RFA-PS-21-004.pdf

Centers for Disease Control and Prevention

National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention Extramural Research

Program Office

Implementing and Evaluating a Data-to-Care Rx Strategy

RFA-PS-21-004

Application Due Date: 01/05/2021

Implementing and Evaluating a Data-to-Care Rx Strategy

RFA-PS-21-004

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Notice of Funding Opportunity (NOFO) Title Implementing and Evaluating a Data-to-Care Rx Strategy Activity Code U01 - Research Project - Cooperative Agreement

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-PS-21-004

Assistance Listings (CFDA) Number(s) 93.943 93.941 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support up to three project sites to develop and implement a strategy to use real-time prescription data, each using a different type of prescription data (e.g., from insurance claims, managed care or other healthcare organizations, pharmacy fulfillment, pharmacy benefits managers, AIDS Drug Assistance Program), to identify persons with HIV who fail to pick up prescribed antiretroviral (ARV) medications by approximately 30 or 60 days of the expected fill date, and to target these individuals for progressive adherence and retention interventions. This strategy is called Data-to-Care Rx (D2C Rx). Because implementation of D2C Rx will likely be nuanced depending on the type of real-time prescription data used to implement the strategy, the study described within this NOFO is intended to determine the effectiveness of D2C Rx strategies implemented using different real-time prescription data. As a research study, appropriate comparison groups must be used. The comparison group can be “controls” (e.g., a contemporary group from the prescription dataset, randomized to intervention or standard of care) or other study designs that do not include controls (e.g., a pre-/post-intervention comparison).

Key Dates Publication Date: To receive notification of any changes to RFA-PS-21-004, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

https://www.grants.gov

Letter of Intent Due Date: 11/30/2020

Application Due Date: 01/05/2021

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 02/23/2021

Secondary Review: 03/29/2021

Estimated Start Date: 09/30/2021

Expiration Date: 01/06/2021 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose: The purpose of this Notice of Funding Opportunity (NOFO) is to support up to three project sites to develop and implement a strategy to use real-time prescription data, each using a different type of prescription data (e.g., from managed care, insurance claims, pharmacy fulfillment, pharmacy benefits manager, AIDS Drug Assistance Program), to identify persons with HIV who fail to pick up prescribed antiretroviral (ARV) medications by approximately 30 or 60 days of the expected fill date, and to target these individuals for progressive adherence and retention interventions. This strategy is called Data-to-Care Rx (D2C Rx). Because implementation of D2C Rx will likely be nuanced depending on the type of real-time prescription data used to implement the strategy, the study described within this NOFO is intended to determine the effectiveness of D2C Rx strategies implemented using different real-time prescription data. As a research study, appropriate comparison groups must be used. The comparison group can be “controls” (e.g., contemporary group from the prescription dataset, randomized to intervention or standard of care) or other study designs that do not include controls (e.g., a pre-/post-intervention comparison).

Mechanism of Support: U01 – Research Project - Cooperative Agreement Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire (four) 4-year project period is $7,144,000. The estimated number of awards will be up to three. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded, and the number of awards, will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $1,786,000, with individual awards ranging from $400,000 to $595,333. The estimated total funding (direct and indirect) for the entire four(4)-year project period will be $7,144,000. The project period is anticipated to run from 09/30/2021 to 09/29/2025.

Application Research Strategy Length: Page limits for the Research Strategy section of the application are clearly specified in Section IV. “Application and Submission Information” of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III. of this announcement are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI for each application.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Application Type. New.

Application Materials. See Section IV.1 for application materials. Please note that Form F is to be used when completing the application package.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act, Section 301(a) [42 USC 241(a)] and Section 318 [42 USC 247c], as amended.

1. Background and Purpose Re-engaging persons with HIV who have fallen out-of-care confers important individual-level health benefits and population-level prevention benefits. Use of HIV surveillance data to identify out-of-care persons is one strategy to identify and re-engage out-of-care persons and is called Data-to-Care or D2C (1). Data-to-Care uses laboratory reports (i.e., CD4 and HIV viral load tests) received by a health department's HIV surveillance program as markers of HIV care.

The laboratory reports are used to identify individuals who either never linked to care after diagnosis, or did not continue to receive care, and to offer these individuals outreach by health departments, providers, or both, to assist them with linking or re-engaging back into HIV care (1). Data-to-Care strategies are widely implemented by health departments with funding from CDC's Integrated Human Immunodeficiency Virus (HIV) Surveillance and Prevention Progr ams for Health Departments (PS 18-1802)(2).

