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.
Who can participate
Age range
25 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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:
This intervention targets under-screened minority individuals who must meet all the following inclusion criteria to be eligible to participate in the study:
* 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 Criteria:
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 b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Concordance of Self-Collected vs. Clinically collected sample (Phase I)
Timeframe: at the visit (approximately 30 minutes) and analysis completed within 2 weeks
2
Feasibility of HPV Self-Collection: Completion of Self-Collection Kit