Actively Recruiting
PopSci CHW4CervixHealth
Led by Thomas Jefferson University · Updated on 2026-01-13
120
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PopSci CHW4CervixHealth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 25 to 65 years
- Scheduled for a Pap smear test appointment at Jefferson OBGYN Center City location (Phase I)
- Willing and able to provide informed consent for participation in the study
- Agree to perform an HPV self-collection procedure during the same visit (Phase I)
- Have not undergone a hysterectomy (intact cervix required)
- Women aged 25 to 65 years (Phase II)
- Under-screened minority women who have not had a Pap smear in the past 3 years if under 30, or in the past 5 years if 30 or older
- Self-identify as Hispanic, Black/African or Black Caribbean, Chinese, Korean, or Vietnamese (Phase II)
- Competent to give consent and able to provide signed and dated informed consent form in their preferred language (Phase II)
You will not qualify if you...
- Current pregnancy (self-reported or confirmed) (Phase I)
- Previous participation in an HPV self-collection study within the past 12 months (Phase I)
- Presence of visible vaginal or cervical infection or symptoms suggesting a genital tract infection (Phase I)
- Inability to comply with study procedures or follow instructions (e.g., due to language barriers or cognitive impairments) (Phase I)
- History of hysterectomy or cervical cancer (Phase II)
- Self-reported participation in a cervical cancer screening or prevention study (Phase II)
- Pregnant (self-reported) (Phase II)
- Inability to provide informed consent (Phase II)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
S
Sandra Dayaratna, MD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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