Submission Checklist to Accompany First Submission of Rfa/Pa Non-Research Announcement s1

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Submission Checklist to Accompany First Submission of Rfa/Pa Non-Research Announcement s1

AMENDMENT I − July 3, 2012

This amendment is to correct the following: i Pages 19 to 20 − Clarification to Required Component ‘C’ (Activities numbered 1 and 2 are required to meet Component C, and activities numbered 3 and 4 are optional.). ii – Page 52, Phases IIA and IIB. Implementation and Evaluation, part D; page 59, Evaluation Criteria; and page 62, Evaluation Criteria, Phase IIA and Phase IIB Implementation and Evaluation (45 points) - Submitting letters of support and MOAs - language added to include letters of support if it is not possible to complete MOAs by the application deadline. iii – Page 41, part I, and page 55, Project Narrative, under Budget, last bullet – Correction to grantee meeting schedule (Language added to clarify that these meetings will be held annually).

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement 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 Appendix. Sample Overarching Logic Model

PART 1. OVERVIEW INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Agency Name: Federal Centers for Disease Control and Prevention (CDC)

Funding Opportunity Title: Secretary’s Minority AIDS Initiative Funding for Care and Prevention in the United States (CAPUS) Demonstration Project

Announcement Type: New – Type 1

Agency Funding Opportunity Number: CDC-RFA-PS12-1210

Catalog of Federal Domestic Assistance Number: 93.940 HIV Prevention Activities for Health Departments

Key Dates: To receive notification of any changes to PS-12-1210 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 Deadline Date: N/A

Application Deadline Date: July 31, 2012 on Grants.gov, 11:59pm U.S. Eastern Standard Time

Executive Summary:

The Centers for Disease Control and Prevention announces the availability of Fiscal Year

(FY) 2012 funds through the HHS Secretary’s Minority AIDS Initiative for a demonstration project for health departments in the United States to support implementation of the National HIV/AIDS Strategy (NHAS). The purpose of this funding opportunity announcement is to reduce HIV-related morbidity, mortality, and related health disparities among racial and ethnic minorities in the United States. Grantees will focus on developing and implementing a demonstration project to address the following goals: 1) increasing the proportion of racial and ethnic minorities with HIV who have diagnosed infection by expanding and improving HIV testing capacity, and 2) optimizing linkage to, retention in, and re-engagement with care and prevention services for newly diagnosed and previously diagnosed racial and ethnic minorities with HIV. These two goals should be achieved by addressing social, economic, clinical, and structural factors influencing HIV health outcomes.

The funding opportunity announcement (FOA) is limited to the 18 health departments or their Bona Fide Agents located in the United States, 12 of which are located in the South.

2 Local health departments, community-based organizations (CBOs), for-profit entities, public nonprofit, private non-profit, faith-based, and tribal organizations and colleges and universities are not eligible to apply for funding under this FOA. The 18 health departments or their Bona Fide Agents are divided into three tiers based upon HIV prevalence (unadjusted) (2009 CDC surveillance data). A list of eligible jurisdictions is located under Section III: Eligibility Information.

Tier 1: Applicants eligible for Tier 1 are limited to six eligible health departments with an HIV prevalence of at least 30,000 cases.

Tier 2: Applicants eligible for Tier 2 are limited to six eligible health departments with an HIV prevalence of at least 16,000 cases but less than 30,000 cases.

Tier 3: Applicants eligible for Tier 3 are limited to six eligible health departments with an HIV prevalence of at least 8,000 cases but less than 16,000 cases.

This FOA addresses the four overarching goals of the National HIV/AIDS Strategy:

 Reducing New HIV Infections

 Increasing Access to Care and Improving Health Outcomes for People Living

with HIV

 Reducing HIV-Related Disparities and Health Inequities

 Achieving a More Coordinated National Response to the HIV Epidemic

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for HIV, Viral Hepatitis,

STD, and TB Prevention (NCHHSTP):

3 The purpose of this FOA is to reduce HIV-related morbidity, mortality, and related health disparities among racial and ethnic minorities in the United States. Grantees will focus on developing and implementing a demonstration project to address the following goals:

1) increasing the proportion of racial and ethnic minorities with HIV who have diagnosed infection by expanding and improving HIV testing capacity, and 2) optimizing linkage to, retention in, and re-engagement with care and prevention services for newly diagnosed and previously diagnosed racial and ethnic minorities with HIV by addressing social, economic, clinical, and structural factors influencing HIV health outcomes.

Relevant GPRA measures are from CDC (1-6) and HRSA (HIV/AIDS Bureau) (7):

1- 2.1.3: Increase the percentage of people living with HIV who know their

serostatus.

2- 2.1.4: Increase the percentage of people diagnosed with HIV infection at earlier

stages of disease (not CDC stage 3: AIDS).

3- 2.2.1: Increase the proportion of newly diagnosed patients linked to clinical care

within three months of their HIV diagnosis

4- 2.2.2: Increase the percentage of HIV-infected persons in publicly funded

counseling and testing sites who were referred to Partner Services

5- 2.2.3: Increase the percentage of HIV-infected persons in CDC-funded counseling

and testing sites who were referred to HIV prevention services.

6- 2.2.6: Reduce the number of new AIDS cases among adults and adolescents per

100,000

4 7- Increase the number of visits for health-related care (primary medical, dental,

mental health, substance abuse, rehabilitative, home health).

Health Equity

This FOA supports efforts to improve the health of populations disproportionately affected by HIV/AIDS by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National

HIV/AIDS Strategy (NHAS). Health disparities in HIV are inextricably linked to a complex blend of social determinants that influence populations most severely affected by this disease. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. (Definitions of health disparity, social determinants of health and health equity are available at http://www.healthypeople.gov/hp2020/advisory/phaseI/glossary.htm.).

Applicants should use epidemiologic and social determinants data to identify communities disproportionately affected by HIV and related diseases and conditions within their jurisdictions. Likewise, applicants should use data describing the social determinants of diseases in their coverage areas to accurately focus activities for reducing health disparities and to identify strategies to promote health equity. In collaboration with partners and appropriate sectors of the community, applicants 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.

5 Details of the health equity strategy and approach are outlined in the NCHHSTP Social

Determinants of Health White Paper (http://www.cdc.gov/socialdeterminants/docs/SDH-

White-Paper-2010.pdf).

Program Collaboration and Service Integration

This FOA supports the NCHHSTP program imperative calling for program collaboration and service integration (PCSI). PCSI promotes improved integrated HIV, viral hepatitis,

STD, and TB prevention and treatment services at the client level through enhanced collaboration at the health department jurisdictional level, as well as organizational program level, thereby offering opportunities to: (1) increase efficiency, reduce redundancy, and eliminate missed opportunities; (2) increase flexibility and better adapt to overlapping epidemics and risk behaviors; and (3) improve operations through the use of shared data, enabling service providers to adapt to, and keep pace with, changes in disease epidemiology and new technologies.

Populations disproportionately affected by HIV, particularly racial and ethnic minorities, are also affected by other infections including TB, hepatitis C virus (HCV), hepatitis B virus (HBV), and STDs. This announcement encourages integration of diagnostic, prevention and care services for these diseases and other infections because of CDC’s understanding of the extent to which:

 STDs increase the risk for acquisition and transmission of HIV.

