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NCT04658888 · ClinicalTrials.gov registry record · NA

St. Joe's Invitation Effectiveness Study

A NA study, sponsored by Milton S. Hershey Medical Center.

Completed
Registry status
NA
Development phase
964
Enrollment target

NCT04658888: Completed NA study, sponsored by Milton S. Hershey Medical Center.

NCT04658888 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 964 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04658888, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.

COMPLETED
Registry status
NA
Development phase
964 participants
Enrollment target

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to request a self-sampling kit) compared to a control arm (letter alone, standard of care) as a reminder that they are out of date for their cervical cancer screening. Women who are out of date with their cervical cancer screening will be identified using the Electronic Medical Record and randomized to the study group in a 2 to 1 ratio (2 for the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

Primary Outcome

To compare the percentage of cervical cancer screenings completed in the control group who received a standard letter with the percentage of cervical cancer screenings completed in the intervention group who receive a modified letter with a self-sampling option.

Interventions

  • DEVICE Evalyn Self-Sampling Brush

Trial Details

FieldValue
Enrollment Target 964 participants
Start Date 2021-04-26
Est. Completion 2022-02-01
Phase NA
Milton S. Hershey Medical Center

396 total trials

What the finished NCT04658888 record still lists

NCT04658888 is an interventional study that assigns participants to a tested intervention. The registered 964 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (31% lower).

The record links to 0 conditions, and to 1 intervention - of which Evalyn Self-Sampling Brush is the first listed.

NCT04658888 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04658888 about?

NCT04658888 is a clinical study titled "St. Joe's Invitation Effectiveness Study". 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 c...

What is the current status of trial NCT04658888?

This trial is currently completed. It is a NA study. The enrollment target is 964 participants. The study started on 2021-04-26. Estimated completion is 2022-02-01.

What interventions are being tested in trial NCT04658888?

The interventions under investigation include: Evalyn Self-Sampling Brush (DEVICE).

Who is sponsoring clinical trial NCT04658888?

This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04658888's enrollment target sits among peer trials

964 123rd of 2000 higher than 1,878 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04658888, the US trial registry maintained by the National Library of Medicine. NCT04658888 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.