CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 964 enrolled
Drug / intervention
Evalyn Self-Sampling Brushdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04658888
NCT04658888N/ACompleted

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Cancer Screening Among Female Patients at Penn State Health St. Joe's Residency Clinic: Letter Notifying Them About Outdated Screen and Postcard With Self-sampling Option

Milton S. Hershey Medical Center·interventional·Posted Dec 9, 2020·Updated Jul 6, 2022

In Brief

A clinical study evaluating Evalyn Self-Sampling Brush for Cervical Cancer Screening. Completed, enrolled 964 participants across 1 site.

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to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 9, 2020
Enrollment StartApr 26, 2021
Primary CompletionDec 1, 2021
Study CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.6 years ago

Interventions

Evalyn Self-Sampling Brushdevice

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