Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Location status: Recruiting
NCT Number: NCT07336134
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.
Interested in participating?
Request Info25 year–65 year
Female
Interventional
Not applicable
Philadelphia, Pennsylvania, 19107, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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:
Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.
Other names: Rovers® Self-Sampling Device, simply Evalyn, Viba-Brush®
Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.
Other names: 4N6FLOQSwabs® Genetics, eSwab®, hDNA Free FLOQSwabs®, flocked swabs, nylon-tipped swabs
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.
Time frame: at the visit (approximately 30 minutes) and analysis completed within 2 weeks
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.
Time frame: Within 12 months
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.
Time frame: From Baseline to Post-Intervention (approximately 18 months)
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.
Contact information is provided by the study sponsor or research team.
Thomas Jefferson University
Other
Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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