Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
Conditions
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
Conditions: official terms
Carcinoma in Situ - Cervical Intraepithelial Neoplasia - Neoplasms - Papillomavirus Infections - Uterine Cervical Dysplasia - Uterine Cervical Neoplasms - Virus Diseases
Conditions: 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
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Intervention
Name: screening method Type: Procedure
Name: cervical Papanicolaou test Type: Other
Name: screening method Type: Procedure
Name: cytology specimen collection procedure Type: Other
Name: questionnaire administration Type: Other
Overall Status
Recruiting
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 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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Female
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
Locations
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States
Status: Active, not recruiting
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Status: Recruiting
Contact: Cady Stanton - 206-543-3327 - homehpv@uw.edu
Start Date
March 2012
Sponsors
University of Washington
Source
University of Washington
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page