Clinician-Collected Versus Patient-Collected Cervical Pap Smears

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patient-Collected Cervical Pap Smear

women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear

Group Type EXPERIMENTAL

Patient-Collected Cervical Pap Smear

Intervention Type DEVICE

Patient-Collected Cervical Papanicolaou Smear

Interventions

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Patient-Collected Cervical Pap Smear

Patient-Collected Cervical Papanicolaou Smear

Intervention Type DEVICE

Other Intervention Names

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SoloPap

Eligibility Criteria

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Inclusion Criteria

* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
* All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding

Exclusion Criteria

* Age \<18 years (not recommended for Pap Smear)
* Known pregnancy
* Women who have had a total hysterectomy (cervix removed)
* Women with vaginal bleeding
* Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes