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Local Tailoring for Cervical Cancer

N/A

Waitlist Available

Led By Devansu Tewari, MD

Research Sponsored by Chun Chao

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within the 3 months after the end of the 2 months intervention window

Awards & highlights

Study Summary

This trial is testing whether a new method of screening for cervical cancer is more effective than the current Pap test.

Eligible Conditions

Cervical Cancer
Human Papillomavirus
Health Literacy
Health Care Utilization

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within the 3 months after the end of the 2 months intervention window

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within the 3 months after the end of the 2 months intervention window

This trial's timeline: 3 weeks for screening, Varies for treatment, and within the 3 months after the end of the 2 months intervention window for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Uptake of primary HPV testing

Secondary outcome measures

Patient-centered outcomes

Provider-centered outcomes

Time to colposcopy after a positive test result

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Local TailoringExperimental Treatment1 Intervention

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.

Group II: Hybrid Usual CareActive Control1 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.

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Who is running the clinical trial?

Chun ChaoLead Sponsor

Patient-Centered Outcomes Research InstituteOTHER

549 Previous Clinical Trials

29,951,776 Total Patients Enrolled

Devansu Tewari, MDPrincipal InvestigatorKPSC Orange County Medical Center Department of Obstetrics and Gynecology

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities to enroll in this medical trial?

"That is correct. According to the information available on clinicaltrials.gov, this research trial has been actively recruiting since March 1st 2019 and was last updated on December 22nd 2021. 45000 patients need to be enrolled from one medical centre."

Answered by AI

What is the enrollment capacity of this clinical trial?

"Affirmative. Clinicaltrials.gov reports that this medical trial, which was uploaded on March 1st 2019, is presently recruiting test subjects. 45000 patients are needed from a single research centre."

Answered by AI

Do elderly individuals qualify as participants in this medical experiment?

"To be accepted into this trial, candidates must meet the age requirement of between 21 to 70 years old. Forty-three studies are available for those under the legal age of consent and 417 are accessible to applicants aged 65 or older."

Answered by AI

Could I be a suitable candidate for this research endeavor?

"This medical trial is seeking 45,000 volunteers aged between 21 and 70 who have access to healthcare. All 12 service areas of KPSC apart from Orange Country will be randomly chosen for the cluster randomized study and participants must include primary care providers (physicians, nurses and medical assistants) as well as department administrators in family medicine/ internal medicine departments or obstetrics & gynecology at those sites. In addition, female patients aged 30-65 receiving cervical cancer screening during data collection period are also eligible for entry into this experiment."

Answered by AI

Recent research and studies

Implementation Science CommunicationsJournal

De-implementation and Substitution of Clinical Care Processes: Stakeholder Perspectives on the Transition to Primary Human Papillomavirus (HPV) Testing for Cervical Cancer Screening

Hahn, Erin E., Corrine Munoz-Plaza, Danielle E. Altman, Chunyi Hsu, Nancy T. Cannizzaro, Quyen Ngo-Metzger, Patricia Wride, et al.. 2021. “De-implementation and Substitution of Clinical Care Processes: Stakeholder Perspectives on the Transition to Primary Human Papillomavirus (HPV) Testing for Cervical Cancer Screening”. Implementation Science Communications. Springer Science and Business Media LLC. doi:10.1186/s43058-021-00211-z.

clinicaltrials.govStudy

Comparing Strategies for Implementing Primary HPV Screening

Chun Chao 2019. "Comparing Strategies for Implementing Primary HPV Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04371887.