Clinical trial · Interventional
St. Joe's Invitation Effectiveness Study
Increasing Cervical Cancer Screening Among Female Patients at Penn State Health St. Joe's Residency Clinic: Letter Notifying Them About Outdated Screen and Postcard With Self-sampling Option
- 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 objective of this study is to evaluate the effectiveness of offering self-sampling for high risk human papilloma virus (HPV) testing in order to increase the number of women who are screened for cervical cancer. The hypothesis of this study is that women who are notified of a need for cervical cancer screening by letter and are also offered a self-sampling kit for cervical cancer screening will have a higher rate of screening than women notified by letter alone. This study will use an intervention arm (letter and option to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the control arm and 1 to the intervention arm). The primary endpoint that will be evaluated in this study is the method of completion of cervical cancer screening and the use of the self-sampling kit, which will be monitored over a three month period after the letters have been mailed. A secondary endpoint will be the overall rate of cervical cancer screening of all people mailed a letter.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evalyn Self-Sampling Brush | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Modified letter with self-sampling request card
- description
- This group will receive a modified letter telling the participant they are out of date with their cervical cancer screening. They will also receive information on the self-sampling kit and will be provided a card that they can send back to the study team in order to have a kit sent to their house. The kit will include a pre-paid mailer so that it can be sent back to the lab for testing. The result will then be shared with the participant.
- interventionNames
- Device: Evalyn Self-Sampling Brush
- type
- NO_INTERVENTION
- label
- Standard letter
- description
- Participants will receive a standard of care letter that tells the participant they are out of date with their cervical cancer screening and should contact their primary care provider to schedule an appointment.
Primary outcomes (2)
- measure
- Percentage of Cervical Cancer Screening
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients at Penn State Health St. Joe's Family and Community Medicine residency clinic or women's health clinic. * Ages 30-65 years * Out-of-date for cervical cancer screening * Able to speak, read, and communicate well in English or Spanish * Not greater than average risk for cervical cancer screening Exclusion Criteria: * Pregnant * Incarcerated * Greater than average risk for cervical cancer (2) * Have a compromised immune system * With in-utero exposure to diethylstilbestrol * Unable to speak, read, and communicate well in English or Spanish * Unable or unwilling to give implied consent or otherwise complete study requirements
References
Publications (2)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4. PMID 29313949
- BACKGROUNDUS Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 21;320(7):674-686. doi: 10.1001/jama.2018.10897. PMID 30140884