In the current CDC-supported D2C model, there is a delay in the identification of out-of-care persons due to the time interval between recommended monitoring tests and the subsequent reporting of these tests to surveillance (3). Thus, the current D2C model identifies persons already out of care rather than identifying persons at risk for dropping out of care. The current D2C model, using laboratory data, cannot intervene in the short time interval between the start of a gap in care (typically 6 months from the last visit) and the point at which a person is declared out of care (3). More real-time data are needed to identify persons at risk of dropping out of care and to intervene prior to a gap in care, or loss to care.

Antiretroviral (ARV) prescription data are a source to identify HIV-infected persons who have https://www.cdc.gov/hiv/effective-interventions/respond/data-to-care/index.html?Sort=Title%3A%3Aasc&Intervention%20Name=Data%20to%20Care https://www.cdc.gov/hiv/funding/announcements/ps18-1802/hiv-prevention-care-plan.html https://www.cdc.gov/hiv/funding/announcements/ps18-1802/hiv-prevention-care-plan.html stopped filling ARV medications, and who are at risk for becoming out of care (3). Prescription data can come from a variety of sources such as prescription claims (e.g., Medicaid, commercial insurance billing data), the AIDS Drug Assistance Program (ADAP), pharmacy fulfillment data, pharmacy benefits manager, managed care organization or other healthcare organization data (3). Because most ARVs are prescribed as a 30-day supply of medication, prescription data can be used to identify persons who are not filling their medications on a monthly basis. Tracking ARV refill data can, therefore, be a more real-time indicator of poor adherence and can act as a harbinger of potential poor retention in care. Using real-time prescription data to identify persons who fail to fill ARV prescriptions, and intervening, could have a significant impact on adherence, and potentially on retention in care; this process is call Data-to-Care Rx or D2C Rx (3).

In 2019, the CDC published a Notice of Funding Opportunity (NOFO) titled Using Real-time Prescription and Insurance Claims Data to Support the HIV Care Continuum (RFA-PS-19-003) (4). The co-operative agreement currently funds an ongoing randomized control trial titled "Antiretroviral Improvement among Medicaid Enrollees (AIMS study)". As part of the AIMS study, Medicaid insurance claims data are used to: a) identify persons with HIV who have failed to fill ART prescriptions in a timely manner and b) to then intervene, with progressive adherence and retention interventions.

Whereas the AIMS study uses Medicaid claims data to implement a D2C Rx strategy, implementation of D2C Rx will be dependent on the type of real-time prescription data (e.g., data from insurance claims, pharmacy fulfillment, managed care or other healthcare organizations, pharmacy benefits managers, ADAP programs) used to implement D2C Rx. As such, the overall goal of this NOFO is to determine the effectiveness of D2C Rx strategies implemented using distinct sources of real-time prescription data. Each application should clearly indicate, in the Approach Section of the application, which one of the following three categories of real-time prescription databases will be used to accomplish project requirements: 1) insurance claims databases (e.g., Medicaid database, commercial insurance database) or ADAP program database; 2) managed care organization or other healthcare database; or 3) pharmacy fulfillment or pharmacy benefits manager database.

References

1. Centers for Disease Control and Prevention. Data to care. Available at: https://effectivei nterventions.cdc.gov/en/2018-design/data-to-care/group-1/data-to-care.

2. Notice of Funding Opportunity: Integrated HIV Surveillance and Prevention Programs for Health Departments, CDC-RFA-PS18-1802. Available at: https://www.cdc.gov/hiv /pdf/funding/announcements/ps18-1802/cdc-hiv-ps18-1802-nofo.pdf

3. Byrd KK, Camp NM, Iqbal K, Weidle P. Pharmacy data as an alternative data source for implementation of a Data-to-Care strategy. J Acquir Immune Defic Syndr 2019; 82:

S53-S56. DOI: 10.1097/QAI.0000000000001969

4. Notice of Funding Opportunity: Using Real-time Prescription and Insurance Claims Data to Support the HIV Care Continuum, CDC-RFA-PS-19-003. Available at: https ://www.grants.gov/web/grants/view-opportunity.html?oppId=308222 https://effectiveinterventions.cdc.gov/en/2018-design/data-to-care/group-1/data-to-care https://www.cdc.gov/hiv/pdf/funding/announcements/ps18-1802/cdc-hiv-ps18-1802-nofo.pdf https://www.cdc.gov/hiv/pdf/funding/announcements/ps18-1802/cdc-hiv-ps18-1802-nofo.pdf https://doi.org/10.1097/QAI.0000000000001969 https://www.grants.gov/web/grants/view-opportunity.html?oppId=308222 https://www.grants.gov/web/grants/view-opportunity.html?oppId=308222

Health Equity:

The program supports efforts to improve the health of populations disproportionately affected by HIV/AIDS, viral hepatitis, sexually transmitted diseases (STDs) and TB by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National HIV/AIDS Strategy available at https://www.whitehouse .gov/administration/eop/onap/nhas.

Health disparity is a particular type of health difference that is closely linked with social or economic disadvantage based on racial or ethnic group, religion, socioeconomic status, gender, mental health, cognitive, sensory, or physical disability, sexual orientation, geographic location, or other characteristics historically linked to discrimination or exclusion [HP 2020 - http://www .healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm]. Health disparities in HIV, viral hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most severely affected by these diseases.

Social determinants are the economic and social conditions that influence the health of individuals, communities and jurisdictions and include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion.

Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. It requires:

Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and Continuous efforts to maintain a desired state of equity after particular health disparities are eliminated.

Programs should use data, including social determinants data, to identify communities within their jurisdiction that are disproportionately affected by HIV, viral hepatitis, STDs and TB and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, programs should consider social determinants of health in the development, implementation, and evaluation of program-specific efforts and use culturally appropriate interventions that are tailored for the communities for which they are intended.

Healthy People 2030 and other National Strategic Priorities This NOFO addresses the Healthy People 2020 (http://www.healthypeople.gov) priority area of HIV and supports the following Healthy People 2020 objectives:

HIV-2: Reduce number of new HIV infections among adolescents and adults HIV-3: Reduce the rate of HIV transmission among adolescents and adults HIV-4: Reduce new AIDS cases among adolescents and adults HIV-22: (Developmental) Increase the proportion of persons with an HIV diagnosis in medical care with a viral load <200 copies/mL at the last test during the 12-month measurement period https://www.whitehouse.gov/administration/eop/onap/nhas https://www.whitehouse.gov/administration/eop/onap/nhas http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm http://www.healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm http://www.healthypeople.gov/

This NOFO also supports the following national goals and objectives (https://files.hiv.gov/s3fs-public/nhas-update.pdf):

Goal 1, Step 1.B: Expand efforts to prevent HIV infection using a combination of effective, evidence-based approaches

Goal 1, Step 1.B.4: Expand prevention with persons living with HIV Goal 2, Step 2.A.2: Ensure linkage to HIV medical care and improve retention in care for people living with HIV

The NOFO is aligned with the following operational strategies of the President's Ending the HIV Epidemic: A Plan for America initiative:

Treat Prevent

Also related to the National HIV/AIDS Strategy, this project supports the HIV Care Continuum Initiative, which calls for coordinated action to increase the number of people with HIV in the United States who have achieved the treatment goal of controlling the HIV virus. For more information, please see http://aids.gov/federal-resources/policies/care-continuum/.

Public Health Impact ARV prescription data have the potential to be a real-time indicator of poor adherence to ARV therapy and a harbinger of poor retention in care. Use of these data can provide public health and clinical care practitioners earlier opportunities to intervene upon non-adherent persons, which can lead to improved adherence to ARV therapy and improved HIV viral suppression.

Relevant Work This NOFO is informed by current Data-to-Care models, where health departments have demonstrated success in using HIV surveillance data to identify persons with HIV who are out of care and re-engaging these individuals in care. Successful Data-to-Care models have been implemented in both local and state health departments and in healthcare systems. More information about the current Data-to-Care model can be found at: https://effectiveinterventions .cdc.gov/en/2018-design/data-to-care/group-1/data-to-care.

2. Approach The project can be broadly categorized into three areas: 1) develop the Data-to-Care Rx (D2C Rx) model and project procedures; 2) implement the D2C Rx model; and 3) evaluate project outcomes and disseminate results.

The project requires access to a real-time prescription data source (e.g., data from prescription claims [e.g., Medicaid, commercial insurer], the AIDS Drug Assistance Program [ADAP], pharmacy fulfillment, pharmacy benefits managers, managed care organizations or other healthcare organizations) and HIV viral load test results.

