rfa-ps-16-006.pdf

Centers for Disease Control and Prevention

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Extramural Research Program Office

Early HIV Treatment to Optimize Patient Health and HIV Prevention

RFA-PS-16-006

Application Due Date: 02/19/2016

Early HIV Treatment to Optimize Patient Health and HIV Prevention

RFA-PS-16-006

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 Extramural Research Program Office (NCHHSTP ERPO) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Funding Opportunity Announcement (FOA) Title Early HIV Treatment to Optimize Patient Health and HIV Prevention Activity Code U18 Research Demonstration – Cooperative Agreements

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-PS-16-006

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.941 Category of Funding Activity:

Health FOA Purpose To support the conduct of a mixed-methods health services research study to assess models for the implementation of immediate antiretroviral therapy (ART) for persons with newly diagnosed acute and early HIV infection. Models will be implemented and evaluated in 2 to 3 HIV care settings. These implementation studies will allow a better understanding of clinical outcomes and patients’ experiences with immediate initiation of antiretroviral (ARV) treatment, including: 1) time to viral suppression and the proportion of patients who remain virally suppressed 12 months after their diagnosis, 2) retention in HIV care, 3) satisfaction with clinical care, 4) changes in HIV transmission risk behavior, and 5) laboratory markers of HIV infection.

NOTE: This FOA has been amended in red text to include a Summary of the Conference Call with Potential Applicants held on January 12, 2016 (Section VIII, pages 31 to 34) and to correct FOA language to state that letters of support are required from a healthcare organization, health department AND laboratory (Section III.5, page 10).

Key Dates Publication Date: To receive notification of any changes to RFA-PS-16-006, 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.

Letter of Intent Due Date: 01/14/2016

Application Due Date: 02/19/2016

On-time submission requires that electronic applications be error-free and made available to CDC for http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u18&Search.x=0&Search.y=0&Search_Type=Activity http://www.grants.gov

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

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date 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: 05/24/2016

Secondary Review: 06/16/2016

Estimated Start Date: 09/30/2016

Expiration Date: 02/20/2016 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) 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 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.

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

Executive Summary Purpose. To support the conduct of a mixed-methods health services research study to assess models for the implementation of immediate antiretroviral therapy (ART) for persons with newly diagnosed acute and early HIV infection. Models will be implemented and evaluated in two to three HIV care settings. These implementation studies will allow a better understanding of clinical outcomes and patients’ experiences with immediate initiation of antiretroviral (ARV) treatment, including: 1) time to viral suppression and the proportion of patients who remain virally suppressed 12 months after their diagnosis, 2) retention in HIV care, 3) satisfaction with clinical care, 4) changes in HIV transmission risk behavior, and 5) laboratory markers of HIV infection.

Mechanism of Support. Cooperative Agreement.

Funds Available and Anticipated Number of Awards. Estimated total funding available, to include direct and indirect costs for the entire project period, is $14,850,000. The project period will be for four years. There will be up to three awards. Awards issued under this FOA 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 funding (direct and indirect) for each award for the first year (12-month budget period) will be $495,000. An estimated $4,950,000 total funding (direct and indirect) will be available for each award for the entire four-year project period, with a maximum award of $495,000 for year 1, $1,650,000 for year 2, $1,980,000 for year 3, and $825,000 for year

4. The project period will run from 09/30/16 to 09/29/20.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. "Applicaiotn and Submission Information" of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1. of this http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1. 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 per application. If necessary, Co-PI(s) may be listed in the application but only one PI may be the primary CDC contact for the award and this must be indicated in the application.

Number of Applications. Each eligible applicant institution may submit only one application.

Application Type. New.

Special Date(s). A potential applicant conference call will be held on Tuesday, January 12, 2016 at 12:00 noon Eastern Time. The bridge number is 1-866-662-8986; passcode 8378091.

Application Materials. See Section IV.1 for application materials. Please note that Form C is to be used when downloading the application package: http://grants.nih.gov/grants/funding/424/SF424 _RR_Guide_General_VerC.pdf Hearing Impaired. Telecommunications for the hearing impaired are available at TTY:

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Sections 301 and 318 of the Public Health Service Act (42 U.S.C. Sections 241 and 247c), as amended.

1. Background and Purpose An estimated 1.1 million people were living with HIV in the United States in 2011 and the incidence of HIV infection among young men who have sex with men (MSM), especially young black MSM, has been increasing. Advances in antiretroviral therapy (ART) have dramatically decreased HIV-related morbidity and mortality and substantially reduced the risk of HIV transmission through suppression of HIV viremia. Persons with acute and early HIV infection (the stage of disease immediately after infection with the virus) are an important group to prioritize for treatment for a number of reasons. First, patients receiving HIV treatment early in the course of infection can gain substantial clinical benefit. Early treatment improves laboratory markers of disease progression and can decrease the severity of acute disease, lower the viral set point, and preserve immune function, which can improve the ability of an individual’s immune system to control the virus on its own, in certain situations. Second, initiation of ART has been shown to be a strong correlate of retention in HIV care among treatment-naïve participants entering care and thus, early treatment might improve retention in life-saving HIV care. Lastly, the high viral load characteristic of early HIV infection contributes disproportionately to HIV transmission; modeling studies have demonstrated that early treatment can reduce the number of new HIV infections by nearly 50%.

To achieve these health benefits, and to prevent further HIV transmission, a priority of the National HIV/AIDS Strategy is to increase the number of people who know their HIV status and access HIV care and ART in the United States. Unfortunately, as of 2011, only 40% of the persons diagnosed with HIV infection were engaged in HIV care and an estimated 30% of all HIV-infected persons had achieved viral suppression, highlighting the need for systematic improvement in how treatment is provided. Modern antiretroviral medications are safe, conveniently dosed (once daily pills), have a high threshold to viral resistance, and can achieve viral suppression in two weeks; these characteristics make the benefits of acute and early HIV treatment achievable. Unfortunately, with the current standard of care, there are typically lengthy delays

(often on the order of several months for a variety of reasons such as enrollment in an insurance plan – see Figure 1) in initiating antiretroviral therapy. In one study evaluating treatment outcomes among persons diagnosed with acute HIV infection, the median time for 50% of the cohort to achieve viral suppression was 10 months. These delays happened during a period when significant immunological damage was occurring and when there was maximum risk for further HIV transmission. Models of immediate HIV treatment (e.g., Figure 2) at the time of HIV diagnosis are needed to improve both access to, and benefit from, HIV treatment.

Figure 1. Existing process for initiation of antiretroviral therapy for persons newly diagnosed with acute or early HIV infection

This example of existing patient flow identifies several potential points for delay in initiating antiretroviral therapy (ART) for those with newly diagnosed acute or early HIV infection. Steps marked with an asterisk (*) represent instances when patients are required to wait and/or return to complete the next step in the process, highlighting several potential points for loss to follow-up. Depending on the patient’s medical coverage and existing resources in the community, patients may be required to wait weeks to months before initiating ART.

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, 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 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 2020 and other National Strategic Priorities Identifying effective methods to increase access to, and use of, clinical HIV prevention and treatment services aligns with the following:

Healthy People 2020 goals related to reducing new HIV infections, increasing HIV testing, and increasing access to care for persons with HIV infection.

National HIV/AIDS Strategy Goals: 1) Reducing New HIV Infections; 2) Increase access to care and improve health outcomes for people living with HIV; and 3) Reducing HIV-related Disparities and Health Inequities.

CDC Winnable Battles Goal: Reduce HIV infections.

Public Health Impact The development of a health service model for expedited ART would improve patient flow by decreasing the number of steps, and the time interval, from diagnosis of HIV infection to initiation of treatment, shown in Figure 2. Administration of immediate ART could substantially reduce the time to viral suppression, providing clinical benefits to the patient and reducing risk of HIV transmission, while awaiting linkage to ongoing HIV care. Additional potential benefits include increased retention in care, decreased risk behavior, and increased patient satisfaction with care.

Figure 2. Proposed process for initiation of immediate antiretroviral therapy for persons newly diagnosed with acute or early HIV infection

Relevant Work Masciotra S. Evaluation of Determine™ HIV-1/2 Ag/Ab combo in the context of acute HIV screening;

Masciotra S. Evaluation of Determine™ HIV-1/2 Ag/Ab combo in the context of acute HIV screening;

CROI 2015 http://www.croiconference.org/sessions/evaluation-determinetm-hiv-12-agab-combo-conte xt-acute-hiv-screening HIV laboratory testing guidance http://www.cdc.gov/hiv/pdf/guidelines_testing_recommendedLabTe stingAlgorithm.pdf Rosenberg ES. Race and age disparities in HIV incidence and prevalence among MSM in Atlanta, GA;

CROI 2014: http://www.croiwebcasts.org/console/player/22065?mediaType=slideVideo&;

HIV incidence report, 2007-2010 http://www.cdc.gov/hiv/pdf/statistics_hssr_vol_17_no_4.pdf HIV Surveillance Report 2013 http://www.cdc.gov/hiv/pdf/g-l/hiv_surveillance_report_vol_25.pdf HIV treatment guidelines http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf Starting antiretroviral treatment early improves outcomes for HIV-infected individuals http://www.nih .gov/news/health/may2015/niaid-27.htm

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

Objectives/Outcomes The objective of the proposed health services research study is to support the development of health services models for immediate antiretroviral (ARV) treatment of persons with newly diagnosed acute or early HIV infection, by implementing and evaluating a model in up to three HIV care venues. These implementation studies will allow a better understanding of clinical outcomes, patients’ perspectives and behavior with immediate initiation of ARV treatment, including: 1) time to viral suppression and the proportion of patients who remain virally suppressed 12 months after their diagnosis, 2) patient retention in HIV care, 3) patient satisfaction with clinical care, 4) changes in HIV transmission risk behavior, and 5) laboratory markers of HIV infection.

