To hear about similar clinical trials, please enter your email below
Trial Title:
HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals
NCT ID:
NCT05528237
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Screening
Self-collection
Self-sampling
Cervical cancer
HPV
HIV
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Flocked swab paired with Roche Cobas 4800
Description:
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.
Arm group label:
HPV self-sampling
Other name:
COPAN 552c FLOQSwabs
Summary:
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
25 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
SHE Clinic
Address:
City:
Seattle
Zip:
98103
Country:
United States
Facility:
Name:
Madison Clinic
Address:
City:
Seattle
Zip:
98104
Country:
United States
Facility:
Name:
MAX Clinic
Address:
City:
Seattle
Zip:
98104
Country:
United States
Start date:
August 18, 2022
Completion date:
October 7, 2022
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
National Center for Advancing Translational Sciences (NCATS)
Agency class:
NIH
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05528237
