Comparing Strategies for Implementing Primary HPV Screening

NCT04371887 | Unknown

• 1 other identifier: CDR-2018C1-10987
• Study Type: interventional
• Target: 45,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervical Cancer; Human Papillomavirus; Health Knowledge, Attitudes, Practice; Health Care Utilization

Keywords

Primary HPV Screening; Cervical Cancer Screening; Local Tailoring; Implementation Strategy

Outcome Measures

Primary Outcomes (1)

• Uptake of primary HPV testing

  Proportion of primary HPV testing of all cervical cancer screening performed for women age 30-65 at the provider level.

  Within the 3 months after the end of the 2 months intervention window

Secondary Outcomes (3)

• Provider-centered outcomes

  Within the 3 months after the end of the 2 months intervention window

• Patient-centered outcomes

  Within the 3 months after the end of the 2 months intervention window

• Time to colposcopy after a positive test result

  Within the 6 months after the end of the 2 months intervention window

Study Arms (2)

Local Tailoring

EXPERIMENTAL

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.

Other: Local Tailoring

Hybrid Usual Care

NO INTERVENTION

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.

Interventions

Local Tailoring OTHER

The "guided local tailoring" approach will employ a standard structured process, including (1) convening a project team, (2) conducting a local diagnostic process to identify likely barriers using provider/patient survey and interviews with providers/administrators, (3) selecting from a pre-developed menu of implementation strategies categorized by core function (form and function menu), and (4) deploying the selected strategies in collaboration with local implementation and improvement consultants.

Local Tailoring

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: For patients, only female patients will be included in this study because male patients will not go through cervical cancer screening.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who are younger than 30 years old
• Providers working for departments other than Ob/Gyn, family or internal medicine

Sponsors & Collaborators

• Chun Chao: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

RECRUITING

Related Publications (5)

• Hahn 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 DERIVED

• Chao 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 DERIVED

• Cannizzaro 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 DERIVED

• Chao 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 DERIVED

• Hahn 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 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Behavior; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Chun R Chao, PhD

  KPSC Department of Research and Evaluation

  PRINCIPAL INVESTIGATOR

• Devansu Tewari, MD

  KPSC Orange County Medical Center Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Cannizzaro, PhD

CONTACT

626-564-7663; nancy.takahashi@kp.org

Chunyi Hsu, MPH

CONTACT

626-564-3508; chunyi.hsu@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist

Model Details: This prospective study will use a cluster randomization design to compare two system-level implementation strategies for primary HPV screening, with outcomes measured at multiple levels. KPSC has 13 service areas linked to over 200 ambulatory clinics. Randomization will be performed at the service area level, since these are system-level implementation strategies. Service areas will first be matched in pairs on key attributes that may be associated with implementation success prior to randomization, such as the size and the number of clinics, access, and current screening rates. Thus, the two service areas in a matched pair will be most like each other in those attributes. Within each pair, the two service areas will then be randomized to determine which receives the local-tailored vs. hybrid usual care approach. The intervention period for both arms will take place immediately after the roll out of primary HPV screening.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 1, 2020
• Study Start: March 1, 2019
• Primary Completion: August 18, 2022
• Study Completion: June 30, 2023
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

US (1)