Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07336134
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT07336134
Study Brief:
Protocol Section:
NCT07336134