RecruitingNot ApplicableNCT07336134

PopSci CHW4CervixHealth

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

Sponsor

Thomas Jefferson University

Enrollment

120 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer Human Papilloma Virus HPV Infection HPV

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.

Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study (PopSci CHW4CervixHealth) is testing whether community health workers can help increase cervical cancer screening rates among underscreened minority women, including those who may prefer self-collection HPV testing (a self-swab test for the human papillomavirus) instead of a traditional Pap smear. **You may be eligible if...** - Phase I: You are a woman aged 25–65, scheduled for a Pap smear at the specified clinic, and have an intact cervix (no hysterectomy) - Phase II: You are a woman aged 25–65, have not had a Pap smear in the recommended timeframe, and self-identify as Hispanic, Black/African American, Black Caribbean, Chinese, Korean, or Vietnamese **You may NOT be eligible if...** - You are currently pregnant - You have already participated in an HPV self-collection study within the past year - You have had a hysterectomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEvalyn® Brush

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

DEVICECopan Floqswab

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

BEHAVIORALCHW4CervicalHealth

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.