Health TrialsbyHealthPanel

PopSci CHW4CervixHealth

ConditionsCervical CancerHpvHuman Papilloma VirusHPV Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-65
SponsorThomas Jefferson University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Evalyn® Brush

    Device

    Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.

  • Copan Floqswab

    Device

    Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.

  • 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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Arm 1: Evalyn Brush Self-Collection - Phase I (Validation)Experimental treatment 1 intervention
Group B: Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation)Experimental treatment 2 interventions
Group C: Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
at the visit (approximately 30 minutes) and analysis completed within 2 weeks
2

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.

Time frame
Within 12 months

Secondary outcomes

1

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.

Time frame
From Baseline to Post-Intervention (approximately 18 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

Roche Pharma AG

Collaborator

Source ClinicalTrials.gov
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