PLEASE NOTE: Applications must clearly identify at the beginning of this section of the application which one of the following three categories of real-time prescription databases will be used to accomplish project requirements: 1) insurance claims databases (e.g., https://files.hiv.gov/s3fs-public/nhas-update.pdf https://files.hiv.gov/s3fs-public/nhas-update.pdf http://aids.gov/federal-resources/policies/care-continuum/

Medicaid database, commercial insurance database) or ADAP program database; 2) managed care organization or other healthcare database; or 3) pharmacy fulfillment or pharmacy benefits manager database.

Expected core activities and outcomes are outlined below:

A real-time prescription database will be used to identify persons with HIV who fail to pick up prescribed ARV therapy after approximately 30 and 60 days of the expected fill date, and to target these individuals for escalating adherence and retention interventions. Persons identified as approximately 30 days late will receive a first line intervention. The first line intervention will be a low intensity intervention (e.g., contact person to assess and address adherence barriers). Persons identified as approximately 60 days late will receive a progressive (more effort-intense) second line intervention (e.g., use disease intervention specialists, linkage coordinators or case managers to locate the individuals, address adherence barriers and re-link the individuals to the prescribing clinic and filling pharmacy). Each project site should use one type of real-time prescription data and not a combination of different types of prescription data (i.e., awardee might choose to use a commercial claims database but should not use both a commercial claims database and a pharmacy fulfillment database). Each project site should enroll a minimum of 600 participants. As a research study, appropriate comparison groups must be used. The comparison group can be "controls" (e.g., contemporary group from the prescription dataset, randomized to intervention or standard of care) or other study designs that do not include controls (e.g., a pre-/post-intervention comparison). Each participant should receive a minimum of 12 months of follow up from the date of the last intervention for the last enrolled participant. The primary study outcome is HIV viral suppression.

The Project Team will be composed of the awardee and other partners, as appropriate, with technical assistance provided by CDC.

The awardee will work with the Project Team to conduct the following activities during the four(4)-year project:

Strategy #1: Develop model to use real-time prescription data to identify persons who fail to pick up prescribed ARVs and to intervene Activities:

Develop procedures for using real-time prescription data to identify persons with HIV who failed to pick up prescribed ARVs by approximately 30 and 60 days of the expected fill date.

o The D2C Rx procedures must be compliant with Health Insurance Portability and Accountability Act (HIPAA) regulations.

o The D2C Rx procedures must abide by confidentiality standards to assure security and confidentiality of personally identifiable information (PII).

Procedures should detail how patient information will be kept secure and confidential.

o Procedures should consider, but are not limited to the following:

What constitutes a failure to fill ARVs (e.g., no claim for any ARV, no claim for each previously filled ARV, no claim for a complete regimen).

What constitutes a failure to fill ARVs by approximately 30 or 60 days.

How to account for participants switching medications (e.g., one medication was discontinued by provider and replaced by another prescription).

How often the data will be queried to identify persons who are late filling

ARV prescriptions.

What grace period (if any) a person will be given to fill their ARV prescriptions after the first-line intervention before conducting a second-line intervention.

Develop process for sharing the real-time prescription data between project partners including data sharing agreements, if required.

Develop first- and second-line interventions for persons who failed to pick up prescribed ARVs by approximately 30 and 60 days, respectively.

o The interventions should be progressive (i.e., the second-line intervention should be a more intensive intervention than the first-line intervention).

o The first-line intervention can be a new intervention or an existing evidence-based or evidence-informed intervention to address adherence barriers (e.g., contact person to assess and address adherence barriers).

o The second-line intervention should be an existing evidence-based or evidence-informed intervention to address adherence barriers.

Determine participant eligibility (inclusion and exclusion) requirements and enrollment procedures.

Develop intervention materials (e.g., data collection tools and instruments, scripts, informed consent).

Determine procedures for selecting comparison groups of persons with HIV (e.g., contemporary group from the prescription dataset, randomized to intervention or standard of care, or pre-/post-comparison).

Train project personnel on project processes and procedures.

Develop timeline for project activities.

o CDC projects that involve the collection of information from 10 or more individuals and are funded by a cooperative agreement are subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. OMB approval is required prior to enrollment of participants and collection of data. The project will be submitted for OMB review by the CDC Project Officer (PO). Institutional Review Board (IRB) approval is required prior to OMB review. The OMB approval process takes approximately 9 - 12 months. As such, the application should consider the OMB process when creating project timelines.