6  Control of TB, viral hepatitis, and STDs is needed to protect the health of HIV-

infected persons.

 HIV, viral hepatitis, and STDs share common risks and modes of transmission.

 Risks for acquiring these diseases are associated with similar behaviors and

environmental conditions and have reciprocal or interdependent effects.

 Clinical course and outcomes of these diseases are influenced by co-infection

(e.g., TB is a leading cause of mortality for people with HIV, and TB accelerates

HIV disease progression).

 Populations disproportionately affected by HIV are also disproportionately

affected by infections such as TB, HCV, HBV, and STDs.

Details of this strategy and approach are outlined in the NCHHSTP PCSI White Paper

(http://www.cdc.gov/nchhstp/programintegration/docs/207181C_NCHHSTP_PCSI

%20WhitePaper-508c.pdf).

Advancing a Public Health Approach to Improve Sexual Health

The FOA supports efforts to improve program impact for prevention of HIV, STD, and viral hepatitis by enhancing traditional disease-specific control efforts with a holistic health promotion framework that more comprehensively addresses broader issues of health and wellness, including sexual health. Sexual health is considered to be a state of physical, emotional, mental, and social well-being in relation to sexuality. Although it is inextricably bound to both physical and mental health, it is not limited to the absence of disease and dysfunction and is an important component of health across the lifespan. It

7 includes the ability to understand and weigh the risks, responsibilities, outcomes, and impacts of sexual actions, and requires a positive and respectful approach to sexuality and sexual relationships and a respect for sexual rights.

HIV, STD, and viral hepatitis are highly stigmatized conditions, associated with sensitive behaviors, and are often concentrated among socially marginalized populations.

Consequently, use of a broader sexual health-focused framework has the potential for reducing the fear, discrimination, and stigma associated with these conditions, thus enabling better reach of prevention and care programs to the general public, populations at risk, and health care providers. A more holistic and comprehensive health-focused framework may also help facilitate more open and honest societal dialogue around sensitive issues that are critically important to comprehensively address human sexuality, relationships, and sexual behavior. This approach is consistent with NHAS, which calls for more comprehensive and holistic approaches to reduce HIV incidence in the United

States and provides an opportunity for working together to advance a public health approach to sexual health that includes HIV prevention and care.

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health- research-nonresearch.pdf.

8 PART 2. FULL TEXT

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority

This program is authorized under Section 301(a) (42 U.S.C. Section 241(a)) and Sections

317(k)(2) and 318 of the Public Health Service Act (42 U.S.C. Sections 247b(k)(2) and

247c), as amended.

Background

In order to make the United States a place “where new HIV infections are rare and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity or socio-economic circumstance, [has] unfettered access to high quality, life-extending care, free from stigma and discrimination,” the National

HIV/AIDS Strategy [NHAS](White House, 2010) sets goals for 1) reducing new HIV infections, 2) increasing access to care and improving health outcomes for people living with HIV, and 3) reducing HIV-related health disparities. To achieve these goals, particularly in a time of increasingly constrained resources, the NHAS also calls for a

9 more coordinated and better targeted national response to the HIV epidemic in the United

States.

A range of factors place some populations at greater risk for HIV. Although HIV affects people of all races, ages, and sexual orientations, some people face greater challenges in protecting their health. CDC surveillance data indicate that African

Americans and Latinos have been disproportionately affected by HIV. In 2010, blacks/African Americans accounted for 46% of all diagnoses of HIV infection. In 2010, the rates of HIV diagnosis were 62.0 per 100,000 in the black/African American population, 20.4 per 100,000 in the Hispanic/Latino population, compared to 7.3 per

100,000 in the white population (CDC, 2012). At the end of 2009, the highest estimated prevalence rate of diagnosed HIV infection was that for blacks/African Americans (951.9 per 100,000 population), followed by Hispanics/Latinos (319.9 per 100,000 population).

The rate among whites was 143.9 per 100,000 population (CDC, 2012). Also, in 2010, the rate of AIDS diagnosis was highest among blacks/African Americans (43.0 per

100,000). The rate among Hispanics/Latinos was 13.7 per 100,000, and among whites it was 4.4 per 100,000.

At the end of 2009, an estimated 476,732 persons in the United States were living with an AIDS diagnosis and the largest percentage, 43% were blacks/African Americans

(CDC, 2012). Furthermore, in 2009, blacks/African Americans had the highest rate of deaths among persons with a diagnosis of HIV infection, estimated at 29.3 per 100,000 population. This disparity is particularly evident in the South – a recent analysis of HIV case fatality rates in the 37 U.S. states with stable HIV name-based reporting systems

10 found that 9 of the 10 states with the highest case fatality rates were located in the southern United States (Hanna et al., 2012).

States with a large number of HIV cases among African Americans and Latinos, and particularly states in the South, share a common set of structural barriers to personal and community health, including high levels of poverty (U.S. Census Bureau, 2010), inadequate rates of health insurance coverage, healthcare provider shortages, and lower levels of educational attainment (Shi, 2001; U.S. Census Bureau, 2012; Reif, Whetten &

Wilson, 2011). Other factors such as unstable housing, higher rates of incarceration, stigma and discrimination against men who have sex with men (Fullilove, 2006), and lack of trust in the government and the health care system (Bird & Bogart, 2005; Francis,

2001; Jordan et al., 2004;) can make it more difficult for some African Americans and

Latinos to protect their health (Reif, Whetten & Wilson, 2011).

The southern US also has a higher proportion of persons living with AIDS in rural and smaller urban areas than other regions; in 2009, rural and smaller urban areas

(populations<500,000) contributed to about a quarter of new AIDS diagnosis in the South

(CDC, 2009). The more rural nature of the epidemic in the southern United States creates additional challenge for HIV prevention and care, as people living in these areas may face limited access to local HIV care providers and few reliable transportation options to reach distant sources of care, lower incomes and/or fewer options for public assistance, and pervasive HIV-related stigma, including homophobia (Cohn et al., 2001;

Golin et al., 2002; Heckman et al., 1998; Kempf et al., 2010; Lishner et al., 1996; Reif,

Whetten & Wilson, 2011; Vyavaharkar et al., 2008).

11 Social and structural determinants of health, which are complex, integrated, and overlapping social structures and economic systems, and are linked to lack of opportunity and lack of resources to protect, improve, and maintain health (CDC, 2010), and thus can directly contribute to disparities in HIV. Key social determinants of health contribute to disparities in health outcomes including HIV, other sexually transmitted infections, teen pregnancy, and chronic diseases. For HIV specifically, these factors include poverty, HIV stigma, homophobia, racism, gender-based discrimination and violence, lack of access to quality health care, low literacy, traditional community norms, high incarceration rates, housing and food insecurity, lack of health insurance coverage, and fragmented health systems.

Successfully reducing HIV-related morbidity, mortality, and, ultimately, incidence, requires health-care delivery and other prevention and care systems that work efficiently across organizational boundaries, coordination among public and private sectors, and social and structural contexts that enhance (rather than undermine) the ability of communities to achieve optimal health outcomes. The purpose of this funding opportunity announcement is to reduce HIV-related morbidity, mortality, and related health disparities among racial and ethnic minorities in the United States by supporting grantees’ efforts to create or strengthen the aforementioned systems and address the effects of negative social and structural contexts. Specifically, grantees will focus on: 1) increasing the proportion of racial and ethnic minorities with HIV who have diagnosed infection by expanding and improving HIV testing capacity, and 2) optimizing linkage to, retention in, and re-engagement with care and prevention services for newly diagnosed and previously diagnosed racial and ethnic minorities with HIV by addressing social,

12 economic, clinical, and structural factors influencing HIV health outcomes. To sustain improvements made in each area and maximize the public health return on their investments, grantees will leverage and strengthen existing systems and infrastructure wherever possible.

