PopSci CHW4CervixHealth

January 9, 2026 updated by: Thomas Jefferson University

Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The self-collection kits will be collected at the clinic (Phase I) or at the end of the workshop (Phase II). A chain-of-custody form for each kit will be associated with the specimen and the clinic nurse will label and prepare to transport them via courier to the Jefferson NJ Molecular Virology lab, Cherry Hill, NJ; Richard Sunday, Lab Supervisor, will process according to Roche, the self-collected vaginal specimens suspended in PreservCyt® may be stored at 2-30°C (35.6- 86°F) for up to 1 month after the date of collection.

Phase I: In person accrual, enrollment and study implementation will take 15-30 minutes.

-Clinic staff will collect self-collection kit at appointment.

Phase II: Workshops will take about 30 minutes to complete and another 30 minutes to complete survey and self-collection kit use.

  • Conduct educational workshops in participants primary language
  • For those choosing to use the self-sample kit, obtain and document e-consent or paper consent from potential participants in their primary language.
  • Provide participants with self-collection testing kits during workshop along with instructions
  • Collect self-collection kit samples from participants and place in pre-made sample bags with appropriate label. CHW will take custody and coordinate with OBGYN clinic staff to drop off self-collected samples
  • Collect post workshop survey and conduct post workshop interviews or focus group
  • OBGYN staff set-up courier to send samples to NJ lab

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Evalyn Brush Self-Collection - Phase I (Validation)
Participants will be provided the Evalyn Brush self-sample kit at their scheduled Pap smear; a self-collected HPV test will also be collected as part of validation purposes for the study. Results will be shared from both their regularly scheduled appointment and the HPV self sample kit.
Device: Evalyn® Brush
Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.
Other Names:
  • Rovers® Self-Sampling Device
  • simply Evalyn
  • Viba-Brush®
Experimental: Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation)
Participants will be assigned to use the Evalyn Brush device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will 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.
Device: Evalyn® Brush
Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.
Other Names:
  • Rovers® Self-Sampling Device
  • simply Evalyn
  • Viba-Brush®
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.
Experimental: Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation)
Participants will be assigned to use the Copan FLOQSwab device to evaluate feasibility and acceptability of use. Trained bilingual community health workers (CHWs) will 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.
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.
Device: Copan Floqswab
Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.
Other Names:
  • 4N6FLOQSwabs® Genetics
  • eSwab®
  • hDNA Free FLOQSwabs®
  • flocked swabs
  • nylon-tipped swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the visit (approximately 30 minutes) and analysis completed within 2 weeks
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.
Within 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Participants' HPV-related knowledge and perceived comfort with self-collection
Time Frame: From Baseline to Post-Intervention (approximately 18 months)
Paired sample t-tests will analyze changes in knowledge scores from baseline to post-intervention. Statistical analysis will be conducted using SPSS 25, with significance set at p < .05.
From Baseline to Post-Intervention (approximately 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Sandra Dayaratna, MD, MBA, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 7, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iRISID-2025-0275
  • JT 44840 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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