Strategy #2: Prepare for program implementation Activities:

Obtain access to real-time prescription data to fulfill project requirements. Examples of real-time prescription data sources include prescription claims (e.g., Medicaid, commercial insurance databases), pharmacy fulfillment data, pharmacy benefits managers, managed care organizations and other healthcare data, or the ADAP program.

o The prescription database must have the necessary data elements to identify failure to fill a prescription within 14 calendar days after the expected fill date and should include all variables necessary to determine the project outcome of adherence to ARV therapy.

o The prescription database should include, but is not limited to, the following:

Patient identifying information (e.g., name and contact information), name of ARV medication or National Drug Codes, days' supply for each ARV prescription, prescription fill date and prescribing provider. The "reverse out date" (i.e., the date that indicates when a medication was returned to shelf because a prescription was ordered but not picked up by the patient) is useful additional information. Data on demographics and eligibility (e.g., date a person was disenrolled from the insurance plan, if using an insurance database; date that a person's insurance was no longer accepted at a pharmacy, if using a pharmacy fulfillment database) are also useful information.

o The awardee must have access to the prescription database for a minimum of one year immediately prior to D2C Rx model implementation, throughout implementation, and for at least 12 months immediately after the date of the last intervention of the last enrolled participant.

Obtain access to data necessary to determine the project?s outcome of HIV viral suppression.

Obtain ethical approval(s), including project IRB approval, and assist project partners in obtaining local IRB approval, if required.

Assist the CDC Project Officer in obtaining OMB approval.

Arrange for and finalize agreements/contracts with project partners (e.g., Memoranda of

Understanding, financial agreements [i.e., contracts], data sharing agreements).

Strategy #3: Implement the D2C Rx program

Using the real-time prescription data, develop list of persons who failed to pick up prescribed ARVs by approximately 30 and 60 days of the expected fill date, and conduct first- and second-line interventions.

Enroll 600 participants; monitor project enrollment and address enrollment problems as they occur.

Obtain participant consent, if required.

Strategy #4: Evaluate project outcomes and disseminate results

Collect, manage and clean project data.

o Develop a data collection system which includes, but is not limited to:

Development of appropriate clinical, pharmacy, medical, laboratory, sociodemographic, process, outcome and other variables to be collected.

Development of data collection tools.

Development of database(s).

Standardized definitions.

Quality control procedures.

Procedures for secure reporting and storage of data.

o Develop a system for secure data sharing between project partners, as applicable.

o Clean data.

o Provide CDC with cleaned, analytic databases of the required data elements, quarterly (at minimum) after implementation has begun.

Analyze project outcomes o Work collaboratively with CDC and Project Team to develop analysis plans.

o Work collaboratively with CDC and Project Team to analyze project data and to determine project outcomes.

o Form a Publication Committee made up of one representative from the awardee institution and partner organizations (as appropriate) to determine rules for authorship of publications, abstracts and presentations and select targeted journals with technical assistance from CDC. Note: Publication of results from the project will be a shared responsibility and will be a collaborative effort.

Publications and presentations based upon data from this project will be required to go through official review and clearance by CDC.

Disseminate results through publications, abstracts and presentations.

Objectives/Outcomes Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

Research Objectives:

1. Develop and implement a model to use real-time prescription data to: a) identify persons with HIV who fail to fill prescribed ARVs within 60 days of expected fill date and b) target these individuals for progressive adherence interventions.

2. Implement progressive adherence interventions to increase the number of persons with HIV who fail to fill prescribed ARVs within 60 days of expected fill date who: a) achieve HIV viral suppression; b) re-initiate ARV therapy; c) are adherent to ARV therapy; and d) are persistent on ARV therapy.

Scientific Knowledge to be Achieved:

Determine if real-time prescription data is an effective method to identify and intervene upon persons who fail to fill prescribed ARVs within 60 days of expected fill date.

Primary Outcomes:

Service model leads to improved viral suppression. Viral suppression is defined as an HIV viral load < 200 copies/mL at most recent test in the measurement period. Sustained viral suppression (two consecutive viral load test results < 200 copies/mL, at least three months apart, in a 12-month measurement period) may also be measured. Potential data sources:

project clinic records, health department records.

