Home Human Papillomavirus or Pap Exam (HOPE) Study - Full Text View

Purpose

Cervical cancer is caused by a virus called human papillomavirus (HPV). Despite the availability of HPV 16/18 vaccines, cervical cancer screening will need to continue as current vaccines do not protect against all HPV types, nor do they protect women already infected with HPVs against development of cervical cancer.

The investigators are doing this study to compare whether HPV testing (self-collected at home) is as effective as the currently recommended approach (Pap tests) for screening for cervical cancer. The investigators want to know if self-collected at home HPV testing is effective, cost-effective, and/or acceptable to patients.

Patients in this study will get either self-collected at home HPV testing or regular Pap test screenings. In the home HPV test group, if your HPV test is positive you will receive a Pap test. In the standard care group, if the patient's Pap test is abnormal you will receive an HPV test. Any cervical cancer screening follow-up examinations will be per currently recommended guidelines.

Based upon data in our clinical practice at the University of Washington clinics and our previous research studies, the investigators expect that self-collected at home HPV testing will be effective, cost-effective, and acceptable to patients.

Condition	Intervention
Cervical Cancer Precancerous Condition	Procedure: Self-collected at home HPV testing

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Cytology Versus at Home HPV Screening for Detection of CIN 2,3, CIS

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

Sensitivity and specificity of self-collected at home human papillomavirus test with reflex cytology [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Compare whether cervical cancer screening of self-collected at home human papillomavirus test with reflex cytology is as effective as the currently recommended approach of cytology with reflex human papillomavirus testing.
Total estimated costs associated with cervical cancer screening [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Compare novel and standard care approaches with respect to over all cost-effectiveness (direct and in-direct costs)
Patient satisfaction with self-collected at home human papillomavirus test screening as measured by study questionnaires [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Compare novel and standard care approaches acceptability to patients

Secondary Outcome Measures:

Sensitivity and specificity of self-collected at home human papillomavirus test with reflex cytology in human papillomavirus vaccinated and unvaccinated women less than 30 years old [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Compare novel and standard care arm performance in human papillomavirus vaccinated and unvaccinated women less than 30 years old
Sensitivity and specificity of human papillomavirus DNA genotyping and detection of aberrantly DNA methylated genes for referring high risk human papillomavirus positive women to colposcopy to identify cervical intraepithelial neoplasia 2,3+ [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
In the novel arm, determine the potential utility of triage of high risk human papillomavirus positive women to colposcopy for identification of cervical intraepithelial neoplasia 2,3+ based on human papillomavirus DNA genotyping or detection of aberrantly DNA methylated genes
Total estimated costs associated with cervical cancer screening in human papillomavirus vaccinated and unvaccinated women less than 30 years old [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Compare novel and standard care arm cost-effectiveness in human papillomavirus vaccinated and unvaccinated women less than 30 years old

Estimated Enrollment:	5400
Study Start Date:	March 2012
Estimated Study Completion Date:	August 2016
Estimated Primary Completion Date:	August 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Novel: 21-29yo, no HPV vacc.	Procedure: Self-collected at home HPV testing Self-collected at home HPV testing followed by in-clinic cytology for triage of HR-HPV positive women
Experimental: Novel: 21-29yo, HPV vacc.	Procedure: Self-collected at home HPV testing Self-collected at home HPV testing followed by in-clinic cytology for triage of HR-HPV positive women
Experimental: Novel: >=30yo	Procedure: Self-collected at home HPV testing Self-collected at home HPV testing followed by in-clinic cytology for triage of HR-HPV positive women
No Intervention: Standard Care: 21-29yo, no HPV vacc.
No Intervention: Standard Care: 21-29yo, HPV vacc.
No Intervention: Standard Care: >=30yo

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female sex
>=21 years old
Able to provide informed consent in English

Exclusion Criteria:

Male sex
Have had hysterectomy
Currently pregnant
Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within two years
Immunocompromised (positive HIV test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs)
Decisionally impaired adults requiring a legally authorized representative

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550783

Locations

United States, Minnesota
University of Minnesota	Not yet recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Shalini Kulasingam, PhD homehpv@uw.edu
Principal Investigator: Shalini Kulasingam, PhD
United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98195
Contact: Emily Boevers, MA 206-543-3327 homehpv@uw.edu
Principal Investigator: Nancy B Kiviat, MD

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Nancy B Kiviat, M.D.	University of Washington
Principal Investigator:	Shalini Kulasingam, Ph.D.	University of Minnesota - Clinical and Translational Science Institute

More Information

Additional Information:

Study Web site This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT01550783 History of Changes
Other Study ID Numbers:	7489, R01CA157469, UWCC-7489, FHCRC-7489
Study First Received:	February 17, 2012
Last Updated:	March 6, 2013
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:

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

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases

Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma

ClinicalTrials.gov processed this record on May 21, 2013