N/A
N=964
St. Joe's Invitation Effectiveness Study
Cervical Cancer Screening
Bottom Line
View on ClinicalTrials.gov: NCT04658888 ↗Enrolled (actual)
964
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Percentage of Cervical Cancer Screening — 40; 95 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Evalyn Self-Sampling Brush (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Cervical Cancer Screening |
40; 95 | — |
| PRIMARY Use of the Self-sampling Kit |
2 | — |
| SECONDARY Overall Rate of Cervical Cancer Screening Over Both the Control and Intervention Group |
135 | — |
Summary
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to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the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.
Eligibility Criteria
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- Out-of-date for cervical cancer screening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
Data sourced from ClinicalTrials.gov (NCT04658888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.