These innovative models should be implemented and evaluated at two to three clinical HIV care sites with the following objectives and outcomes:

Targeting immediate HIV treatment in disproportionately affected groups (e.g., men who have sex with men [MSM], racial and ethnic minorities).

Identifying and enrolling persons with acute or early HIV infection. Applicants should partner with HIV testing programs that provide either frequent HIV testing (at least every 6 months) or pre-exposure prophylaxis to persons at high risk of HIV acquisition, especially MSM. Gay and bisexual men are disproportionately affected by HIV and an early treatment protocol will need to be effective in this population to have a national impact on the HIV epidemic.

Conducting a post-test counseling process with assessment of patients assessed for, and offering, immediate ART.

Assessing and addressing behavioral health and social services needs (e.g., mental health, substance abuse, or housing issues).

Assessing and addressing additional barriers (e.g., health insurance coverage, clinic enrollment processes).

Increasing access to same-day or walk-in HIV clinical services.

Conducting STAT laboratory tests (e.g., CBC and renal and liver function tests) that might be necessary before ART can be initiated, and rapid HIV-specific laboratory tests (e.g., CD4, viral load, and HIV genotype) that are necessary but may not be available at the time of ART initiation.

Developing a sustainable plan to provide same-day medication starter packs.

Developing protocols to alter the ART regimen, if HIV drug resistance is detected via rapid HIV-specific laboratory testing.

Providing adherence support.

http://www.croiconference.org/sessions/evaluation-determinetm-hiv-12-agab-combo-context-acute-hiv-screening http://www.croiconference.org/sessions/evaluation-determinetm-hiv-12-agab-combo-context-acute-hiv-screening http://www.cdc.gov/hiv/pdf/guidelines_testing_recommendedLabTestingAlgorithm.pdf http://www.cdc.gov/hiv/pdf/guidelines_testing_recommendedLabTestingAlgorithm.pdf http://www.croiwebcasts.org/console/player/22065?mediaType=slideVideo& http://www.cdc.gov/hiv/pdf/statistics_hssr_vol_17_no_4.pdf http://www.cdc.gov/hiv/pdf/g-l/hiv_surveillance_report_vol_25.pdf http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf http://www.nih.gov/news/health/may2015/niaid-27.htm http://www.nih.gov/news/health/may2015/niaid-27.htm

Seamlessly transitioning patients from the immediate treatment program into an ongoing HIV care program without disruptions of ART or HIV care provision.

Administering a pre- and post-survey (approximately 20 inutes) to a subset of patients (25%) before enrollment and at a later time after ART has been initiated, to understand patient risk factors for HIV, decision-making processes regarding whether or not to enroll in treatment or to defer treatment to a later time, satisfaction with the decision chosen, as well as additional behavioral health and social services and adherence support.

Applications should describe model(s) to provide early (preferably same-day using starter packs; see Figure 2 as an example) treatment for persons newly diagnosed with acute or early HIV infection. Applications should address, in detail, strategies to achieve a streamlined and patient-centered approach to HIV treatment for persons with acute or early HIV infection. Models may be compared to existing standards for linkage to HIV care and treatment initiation. Applications should describe a detailed plan to evaluate patient outcomes.

Target Population The objective of the proposed health services research study is to support the development of health services models for immediate antiretroviral (ARV) treatment of persons with newly diagnosed acute or early HIV infection, by implementing and evaluating a model in up to three HIV care venues. These innovative models should be implemented and evaluated at two to three clinical HIV care sites and target immediate HIV treatment in disproportionately affected groups (e.g., men who have sex with men [MSM], racial and ethnic minorities).

Collaboration/Partnerships Collaborations and partnerships with clinics providing primary HIV care and ART for young black MSM are strongly recommended. Also, eligible applicants should collaborate with healthcare facilities or health departments with the capacity to provide all necessary HIV clinical services and obtain relevant laboratory tests for this proposed study.

Evaluation/Performance Measurement As part of the application, the PI should include measurable goals and aims based on a four-year research project period. The grantee will collaborate with CDC to: 1) establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the applicant’s project plan, and 2) develop and implement project performance measures that are based on specific programmatic objectives. Also, funded PIs must submit an annual progress report showing their activities and outcomes based on their overall research goals and timeline. For more information on required Reporting, please see Section VI of this FOA.

