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

Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS

Sponsors

Lead Sponsor: University of Washington

Collaborator: National Cancer Institute (NCI)

Source University of Washington
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.

Overall Status Completed
Start Date March 2012
Completion Date November 16, 2017
Primary Completion Date November 16, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old Up to 4 years
Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old Up to 4 years
Overall cost-effectiveness and acceptability Up to 4 years
Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening Up to 4 years
Sensitivity and specificity for CIN 1+ of novel home-based testing Up to 4 years
Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old Up to 4 years
Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old Up to 4 years
Enrollment 1335
Condition
Intervention

Intervention Type: Other

Intervention Name: Cervical Papanicolaou Test

Description: Undergo standard of care Pap test screening

Arm Group Label: Group II (clinic-based standard of care screening)

Other Name: Cervical Pap Test

Intervention Type: Other

Intervention Name: Cytology Specimen Collection Procedure

Description: Undergo home-based HPV screening

Arm Group Label: Group I (home-based HPV screening)

Other Name: Cytologic Sampling

Intervention Type: Other

Intervention Name: Questionnaire Administration

Description: Ancillary studies

Intervention Type: Procedure

Intervention Name: Screening Method

Description: Undergo standard of care Pap test screening

Arm Group Label: Group II (clinic-based standard of care screening)

Intervention Type: Procedure

Intervention Name: Screening Method

Description: Undergo home-based HPV screening

Arm Group Label: Group I (home-based HPV screening)

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

Gender: Female

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Nancy Kiviat Principal Investigator Fred Hutch/University of Washington Cancer Consortium
Location
Facility:
University of Minnesota/Masonic Cancer Center | Minneapolis, Minnesota, 55455, United States
Fred Hutch/University of Washington Cancer Consortium | Seattle, Washington, 98109, United States
Location Countries

United States

Verification Date

April 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group I (home-based HPV screening)

Type: Experimental

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.

Label: Group II (clinic-based standard of care screening)

Type: Experimental

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Screening

Masking: None (Open Label)

Source: ClinicalTrials.gov