Testing is critical to both HIV prevention and care. Studies have shown that individuals are more infectious during the early stage of their infections and are thus more likely to transmit HIV to others (Brenner et al., 2007; Hollingsworth, Anderson,

Fraser, 2008; Wawer et al., 2005). Research also suggests that people who are unaware of their HIV status are more likely than those who are aware of their status to engage in

HIV transmission risk behaviors (Marks, et al., 2005). Finally, data from cohort studies and simulation models indicate that persons diagnosed late in the course of their infections (especially those whose first CD4 counts are <200 cells/mm3 or between 200 and 350 cells/mm3) may not enjoy the same life expectancy gains as those who are diagnosed earlier in the course of their infections (May et al., 2011; Nakagawa et al.,

2012). Early diagnosis of HIV infections thus has profound individual and public health ramifications. Not only does it offer individuals the opportunity to take steps to decrease their risk of transmitting the virus to others, but it also serves as a portal to treatment and care services that can extend and improve the quality of their lives. Broad adoption of routine HIV testing for all adults and adolescents seen in medical care settings, as recommended by CDC (2006), and expansion of HIV testing in non-clinical settings are thus crucial strategies for meeting the goals of the National HIV/AIDS Strategy

(Valdiserri, 2011). HIV testing should also be conducted in settings such as substance

13 abuse and mental health treatment programs given the evidence of links between substance use and mental health issues and HIV.

Testing technology continues to improve but has not been adopted uniformly across jurisdictions. Two lab tests have recently been introduced to the US market

(fourth generation antigen/antibody combo assays) that allow detection of infection approximately 5-7 days after nucleic acid can be detected (Bentsen et al, 2011; Chavez et al, 2011; Masciotra et al., 2011). Such tests improve detection during the early period of infection previously shown to be associated with higher transmission risk (Brenner et al.,

2007; Hollingsworth et al., 2008; Wawer et al., 2005). Furthermore, many lab-based tests are now conducted on automated multi-platform analyzers that allow rapid turn-around of results and the ability to test for other infections such as hepatitis B and C. Various studies have shown that new technology, combined with an updated testing algorithm, can improve HIV diagnosis through earlier detection and faster results (Delaney et al.,

2011; Masciotra et al., 2011; Styer et al., 2011; Wesolowski et al., 2011). In addition to these advances in laboratory based testing, some point-of-care finger-stick methods also have improved ability to detect HIV infection sooner (Branson et al., 2012; Masciotra et al., 2011; Owen et al., 2012). Addressing relevant barriers to implementation of the latest testing technology and practices in populations with high burdens of disease and late diagnoses could substantially improve HIV prevention efforts as well as linkage to care for infected individuals.

For an HIV diagnosis to lead to treatment that extends an individual’s life and decreases his or her infectiousness, robust HIV testing efforts must be complemented by similarly robust programmatic and monitoring systems that actively link HIV-infected

14 persons to care and prevention services, retain them in those services, and re-engage them if and when they are lost from care systems. Unfortunately, according to a recent synthesis of data from published studies and three national surveillance systems, approximately 77% of persons diagnosed with HIV were linked to care within 3–4 months of their diagnoses, and 51% were retained in ongoing care (CDC, 2011). As a consequence of the substantial attrition at these and other points along the HIV care continuum, only an estimated 35% of persons diagnosed with HIV (or 28% of all those living with HIV) in the United States are virally suppressed.

Identifying a greater proportion of persons with undiagnosed HIV infection; utilizing the most up-to-date testing technology; improving the speed with which persons enter care; improving the strength and cohesion of systems and processes in place to support their long-term retention in care, and adherence to treatment; and addressing the social and structural determinants of health that are linked to HIV testing, linkage, and retention are thus necessary prerequisites to the ultimate goals of HIV prevention and care: improving health, extending lives, and preventing further HIV transmission.

Purpose

The purpose of this FOA is to reduce HIV-related morbidity, mortality, and related health disparities among racial and ethnic minorities in the United States. Grantees will focus on developing and implementing a demonstration project to address the following goals:

1) increase the proportion of racial and ethnic minorities with HIV who have diagnosed infection by expanding and improving HIV testing capacity, and 2) optimize linkage to, retention in, and re-engagement with care, treatment, and prevention services for newly

15 diagnosed and previously diagnosed racial and ethnic minorities with HIV. These two goals should be achieved by addressing social, economic, clinical, and structural factors influencing HIV health outcomes [See Appendix 1 for a sample overarching logic model]. Modifying health-care delivery and other prevention and care systems to work more efficiently across organizational boundaries, improving coordination among public and private sectors, and addressing key social and structural determinants that are barriers to achieving optimal health outcomes, will ultimately have the greatest impact on reducing HIV-related morbidity, mortality, and health disparities. This project will also require grantees to evaluate systems, leverage existing resources and tools (e.g., http://www.careacttarget.org/topics/engagement.asp and http://www.annals.org/content/early/2012/03/05/003-4819-156-11-201206050-

00419.full), and carefully utilize these new funds to obtain a greater return on public health investments that directly address the overarching goals of the project. Project development, implementation, and evaluation activities will require grantees to coordinate and collaborate with all appropriate local health departments, local planning groups, community based organizations (CBOs), community health centers, mental health and substance abuse programs, Title X family planning clinics, local communities, tribal organizations, and other governmental and non-governmental (including private businesses and community institutions) entities in the planning and implementation of this FOA’s activities.

Overarching Project Framework

16 State health departments are uniquely positioned to take a leadership role in supporting the optimization of services across public, private, and community-based organizations to achieve objectives of increased identification of HIV infection, earlier entry to HIV care and increased consistency of care. In order to strengthen existing approaches to testing, linkage to, retention in, and re-engagement with HIV care and prevention among racial and ethnic minorities, eligible health departments must develop a work plan that includes;

1) all required components listed below, and 2) any additional supplemental/optional components or other approaches the jurisdiction selects to help achieve the overarching goals of the project. Grantees must fund community-based organizations (e.g., AIDS service organizations, faith-based organizations, sororities, fraternities, and other non- profit organizations) within their jurisdiction using a minimum of 25% of the total award for the development of human capital, skills, partnerships, and infrastructure development, as appropriate, to implement the activities required by the funding opportunity announcement. Grantees should maximize the public health impact of the resources in which they invest to improve testing and linkage/retention/re-engagement outcomes. Because there is not one approach that will work effectively to address the overarching goals of the project across all jurisdictions, grantees should examine and evaluate approaches that include the required components and those additional supplemental and optional components that will, when combined, have the greatest public health impact. These combined activities should also have the greatest potential to address the social and structural determinants of health that are known to create the most significant barriers to testing, linkage to, retention in, and re-engagement with care and prevention in the applicant’s jurisdiction. This framework acknowledges that prevention

17 and care/treatment synergistically contribute to reducing HIV-related morbidity, mortality, and related health disparities among racial and ethnic minorities in the United

States.

