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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05528237
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Flocked swab paired with Roche Cobas 4800 — DEVICE
    Consenting individuals will insert the sterile flocked swab into the vagina, rotate at least once, and store in the provided dry tube. The sample will be stored at ambient temperature and routed to the lab for HPV testing with Roche Cobas 4800.

Study Details

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 Dates

Start date
Aug 18, 2022
Status verified
Aug 2022
Primary completion
Sep 30, 2022
Completion
Oct 7, 2022

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: HPV self-sampling
    Participants will be offered self-collection kits for HPV-based cervical cancer screening.

Primary Outcome Measure

Proportion of eligible individuals who accept self-sampling kits [ Time Frame: Baseline (during clinical and/or study recruitment encounter) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Madison ClinicSeattleWashington98104-
MAX ClinicSeattleWashington98104-
SHE ClinicSeattleWashington98103-

Find similar trials in Seattle, WA

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Madison Clinic· Seattle, WAMAX Clinic· Seattle, WASHE Clinic· Seattle, WA

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