Clinical trial · Interventional
Comparing Strategies for Implementing Primary HPV Screening
Comparing Strategies for Implementing Primary HPV Testing for Routine Cervical Cancer Screening
- 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)
Cervical cancer screening is an important component of women's health care. Most adult women are familiar with the conventional screening modality, Pap test, which has successfully reduced the burden of cervical cancer in industrialized countries. However, Pap test has limited accuracy and can miss a progressing disease. Advancement in knowledge and technology has led to changes in national recommendations to focus on the testing of high-risk human papillomavirus (HPV) infection, the cause of cervical cancer. Screening with primary HPV testing detects more diseases compared with Pap test alone or co-testing, and requires less number of tests. However, despite the advantages of primary HPV screening over conventional approaches, the switch to primary HPV screening is limited in the United States. The scientific literature reports barriers at both the provider and women level, which include lack of knowledge, resistance, and attachment to Pap test. We currently have insufficient guidance on how to select and deploy implementation strategies most likely to facilitate use of newly recommended cancer screening modality. This project seeks to generate evidence regarding effective strategies to achieve successful implementation of the primary HPV testing for routine cervical cancer screening in a large community-based health care system. A successful implementation will be defined by uptake of the primary HPV screening, adequate knowledge of the HPV test for both patients and providers, and patient/provider satisfaction during the transition. This project is important to most adult women, as a timely adoption of the best evidence-based cancer screening approach means better patient outcomes. Further, the proposed project will not only inform about cervical cancer screening, but other clinical conditions when a physician practice change is recommended by professional societies and/or national guideline body. By engaging patients, providers and other professional stakeholders in this project, we ensure that successful project outcomes are those most important for women and their doctors. Further, the stakeholder partners will help ensure generalizability of our findings to other health care systems, design strategies that maximize completeness in data collection, and lead the dissemination effort for wide application of the knowledge to be gained in this project.
Conditions
Conditions (4)
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 |
| Health Care Utilization | — | UNRESOLVED | — |
| Health Knowledge, Attitudes, Practice | — | UNRESOLVED | — |
| Human Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Tailoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Local Tailoring
- description
- The intervention arm will consist of six KPSC service areas randomly assigned to the intervention arm. Immediately after primary HPV screening opens at KPSC, the intervention arm will receive the local tailoring interventions. All providers (physicians, nurses and medical assistants) and department administrator from the primary care departments (family medicine and internal medicine) and the department of obstetrics and gynecology at these six service areas randomized to this arm will be included in the study, as well as female patients at these service areas between age 30-65 who received cervical cancer screening during the data collection period.
- interventionNames
- Other: Local Tailoring
- type
- NO_INTERVENTION
- label
- Hybrid Usual Care
- description
- The hybrid-usual care arm will consist of six KPSC service areas randomly assigned to this arm. The hybrid usual care arm will receive regional educational activities for the transition (as will the intervention arm) before the roll out of primary HPV testing. However, they will not receive any research-led intervention or adaptation guidance after primary HPV screening opens at KPSC. All providers (physicians, nurses and medical assistants) and department administrator from the primary care departments (family medicine and internal medicine) and the department of obstetrics and gynecology at these six service areas randomized to this arm will be included in the study, as well as female patients at these service areas between age 30-65 who received cervical cancer screening during the data collection period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: This is a cluster randomized trial. All KPSC's 12 service areas except Orange Country will be randomized and included in this study. All providers (physicians, nurses and medical assistants) and department administrator from the primary care departments (family medicine and internal medicine) and the department of obstetrics and gynecology at these 12 service areas randomized to this arm will be included in the study, as well as female patients at these service areas between age 30-65 who received cervical cancer screening during the data collection period. Exclusion Criteria: * Patients who are younger than 30 years old * Providers working for departments other than Ob/Gyn, family or internal medicine
References
Publications (5)
- DERIVEDHahn EE, Munoz-Plaza C, Hsu C, Cannizzaro NT, Ngo-Metzger Q, Gould MK, Mittman BS, Hodeib M, Tewari D, Chao CR. Locally-tailored vs. centrally-administered strategies for implementation of primary human papillomavirus (HPV) screening in an integrated healthcare system: a qualitative research study. Front Health Serv. 2025 Jul 15;5:1595934. doi: 10.3389/frhs.2025.1595934. eCollection 2025. PMID 40735691
- DERIVEDChao CR, Cannizzaro N, Hahn EE, Shen E, Hsu C, Ngo-Metzger Q, Gould MK, Munoz-Plaza CE, Kanter MH, Wride P, Ajamian LH, Hodeib M, Broder BI, Curiel IT, Castaneda A, Ong SK, Tewari K, Eskander RN, Tewari D, Mittman BS. A pragmatic randomized trial to compare strategies for implementing primary HPV testing for routine cervical cancer screening in a large healthcare system. Implement Sci. 2025 May 12;20(1):21. doi: 10.1186/s13012-025-01432-9. PMID 40355876
- DERIVEDCannizzaro NT, Mittman BS, Hahn EE, Ngo-Metzger Q, Gould MK, Hsu C, Shen E, Tewari D, Chao CR. Primary Human Papillomavirus Screening: Women's Perceptions of New Cervical Cancer Screening Recommendations. J Womens Health (Larchmt). 2024 Dec;33(12):1614-1624. doi: 10.1089/jwh.2023.1180. Epub 2024 Sep 11. PMID 39258727
- DERIVEDChao CR, Cannizzaro NT, Hahn EE, Tewari D, Ngo-Metzger Q, Hsu C, Shen E, Wride P, Hodeib M, Gould M, Mittman BS. A study protocol for a cluster randomized pragmatic trial for comparing strategies for implementing primary HPV testing for routine cervical cancer screening in a large health care system. Contemp Clin Trials. 2023 Jan;124:106994. doi: 10.1016/j.cct.2022.106994. Epub 2022 Nov 4. PMID 36336248
- DERIVEDHahn EE, Munoz-Plaza C, Altman DE, Hsu C, Cannizzaro NT, Ngo-Metzger Q, Wride P, Gould MK, Mittman BS, Hodeib M, Tewari KS, Ajamian LH, Eskander RN, Tewari D, Chao CR. De-implementation and substitution of clinical care processes: stakeholder perspectives on the transition to primary human papillomavirus (HPV) testing for cervical cancer screening. Implement Sci Commun. 2021 Sep 23;2(1):108. doi: 10.1186/s43058-021-00211-z. PMID 34556189