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PopSci CHW4CervixHealth

RecruitingNA

Sponsor: Thomas Jefferson University

Conditions: Cervical Cancer, Hpv, Human Papilloma Virus, HPV Infection

Interventions: Evalyn® Brush, Copan Floqswab, CHW4CervicalHealth

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 25 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

Philadelphia, Pennsylvania, United States