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N/A N=2,474 Randomized Single-blind Screening

Prospective Evaluation of Self-Testing to Increase Screening

Cervical Cancer · Human Papillomavirus Infection

Bottom Line

View on ClinicalTrials.gov: NCT03898167 ↗
Enrolled (actual)
2,474
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Primary Screening Participation — 144; 340; 381 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Telephone Recall (Behavioral); Mailed HPV Self-Sampling Kit (Behavioral); Patient Navigation (Behavioral)
Age
Adult, Older Adult · 30+ yrs
Sex
Female
Sponsor
Baylor College of Medicine
Primary completion
Mar 2024

Outcome Measures

OutcomeResultp-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 —

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.

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
View full record on ClinicalTrials.gov →

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.

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