Secondary Outcomes:

1. Service model leads to re-initiation of ARV therapy. [Re-initiation of ARV therapy is defined as a person filling ARV prescription after lapse in filling. Potential data source:

prescription database.]

2. Service model leads to improved adherence to ARV therapy. [Adherence is defined as a Proportion of Days Covered (PDC) of > 90 percent. Potential data source: prescription database.]

3. Service model leads to improved persistence to ARV therapy. [Persistence is defined as the time from the prescription fill until the patient has a gap in therapy. Potential data source: prescription database.]

Target Population Persons with HIV who are prescribed ARV therapy.

Collaboration/Partnerships The application should propose working collaboratively with other project partners to fulfill project requirements, as appropriate. Potential project partners include the source of the real-time prescription data (e.g., insurer, ADAP program, Pharmacy Benefits Manager (PBM), managed care organization), health department and healthcare organizations. It is strongly suggested that applicants collaborate with potential project partners to develop their application.

The application should include Letters of Support from each intended project partner and from consultants, if applicable.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a four (4)-year research project period. The application should include specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application's project plan and describe the development and implementation of project performance measures based on specific programmatic objectives.

The performance monitoring plan should include key evaluation questions for both processes (e.g., Were procedures for using real-time prescription data to identify persons with HIV who failed to pick up prescribed ARVs by approximately 30 and 60 days developed?) and outcomes (e.g., Did persons who failed to pick up prescribed ARVs by approximately 30 and 60 days receive first- and second-line interventions?) and outcome measures (e.g., percentage increase of people with HIV with viral suppression pre- and post- first- and/or second-line intervention).

The plan should also include the potential data sources and reporting frequency.

Translation Plan Potential target audiences include professional public health associations (e.g., American Public Health Association), professional HIV organizations (e.g., American Academy of HIV Medicine), pharmacy associations (e.g., American Pharmacist Association) as well as public health, medical, and pharmacy practitioners. Results should be submitted for presentation at local, regional or national conferences and for publication in peer-reviewed journals or other publications.

Section II. Award Information Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $7,144,000 Estimated total funding available for the first year (first 12-month budget period), including direct and indirect costs: $1,786,000 Estimated total funding available for the entire four (4)-year project period, including direct and indirect costs: $7,144,000

Anticipated Number of Awards: 3

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $595,333 Per Budget Period Award Floor: $400,000 Per Budget Period Total Period of Performance Length: 4 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and

Universities (HBCUs) Tribally Controlled Colleges and

Universities (TCCUs) Alaska Native and Native Hawaiian

Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of

Higher Education)

Governments:

Eligible Agencies of the Federal

Government U.S. Territory or Possession

Other:

Faith-based or Community-based

Organizations Regional Organizations Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs):

FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility

4. Justification for Less than Maximum Competition N/A

5. Responsiveness N/A

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://cage.dla.mil/

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/index.html .

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

https://cage.dla.mil/ https://www.sam.gov/index.html https://www.Grants.gov https://era.nih.gov/ https://www.grants.gov

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Section IV. Application and Submission Information

1. Address to Request Application Package In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via:

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms.

Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Letters of Support from partners or other organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

Please include all of the eight (8) mandatory forms listed below in the application package:

Mandatory

1. SF424(R&R)[V2.0];

2. PHS 398 Cover Page Supplement [V4.0];

3. Research and Related Other Project Information [V1.4];

4. Project/Performance Site Location(s) [V2.0];

5. Research and Related Senior/Key Person Profile (Expanded) [V2.0];

6. Research and Related Budget [V1.4];

7. PHS 398 Research Plan [V4.0];

8. PHS Human Subjects and Clinical Trials Information [V1.0].

If multiple collaborating institutions will be involved, please include in this section of the https://public.era.nih.gov/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf application your single IRB (sIRB) Plan:

Describe how you will comply with the single IRB review requirement under the Revised Common Rule at 45 CFR 46.114 (b) (cooperative research). If available, provide the name of the IRB that you anticipate will serve as the sIRB of record.

Indicate that all identified engaged institutions or participating sites will agree to rely on the proposed sIRB and that any institutions or sites added after award will rely on the sIRB.

Briefly describe how communication between institutions and the sIRB will be handled.

Indicate that all engaged institutions or participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.

Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.

Note: If you anticipate research involving human subjects but cannot describe the…