Trials / Recruiting
RecruitingNCT04093388
Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- Female
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to find out if a self-administered (by the patient) Papanicolaou (Pap) smear is as accurate as a traditional Pap smear administered by a healthcare provider.
Detailed description
Papanicolaou (Pap) smears will be both self-obtained by the patient and obtained by a licensed physician, nurse practitioner, or physician assistant. Specimens will then be collected by the nurse or medical assistant who will label each specimen separately. Specimens will be blinded so that the pathologist will not know which specimen was self-collected and which provider-collected. Specimens will then be sent to our clinical laboratory provider (LabCorp) for analysis. Once results from the Pap smears are received, participants will be notified in the usual manner in our clinical practice. Finally, analysis will be conducted to ascertain whether or not a self-administered (by the patient) Pap smear is as accurate as a traditional Pap smear administered by a healthcare provider.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Self-PAP | A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted. |
| DIAGNOSTIC_TEST | Traditional Pap smear | A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted. |
Timeline
- Start date
- 2021-04-26
- Primary completion
- 2026-12-31
- Completion
- 2027-06-30
- First posted
- 2019-09-18
- Last updated
- 2026-03-31
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04093388. Inclusion in this directory is not an endorsement.