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The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Neoplasia

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Trial Information

The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City


Inclusion Criteria:



- Valid Pap smear in last 1-3 months obtained at participating clinic

- 18 years or older

- Self-report being able to read in English and/or Spanish

- Willing to sign informed consent

Exclusion Criteria:

- Used vaginal product (douche, spermicide, antifungal) in last 48 hours

- Last menses started ≤ 4 days prior to enrollment visit

- No uterus / history of hysterectomy

- Self-report currently pregnant

- Self-report currently breastfeeding

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Outcome Measure: sensitivity, specificity, kappa compared to gold standard

Outcome Time Frame:

cross-sectional

Safety Issue:

No

Principal Investigator

Carolyn Westhoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAD1382

NCT ID:

NCT00702208

Start Date:

September 2008

Completion Date:

January 2010

Related Keywords:

  • Cervical Neoplasia
  • cervical cytology
  • Pap smear
  • self-sampling
  • abnormal
  • normal
  • Neoplasms

Name

Location
Columbia University Presbyterian Hospital New York, New York  10032