Cervical Cancer Screening
Conditions
Brief summary
The purpose of this study is to help people who have missed their regular cervical cancer screening. The investigators are evaluating whether mailing an HPV self-sampling kit to participant home makes it easier and more convenient for people to get screened for cervical cancer. This study will also help to understand if people find this process acceptable and whether it is an effective way to improve screening rates.
Interventions
DIAGNOSTIC_TESTBD Onclarity HPV test
Self-collected cervicovaginal sample
DIAGNOSTIC_TESTStandard Pap Smear
Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Participants will have the option to op-in for an at-home HPV sampling test or receive a standard pap smear.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Women, transgender men, and nonbinary individuals aged 30 to 75 who have a cervix. * No history of hysterectomy or cervical cancer. * No documented cervical cancer screening within guideline-recommended intervals: specifically, no Pap test in the past 3.5 years, no Pap/HPV co-test in the past 5.5 years, and no standalone HPV test results in the past 5.5 years. (A 6-month grace period is included to allow time for response to usual care outreach.) * At least two visits to University Hospital ambulatory care over the past five years, ensuring opportunity for follow-up and continuity of care.
Exclusion criteria
* History of cervical dysplasia within the past 3.5 years, reflecting those likely under active surveillance or treatment protocols. * Currently pregnant, due to differing screening recommendations and clinical considerations. * Prior or current diagnosis of cervical cancer or ongoing treatment for cervical neoplasia. * Physical, cognitive, or functional limitations that would preclude use of the mailed self-sampling kit without assistance. Examples include severe arthritis or significant impairment affecting self-collection capability. * Lack of a telephone number or reliable mailing address on file. * Inability to communicate in English or Spanish, given study materials and staffing capabilities. Use of additional language services is not available. * Current enrollment in other cervical cancer screening or intervention studies that may interfere with participation or outcomes. * Inability to provide informed consent or comprehend study procedures based on cognitive capacity, as assessed by the Research Coordinator during initial contact.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of CC screening within 6 months of initial outreach. | Outcome will be measured at 6 months post-initial outreach call. | Defined as either (a) return of a valid HPV self-sample kit to the processing laboratory, or (b) attendance for a clinic-based Pap test documented in the medical record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screening Pathway Choices and Performance | From enrollment to the end of participation at 9 months | Proportion of participants selecting self-sampling vs clinic-based Pap test (percentage of women choosing each modality after initial outreach) |
| Clinical Follow-Up and Downstream Outcomes | From enrollment to the end of participation at 9 months | Clinical follow-up completion after abnormal results (attendance at colposcopy or initiation of treatment). |
| Exploratory and Patient-Reported Outcomes | From enrollment to the end of participation at 9 months | Associations between demographic/clinical factors and screening completion (e.g., race/ethnicity, insurance status, education, prior screening history). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAna Tergas, MD, MPH
Rutgers, The State University of New Jersey
Outcome results
None listed