Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Women aged 25-49 years seeking offered HPV testing (either self-collection or clinician collection of samples) and treatment of precancerous lesions as part of service package in study facilities will be enrolled in the study and interviewed at different time points.

A subset of the women screened will be selected for in-depth interview to gather data on: ease of use of self-collection kits for cervical cancer screening, receipt of the test results, and treatment for precancer. Another subset of women will be selected after HPV screening to participate in client exit interview.

Interviews will be conducted among women from the general population and HIV+ women after screening for HPV. A small subset of participants will be interviewed after receiving treatment for precancer. HPV test results and outcome of the precancer treatment if indicated will be documented.

HPV testing

MARK M KABUE, Dr.PH

Meg Bartram

Linda Traore, MD

Jean-Claude Comoe, MD

Mark Kabue, Dr.PH

Nemdia Daceney

The goal is to assess the feasibility and acceptability of integrating into existing health systems, provision of HPV screening and treatment of pre-cancerous cervical cancer lesions with ablative treatments in Burkina Faso, Côte d'Ivoire, Guatemala, and the Philippines. Study findings will inform implementation of cervical cancer prevention and treatment services as part of a global effort to eliminate cervical cancer, with particular relevance for low-and-middle income countries. This will inform country strategy and guidelines on offering integrated cervical cancer prevention and treatment services in a manner that is culturally sensitive, client oriented, and system appropriate.

Research question:

1. How feasible is it to implement integrated HPV testing (including self-collection of samples) and ablative treatment of lesions precancerous cervical cancer lesions among HPV+ women aged 30-49 years (general population) and 25-49 years (WLHIV), leveraging on the existing health systems in the four study countries?
2. What is the acceptability of HPV screening through self-collection or clinician collection of sample, and ablative treatment of precancerous lesions among women accessing cervical cancer services in the study sites?
3. What is the cost of implementing integrated cervical cancer screening and precancer treatment services (Supply: counselling, HPV testing, treatment, training health care providers, etc.), and user-related costs (travel, out of pocket expenses opportunity costs, etc.) in the SUCCESS project supported sites?
4. Which factors influence the successful implementation of integrated HPV screening and treatment services (e.g. perceptions, experience of care, religious beliefs, culture, individual characteristics, availability of services, cost, etc.)?

Methodology:

We will utilize a hybrid effectiveness implementation Type III study design, using mixed methods approach. We will screen 2227 women in each country (disaggregated by general population and WLHIV) and follow those who are HPV positive to determine the completion of screen-to-treat within three months.

Quantitative and qualitative data will be collected from clients, service providers, key stakeholders, and secondary analysis of service delivery including laboratory data will be analyzed to assess acceptability and feasibility of implementing integrated cervical cancer screening and treatment services in the four countries.

SUCCESS - Feasibility of HPV Testing and Treatment of Pre-cancerous Cervical Cancer Lesions (HPV Study)

Feasibility and Acceptability of Implementing Integrated HPV Testing and Treatment of Pre-cancerous Cervical Cancer Lesions in Burkina Faso, Côte d'Ivoire, Guatemala, and the Philippines

Proportion of HPV positive women who undergo treatment for precancerous cervical lesions within three months of screening

Assess the adoption, satisfaction, and uptake of the cervical cancer services by the users and the providers

Assess the adoption and practicability of providing the cervical cancer services through the mechanisms that exist in of each of the four countries

The cost of providing the services and the user costs

UNITAID

Expertise France

World Health Organization

Jhpiego

Sr. Monitoring Evaluation and Research Advisor

Women aged 30-64 years who signed informed consent and comply with inclusion and exclusion criteria.

Women who signed informed consent will be screened with HPV testing.

HPV screening

Rolando Herrero, MD, PhD

HPV testing for primary cervical cancer screening of women over 30 years of age is likely to become the standard of care in the near future in many areas of the world. Its high sensitivity can significantly improve the effectiveness of screening programs and its prolonged negative predictive value can allow extension of screening intervals. However, a single HPV test has low positive predictive value and can lead to unnecessary workup and over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000 women with HPV testing and compare several triage approaches that can follow HPV testing in order to make an HPV-based screening programme efficient, affordable and sustainable.

