Clinical trial · Interventional
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer: the STEP Trial
- 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 Self-Testing options in the Era of Primary HPV screening for cervical cancer (STEP) trial will evaluate effectiveness of home-based HPV kits for improving cervical cancer screening uptake and its cost-effectiveness. The investigators will compare cervical cancer screening uptake within six months among women randomized to different outreach approaches based on prior screening behavior: A) Adherent and coming due: direct mail HPV kit vs. opt-in HPV kit vs. education; B) Overdue: direct mail HPV kit vs. education; C) Unknown: opt-in HPV kit vs. education.
Conditions
Conditions (14)
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 |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Genital Neoplasms, Female | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| HPV Infection | — | UNRESOLVED | — |
| HPV-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
| HPV-Related Malignancy | Human Papillomavirus-Related Malignant Neoplasm | ALIAS | 0.90 |
| Human Papilloma Virus | — | UNRESOLVED | — |
| Neoplasms | Neoplasm |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Direct Mail | Behavioral | — | UNRESOLVED |
| Education | Behavioral | — | UNRESOLVED |
| Opt-in | Behavioral | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- interventionNames
- Other: Usual Care
- type
- ACTIVE_COMPARATOR
- label
- Education
- interventionNames
- Behavioral: Education
- type
- ACTIVE_COMPARATOR
- label
- Direct Mail
- interventionNames
- Behavioral: Direct Mail
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Currently enrolled at Kaiser Permanente Washington * Female sex * 30 years to 64 years of age * An intact cervix * Has a primary care provider at Kaiser Permanente Washington Exclusion Criteria: * Anyone flagged by the delivery system as being on a non-routine screening schedule * Previously randomized to the intervention arm of the HOME trial or invited to the PATH study (Participants from the PATH study and individuals randomized to the intervention arm in the HOME Study are excluded from STEP because their prior inclusion in a STEP-related research study could influence their screening uptake and affect the outcome of this trial.) * On "do not contact list" for research studies * Currently pregnant or had a pregnancy-related procedure within prior 3 months * Language interpreter needed
References
Publications (2)
- DERIVEDTiro JA, Metcalfe S, Muthukrishnan M, Jose A, Hansen K, Lin J, Dorsey CN, Gao H, Lacey C, Anderson ML, Meenan RT, Green BB, Buist DSM, Sparks A, Winer RL. Promoting cervical cancer screening via a mailed HPV self-collection kit: Reactions from screeners and non-screeners. Patient Educ Couns. 2026 Jan;142:109374. doi: 10.1016/j.pec.2025.109374. Epub 2025 Oct 3. PMID 41067140
- DERIVEDWiner RL, Lin J, Anderson ML, Tiro JA, Green BB, Gao H, Meenan RT, Hansen K, Sparks A, Buist DSM. Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1971-1981. doi: 10.1001/jama.2023.21471. PMID 38015219