NCT07336134 · Thomas Jefferson University
PopSci CHW4CervixHealth
What this study is about
Phase I: Validating self-collection kit by comparing their results with clinical Pap smear results in a group of participants of 20 patients.
View original scientific description
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.
Interventions
DEVICE
Evalyn® Brush
Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.
DEVICE
Copan Floqswab
Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.
BEHAVIORAL
CHW4CervicalHealth
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.
Primary outcome measures
Diagnostic Concordance of Self-Collected vs. Clinically collected sample (Phase I)
Time frame: at the visit (approximately 30 minutes) and analysis completed within 2 weeks
Concordance rate between self-collection kit results and clinical Pap smear findings (measured as agreement in detection of HPV and/or abnormal cytology). Agreement between the two methods will be evaluated using Cohen's kappa statistic, with values interpreted based on standard benchmarks for strength of agreement. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) will be calculated to determine the accuracy of self-collection kits relative to the clinician-collected gold standard.
Feasibility of HPV Self-Collection: Completion of Self-Collection Kit
Time frame: Within 12 months
Feasibility will be assessed as the number of participants who proceed with HPV self-collection using the study kit out of the total number of participants enrolled in the study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- Philadelphia, Pennsylvania
Collaborators
Roche Pharma AG
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 13, 2026 · Source of record for eligibility and locations