The study will be conducted in several Latin American countries. Currently, the study has started in one site in Colombia and soon another site in Mexico will start. In each participating center, women aged 30-64 years who are attending clinics for cervical screening will be invited to participate in the study. Women who agree to participate and sign the corresponding Institutional Review Board (IRB) approved consent forms will undergo a pelvic examination, and cervical cells for primary screening and triage will be collected. Recruitment specimens will be used for primary screening with an established HPV DNA test (Food and Drug Administration FDA approved). All women who are HPV-positive by the recruitment test will be referred for a standardized colposcopy examination for diagnosis. At the colposcopy visit, but before colposcopy is performed, a risk factor interview will be administered and participants will undergo visual inspection of the cervix with acetic acid (VIA) and collection of additional cervical cells and a blood specimen. The results of VIA will not be disclosed to the colposcopist. During colposcopy, the colposcopists will obtain (2-4) biopsies from any abnormally-appearing areas to ascertain neoplastic outcomes (CIN3+) and to direct treatment as required. All women who attend colposcopy will have a second round of HPV testing approximately 18 months after recruitment and those who are HPV-positive will be referred to colposcopy for final diagnosis. Data management and study supervision will be the responsibility of the International Agency for Research on Cancer (IARC) and the local Principal Investigators, most of whom are experienced HPV researchers.

The combined number of histologically-confirmed diagnoses of CIN3+, including CIN2 lesions positive for p16, (estimated n=500) will be the outcome of primary interest for evaluation of the performance of the various triage modalities. Our initial analyses will focus on comparisons of triage strategies that employ a single method: VIA, conventional/liquid-based cytology, HPV DNA genotyping, HPV RNA detection, detection of E6 proteins of high risk HPV types, or markers of HPV-induced cell-cycle alterations (e.g., p16, ki67, etc). To the extent possible, molecular testing for HPV triage will be carried out on the recruitment specimens to simulate a 'reflex testing' approach wherein screening and triage are done on the same specimen without additional visits. Subsequent analyses will consider various alternative strategies that employ more than one triage methodology; e.g., HPV DNA genotyping followed by cytology. The effectiveness and costs of each alternative strategy will be assessed under various scenarios of feasibility, cost, and effectiveness.

One dry and two liquid cervical samples will be collected at entry. Sample fate will depend on a liquid HPV test. If positive: the dry sample will be used for the E6 protein strip test, the liquid sample for liquid-based cytology and the p16/ki67 test, and 10 aliquots from the second liquid sample will be stored. If negative: the dry sample will be stored for the E6 strip test until the end of the study. Testing will be done based on evidence towards usefulness in primary screening, two aliquots from the first liquid sample will be stored and, the second liquid sample will be discharged. At initial colposcopy, a cervical sample (6 aliquots) and a 10mL blood sample (serum, plasma and buffy-coat) will be collected and stored. All samples will be used for testing of triage techniques.

Cervical Cancer Screening With Human Papillomavirus Testing

Multicentric Study of Cervical Cancer Screening and Triage With Human Papillomavirus (HPV) Testing

There will be two HPV screening rounds. Women who test negative for HPV at initial screening will finish their participation. HPV positive women will be: 1) referred to colposcopy, 2) invited for a second HPV screening round if not yet treated, and 3) referred to final colposcopy if HPV positive at second screening. Clinical management will be based on local histology.

Histology specimens will be externally reviewed by one highly experience international pathologist. If the local and external results are the same, this will become the final histology. If there is disagreement, the specimen will be sent to a third pathologist (be blinded to previous readings). The final diagnosis will then be that agreed by two pathologists (local and either external or both external). Remaining discrepancies will be solved by adjudication at a multi-headed microscope. Worst histology on review will be used to define outcome measures.

International Agency for Research on Cancer

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Infections

Symptoms and General Pathology

Digestive System Diseases

Diabetes Mellitus

Chlamydia Infections

Communicable Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Bacterial

Monthly email communication: Monthly standard communication via email informing physicians of their health maintenance completion rate over the prior three-month period. The email will also include a link to the performance dashboard, a link to a FAQ page that outlines their incentive plan, a link to helpful resources such as care guidelines, key tips from top performers, the quality measure on which they are performing the best, and the two quality measures that they could improve on the most.

Monthly email communication as in Arm 1

Social comparison: In addition to the information given in Arm 1 email messaging, physicians in this arm will receive a list of the names of the top 25 performers from the prior month, and a high performer benchmark. Each physician in this group will receive a personalized message and subject line based on where in the performance distribution they fall (categories: top 25 performers, high performers, nearly high performers, and low performers). Message content will incorporate language utilizing principles of social comparison theory.

Monthly email communication as in Arm 1 and Arm 2.

Social comparison as in Arm 2.

Quality improvement leadership training: Physician leads and clinic managers within clinics randomized to Group 3 will receive an in-person quality improvement and primary care clinic performance training, using the principles of quality improvement, self-determination theory and social comparison. Clinic leaders will be trained on how to guide these conversations, formulate their own performance/quality improvement goals, design effective strategies to reach these goals, and track their clinic's progress. Check-in emails and calls will be provided on a monthly basis to follow up on clinic-based quality improvement efforts and share key take-aways from the new Primary Care Clinical Excellence Recognition Program. This program aims to support a positive and collaborative culture of clinical excellence by recognizing and sharing best practices from high performing physicians and clinical teams.

