Finding studies
Finding studies
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Lead
University of Washington
With
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.
Age
21–any
Sex
FEMALE
Healthy volunteers
Accepted
