Clinical trial · Interventional
PopSci CHW4CervixHealth
Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab
NCT07336134CI-TRIAL-00121510recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Hpv | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
| Human Papilloma Virus | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHW4CervicalHealth | Behavioral | — | UNRESOLVED |
| Copan Floqswab | Device | — | UNRESOLVED |
| Evalyn® Brush | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: Evalyn Brush Self-Collection - Phase I (Validation)
- description
- 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.
- interventionNames
- Device: Evalyn® Brush
- type
- EXPERIMENTAL
- label
- Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation)
- description
- 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.
- interventionNames
- Device: Evalyn® Brush
- Behavioral: CHW4CervicalHealth
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 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: This intervention targets under-screened minority individuals who must meet all the following inclusion criteria to be eligible to participate in the study: * 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. Exclusion Criteria: 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
References
Publications (0)
Data not yet available
No reference posted for this study.