Cervical CancerNCT04371887
Comparing Strategies for Implementing Primary HPV Screening
A study testing Local Tailoring in people with Cervical Cancer and Human Papillomavirus, run by Chun Chao at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Cervical Cancer, Human Papillomavirus, Health Knowledge, Attitudes, Practice
- What is being tested?
- Local Tailoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are younger than 30 years old
- Providers working for departments other than Ob/Gyn, family or internal medicine
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente Southern California
Pasadena, California, 91101
Nancy Cannizzaro, PhD, 626-564-7663, nancy.takahashi@kp.org
Chunyi Hsu, MPH, 626-564-3508, chunyi.hsu@kp.org
About this study
Official title: Comparing Strategies for Implementing Primary HPV Testing for Routine Cervical Cancer Screening
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.
Read the detailed description
Definition: Extended description of the protocol, including more technical information (as compared to the Brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures.
Limit: 32,000 characters.
Background and Significance: Strong evidence supports testing for the high risk human papillomavirus (HPV) infection, the etiology agent of cervical cancer, in routine cervical cancer screening. In 2014, the FDA approved the first test for primary HPV screening. Between 2015 and 2017, professional societies and national guideline bodies released practice recommendation for primary HPV screening. However, none of the large health care systems in the U.S. have systematically adopted this new screening strategy. Kaiser Permanente Southern California (KPSC) is preparing to transition to primary HPV screening in 2019, with considerable expected impact and barriers at multiple levels. There is a critical gap of knowledge on effective strategies to guide implementation of uptake of new evidence-based practice, especially around cancer screening where changes to clinical practice guidelines often created confusion among clinicians and patients. The overarching goals of this application is to generate insights and evidence regarding barriers and facilitators and effective strategies to achieve clinical practice substitution. Study Aims: SA1) Compare a local-tailored vs. a centralized approach for facilitating adoption of primary HPV testing for cervical cancer screening on (a) implementation outcomes including uptake of primary HPV screening, acceptability, appropriateness and feasibility; and (b) stakeholder-centered outcomes including knowledge, experience, behavior and satisfaction; SA2) Explain variations in implementation strategy effectiveness on study outcomes by multi-level factors; and SA3) Develop guidance for use of the effective implementation strategies in additional settings and for additional implementation problems. Study Descriptions: We will conduct a prospective, cluster randomized programmatic trial to compare and evaluate a local-tailored versus a centralized implementation approach. The local tailoring strategy will be guided by a structured process, using a menu of core functions and forms with evidence-based barrier assessment and intervention options. The centralized implementation will be based on the prevalent KPSC regional approach to new practice implementation, involving the design of a multi-component approach that is delivered in a relatively consistent manner. Twelve of the 14 KPSC medical centers will be randomized to receive one of the two implementation approaches, with two medical centers serving as pilot sites. The study subject will include screening age women, primary care and obstetrics \& gynecology physicians, as well as clinic staff, administrators and operational leaders. The primary outcome of interest is uptake of primary HPV screening at the provider level. The secondary outcomes include stakeholder-centered outcomes such as knowledge and satisfaction, and additional implementation and system outcomes as well as implementation process evaluation. Data collection will be via electronic medical record extraction, patient and provider surveys, and semi-structured key-informant interviews. Multi-level models and generalized estimating equations will be used to evaluate the effect of the local-tailored approach on each outcomes of interest. Effect heterogeneity by multi-level factors will be examined by interaction terms. Content analysis will be used to evaluate qualitative data collected for Aims 1 and 3. We will use the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) to inform our overall study approach and provide rigor and structure to our analyses.
- Conditions
- Cervical Cancer, Human Papillomavirus, Health Knowledge, Attitudes, Practice, Health Care Utilization
- Being tested
- Local Tailoring
- Keywords
- Primary HPV Screening, Cervical Cancer Screening, Local Tailoring, Implementation Strategy
- Medical subject headings
- Uterine Cervical Neoplasms, Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local TailoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the 3 months after the end of the 2 months intervention window
Secondary outcomes (3)
Provider-centered outcomes
Knowledge about the efficacy of the new test. We will assess provider knowledge via provider surveys which elicits information on provider knowledge and practice on cervical cancer screening. Provider delivery of education during patient screening visit will be measured in provider survey, including whether education is delivered and average time spent on patient education/counseling. Provider/staff satisfaction of the transition process and provider resistance to the new screening modality will be ascertained via survey questions.
Measured: Within the 3 months after the end of the 2 months intervention window
Patient-centered outcomes
Knowledge about the new test and why the change is made. To measure this outcome, we will use and modify validated survey questions on HPV test knowledge. Emotional reactions (stigma and shame) of a positive HPV test result will be measured using survey questions developed by Waller et al. Patient satisfaction during the transition may be measured with survey questions such as "Were you able to discuss all your concerns/questions about the new screening approach with your provider?" "Where these concerns/questions adequately addressed?" "Did you get your test result back in a timely manner?" "Did someone explain to you what the test result mean?" and "How satisfy are you with the screening experience?"
Measured: Within the 3 months after the end of the 2 months intervention window
Time to colposcopy after a positive test result
Time to colposcopy after a positive test result represents the combination of correct and timely referral, patient compliance, and availability of colposcopy appointments and will be measured using laboratory and utilization data collected in KPSC's electronic medical records.
