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