Clinical trial · Interventional
Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
NCT02005510CI-TRIAL-00047147completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mailed in-home high-risk HPV testing kit | Behavioral | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- In-home HPV Screening
- description
- Usual care PLUS a mailed in-home high-risk HPV testing kit (accompanied by an invitational letter, research information sheet, and illustrated instructions for using the kit). "Usual care" consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.
- interventionNames
- Behavioral: Mailed in-home high-risk HPV testing kit
- Other: Usual care
- type
- PLACEBO_COMPARATOR
- label
- Usual Care
- description
- Usual care. "Usual care" consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDWiner RL, Lin J, Tiro JA, Miglioretti DL, Beatty T, Gao H, Kimbel K, Thayer C, Buist DSM. Effect of Patient Characteristics on Uptake of Screening Using a Mailed Human Papillomavirus Self-sampling Kit: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2244343. doi: 10.1001/jamanetworkopen.2022.44343. PMID 36449291
- DERIVEDWiner RL, Lin J, Tiro JA, Miglioretti DL, Beatty T, Gao H, Kimbel K, Thayer C, Buist DSM. Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914729. doi: 10.1001/jamanetworkopen.2019.14729. PMID 31693128