About this trial
Phase I: Validating self-collection kit by comparing their results with clinical Pap smear results in a cohort of 20 patients.
Phase II: Evaluate the feasibility and acceptability of the CHW4CervicalHealth: Use of a self-collection kit to improve cervical health screening intervention aimed to promote HPV self-collection uptake among screening-eligible and under-screened ethnic minority women in the community.
Eligibility criteria
Qualifiers
Women aged 25-65 years
Scheduled for a Pap smear test appointment at Jefferson OBGYN Center City location
Willing and able to provide informed consent for participation in the study
Agree to perform an HPV self-collection collection procedure during the same visit
Disqualifiers
Current pregnancy (self-reported or confirmed)
Previous participation in an HPV self-collection study within the past 12 months
Presence of visible vaginal or cervical infection or symptoms suggestive of a current genital tract infection
Inability to comply with study procedures or follow instructions (e.g., due to language barriers or cognitive impairments)
Trial design
Treatments tested in this trial
- Evalyn® Brush
- Copan Floqswab
- CHW4CervicalHealth
Treatment groups
Sponsors and collaborators
Thomas Jefferson University
Lead sponsor
Roche Pharma AG
Collaborator