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NCT Number: NCT07336134

PopSci CHW4CervixHealth

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.

Recruiting

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evalyn® Brush

Device

Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.

Other names: Rovers® Self-Sampling Device, simply Evalyn, Viba-Brush®

Copan Floqswab

Device

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

CHW4CervicalHealth

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra Dayaratna, MD, MBA

CONTACT

[email protected]

617-834-3894

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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