The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females. Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.
The SoloPap "kit" provides to subjects who would not otherwise have a Pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. The current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether SoloPap is truly noninferior to clinician-collected Pap smears in detecting cervical pathology. It will also determine user preference and willingness to perform a self- test.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Patient-Collected Cervical Papanicolaou Smear
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Las Vegas, Nevada, United States
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
whether the SoloPap™ cervical cell sample collection kit used by the subject (patient) is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.
Time frame: 1 hour
Patient Opinions
Results from a survey about simple subject attitudes regarding the SoloPap. Patient Solo Pap Kit Questions 1. Did you experience any discomfort while using the Solo Pap Kit? Yes / No 2. Would you use the Solo Pap Kit for future Pap Tests? Yes / No 3. Would you recommend the Solo Pap Kit to a friend or family member? Yes / No
Time frame: Directly after interventions (Solo Pap and physician-collected pap smear samples)
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