N/A
N=16,231
Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02005510 ↗Enrolled (actual)
16,231
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse — 12; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mailed in-home high-risk HPV testing kit (Behavioral); Usual care (Other)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse |
12; 8 | — |
| PRIMARY Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse |
12; 7 | — |
| SECONDARY Number of Participants That Completed Uptake of Cervical Cancer Screening |
2618; 1719 | — |
| SECONDARY Number of Participants With an Abnormal Screening Result |
225; 114 | — |
| SECONDARY Experiences and Attitudes Associated With In-home HPV Testing Uptake |
116; 156; 119; 964 | — |
| SECONDARY Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results |
46; 29 | — |
Summary
The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV) screening kits is effective in increasing uptake of cervical cancer screening and early detection and treatment of cervical neoplasia in underscreened women.
Eligibility Criteria
Inclusion Criteria
- Female
- 30 to 64 years of age
- Have a primary care provider at Group Health
- Received annual "birthday letter" with Pap screening reminder 5 months earlier
- No Pap test in the past 3.4 years
- Continuously enrolled at Group Health for at least 3.4 years
- No hysterectomy
Exclusion Criteria
- Currently pregnant
- Language interpreter needed
- On "do not contact list" for research studies
Data sourced from ClinicalTrials.gov (NCT02005510). 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.