Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-14 @ 3:42 AM
Study NCT ID:
NCT07336134
Status:
RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PopSci CHW4CervixHealth
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JT 44840 | OTHER | JeffTrial Number | View |