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| ID | Type | Description | Link |
|---|---|---|---|
| JT 44840 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Evalyn Brush Self-Collection - Phase I (Validation) | Experimental | 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. |
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| Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation) | Experimental | 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. |
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| Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evalyn® Brush | Device | Participants use Evalyn® Brush device to collect a cervical sample for HPV testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Concordance of Self-Collected vs. Clinically collected sample (Phase I) | Concordance rate between self-collection kit results and clinical Pap smear findings (measured as agreement in detection of HPV and/or abnormal cytology). Agreement between the two methods will be evaluated using Cohen's kappa statistic, with values interpreted based on standard benchmarks for strength of agreement. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) will be calculated to determine the accuracy of self-collection kits relative to the clinician-collected gold standard. | at the visit (approximately 30 minutes) and analysis completed within 2 weeks |
| Feasibility of HPV Self-Collection: Completion of Self-Collection Kit | Feasibility will be assessed as the number of participants who proceed with HPV self-collection using the study kit out of the total number of participants enrolled in the study. | Within 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Participants' HPV-related knowledge and perceived comfort with self-collection | Paired sample t-tests will analyze changes in knowledge scores from baseline to post-intervention. Statistical analysis will be conducted using SPSS 25, with significance set at p < .05. | From Baseline to Post-Intervention (approximately 18 months) |
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Inclusion Criteria:
Phase I:
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:
Exclusion Criteria:
Phase I:
Phase II:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Dayaratna, MD, MBA | Contact | 617-834-3894 | Sandra.Dayaratna@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sandra Dayaratna, MD, MBA | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Phase I: The validation consists of patients using a self-sample kit at their scheduled Pap smear at Jefferson OBGYN.
Phase II: The CHW4CervixHealth intervention consists of CHW facilitated 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.
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| Copan Floqswab | Device | Participants use the Copan Floqswab device to collect a cervical sample for HPV testing. |
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| 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. |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |