NCT07336134

PopSci CHW4CervixHealth

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Cervical Cancer
• Hpv
• Human Papilloma Virus
• HPV Infection

Interventions

Type	Name	Description
DEVICE	Evalyn® Brush	Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.
DEVICE	Copan Floqswab	Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.
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.

Timeline

• Start date: 2025-10-22
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study