NCT01550783

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

Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,335 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atypical Squamous Cell of Undetermined Significance
• Cervical Carcinoma
• Cervical Intraepithelial Neoplasia Grade 2/3
• Health Status Unknown
• Human Papillomavirus Infection
• Low Grade Cervical Squamous Intraepithelial Neoplasia
• Stage 0 Cervical Cancer

Interventions

Type	Name	Description
OTHER	Cervical Papanicolaou Test	Undergo standard of care Pap test screening
OTHER	Cytology Specimen Collection Procedure	Undergo home-based HPV screening
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Screening Method	Undergo standard of care Pap test screening
PROCEDURE	Screening Method	Undergo home-based HPV screening

Timeline

• Start date: 2012-03-01
• Primary completion: 2017-11-16
• Completion: 2017-11-16
• First posted: 2012-03-12
• Last updated: 2020-07-31

Locations

2 sites across 1 country: United States