PopSci CHW4CervixHealth
Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab
Thomas Jefferson University
120 participants
Oct 22, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria11
- Phase I:
- 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
- Have not undergone a hysterectomy (intact cervix required)
- Phase II:
- Women aged 25-65 years
- Who has not had a Pap smear in the past three to five years based on age of prior screening and type of screening. If under the age of 30, in the past 3 years and if over the age of 30, in the past 5 years. Participant will self-report normal pap smear and date.
- Self-identify as Hispanic, Black/African or Black Caribbean, Chinese, Korean, or Vietnamese
- Competent to give consent and provide signed and dated informed consent form in their preferred language.
Exclusion Criteria11
- Phase I:
- 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)
- Phase II:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Have a history of hysterectomy, cervical cancer
- Self-report participation in a cervical cancer screening or other prevention study
- Pregnant (self-reported)
- Inability to provide informed consent
Interventions
Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.
Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.
The CHW4CervicalHealth intervention is a community health care worker (CHW)-led education and support program designed to promote HPV self-collection among underserved women. Trained bilingual CHWs provide culturally-tailored community workshops about cervical health and cervical cancer prevention, distribution and collection of HPV self-collection, and follow-up from results when appropriate.
Locations(1)
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NCT07336134