HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals

Enrolling by invitation · Not applicable

Conditions studied: Cervical Cancer

In brief

The objective of this study is to evaluate self-collection of vaginal samples for HPV testing as an alternative cervical cancer screening strategy for persons with HIV and/or limited access to care. Self-collection kits will be offered to persons who refuse a Pap smear or are overdue (\>=6 months) for cervical cancer screening, with screening uptake recorded as a primary outcome. Kits will be offered in-clinic to individuals who refuse a Pap smear, and individuals overdue for screening will have the option to receive and return kits in the mail. The investigators will additionally administer a phone-based survey to evaluate knowledge about HPV and cervical cancer, barriers and facilitators to screening, and attitudes towards screening. Data from medical records will be abstracted to describe the clinical characteristics of the sample and measure receipt of follow-up procedures. Focus groups will be conducted with clinic administrators, staff, and HIV and women's health experts to evaluate clinic and provider barriers and facilitators to cervical cancer screening. The investigators hypothesize that HPV self-sampling will result in favorable patient-centered outcomes and could reduce disparities in access to screening.

Key facts

Study ID

NCT05528237

Run by

University of Washington

People needed

50

Starts

2022-08-18

Expected to finish

2022-10-07

Last updated by the study team

2022-09-06

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age >=25 and <65 (individuals without diagnosed HIV) or >=30 years (individuals with diagnosed HIV)
• Female sex at birth
• Proficient in English or Spanish
• Refused a Pap smear or are >=6 months overdue for cervical cancer screening

You may not qualify if…

• Current pregnancy
• Complete hysterectomy
• History of cervical cancer
• Unable to provide informed consent

Where it is running

• SHE Clinic — Seattle, Washington, United States
• Madison Clinic — Seattle, Washington, United States
• MAX Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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