This is the base communication that all physicians will receive.

Standard communication email

The social comparison is added onto the standard communication email to provide some peer comparison between the physicians.

Social comparison Intervention

Clinic and Physician leads will be provided with a clinic leadership training seminars in leadership, quality improvement, and support from the Quality Improvement team at UCLA Health.

Leadership Training

As part of UCLA Health's commitment to developing a premier integrated health system built on a foundation of physician-led, team-based primary care, the Department of Medicine (DOM) recently implemented a new performance based incentive plan called the Primary Care Clinical Excellence (PCCE) Incentive Plan. This incentive plan was developed to motivate providers to improve health maintenance screening rates.

The UCLA Health DOM Quality team is leading the implementation and evaluation of this new incentive plan across our primary care network. In addition, the DOM Quality team has partnered with the UCLA Anderson School of Management to study the most efficacious ways to frame and communicate performance based incentives.

Understanding the factors that motivate physicians to deliver the highest quality primary care will provide pivotal insights into the successful implementation of performance based programs nationwide. The investigators believe that physicians who receive communication built on behavioral principles will demonstrate more motivation towards and success at meeting national primary care screening guidelines.

Currently, UCLA Health has 42 primary care clinics staffed with approximately 205 PCP's serving more than 300,000 patients. In order to improve health maintenance screening rates associated with the performance based program, the investigators will use a communication strategy that leverages behavioral principles to motivate providers to improve health maintenance screening rates.

The investigators will implement a three-arm experimental communication campaign that includes monthly messages. The communication strategy will utilize behavioral change theory (particularly social comparison and recognition) to improve physician performance in health maintenance quality metrics.

This study will primarily focus on one quality domain of the PCCE incentive program-Clinical Quality. Two further quality domains of the PCCE incentive program will serve as exploratory measures: Patient Experience and Professional Participation.

For the primary outcome measure and high-priority secondary outcome measures, the investigators will first evaluate whether the combination of arms 2 and 3 differs from arm 1 in terms of the measures listed in the Outcome Measures section. If this comparison is statistically significant, the investigators will next compare arms 1 vs 2. and then, if also significant, the investigators will compare arms 1 vs 3 and 2 vs 3. For the 1 vs 3 and 2 vs 3 comparisons, we will use a Holm-Bonferroni p-value correction. These comparisons of treatment arms will be performed at the patient level using a mixed effects regression model, including random physician and clinic effects to account for clustering of patients. Control variables include (1) patient baseline order rates (or completion rates depending on the outcome measure) in July-October 2019, (2) patient characteristics (age, gender, comorbidity, insurance plan, zip code), and (3) physician characteristics (gender, race, years practiced, years at UCLA Health). Unless otherwise specified, p-values less than 0.05 will be considered statistically significant.

Parallel cluster randomized trial. Groups will be clustered at the clinic level taking into consideration total Clinical FTE, Primary Care network group, and baseline HM completion rates.

Primary Care Clinical Excellence Incentive Study

Effects of Social Comparison Performance Feedback on Primary Care Quality

There is no IPD sharing plan for this study.

For each patient who visits a given PCP in our sample from November 5, 2019 to March 3, 2020, we will consider all Focus Quality Measures open at his/her first visit to the PCP, and calculate the percent of these measures ordered within 7 days following his/her first visit.

Focus Quality Measures include: Diabetes HGB A1C, Diabetes Eye Exam, Diabetes Foot Exam, Diabetes Nephropathy Monitoring, Colon Cancer Screening, Breast Cancer screening, Cervical Cancer Screening, chlamydia screening, and HPV depending on primary care specialty. These Focus Measures are based on the USPSTF primary care recommendations.

\[Note: The original intent was to run the study over an eight month period - from November 1, 2019 through June 30, 2020 - but was cut short due to the COVID-19 pandemic. Our revised time frame includes (1) four full cycles (months) of the intervention (11/05/2019-03/03/2020) and four months prior to the experiment as a baseline period\]

For each patient who visits a given PCP in our sample from November 5, 2019 to March 3, 2020, we will consider all Focus Quality Measures that are open between November 5, 2019 and March 3, 2020. We will calculate the percentage of these measures completed between November 5, 2019 and March 10, 2020 as well as the percentage completed between November 5, 2019 and July 3, 2020.

For each patient who visits a given PCP in our sample from November 5, 2019 to March 3, 2020, for each Focus Quality Measure open at his/her first visit to the PCP, we will assess whether the open measure is ordered within 7 days following his/her first visit.

