St. Joe's Invitation Effectiveness Study

Completed · Not applicable

Conditions studied: Cervical Cancer Screening

In brief

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to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the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.

Key facts

Study ID

NCT04658888

Run by

Milton S. Hershey Medical Center

People needed

964

Starts

2021-04-26

Expected to finish

2022-02-01

Last updated by the study team

2022-07-06

Who can join

Age: 30 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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• Out-of-date for cervical cancer screening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

You may not qualify if…

• 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

Where it is running

• Penn State College of Medicine — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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