Home Human Papillomavirus or Pap Exam (HOPE) Study

• 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

• 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

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.

• Cervical Cancer
• Precancerous Condition

• Experimental: Novel: 21-29yo, no HPV vacc.
  Intervention: Procedure: Self-collected at home HPV testing
• Experimental: Novel: 21-29yo, HPV vacc.
  Intervention: Procedure: Self-collected at home HPV testing
• Experimental: Novel: >=30yo
  Intervention: Procedure: Self-collected at home HPV testing
• No Intervention: Standard Care: 21-29yo, no HPV vacc.
• No Intervention: Standard Care: 21-29yo, HPV vacc.
• No Intervention: Standard Care: >=30yo

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