Required Components

A. HIV testing, linkage to, retention in, and re-engagement with care, treatment, and

prevention. Increase the identification of HIV infections in clinical and non-

clinical settings by enhancing existing systems and technology to deliver routine

opt-out HIV screening and targeted HIV testing, and ensure immediate linkage to

care for racial and ethnic minorities with HIV infection. Enhance existing

approaches or adopt novel approaches for improving linkage to, retention in, and

re-engagement with care, treatment, and prevention services for HIV-positive

persons; such approaches should include structural interventions. Improve HIV

medication adherence among HIV-positive persons to improve viral suppression,

prevent viral resistance, and maintain optimal health outcomes. Support expanded

access to and use of antiretroviral therapy according to the most recent HHS

guidelines. (http://www.aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-

treatment-guidelines /0).

B. Navigation Services. Enhance patient/client navigation services at all stages of

care, including pre-diagnosis, linkage to, retention in, and re-engagement with

HIV and related care, treatment, prevention, and psychosocial services (e.g.,

18 substance abuse and mental health treatment), housing and employment

assistance, and other social services.

C. Use of surveillance data and data systems to improve care and prevention.

Develop new, or expand existing, systems and technologies that facilitate the

routine use of laboratory surveillance data to: a) monitor clinical outcomes that

indicate HIV-positive persons’ progress along the continuum of care, b) help

people with HIV link to, remain in, or re-engage with, the health care system, and

c) improve the quality of care and prevention services provided to persons with

HIV. Activities numbered 1 and 2 are required to meet Component C and

activities numbered 3 and 4 are optional.

1. Enhance laboratory data systems for reporting to health departments tests

related to HIV diagnosis, CD4+ T-lymphocyte (CD4) count, and HIV viral

load (VL).

2. Expand the use of laboratory surveillance data for programmatic improvement

so that when client-level laboratory data indicate poor clinical outcomes (e.g.,

persistently low CD4 count, high viral load, or lack of recent laboratory data

indicating potential loss to care) health department staff contact the patient,

the patient’s provider, or both, to re-establish engagement in care, improve

services, and overcome structural, social, or economic obstacles to achieving

desired health outcomes

19 3. Reduce policy barriers for reporting and use of laboratory-based surveillance

data.

4. Expand support in setting-up medical record systems to improve monitoring

of patient outcomes (e.g., support clinics, community health centers, and other

providers to upgrade electronic medical record systems to include automated

reminders indicating a patient with an unknown serostatus is due for HIV

testing or an HIV-positive patient needs follow-up for missing clinic visits).

D. Address social and structural factors directly affecting HIV testing, linkage to,

retention in, and re-engagement with care, treatment, and prevention. Conduct

critical activities aimed at mitigating social and structural factors (described in the

Background Section) that affect the identification of racial and ethnic minorities

with undiagnosed HIV infection, or the successful linkage to, retention in, and re-

engagement with care, treatment, and prevention services of persons who know

their HIV infection status.

Supplemental/Optional Components

To enhance the impact of the demonstration project, the following activities are provided as elaborations of required strategies or examples of other activities that may help the grantee meet the overarching goals of the demonstration project. First, some activities described below are elaborations of different ways to implement specific required

20 components listed above (e.g., navigation is a required component, but the jurisdiction can choose how to do navigation from the examples below or from other recognized methods). Other activities described below may be added to the project plan. These activities differ in scope and complexity. Grantees should consider selecting a set of supplemental and optional activities that can enhance their required activities and be funded and implemented to scale to meet the overarching goals of the demonstration project.

A. Improve Coordination, Integration, and Quality of HIV Service Delivery

Support the development of new infrastructure or expansion of existing infrastructure

to facilitate continuous quality improvements (CQI) in HIV testing, linkage and

retention in HIV care and address the most pressing social and structural determinants

of health for racial and ethnic minority populations in the jurisdiction. CQI processes

should be used to identify community, organizational, or provider-level areas for

improvement; develop, assess, and—if successful—scale-up processes and

interventions that yield improvements; and maximize the returns from public and

private investments (including data that can be used for CQI). The following

activities could be incorporated in such an effort:

1. Utilize Advances in HIV Testing: Strengthen systems in healthcare and

community-based settings to deliver HIV testing utilizing the most

21 technologically advanced diagnostic approaches that are or become available

during the funding period (e.g., purchasing or renting laboratory multi-platform

analyzers, using 4th generation antigen/antibody tests and the new lab testing

algorithm as recommended by the CDC and the Clinical and Laboratory

Standards Institute (CLSI, 2011) or if laboratory-based tests are not feasible,

using blood-based point of care rapid HIV tests that are most sensitive for early

infections) to enhance testing efficiencies, increase delivery of test results, and

improve detection of acute infection. Expand access to HIV tests in healthcare

settings with the goal of universal offer of HIV tests to adults [18 – 64 years] seen

in emergency rooms or admitted to hospitals in the highest prevalence regions of

the jurisdiction. Standardize reporting of acute HIV infections to the health

department.

2. Utilize Health Information Technology to Expand Provider Reach: Integrate web-

based and other health information technology into primary health care settings

and community health centers including federally qualified health centers. This

will expand the reach of HIV specialists by utilizing state-of-the-art technology

(e.g., telehealth) to offer primary care providers servicing underserved areas

training, advice, and support in delivering best-practice care.

3. Enhance Service Linkage and Referral Systems: Enhance coordination and

integration of HIV services across sectors (e.g., housing, education, employment,

mental health/substance use, food/financial assistance) and strengthen linkage and

referral mechanisms and tracking systems for needed services. Promote optimal

management of HIV infection by increasing co-location of medical and other

22 social services. Prioritize developing a local referral network that includes

monitoring referral outcomes and establishing formal agreements among agencies

that outline specific roles for follow-up of persons not linked to care or who have

dropped out of care. Strengthen systems to deliver trainings and logistical support

to partnering agencies on interventions found to be successful in linking positive

clients to medical care (e.g., ARTAS).

4. Enhance Patient Navigation Services: Develop or enhance systems for providing

patient navigation services (assisting patients obtaining necessary information,

support, and skills to access complex medical system) in high-prevalence clinical

and non-clinical venues across the jurisdiction to function as an active supporter

for linkage, retention and re-engagement of HIV-positive persons in care. Patient

navigation activities can be staffed by service linkage specialists, disease

intervention specialists, peer navigators, or other staff as appropriate in the

jurisdiction. Developing multi-organizational and community-serving teams may

be an efficient approach to maximizing the coverage of patient navigation

services across the jurisdiction.

5. Improve Culturally Competent Health Systems: Strengthen system capacity to

deliver “culturally competent” health services through supporting trainings and

evidence based programs that focus on delivery of sociocultural and linguistically

appropriate services. Take steps to increase the number and diversity of available

providers of clinical care and related services promoting testing, linkage to,

retention in, and re-engagement with care. Provide anti-stigma training and

diversity or sensitivity training on working with racial, ethnic and sexual

23 minorities. Provide resources to incorporate bilingual staff and interpreter

services across all points in the HIV service delivery spectrum and within

appropriate partnering agencies. Increase the availability of easily understood

patient-health information.

