Clinical trial · Interventional
Mail-in HPV Screening Program in NJ
A Mail-based HPV Sampling Program to Increase Cervical Cancer Screening in New Jersey
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BD Onclarity HPV test | Diagnostic Test | — | UNRESOLVED |
| Standard Pap Smear | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Pap Smear
- description
- Participants will have the option to choose a standard pap smear for cervical cancer screening
- interventionNames
- Diagnostic Test: Standard Pap Smear
- type
- EXPERIMENTAL
- label
- HPV Self-Sampling Test
- description
- Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening
- interventionNames
- Diagnostic Test: BD Onclarity HPV test
Primary outcomes (1)
- measure
- Completion of CC screening within 6 months of initial outreach.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available