home-based HPV screening
Primary Outcome Measure Information:
Title
Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old
Time Frame
Up to 4 years
Title
Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old
Time Frame
Up to 4 years
Title
Overall cost-effectiveness and acceptability
Description
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.
Time Frame
Up to 4 years
Title
Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening
Description
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.
Time Frame
Up to 4 years
Title
Sensitivity and specificity for CIN 1+ of novel home-based testing
Description
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.
Time Frame
Up to 4 years
Title
Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old
Description
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
Time Frame
Up to 4 years
Title
Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old
Description
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
Time Frame
Up to 4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to provide informed consent in English Exclusion Criteria: Have had hysterectomy 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Kiviat
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31264912
Citation
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.
Results Reference
derived
PubMed Identifier
28332888
Citation
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.
Results Reference
derived

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

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