6. Enhance Capacity of Medical Care Providers to Deliver High Quality Clinical

Services: Improve capacity of providers and other staff in the jurisdiction to

deliver high-quality HIV clinical care services through increased training

programs and provider-based peer programs. Provider-specific trainings on HIV

care could prioritize existing marketing efforts that can be tailored to jurisdictions

including:

i. For HIV testing (1) HIV Screening. Standard Care

( (www.cdc.gov/hivstandardcare) providing tools to physicians to help

facilitate routine HIV screening, (2) One Test. Two Lives

(www.cdc.gov/1test2lives) providing information and resources to

physicians and nurse midwives to encourage testing pregnant women for

HIV infection and reduce the number of infants born with HIV.

ii. For Persons with HIV in care (1) Prevention IS Care

(www.cdc.gov/preventioniscare) informing providers of the importance of

providing prevention services to PLWHA, (2) Ask, Screen, Intervene

(http://depts.washington.edu/nnptc/online_training/asi/) providing

guidance to providers who care for HIV-positive persons, (3) the National

Quality Center’s “in + care” campaign (http://incarecampaign.org/), and

(4) Support for high quality care and treatment of HIV disease should

24 include the training provided by AIDS Education and Treatment Centers

(AETCs). For more information, go to http://www.aids-ed.org/ .

7. Mobilize Service Providers: Establish a system (e.g., community of practice,

community of health, or similar framework) to mobilize service providers within

and across systems for more focused and sustained efforts to expand HIV testing

and increase rates of linkage to and retention in HIV medical care. This system

should be designed to identify barriers to prevention and care, share experiences,

tools, and strategies for solving the problems, and making recommendations for

enhancing prevention and care activities in the jurisdiction.

B. Improve Access to HIV Testing, Linkage to and Retention in Care Services

Implement programs and provide technical assistance to address social and structural

determinants of health that impede access to and utilization of testing, linkage and

care services for racial and ethnic minority populations. Support HIV testing, linkage

to and retention in care services in hospitals, clinics, CBOs, and healthcare providers.

The following activities could be utilized to address this component:

1. Address Structural Barriers to Access and Coverage: Develop new, or improve

existing, strategies to ensure that testing is covered by the largest health insurance

providers (private and public, including Medicaid) in the jurisdiction and that

resources are available to facilitate the provision of testing with integrated linkage

to care and re-engagement in care services. Setting-specific strategies to increase

provision of HIV testing and successful linkage to care could include:

25 i. Hospitals, emergency departments, primary care practices, and community

health centers: Implement enhanced testing initiatives (including

incentivized programs) to encourage routine delivery of HIV screening to

all patients.

ii. Mental health/substance abuse treatment facilities and drug courts:

Implement enhanced testing initiatives (including incentivized programs)

to encourage integration of routine HIV screening into treatment

protocols. Consider introducing a requirement that all programs receiving

public funds to provide drug treatment must provide HIV testing to their

clients.

iii. Domestic violence and homeless shelters

Implement enhanced testing initiatives (including incentivized programs)

to encourage integration of routine HIV screening for populations at-risk

for HIV.

iv. Correctional facilities: Establish policies and procedures to link HIV-

positive inmates to community-based care facilities before release and to

provide follow-up after release until the person is engaged in HIV care.

Work with correctional and probation systems to expand opportunities for

HIV testing.

2. Improve Physical Access to Services: Improve physical access to testing, linkage

and re-engagement services in underserved communities. This might include

utilizing mobile units, providing transportation, and targeting venues catering to

persons at increased-risk for HIV-infection who may not otherwise access

26 medical care (e.g., drug courts, jails, parole and probation facilities, domestic

violence and homeless shelters, clubs and public sex environments, and substance

abuse and mental health treatment agencies). Encourage resource pooling and

collaboration with other local programs that provide services to the same

rural/marginalized/hard-to-reach populations to increase the potential

sustainability of activities.

3. Expand Existing or Utilize Novel Approaches to Testing, Linkage, and Retention

in the Jurisdiction: Implement effective strategies (e.g., social network strategy)

coupled with the most sensitive testing technology applicable to maximize non-

clinical access to testing to allow earlier detection of infection for populations that

have dense sexual, social or drug-using and abusing networks and do not

routinely seek medical care. Increase resources for disease intervention specialists

to increase the number of people out-of-care who are located and re-engaged in

care. Utilize early/outreach intervention programs (motivational interviewing,

peer support, patient advocacy) in combination with medical case management

programs to further facilitate linkage and retention in care. Expand case

management systems for improved linkage and retention through strengthening

patient navigation capabilities and tracking, including broader use of clinical

teams (nurses, social workers, nurse practitioners, substance abuse and mental

health practitioners) that are integrated into high-volume clinical settings.

4. Utilize Community Pharmacists to Support Adherence and Retention in Care:

Develop novel approaches to working with community pharmacists to support

adherence and retention in care. Community pharmacists could also support re-

27 engagement services by identifying clients who are not filling prescriptions on a

timely basis and develop a mechanism(s) for the pharmacy to provide re-

engagement services directly or through collaboration with the health department

or another third party providing re-engagement services.

5. Improve Partner Services: Improve the coordination and coverage of partner

services. Where direct-hire health department resources are insufficient,

encourage removal of system-level policies that are barriers to third-party delivery

of partner services (e.g., CBOs or health care providers). Implement and increase

access to internet-based partner services and the delivery of partner services with

related technologies (e.g., SMS-text messaging, smart phone applications, social

networking and geosocial networking internet sites). See (1) the CDC Partner

Services Providers (PSP) Quick Guide developed and designed to provide

guidance on integrated delivery of partner services at the client level.

(http://www.cdc.gov/std/Program/PartSerQuickGuideJan-2012.pdf), (2) the

National Coalition of STD Directors Guidelines for Internet-based Partner

Services (http://www.internetinterventions.org/InternetPartnerServices.pdf), (3)

Recommendations for Partner Services Programs for HIV Infection, Syphilis,

Gonorrhea, and Chlamydial Infection

(http://www.cdc.gov/mmwr/preview/mmwrhtml/rr57e1030a1.htm).

6. Enhance Social Media and Marketing Efforts: Deliver strategic, culturally

competent, community-based social media and marketing campaigns to increase

public awareness of services available, de-stigmatize HIV and HIV medical care,

reduce homophobia, empower disproportionately affected populations, and

28 promote testing, linkage to, retention in, and re-engagement with care. Prioritize

existing social media efforts that can be tailored to jurisdiction specific

requirements from CDC’s Act Against AIDS campaign

(http://www.actagainstaids.org/about/index.html) as well as the more targeting

campaigns from this effort including, (a) Testing Makes Us Stronger (or

www.hivtest.org/stronger) to encourage testing among black gay and bisexual

men (http://www.hivtest.org/stronger), (b) Take Charge. Take the Test

(http://www.actagainstaids.org) to encourage black women to protect themselves

and get tested for HIV.

Structure of the Project

In keeping with the spirit and goals of the NHAS, and in recognition of the complex, interrelated, and multi-sectorial nature of these goals, a multi-agency federal partnership will provide federal leadership for the activities laid out in this FOA. The Centers for

Disease Control and Prevention (CDC), Division of HIV/AIDS Prevention will be the lead federal agency. Other federal partners will include: 1) the Department of Health and Human Services (HHS) (the Office of HIV/AIDS and Infectious Disease Policy

(OHAIDP), the Office of Minority Health (OMH), and the Office on Women’s Health

(OWH)), 2) the Health Resources and Services Administration (HRSA) (both the

HIV/AIDS Bureau (HAB) and the Bureau of Primary Health Care (BPHC)), and 3) the

Substance Abuse and Mental Health Services Administration) (SAMHSA), and others.

