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Immunoglobulins

HBV infection status determined by enzyme-linked immuno-assay (ELISA)

HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).

Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

ELISA testing

A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.

Rapid testing

Julie Bottero, MD

With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care.

In terms of prevention, France has very low immunization coverage (27.7%) and a high percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly explained by poor knowledge of hepatitis B infection in the general population and an underestimation of the health impact of hepatitis B by doctors and health officials. Until recently, there have been no national guidelines governing its implementation (which is variable depending on the structures where screening is performed) and an insufficient evaluation of screening practices. Thus, data on the severity of liver disease, indications for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely, particularly to address the issue of people who do not come back and collect their results and to better adapt "counselling", their usefulness to detect of hepatitis B virus has not been evaluated to date.

The main objective of the Optiscreen B Study is to determine the benefit, if any, of using rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B. Individuals risk of HBV-infection will be randomized into 2 groups, one group for which screening will be performed by usual serological test and a second group for which screening will be based on rapid tests. Centers will be selected to represent a diverse range of health centers whose aims include screening, prevention and/or vaccination.

Application of HBV Rapid Tests as a Tool for Wide-Use Screening

Is the Combination of Screening Algorithms and Use of Hepatitis B Rapid Tests Useful in Optimizing the Screening and Prevention of Hepatitis B?

Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee.

Subjects who are considered required to seek further care are as follows:

* those who need HBV vaccination (non-immunized)
* those who are infected with hepatitis B virus (infected)

Of these patients, subjects who have achieved appropriate care are considered as follows:

* non immunized subjects who have initiated HBV vaccination sequence (vaccinated)
* infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care)

The percentage of patients appropriately seeking care will be then calculated by the following formula:

((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))\*100

ANRS, Emerging Infectious Diseases

Gilead Sciences

Roche Pharma AG

Mairie de Paris

BioMérieux

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Any event possibly related to physical HBV test.

HBV infection status determined by enzyme-linked immuno-assay (ELISA)

ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

ELISA Testing

HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).

ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.

Rapid Testing

Total

Age, Continuous

Sex: Female, Male

Low (<2.0%)

Intermediate (2.0-8.0%)

High (>8.0%)

HBV prevalence of birth country

Social security

Health insurance plan

All participants completing their intervention.

Low prevalence of HBV infection; individuals with barriers to healthcare were underrepresented; Quick Profile anti-HBsAb rapid test unable to confirm nonimmunized status; intervention had same-day blood draws, which is not done in routine practice.

Dr. Julie Bottero

Power calculations were performed to detect \>15% difference in immediate linkage-to-care and vaccination. We hypothesized from discussions with an expert panel that \~30% of participants would have appropriate care with standard HBV serology. Assuming type 1 error=0.05 and power=80%, 152 participants per arm would be needed. As \~40% of the population would be nonimmunized or HBsAg-positive from previous data, a minimum 375 participants per arm would be required.

Only participants needing further medical intervention were included in analysis: non-immunized (HBsAg negative, anti-HBc antibody negative, anti-HBs antibody negative) or infected (HBsAg positive).

Percentage of Patients Appropriately Seeking Care

Overall Study

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The investigators will determine the best intervention and strategy (and thus implementers) based on high ranking barriers/facilitators identified in focus groups. A minimum of 2 implementation strategies will be developed and implemented at each level (patient, provider, system) at each site that considers (1) implementation strategy; (2) mechanism in which the strategy impacts the identified determinant (3) the determinant; (4) moderators that may influence the impact of the strategy; (5) the preconditions necessary for successful implementation; and (6) implementation outcomes affected. Each community health center (CHC) will serve as its own separate subject, and individual strategies will be tested using single case experimental design (SCED) at each CHC using component analysis to rapidly test and optimize our strategies. In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured.

In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured.

The investigators will be conducting focus groups and identifying barriers and facilitators, and the investigators will be matching identified barriers and facilitators to implementation strategies at the patient, provider, and system level which the investigators will be testing using rapid-cycle methods.

Implementation Science Strategy

Adjoa Anyane-Yeboa, MD, MPH

Nathan Yoguez, MPH

Stephen Tringale, MD

Madhur Kuckreja, MD

Heidi Emerson, PhD

Lisa Jones, MD

The investigators will use a mixed methods study i.e. focus groups involving CHC staff as well as quantitative study which involves analyzing data that is available from the EHR and DRVS population management platform.

Aim 1: Describe the demographics of the populations aged 45 - 49, 50-4, and over 55 to understand baseline screening needs and disparities.

Overview: The investigators will characterize the population in these age groups in order to understand resources needed to screen patients at age 50 and to expand screening to the USPSTF's draft guideline if passed.

Setting: The investigators will select 4 CHCs with distinctly diverse populations for Aim 1 and Aim 2.

Approach: The investigators will examine data from the EHR and the DRVS platform to determine: (1) the size and demographics of the three age groups; (2) the frequency in which this population presents to the CHC for primary care and other visits; and (3) current screening initiation patterns. Based on the findings of the investigator's initial evaluation, the investigators will estimate the additional colorectal cancer screening tests that will be required to screen this population promptly at age 50 and the additional resources that will be needed at each health center to meet this need. The investigators will also estimate the impact of a lower age of screening initiation. Analysis will be stratified by race/ethnicity, gender, age and insurance status to assess for any disparities that might be present.

Data Collection and Management: The DRVS population management platform provides the data needed to evaluate Aim 1. The Implementation Science Center for Cancer Control Equity (ISCCCE) data management team will pull the data needed for the participating CHCs, once selected. The investigators have existing data use agreements that will be amended for this specific project. Data flows and management procedures have already been established and will serve to expedite this study.

