N/A
Completed N=2,474
Prospective Evaluation of Self-Testing to Increase Screening
Source: ClinicalTrials.gov NCT03898167 ↗Enrolled (actual)
2,474
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Primary Screening Participation — 144; 340; 381 Participants
Summary
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. This study evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Screening Participation |
144; 340; 381 | — |
| SECONDARY Screening Tests Results |
6; 38; 49; 138; 288; 312 | — |
| SECONDARY Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result |
2; 22; 33; 4; 14; 15 | — |
Eligibility Criteria
Inclusion Criteria
- no history of hysterectomy or cervical cancer
- no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years
- patient of Harris Health System in Harris County (Houston), Texas
- have at least 2 visits to ambulatory care within Harris Health System in the past 5 years
- be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months
Exclusion Criteria
- no valid telephone contact information
- unable to communicate in English or Spanish*
- currently pregnant
- history of cervical dysplasia in the past 3.5 years
Data sourced from ClinicalTrials.gov (NCT03898167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.