PopSci CHW4CervixHealth

NCT07336134 | Recruiting FDA Device

• 2 other identifiers: iRISID-2025-0275JT 44840
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HPV Infection; Cervical Cancer; Hpv; Human Papilloma Virus

Keywords

Copan FLOQswab; Evalyn® Brush; HPV self-collection; self-collection; community health workers; underscreened women; concordance

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (1)

• Change in Participants' HPV-related knowledge and perceived comfort with self-collection

  From Baseline to Post-Intervention (approximately 18 months)

Study Arms (3)

Arm 1: Evalyn Brush Self-Collection - Phase I (Validation)

EXPERIMENTAL

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

Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation)

EXPERIMENTAL

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; Behavioral: CHW4CervicalHealth

Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation)

EXPERIMENTAL

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.

Device: Copan Floqswab; Behavioral: CHW4CervicalHealth

Interventions

Evalyn® Brush DEVICE

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

Also known as: Rovers® Self-Sampling Device, simply Evalyn, Viba-Brush®

Arm 1: Evalyn Brush Self-Collection - Phase I (Validation); Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation)

Copan Floqswab DEVICE

Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.

Also known as: 4N6FLOQSwabs® Genetics, eSwab®, hDNA Free FLOQSwabs®, flocked swabs, nylon-tipped swabs

Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation)

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.

Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation); Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Dayaratna, MD, MBA

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Dayaratna, MD, MBA

CONTACT

617-834-3894; Sandra.Dayaratna@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase I: The validation consists of patients using a self-sample kit at their scheduled Pap smear at Jefferson OBGYN. Phase II: The CHW4CervixHealth intervention consists of CHW facilitated 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.

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: January 13, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)