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St. Joe's Invitation Effectiveness Study

NCT04658888 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 964

Last updated 2022-07-06

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to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the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

Conditions

  • Cervical Cancer Screening

Interventions

DEVICE

Evalyn Self-Sampling Brush

A self-sampling brush to collect cervical cancer cells for screening purposes.

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Christina Scartozzi, DO · Penn State College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2021-12-01
Completion
2022-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658888 on ClinicalTrials.gov