Clinical trial NCT01550783: Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
Official title: Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: Cervical cancer
Atypical squamous cells of undetermined significance
Stage 0 cervical cancer
Cervical intraepithelial neoplasia grade 1
Cervical
intraepithelial neoplasia grade 2
Cervical intraepithelial neoplasia grade 3
Human papillomavirus
HPV
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-12
Enrollment: 1335
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old
timeFrame: Up to 4 years
measure: Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old
timeFrame: Up to 4 years
measure: Overall cost-effectiveness and acceptability
timeFrame: Up to 4 years
measure: Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening
timeFrame: Up to 4 years
measure: Sensitivity and specificity for CIN 1+ of novel home-based testing
timeFrame: Up to 4 years
measure: Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old
timeFrame: Up to 4 years
measure: Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota/Masonic Cancer Center
state: Minnesota
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Nancy Kiviat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feder MA, Kulasingam SL, Kiviat NB, Mao C, Nelson EJ, Winer RL, Whitham HK, Lin J, Hawes SE. Correlates of Human Papillomavirus Vaccination and Association with HPV-16 and HPV-18 DNA Detection in Young Women. J Womens Health (Larchmt). 2019 Oct;28(10):1428-1435. doi: 10.1089/jwh.2018.7340. Epub 2019 Jul 2.
citation: Mao C, Kulasingam SL, Whitham HK, Hawes SE, Lin J, Kiviat NB. Clinician and Patient Acceptability of Self-Collected Human Papillomavirus Testing for Cervical Cancer Screening. J Womens Health (Larchmt). 2017 Jun;26(6):609-615. doi: 10.1089/jwh.2016.5965. Epub 2017 Mar 23.