Measured: Within the 6 months after the end of the 2 months intervention window
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Mar 2019
- Primary completion18 Aug 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chun Chao
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Chun Chao, Kaiser Permanente
- Investigators
- Chun R Chao, PhD, Principal investigator, KPSC Department of Research and EvaluationDevansu Tewari, MD, Principal investigator, KPSC Orange County Medical Center Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371887
- Sponsor's protocol ID
- CDR-2018C1-10987
- Status last verified
- Dec 2021
- First submitted
- 30 Apr 2020
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40735691Chao 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.
PubMed 40355876Cannizzaro 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.
PubMed 39258727Chao 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.
PubMed 36336248Hahn 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.
PubMed 34556189
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Strategies for Implementing Primary HPV Testing for Routine Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT04371887
- Acronym / sponsor ID
- CDR-2018C1-10987
- Conditions
- Cervical Cancer, Human Papillomavirus, Health Knowledge, Attitudes, Practice, Health Care Utilization
- Keywords
- Primary HPV Screening, Cervical Cancer Screening, Local Tailoring, Implementation Strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45,000 participants (estimated)
- Lead sponsor
- Chun ChaoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 18 Aug 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Definition: Extended description of the protocol, including more technical information (as compared to the Brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures.
Limit: 32,000 characters.
Background and Significance: Strong evidence supports testing for the high risk human papillomavirus (HPV) infection, the etiology agent of cervical cancer, in routine cervical cancer screening. In 2014, the FDA approved the first test for primary HPV screening. Between 2015 and 2017, professional societies and national guideline bodies released practice recommendation for primary HPV screening. However, none of the large health care systems in the U.S. have systematically adopted this new screening strategy. Kaiser Permanente Southern California (KPSC) is preparing to transition to primary HPV screening in 2019, with considerable expected impact and barriers at multiple levels. There is a critical gap of knowledge on effective strategies to guide implementation of uptake of new evidence-based practice, especially around cancer screening where changes to clinical practice guidelines often created confusion among clinicians and patients. The overarching goals of this application is to generate insights and evidence regarding barriers and facilitators and effective strategies to achieve clinical practice substitution. Study Aims: SA1) Compare a local-tailored vs. a centralized approach for facilitating adoption of primary HPV testing for cervical cancer screening on (a) implementation outcomes including uptake of primary HPV screening, acceptability, appropriateness and feasibility; and (b) stakeholder-centered outcomes including knowledge, experience, behavior and satisfaction; SA2) Explain variations in implementation strategy effectiveness on study outcomes by multi-level factors; and SA3) Develop guidance for use of the effective implementation strategies in additional settings and for additional implementation problems. Study Descriptions: We will conduct a prospective, cluster randomized programmatic trial to compare and evaluate a local-tailored versus a centralized implementation approach. The local tailoring strategy will be guided by a structured process, using a menu of core functions and forms with evidence-based barrier assessment and intervention options. The centralized implementation will be based on the prevalent KPSC regional approach to new practice implementation, involving the design of a multi-component approach that is delivered in a relatively consistent manner. Twelve of the 14 KPSC medical centers will be randomized to receive one of the two implementation approaches, with two medical centers serving as pilot sites. The study subject will include screening age women, primary care and obstetrics \& gynecology physicians, as well as clinic staff, administrators and operational leaders. The primary outcome of interest is uptake of primary HPV screening at the provider level. The secondary outcomes include stakeholder-centered outcomes such as knowledge and satisfaction, and additional implementation and system outcomes as well as implementation process evaluation. Data collection will be via electronic medical record extraction, patient and provider surveys, and semi-structured key-informant interviews. Multi-level models and generalized estimating equations will be used to evaluate the effect of the local-tailored approach on each outcomes of interest. Effect heterogeneity by multi-level factors will be examined by interaction terms. Content analysis will be used to evaluate qualitative data collected for Aims 1 and 3. We will use the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) to inform our overall study approach and provide rigor and structure to our analyses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Local Tailoring | Experimental | Other: Local TailoringThe 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. |
| 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are younger than 30 years old
- Providers working for departments other than Ob/Gyn, family or internal medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local TailoringThe "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. | Other | Local Tailoring |
Primary outcome
Uptake of primary HPV testing
Time frame: Within the 3 months after the end of the 2 months intervention window
Proportion of primary HPV testing of all cervical cancer screening performed for women age 30-65 at the provider level.
3 secondary outcomes
Provider-centered outcomes
Time frame: Within the 3 months after the end of the 2 months intervention window
Patient-centered outcomes
Time frame: Within the 3 months after the end of the 2 months intervention window
Time to colposcopy after a positive test result
Time frame: Within the 6 months after the end of the 2 months intervention window
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Derived from this study: PubMed 40735691Hahn 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.
- Derived from this study: PubMed 40355876Chao 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.
- Derived from this study: PubMed 39258727Cannizzaro 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.
- Derived from this study: PubMed 36336248Chao 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.
- Derived from this study: PubMed 34556189Hahn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun R Chao, PhD principal investigator
KPSC Department of Research and Evaluation
Devansu Tewari, MD principal investigator
KPSC Orange County Medical Center Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Tailoring in people with Cervical Cancer and Human Papillomavirus, run by Chun Chao at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy Cannizzaro, PhD (626-564-7663, nancy.takahashi@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of primary HPV testing (time frame: Within the 3 months after the end of the 2 months intervention window). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04371887, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.