Cervical Cancer, Hpv, HPV Infection, Human Papilloma Virus
Conditions
Keywords
Copan FLOQswab, Evalyn® Brush, HPV self-collection, self-collection, community health workers, underscreened women, concordance
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.
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
Interventions
DEVICEEvalyn® Brush
Participants use Evalyn® Brush device to collect a cervical sample for HPV testing.
DEVICECopan Floqswab
Participants use the Copan Floqswab device to collect a cervical sample for HPV testing.
BEHAVIORALCHW4CervicalHealth
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.
Sponsors
Thomas Jefferson University
Roche Pharma AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Concordance of Self-Collected vs. Clinically collected sample (Phase I) | 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. |
| Feasibility of HPV Self-Collection: Completion of Self-Collection Kit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participants' HPV-related knowledge and perceived comfort with self-collection | 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. |
Countries
United States
Contacts
CONTACTSite Public Contact
PRINCIPAL_INVESTIGATORSandra Dayaratna, MD, MBA
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Outcome results
None listed