For each patient who visits a given PCP in our sample from November 5, 2019 to March 3, 2020, for each Focus Quality Measure open between November 5, 2019 to March 3, 2020, we will assess whether the measure is completed (1) between November 5, 2019 and March 10, 2020 as well as (2) between November 5, 2019 and July 3, 2020.

As measured by aggregate order rates for Complementary Health Maintenance Measures within seven days after each patient's first visit. Complementary Measures (Abdominal Aortic Aneurysm Screening, Osteoporosis Screening, Hepatitis C Screening, HIV Screening, Pneumococcal Vaccination, Tetanus Vaccination, Tdap Vaccination During Pregnancy, Shingles Vaccination, Meningitis Vaccination, Measles Mumps Rubella Vaccination, Polio Vaccination, Hepatitis A Vaccination, Hepatitis B vaccination, Pneumococcal Vaccination for Patients with Diabetes, Statin for Primary ASCVD Prevention, Aspirin for Secondary ASCVD Prevention, and Annual Wellness Visit) are based on USPSTF primary care recommendations regarding disease management, infectious disease screening, and standard vaccinations.

As measured by patient level aggregate performance Complementary Health Maintenance Measures (1) between November 5, 2019 and March 10, 2020 as well as (2) between November 5, 2019 and July 3, 2020.

Physicians will be surveyed to evaluate their level of burnout throughout the study period.

Physicians will be surveyed for their satisfaction throughout the study period.

Physicians will be surveyed regarding their provider experience throughout the study period.

Payment of performance based financial incentive to physicians throughout the study period.

Physician performance in patient satisfaction surveys throughout the study period.

Physician performance in professional participation will be based on provider/physician surveys throughout the study period.

For each patient who visits a given PCP in our sample from November 5, 2019 to March 3, 2020, we will consider all Focus Quality Measures that are open between November 5, 2019 and March 3, 2020, and calculate the percentage of these measures ordered between November 5, 2019 and March 10, 2020.

HM order rate is determined by the aggregate order rate of measures within the primary care Health Maintenance module of EPIC EHR ("Focus Quality Measures") and other Quality Measures that are not in the Health Maintenance module ("Complementary Measures"). Both the Focus Quality Measures and Complementary Measures are based on USPSTF primary care recommendations regarding disease management, infectious disease screening, cancer screening, and standard vaccinations.

HM completion rate is determined by the aggregate completion rate of variables within the primary care Health Maintenance module of EPIC EHR ("Focus Quality Measures") and other Quality Measures that are not in the Health Maintenance module ("Complementary Measures").

For each patient who visits a given PCP in our sample from November 5, 2019 to March 3, 2020, for each Focus Quality Measure open between November 5, 2019 to March 3, 2020, we will assess whether the measure is ordered between November 5, 2019 and March 10, 2020.

For each primary care physician, we assign patients to their panel using an attribution model. This model assigns patients to a physician if they have been seen by that physician within the last 3 years. Additional patient attribution logic includes: 1) the physician with a preventive/wellness visit in the prior 1 year is attributed first, 2) if there is no preventive/wellness visit in the prior 1 year, the physician with the largest number of visits is attributed, and 3) if there is a tie in either the preventive/wellness visit or number of visit scenario, the physician with the most recent visit is attributed. Once patients are assigned using the above attribution model, patients who have at least one visit with their attributed physician from November 5, 2019 to March 3, 2020 will be included in our evaluation.

For each physician, we will identify the number of new patients they have from November 5, 2019 to March 3, 2020.

For each patient who visits a given PCP in our sample from November 5, 2019 to March 3, 2020, we will measure the total number of times he/she visits the PCP from November 5, 2019 to March 3, 2020.

For each patient who visits a given PCP in our sample from November 5, 2019 to March 3, 2020, we will measure the number of open measures he/she has at the first visit as well as the total number of open measures he/she has from November 5, 2019 to March 3, 2020.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SUCCESS - Feasibility of HPV Testing and Treatment of Pre-cancerous Cervical Cancer Lesions (HPV Study)	NCT05133661	Cervical Cancer	HPV testing	25 Years - 49 Years	Jhpiego
Cervical Cancer Screening With Human Papillomavirus Testing	NCT01881659	CIN3 CIN2 Cervical Cancer	HPV screening	30 Years - 64 Years	International Agency for Research on Cancer
Primary Care Clinical Excellence Incentive Study	NCT04237883	Behavioral Econ... Primary Health ... Health Maintena... Diabetes Colorectal Canc... Cervical Cancer... Chlamydia Scree... HPV Screening	Standard commun... Social comparis... Leadership Trai...	18 Years -	University of California, Los Angeles

Spots Global Cancer Trial Database for hpv screening