Together, this federal partnership will oversee all stages of the project.

29 There will be two phases of the project; a 6-month development phase followed by ongoing implementation and evaluation for the duration of the project. In Phase I the development phase, grantees will collaborate with local and federal partners to finalize the components of their demonstration project. The grantee must fund community-based organizations (e.g., AIDS service organizations, faith-based organizations, sororities, fraternities, and other non-profit organizations) within their jurisdiction using a minimum of 25% of the total award for the development of human capital, skills, partnerships, and infrastructure development, as appropriate, to implement the activities required by this

FOA. Following completion of all developmental activities and formal approval by CDC and federal partners, grantees will begin implementing (Phase IIA) and evaluating (Phase

IIB) their demonstration projects. Grantees are required to coordinate and collaborate with all appropriate local health departments, local planning groups, community based organizations (CBOs), community health centers, mental health and substance abuse programs, Title X family planning clinics, local communities, tribal organizations, and other governmental and non-governmental (including private businesses and community institutions) entities in the planning and implementation of this FOA’s activities.

This program addresses the “Healthy People 2020” focus areas of HIV prevention.

Program Implementation

Recipient (Grantee) Activities

Phase I. Development

30 A. Identify, engage, and coordinate the development of the demonstration project

with key stakeholders and partners. This may include, but need not be limited to,

prevention and care providers from the public and private sectors, community

health centers, mental health and substance abuse services, local communities,

governmental and non-governmental entities, local planning groups, and

community-based organizations. In conducting this activity, consider all existing

federal, state, and local funding to avoid duplication.

B. Identify major social and structural determinants of health affecting testing,

linkage to, retention in, and re-engagement with HIV care among racial and ethnic

minorities, particularly those groups most affected by HIV in the jurisdiction.

C. Determine HIV testing, linkage to, retention in, and re-engagement with HIV care

rates for population subgroups, and develop a plan to implement and maintain

laboratory reporting of all HIV-related tests and upload all lab data into the

surveillance software (eHARS) and transmit all data to CDC.

D. Develop a jurisdiction-specific treatment cascade diagram, specifying estimated

numbers and percentages of persons living with HIV who are diagnosed, linked to

care, retained in care, receiving antiretroviral treatment, and who have achieved

viral suppression.

E. Select a final set of programmatic activities to address the overarching goals of

the demonstration project through collaboration with local and federal partners.

Activities should include required components as well as any additional optional

and supplemental components selected to address social and structural

determinants of health affecting testing, linkage to, retention in, and re-

31 engagement with care and providing the greatest impact on the local HIV

epidemic among racial and ethnic minorities in the jurisdiction. Activities should

be coordinated with existing activities funded by federal, state, and local partners.

F. Identify and begin to address capacity building needs related to the overarching

project goals.

G. The grantee must fund community-based organizations (e.g., AIDS service

organizations, faith-based organizations, sororities, fraternities, and other non-

profit organizations) within their jurisdiction at a minimum of 25% of the total

award for the development of human capital, skills, partnerships, and

infrastructure development, as appropriate, to implement the activities required by

the funding opportunity announcement. Capacity building efforts should focus on

developing skills related to the overarching project goals (i.e., to improve linkage

and retention in care outcomes, to address the initiation of and adherence to ART,

and strengthen social support and services for HIV-positive persons).

H. Refine the logic model that was submitted with the funding application to

graphically describe the relationship between the demonstration project activities

and expected outcomes (this model may be an adaptation of the “grantee logic

model” included with this FOA).

I. Finalize a detailed work plan that describes the demonstration project activities as

well as monitoring and evaluation, and quality assurance activities. A draft of the

demonstration project work plan, logic model, and timeline are due with the

application and the final work plan is due to CDC six months after initial funding.

32 J. Identify ways to expand implementation of the demonstration project by

leveraging other resources to support the goals of the demonstration project. Also

consider sustainability issues in developing the plan.

K. Collaborate with CDC, OHAIDP, OMH, OWH, HRSA, SAMHSA, and other

technical assistance entities to provide ongoing training, technical assistance, and

consultation to all staff conducting the demonstration project.

Phase IIA. Implementation

A. Begin implementation of the CDC/federal partner-approved demonstration project

work plan within 6 months of funding.

B. Identify, engage, and coordinate the implementation and evaluation of the

demonstration project with key stakeholders and partners, which may include but

need not be limited to prevention and care providers from the public and private

sector, community health centers, mental health and substance abuse services,

social services, local communities, governmental and non-governmental entities,

local planning groups, and community-based organizations.

C. Address major social and structural determinants of health affecting testing,

linkage to, retention in, and re-engagement with care among racial and ethnic

minorities.

D. Continue to address capacity building needs related to the overarching project

goals.

33 E. Leverage systems that are in place and existing resources to obtain a greater

return on public health investments that directly address the overarching goals of

the project.

F. Work collaboratively with funded CBOs to ensure successful implementation of

the activities required by the funding opportunity announcement.

G. Revise and update the logic model, detailed work plan, and monitoring and

evaluation, and quality assurance activities as needed during the course of the

demonstration project.

H. Fully implement and maintain laboratory reporting of all HIV-related tests and

upload all lab data into the surveillance software (eHARS) and transmit all data to

CDC. Ensure that data are sufficiently timely and complete for monitoring of

project implementation and outcomes.

I. Continue to identify ways to expand implementation of project activities by

leveraging other resources to support the goals of the demonstration project.

J. Maintain appropriate and sufficient staffing in relation to staff persons' respective

roles and responsibilities in implementing the demonstration project. Hire new

personnel (if needed).

K. Ensure that current and new staff have adequate training to implement activities

of the demonstration project.

L. Collaborate with the evaluation team identified by federal partners and tasked

with additional evaluation of grantees’ overall programmatic implementation of

their demonstration project.

34 M. Collaborate with CDC, federal partners and other technical assistance entities to

provide ongoing training, technical assistance, and consultation to all staff

conducting activities of the demonstration project.

N. Participate in efforts to disseminate project findings and lessons learned within

the jurisdiction, and contribute to dissemination efforts at the local, regional, and

national level.

O. Attend one grantee meeting each year with other funded grantees during Years 1,

2, and 3. All grantee meetings will take place in Atlanta, GA, and the grantee

should allocate funds for the Project Director, evaluator, and one other key staff

person to attend one 2-day meeting per year.

Phase IIB. Program Monitoring and Evaluation

A. Performance assessment

1. This FOA is designed to increase the overall impact of prevention

activities on HIV-related morbidity, mortality, and incidence by enhancing

public health systems and processes that determine when in the course of

their infections racial and ethnic minorities living with HIV are diagnosed;

if and when racial and ethnic minorities diagnosed with HIV are linked to

care; and whether HIV-positive individuals are effectively retained in care.

Accordingly, program performance will primarily be assessed using

impact and outcome measures that can be calculated using existing, HHS-

35 supported data systems (e.g., HIV disease surveillance). Any additional

community level or population based impact measures identified by the

federal partners or the grantee will be collected using similarly extant data

systems (e.g., the Ryan White Services Report) and in close collaboration

with local HIV prevention programs and other federal partners.

