Recruiting

Self-Collection Kit

Sponsor:

Thomas Jefferson University

Code:

NCT07336134

Conditions

Cervical Cancer

Hpv

Human Papilloma Virus

HPV Infection

Eligibility Criteria

Sex: Female

Age: 25 - 65

Healthy Volunteers: Accepted

Interventions

Evalyn® Brush

Copan Floqswab

CHW4CervicalHealth

Study Details

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.

Conditions

Cervical Cancer

Hpv

Human Papilloma Virus

HPV Infection

Study ID

NCT07336134

Start date

Oct 22, 2025

Status verified date

Aug, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

Evalyn® Brush

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

Copan Floqswab

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

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.

Primary outcome measure

  • Diagnostic Concordance of Self-Collected vs. Clinically collected sample (Phase I) [ Time Frame: at the visit (approximately 30 minutes) and analysis completed within 2 weeks ]
  • Feasibility of HPV Self-Collection: Completion of Self-Collection Kit [ Time Frame: Within 12 months ]

Central Contacts and Locations

Central contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Sandra Dayaratna, MD, MBA

215-600-9151ONCTrialNow@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Copan FLOQswab
  • Evalyn® Brush
  • HPV self-collection
  • self-collection
  • community health workers
  • underscreened women
  • concordance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-08-11.