Back to search results

Evaluating HPV Self-Collection for Cervical Cancer Prevention

This study, called PopSci CHW4CervixHealth, is looking at better ways to screen for Human Papillomavirus (HPV), which can cause cervical cancer. It's testing two self-collection devices, Evalyn® Brush and Copan Floqswab, for HPV testing. The study also includes a program called CHW4CervicalHealth, led by community health workers, to teach women about cervical health and encourage them to use these self-collection kits. The goal is to see how well these self-collected samples match samples taken by a doctor, and if the CHW program helps more women get screened. Women aged 25-65 who have not had a hysterectomy can join. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 120 women in two phases. Phase I compares self-collected samples to clinic samples, and Phase II evaluates a community health worker program.
What's involved
In Phase I, you would have a self-collection procedure during your Pap smear appointment (about 30 minutes). In Phase II, you would attend a 30-minute workshop and complete a survey and self-collection kit use (another 30 minutes).
Compensation
Not stated in the trial record.
Follow-up
Your diagnostic results will be analyzed within 2 weeks. The feasibility of completing the self-collection kit will be measured within 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07336134

PopSci CHW4CervixHealth

Recruiting
NAAges 25–65InterventionalHealth services
Thomas Jefferson University
~120 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Evalyn® BrushCopan FloqswabCHW4CervicalHealth

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic Concordance of Self-Collected vs. Clinically collected sample (Phase I)
Measured over at the visit (approximately 30 minutes) and analysis completed within 2 weeks
+1 more outcome measured

Conditions

Cervical Cancer
Hpv
Human Papilloma Virus
HPV Infection

Explore related trials

Cervical CarcinomaHuman Papillomavirus Infection

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Sandra Dayaratna, MD, MBA · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who to contact

Site Public Contact
[email protected]
215-600-9151
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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)
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

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)
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

What this trial measures

  • Diagnostic Concordance of Self-Collected vs. Clinically collected sample (Phase I)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 KitWithin 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.