Aim 2: Conduct focus groups with key personnel to identify barriers and facilitators to screening in 4 different health centers with uniquely diverse populations.

Overview: The investigators will conduct focus groups to understand barriers and facilitators to colorectal cancer screening including perceptions around the change in screening age, attitudes about specific strategies to facilitate colorectal cancer screening (e.g. use of technological-based solutions to prompt screening, task shifting with integration of medical assistants into the screening process), proposed strategies to improve screening at the health center, and other likely barriers and facilitators.

Approach: The investigators will conduct focus groups with key personnel at the 4 participating health centers. The investigators will include an administrative leader and population health managers, data analysts and quality improvement staff, as well as nurse/practice managers, medical assistants, and providers (MD, NP, and/or PA). Focus groups will address: (1) barriers and facilitators to timely screening initiation; (2) perceptions around using technological solutions to prompt colorectal cancer screening; and (3) perceptions about task-shifting with integration of the medical assistants into the colorectal cancer screening process. Distinct barriers and facilitators/determinants will be identified at the patient, provider and system-level. These determinants will be prioritized (high, medium, low) based on number of times referenced in the interviews.

Data Analysis: Focus group data will be analyzed to identify key themes related to barriers and facilitators to screening.

Outcomes: The outcome of this aim will be identified barriers and facilitators to colorectal cancer screening at health centers with a key focus on understanding perceptions around utilization of technological solutions (e.g. pre-existing text message platforms at health centers, electronic registries) and integration of the medical assistants into the CRC screening workflow.

Aim 3: Develop and test intervention components to anticipate and address barriers and facilitators at the patient, provider and system-level using rapid cycle methods.

Overview: We will identify implementation strategies at patient, provider and systems-levels and match to identified Aim 2 barriers and facilitators, use design probes to understand the workflows and preconditions for implementation strategies, and individually test strategies using rapid cycle methods.

Approach:

* Development of Implementation Strategies: High ranking barriers from Aim 2 will be matched with implementation strategies that are most likely to influence implementation outcomes. A minimum of 2 implementation strategies will be developed at each level. When identifying strategies, we will consider the: (1) implementation strategy; (2) mechanism in which the strategy impacts the identified determinant (3) the determinant; (4) moderators that may influence the impact of the strategy; (5) the preconditions necessary for successful implementation; and (6) implementation outcomes affected.
* Design Probes: We will conduct design probes to understand the culture, climate and preconditions to implementation at each health center. We will use design probes to further understand the day-to-day workings at the health center and workflows. We will further tailor our implementation strategies based on additional barriers and facilitators that are identified from design probes.
* Rapid Cycle Testing: Individual strategies will be tested using single case experimental design (SCED). In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured. For our study each CHC will serve as a separate subject. We will conduct a series of single case experiments at each CHC using component analysis to rapidly test and optimize our strategies. Component analysis allows researchers to assess several interventions or components of an intervention individually or as a treatment package in multiple assessments. A minimum of 2 strategies at each level (patient, provider, system) will be tested at each clinic site. For example, a patient-level strategy might include text messaging to patients, which is enabled by the DRVS platform. We might test whether single or multiple text messages around a patient's birthday can prompt screening uptake, or if messages prior to a health care visit increases uptake of screening offered. An example at the provider-level might include the impact of a motivational training if staff identify difficulty motivating patients as a barrier. A systems-level strategy might include incorporating CRC screening into the workflows of the health center using the medical assistants, if provider time limitations are identified as a barrier.
* Post-Implementation Survey: When implementation testing ends, our team will send out a survey to any CHC staff member (administrative leader and population health managers, data analysts and quality improvement staff, as well as nurse/practice manager, medical assistant, and provider \[MD, NP, and/or PA\]) involved with the implementation of strategies at the health center level, and the survey information we will collect will assess perceptions on feasibility, appropriateness, and acceptability of the implementation strategy used.

The investigators will use a mixed methods approach involving qualitative focus groups with health center providers and staff to identify barriers and facilitators to screening, and implementation science methods to test multilevel implementation strategies at the health centers.

Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study

No IPD will be shared with other researchers.

The investigators will measure the acceptability of the implementation strategies determined in Aim 2. This will be measured through a post-implementation survey given to the CHC staff members who participate in systems-level implementation at the two CHC pilot test sites in Aim 3.

The investigators will measure the feasibility of the implementation strategies determined in Aim 2. This will be measured through a post-implementation survey given to the CHC staff members who participate in systems-level implementation at the two CHC pilot test sites in Aim 3.

The investigators will measure the appropriateness of the implementation strategies determined in Aim 2. This will be measured through a post-implementation survey given to the CHC staff members who participate in systems-level implementation at the two CHC pilot test sites in Aim 3.

The secondary outcomes will be change in colorectal cancer screening rate. This will be measured by the difference in the colorectal cancer screening tests ordered and completed compared to the pre-implementation period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of HBV Rapid Tests as a Tool for Wide-Use Screening	NCT01767597	Hepatitis B Liver Cirrhosis Carcinoma, Hepa...	ELISA testing Rapid testing	18 Years -	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study	NCT05524428	Colo-rectal Can...	Implementation ...	18 Years -	Massachusetts General Hospital
Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study	NCT05524428	Colo-rectal Can...	Implementation ...	18 Years -	Massachusetts General Hospital
Application of HBV Rapid Tests as a Tool for Wide-Use Screening	NCT01767597	Hepatitis B Liver Cirrhosis Carcinoma, Hepa...	ELISA testing Rapid testing	18 Years -	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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