CHW4CervixHealth: HPV self-collection kits with community health workers

Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab

This project will test whether giving self-collection HPV kits during community workshops led by community health workers helps increase screening among under-screened women aged 25–65 and will first compare kit results to clinical Pap smears.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 25 Years to 65 Years
• Sex: Female
• Sponsor: Thomas Jefferson University (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT07336134 on ClinicalTrials.gov

What this trial studies

The project has two phases: Phase I will validate two self-collection devices by comparing results from self-collected samples to clinical Pap smear results in a cohort of 20 women attending a Jefferson OBGYN appointment. Phase II will run brief community workshops delivered in participants' primary language, where community health workers will offer self-collection kits, collect samples, and obtain post-workshop surveys and interviews to measure feasibility and acceptability. Self-collected samples will be labeled with chain-of-custody forms and sent by courier to a molecular virology lab in Cherry Hill, NJ for processing and HPV testing. The intervention targets screening-eligible women aged 25–65, focusing on under-screened Hispanic, Black/African/Caribbean, Chinese, Korean, and Vietnamese participants for the community workshops.

Who should consider this trial

Good fit: Ideal candidates are women aged 25–65 who are either scheduled for a Pap appointment (Phase I) or are under-screened ethnic-minority women who have not had guideline-recommended Pap screening in the past 3–5 years (Phase II).

Not a fit: Women who have had a hysterectomy, are outside the 25–65 age range, or are already up-to-date with cervical screening are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could increase cervical cancer screening uptake and earlier HPV detection among under-screened minority women by offering convenient, acceptable self-collection in community settings.

How similar studies have performed: Prior studies have shown that HPV self-sampling devices often detect HPV with sensitivity comparable to clinician-collected samples and are acceptable to many women, though workshop delivery led by community health workers is a less-studied implementation approach.

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:

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

Where this trial is running

Philadelphia, Pennsylvania

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Sandra Dayaratna, MD, MBA — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
• Study coordinator: Sandra Dayaratna, MD, MBA

Conditions Cervical Cancer; Hpv; Human Papilloma Virus; HPV Infection; Copan FLOQswab; Evalyn® Brush; HPV self-collection; self-collection