2. Guidance on program monitoring and evaluation (M&E) and performance

measures will be provided by the federal partners on an ongoing basis

throughout the project period.

3. The grantee will collaborate with federal partners to establish measurable

program objectives for each activity described in the applicant’s approved

program plan.

4. The grantee will collaborate with federal partners to develop and

implement program process measures that are based on its specific

programmatic objectives.

5. The grantee is encouraged to pursue additional data and/or conduct

additional analytic and evaluative activities that could enhance its ability

to assess and iteratively improve the community-level quality, impact, and

sustainability of HIV prevention services. For example, the grantee could

collect cost data to assess the long-term viability of a linkage to care

mechanism or develop data sharing agreements with the state Medicaid

Office and major private insurance providers serving its jurisdiction.

6. The grantee will be required to provide descriptions of the development

and implementation of program activities in annual progress reports and

36 other formats as required by the federal partners. The federal partners will

provide the template and guidance for these reports. The initial progress

report should include a description of the applicant’s use of current

surveillance and other relevant data for program planning.

7. The application should include language describing plans and proposed

budget for the following types of program monitoring and evaluation

elements:

i. Data collection, management, and data analysis

ii. Data utilization: how, by whom, and when data will be used to

measure progress toward meeting objectives and to improve

program performance

iii. Data sharing with participating healthcare/non-healthcare facilities,

CBOs or other service organizations, and key stakeholders,

including cost estimates to access nontraditional or private data

sources, is such access is proposed by the applicant

B. Procedures for data security and confidentiality:

In accordance with H.19 308(d) Contract Clause for Safeguards for Individuals and

Establishments against Invasions of Privacy and with Subsection (m) of the Privacy

Act of 1974 (5 U.S.C. 552a) and Section 308(d) of the Public Health Service Act (42

U.S.C. 242m), the applicant is required to comply with the applicable provisions of the Privacy Act and to undertake other safeguards to protect individuals and establishments against invasions of their privacy. To successfully meet these requirements over the course of this cooperative agreement, the grantee must:

37 1. Comply with all federal (i.e., HHS, and/or CDC) information systems and

information processing security policies. For example, local policies and

procedures should clearly describe required physical security attributes of

all facilities; procedures for protecting, controlling, and handling data

during performance of the project, including any development and testing

activities; required limitations on employees with respect to the

reproduction, transmission, or disclosure of data; physical storage

procedures to protect data; procedures for the destruction of source

documents and other contract-related waste material; and personnel

security procedures.

2. Ensure that data collection, entry, management, submission, analysis,

utilization, and dissemination procedures are consistent with CDC security

and confidentiality guidelines, as outlined above.

3. Develop and maintain ‘rules of behavior’ for persons who have access to

data systems under the agency’s responsibility. State and local data system

rules of behavior need to be responsive to CDC data security policies.

4. The applicant should sign and submit to CDC an interagency

Memorandum of Understanding (MOU) regarding protection of sensitive

data collected for this program. The MOU will be provided to grantees on

receipt of award or shortly thereafter.

5. Ensure all agency personnel having access to identifiable and confidential

information receive appropriate annual training and sign confidentiality

38 pledges (Non-Disclosure Agreement). CDC will provide on-line training

materials.

6. Conduct a privacy impact assessment (PIA) on all information systems

acquired, developed, or used in conjunction with data collected for this

project.

7. Annually review and validate system user accounts to ensure continued

need for access to system.

8. Work with CDC on an ongoing basis to review security controls and

measures and ensure continued compliance with federal information

security regulations.

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

HHS/CDC and Federal Partner Activities:

In a cooperative agreement, all HHS staff including CDC, OHAIDP, OMH, OWH,

HRSA, SAMHSA, and other federal partners are substantially involved in the program activities, above and beyond routine grant monitoring. Federal partner activities for this program are as follows:

A. Provide consultation and technical assistance to grantees on both phases of the

demonstration project.

39 1. Provide each grantee with a “federal support team” of scientists and

program staff from across federal agencies and offices who will serve as

the grantee’s principle contacts and coordinate, facilitate access to, and/or

provide specific technical assistance during both phases of the

demonstration project.

B. Work with grantees to identify and address capacity building and technical

assistance needs that are crucial to the success of the demonstration project, and

that are not currently addressed by other funding sources.

C. Facilitate coordination, collaboration, and where feasible, service integration

among federal agencies, other CDC programs, health departments and their

programmatic divisions, local planning groups, directly-funded CBOs, national

capacity building assistance providers, care providers and other recipients of Ryan

White HIV/AIDS Treatment Extension Act of 2009, and other critical partners

working with at risk populations and towards common goals of risk reduction,

disease detection, and a continuum of HIV prevention, care, and treatment.

D. Monitor grantee progress in developing and implementing the demonstration

project; work with grantees through consultation via site visits, email, telephone;

and review progress reports to support development and implementation of the

demonstration project.

E. Monitor grantee progress in developing monitoring and evaluation plans and work

with grantees through consultation via site visits, email, telephone, and review of

progress reports and other data reports to support progress, program improvement,

40 and reduce HIV morbidity and mortality and related health disparities among

racial and ethnic minorities in the United States.

F. Provide requirements and data standards for laboratory reporting of HIV- related

tests, uploading of such data into the surveillance software, and analysis of data

to plan and measure outcomes.

G. Provide requirements and expectations for standardized and other data reporting

and support monitoring and evaluation (M&E) activities with contractual

technical assistance, web-based training on M&E, M&E-related materials such as

data collection tools, and on-line TA via the NHM&E Service Center and other

sites supported by the federal partners.

H. Obtain necessary federal clearances.

I. Convene, plan, and facilitate joint grantee meetings (one per year) during the

project period.

II. AWARD INFORMATION

Type of Award: Cooperative Agreement. Award Mechanism: U65 Fiscal Year Funds: FY 2012 Approximate Current Fiscal Year Funding: $14,184,912 Approximate Total Project Period Funding: $44,184,912 (This amount is an estimate, and is subject to availability of funds.) These amounts include direct and indirect costs.

Approximate Number of Awards: Eligible health departments are divided into three tiers for eligibility and funding purposes. An estimated 6 awards (with a maximum of 9 awards) is anticipated (Tier 1= up to 4 awards; Tier 2= up to 4 awards; Tier 3= up to 4 awards).

Approximate Average Award: Tier 1= $3,000,000; Tier 2= $2,000,000; Tier 3= $1,200,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

41 Floor of Individual Award Range: Tier 1= $2,500,000; Tier 2= $1,650,000; Tier 3= $1,000,000

Ceiling of Individual Award Range: Tier 1= $3,500,000; Tier 2= $2,350,000; Tier 3= $1,400,000

Anticipated Award Date: September 30, 2012 Budget Period Length: Twelve Months Project Period Length: Three Years

Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the grantee (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

III. ELIGIBILITY INFORMATION

Eligible Applicants

Eligible applicants that can apply for this funding opportunity are listed below:

The FOA is to support a service limited competition funding opportunity announcement for the following 18 eligible state, local, and territorial health departments. An estimated six jurisdictions will be funded, with a maximum of nine. The following organizations are eligible to apply:

Alabama State Department of Public Health California Department of Public Health District of Columbia Department of Health Florida State Department of Health Georgia State Department of Public Health Illinois Department of Public Health Louisiana State Department of Health and Hospitals Maryland State Department of Health and Mental Hygiene Missouri Department of Health and Senior Services Mississippi State Department of Health North Carolina State Department of Health and Human Services

42 Ohio Department of Health Pennsylvania Department of Health Puerto Rico Health Department South Carolina State Department of Health and Environmental Control Tennessee State Department of Health Texas Department of State Health Services Virginia State Department of Health

A Bona Fide Agent is an agency/organization identified by the state, local or territorial health department as eligible to submit an application under their eligibility in lieu of a state, local, or territorial application. If applying as a bona fide agent of a state, territorial, or local government, a legal, binding agreement as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.

