PopSci CHW4CervixHealth

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07336134
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Evalyn® Brush — DEVICE
    Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.
  • Copan Floqswab — DEVICE
    Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 22, 2025
Status verified
Jan 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Sandra Dayaratna, MD, MBA
[email protected]
617-834-3894

Find similar trials in Philadelphia, PA

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Thomas Jefferson University· Philadelphia, PA

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