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
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.
Study Type
Interventional
Primary Outcome
Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old
Condition
Atypical Squamous Cell of Undetermined Significance
Intervention
Cervical Papanicolaou Test
Study Arms / Comparison Groups
Group I (home-based HPV screening)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
1335
Start Date
March 2012
Completion Date
November 16, 2017
Primary Completion Date
November 16, 2017
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
Ages
21 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Nancy Kiviat, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01550783
Organization ID
7489
Secondary IDs
NCI-2013-00745
Responsible Party
Sponsor
Study Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Nancy Kiviat, Principal Investigator, Fred Hutch/University of Washington Cancer Consortium
Verification Date
April 2018