The successful grantee will implement a health services model for immediate ART for persons diagnosed with acute or early HIV infection, and collect data to evaluate. The grantee will prepare a sampling plan; study protocol; data collection instruments; data management and security plan; data quality assurance and data analysis procedures; and OMB and IRB applications for the study. In this research study, the grantee will evaluate the following key outcomes:

Proportion of patients who remain virally suppressed 12 months after their diagnosis;

Retention in HIV care;

Patient satisfaction with clinical care;

Changes in HIV transmission risk behavior;

Laboratory markers of viral suppression.

Translation Plan

The results of this research will be made available to a wide range of potential users and stakeholders. Key findings will be presented at national meetings and published in peer-review journals. Findings related to effective health services models for immediate ART for acute and early HIV infection will also be disseminated to clinicians, the public health workforce, and community-based stakeholders to inform their efforts to implement these models. In addition, findings related to self-reported risk behaviors of people living with HIV (PLWH) who initiate immediate ART, compared to usual care, will inform both HIV prevention efforts.

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: $14,850,000 Year 1: $1,485,000 for up to 3 awards;

Year 2: $4,950,000 for up to 3 awards;

Year 3: $5,940,000 for up to 3 awards;

Year 4: $2,475,000 for up to 3 awards.

Estimated total funding available for the first year (12-month budget period) is $1,485,000 for up to 3 awards.

Estimated total funding available for the entire four-year project period is $14,850,000 for up to 3 awards.

Anticipated Number of Awards: 3 The ceiling for an individual award is $495,000, including direct and indirect costs, for the first 12-month budget period.

The floor for an individual award is $300,000, including direct and indirect costs, for the first 12-month budget period.

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

Award Ceiling: $495,000 Per Budget Period Award Floor: $300,000 Per Budget Period Total Project Period Length: 4 year(s)

Throughout the project period, 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/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

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 Others (see text field entitled "Additional Information on Eligibility" for clarification)

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:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by

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" when submitting via www.grants.gov.

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 http:// ecfr.gpoaccess.gov /cgi/t/text/ text-idx?c=ecfr& sid=512ff78311f427c00454772dcf21523a&rgn=div8 &view=text&node=48:1.0.1.6.34.0.1.18& idno=48

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 institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements Additional Information on Eligibility

Applicant organizations that request funding above the ceiling amount of the award will not be forwarded to peer review or considered for funding.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Applications submitted under this funding opportunity announcement must not include activities that overlap with simultaneously-funded research already awarded to applicants under other awards.

The application must include evidence of the investigative team’s research experience in HIV diagnostics, HIV treatment and primary care.

The application must include a letter of support showing evidence of collaboration with a healthcare organization, health department, and laboratory to provide the necessary clinical and laboratory data to evaluate the health service models.

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48

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://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf 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/portal/SAM/#1.

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 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 registration process at least four (4) weeks prior to the application due date.

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 grantee 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 grantee 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.

https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform https://www.sam.gov/index.html

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http: //www.hhs.gov /asfr /ogapa /aboutog /hhsgps107.

pdf), applications received in response to the same funding opportunity announcement 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 FOA 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.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement 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 forms package associated with this FOA includes all applicable components, mandatory and optional.

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

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded from http://grants.nih.gov/grants/forms.htm

3. Letter of Intent Due Date for Letter of Intent: 01/14/2016

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/forms.htm

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant

Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Gregory Anderson, MPH, MS

Extramural Research Program Office

Office of the Associate Director of Science

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS E-60

Atlanta, GA 30333

Telephone: 404-718-8833

Fax: 404-718-8822

Email: GAnderson@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health. 3. Research Strategy – the research strategy mailto:GAnderson@cdc.gov should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline. 4. Inclusion Enrollment Report (Renewal and Revision applications ONLY) 5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects 7. Inclusion of Women and Minorities 8. Targeted/Planned Enrollment Table (for New Application ONLY) 9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals 11. Select Agent Research 12. Multiple PD/PI Leadership Plan. 13.

Consortium/Contractual Arrangements 14. Letters of Support 15. Resource Sharing Plan(s) 16.

Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 25 pages for all appendices.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.pdf).

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/ processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date 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).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center ( 1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact TIMS at 770-488-2700; pgotim@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states “rejected,” do #2a or #2b.

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed. b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 02/19/2016

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372)

Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order 12372 (http://www.archives.gov/federal-register/codification/executive-order/12372.html). This order sets up a system for state and local review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list:

http://www.whitehouse.gov/omb/grants_spoc/.

11. Funding Restrictions http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 mailto:support@grants.gov mailto:www.pgotim@cdc.gov http://www.archives.gov/federal-register/codification/executive-order/12372.html http://www.whitehouse.gov/omb/grants_spoc/

Funds related to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board (IRB) approvals are in place.