PopSci CHW4CervixHealth

NCT ID: NCT07336134

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-22
• Study Completion Date: 2026-07-01

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

Conditions

Cervical Cancer; Hpv; Human Papilloma Virus; HPV Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm 1: Evalyn Brush Self-Collection - Phase I (Validation)

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.

Group Type: EXPERIMENTAL

Evalyn® Brush

Intervention Type: DEVICE

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

Arm 2: Evalyn Brush Self-Collection - Phase II (Community Implementation)

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.

Group Type: EXPERIMENTAL

Evalyn® Brush

Intervention Type: DEVICE

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

CHW4CervicalHealth

Intervention Type: 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.

Arm 3: Copan FLOQSwab Self-Collection - Phase II (Community Implementation)

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.

Group Type: EXPERIMENTAL

Copan Floqswab

Intervention Type: DEVICE

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

CHW4CervicalHealth

Intervention Type: 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.

Interventions

Evalyn® Brush

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

Intervention Type: DEVICE

Copan Floqswab

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

Intervention Type: DEVICE

CHW4CervicalHealth

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Rovers® Self-Sampling Device; simply Evalyn; Viba-Brush®; 4N6FLOQSwabs® Genetics; eSwab®; hDNA Free FLOQSwabs®; flocked swabs; nylon-tipped swabs

Eligibility Criteria

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:

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Dayaratna, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sandra Dayaratna, MD, MBA

Role: CONTACT

Sandra.Dayaratna@jefferson.edu

617-834-3894

Facility Contacts

Sandra Dayaratna, MD, MBA

Role: primary

Sandra.Dayaratna@jefferson.edu

617-834-3894

Other Identifiers

JT 44840

Identifier Type: OTHER

Identifier Source: secondary_id

iRISID-2025-0275

Identifier Type: -

Identifier Source: org_study_id