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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01550783
First received: February 17, 2012
Last updated: May 28, 2014
Last verified: May 2014

February 17, 2012
May 28, 2014
March 2012
August 2016   (final data collection date for primary outcome measure)
  • Sensitivity and specificity for CIN 1+ of novel home-based testing [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.
  • Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.
  • Overall cost-effectiveness and acceptability [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The results from the trial (sensitivity, specificity, and costs) will be used in conjunction with a Markov model to determine cost per LY and cost per QALY. Model outcomes (per 100,000 screened) will include the expected numbers of false-positive test results, colposcopies, cases of CIN 1+, cases of cancer, cancer deaths, life expectancy and quality adjusted life-expectancy. Strategies will be compared using incremental cost-effectiveness ratios. Costs and outcomes will be discounted at 3% annually. One, 2-way and probabilistic sensitivity analyses conducted for all inputs to the models.
  • Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty
  • Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Estimates of sensitivity and specificity for detection of CIN 1 will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty
  • Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT01550783 on ClinicalTrials.gov Archive Site
Not Provided
  • 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
Not Provided
Not Provided
 
Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS

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 over all 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Atypical Squamous Cells of Undetermined Significance
  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia Grade 1
  • Cervical Intraepithelial Neoplasia Grade 2
  • Cervical Intraepithelial Neoplasia Grade 3
  • Health Status Unknown
  • Human Papilloma Virus Infection
  • Stage 0 Cervical Cancer
  • Procedure: screening method
    Undergo standard of care Pap test screening
  • Other: cervical Papanicolaou test
    Undergo standard of care Pap test screening
    Other Name: cervical Pap test
  • Procedure: screening method
    Undergo home-based HPV screening
  • Other: cytology specimen collection procedure
    Undergo home-based HPV screening
    Other Name: cytologic sampling
  • Other: questionnaire administration
    Ancillary studies
  • Experimental: Group I (home-based HPV screening)
    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.
    Interventions:
    • Procedure: screening method
    • Other: cytology specimen collection procedure
    • Other: questionnaire administration
  • Experimental: Group II (clinic-based standard of care screening)
    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.
    Interventions:
    • Procedure: screening method
    • Other: cervical Papanicolaou test
    • Other: questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
Not Provided
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Able to provide informed consent in English

Exclusion Criteria:

  • Have had hysterectomy
  • Currently pregnant
  • Received treatment of cervical dysplasia with loop electrosurgical excision procedure (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
Female
21 Years and older
Yes
United States
 
NCT01550783
7489, NCI-2013-00745, 7489, P30CA015704, R01CA157469
Yes
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Nancy Kiviat Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP