CHW4CervixHealth: HPV self-collection kits with community health workers
Official title: Uptake of HPV Self-sampling in Underserved Minority Women Using a Community Health Worker Model: Comparison of Evalyn Brush and Copan Floqswab
Run by Thomas Jefferson University · NCT07336134 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 25 Years to 65 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | October 22, 2025 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | August 11, 2026 |
| Trial ID | NCT07336134 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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).
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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: Site Public Contact
- Email: ONCTrialNow@jefferson.edu
- Phone: 215-600-9151
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.