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

University of Washington

Status: Invitation-only

Conditions: Cervical Cancer

Treatments: Device: Flocked swab paired with Roche Cobas 4800

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05528237

STUDY00014442

5KL2TR002317-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

HPV self-sampling

Experimental group

Description:

Participants will be offered self-collection kits for HPV-based cervical cancer screening.

Treatment:

Device: Flocked swab paired with Roche Cobas 4800