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

University of Washington

Status: Completed

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

Treatments: Other: Cervical Papanicolaou Test; Other: Questionnaire Administration; Other: Cytology Specimen Collection Procedure; Procedure: Screening Method

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01550783

NCI-2013-00745 (Registry Identifier)

R01CA157469 (U.S. NIH Grant/Contract)

7489 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,335 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,335 participants in 2 patient groups

Group I (home-based HPV screening)

Experimental group

Description:

Participants collect 2 vaginal specimens using polyester swabs that are then placed in a specimen tube. Specimens are then submitted to the Harborview Medical Center clinical pathology lab. 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.

Treatment:

Other: Questionnaire Administration

Procedure: Screening Method

Other: Cytology Specimen Collection Procedure

Procedure: Screening Method

Group II (clinic-based standard of care screening)

Experimental group

Description:

Participants undergo standard of care cervical cancer screening and follow-up. That is, participants undergo Pap testing. Participants with an abnormal Pap test undergo HPV testing, colposcopy, cervical biopsy and/or ECC. Participants with cervical biopsies showing precancerous changes are offered to undergo LEEP or are referred to appropriate care.

Treatment:

Other: Questionnaire Administration

Procedure: Screening Method

Procedure: Screening Method

Other: Cervical Papanicolaou Test