Human Papillomavirus Infection Clinical Trial
Official title:
Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
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.
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.
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