As both the National HIV/AIDS Strategy (NHAS) and DHAP’s Strategic Plan (2011-

2015) note, in the face of increasingly constrained resources and a concentrated, inequitably distributed epidemic, HIV prevention funding must be allocated to those communities and regions that shoulder the greatest share of the national burden. In addition, reducing HIV-related health disparities is one of the three primary goals of the

NHAS.

Because of the high disease burden among racial and ethnic minority populations, the disproportionate rate of AIDS diagnoses and associated mortality, and the pervasive impact of social and structural determinants of health, eligibility for this funding is limited to 18 state, local, or territorial health departments in the United States. In line with the Secretary’s Minority AIDS Initiative Funding and the National HIV/AIDS

43 Strategy’s focus on decreasing health disparities and maximizing reductions in national incidence and mortality, the 18 jurisdictions were selected based upon meeting the following three criteria:

1. Burden of illness. Jurisdictions that had greater than 5,000 HIV cases among

African Americans and Latinos were included.

2. Disproportionately affected areas. Jurisdictions that had an AIDS diagnosis rate of over 6 per 100,000 in 2010 were included. This focus on disproportionately affected geographic areas is in concordance with the National HIV/AIDS Strategy’s focus on decreasing health disparities.

3. Social determinants of health. Those jurisdictions with a teen birth rate over 25 per 1,000 were included. This indicator allowed a focus on jurisdictions with underlying social and economic factors that impede HIV prevention and care.

To balance funding between the 18 eligible jurisdictions, the health departments are divided into three tiers with higher, medium, and lower HIV morbidity. The tiers are defined at natural HIV prevalence cut-points for funding purposes:

Tier 1: Applicants eligible for Tier 1 are limited to six eligible health departments with an HIV prevalence of at least 30,000 cases.

Tier 2: Applicants eligible for Tier 2 are limited to six eligible health departments with an HIV prevalence of at least 16,000 cases but less than 30,000 cases.

Tier 3: Applicants eligible for Tier 3 are limited to six eligible health departments with an HIV prevalence of at least 8,000 cases but less than 16,000 cases.

44 The table below is the estimated prevalence for persons diagnosed with HIV, year-end

2009 – United States and Puerto Rico (2010 HIV Surveillance Report) http://www.cdc.gov/hiv/surveillance/resources/reports/2010report/index.htm.

Living with HIV, year-end 2009, –United States (16 states, District of Columbia, and Puerto Rico) – (from 2010 HIV Surveillance Report) California Department of Public Health 106,191 Florida State Department of Health 94,282 Texas Department of State Health Services 62,363 TIER Georgia Department of Public Health 34,754 1 Illinois Department of Public Health 32,016 Pennsylvania Department of Health 31,498 Maryland State Department of Health and Mental Hygiene 29,542 North Carolina State Department of Health and Human Services 23,858 TIER Virginia State Department of Health 19,866 Puerto Rico Health Department 18,406 2 Louisiana State Department of Health and Hospitals 16,854 Ohio Department of Health 16,671 Tennessee State Department of Health 15,331 District of Columbia Department of Health 14,097 South Carolina State Department of Health and Environmental TIER Control 13,917 Missouri Department of Health and Senior Services 10,900 3 Alabama State Department of Public Health 10,761 Mississippi State Department of Health 8,142

Required Registrations

Registering your organization through www.Grants.gov, the official agency-wide E-grant website, is the first step in submitting an application online. Registration information is located on the “Get Registered” screen of www.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, the Grants.gov registration process also requires that you register your organization with the Central Contractor Registry (CCR) and DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) which will require up to at least 4 weeks to complete registration in its entirety. The CCR registration can require an additional two weeks to complete. You are required to maintain a current registration in CCR. CCR registration must be renewed annually.

Central Contractor Registration and Universal Identifier Requirements 45 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 Authorized Organization Representative (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 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 Central Contractor Registry (CCR) and 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. CCR 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 CCR internet site at www.ccr.gov.

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

Cost Sharing or Matching

Cost sharing or matching funds are not required for this program.

Other

If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process. The applicant will be notified that the application did not meet the eligibility requirements.

The successful applicant may be responsible for planning, implementing, and coordinating infrastructure development requirements supporting the primary public health purpose of this FOA.

Special Requirements: If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified the application did not meet submission requirements. • Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.

46 • Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.

Maintenance of Effort Maintenance of Effort is not required for this program.

IV. Application and Submission Information

Submission Dates and Times

This announcement is the definitive guide on LOI and application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the applicant will be notified the application did not meet the submission requirements.

Letter of Intent (LOI) Deadline Date: Not Applicable

Application Deadline Date: July 31, 2012 ON GRANTS.GOV, 11:59pm U.S. Eastern Standard Time.

Applicants must download the SF424 application package associated with this funding opportunity from Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC Procurement and Grant Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 email:[email protected] Monday-Friday 7:00am – 4:30pm U.S. Eastern Standard Time for further instruction. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800- 518-4726 or by email at [email protected]. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

47 Content and Form of Application Submission

Unless specifically indicated, this announcement requires submission of the following information:

All applicants are required to sign and submit CDC Assurances and Certifications that can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm Print, scan and upload as an additional attachment into the application package.

Note: Limit file names to 50 characters and do not use special characters (example: &, -,*,%,/,#) including periods (.), blank spaces and accent marks, within application form fields and file attachment names. An underscore (_) may be used to separate a file name. Also, do not attach multiple documents with the same file name. Please do not cut & paste information into any fields within the application package all information must be typed.

A letter of intent is not applicable to this funding opportunity announcement.

A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

Project Narrative A project narrative must be submitted with the application forms. All electronic narratives must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format:  Maximum number of pages: 25. If the applicant’s narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed;  Font size: 12 point, unreduced, Times New Roman;  Double spaced;  Paper size: 8.5 by 11 inches (preferred), or generally accepted paper size;  Page margin size: One inch;  Number all document pages of the application (excluding the forms provided in the application package) sequentially from page one (Application Face Page) to the end of the application, including charts, figures, tables, and appendices; and

The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:

48 Phase 1. Development

A. Describe the current activities and challenges for: 1) HIV testing in clinical and

non-clinical settings, 2) immediate linkage to care; 3) retention in and re-

engagement with care among racial and ethnic minorities in the jurisdiction.

B. Describe the major social and structural determinants of health affecting testing,

linkage to, retention in, and re-engagement with HIV care among racial and ethnic

minorities in the jurisdiction.

C. As part of the narrative, provide a detailed work plan that describes demonstration

project activities as well as monitoring and evaluation, and quality assurance

activities. A draft of the demonstration project work plan, logic models

(Attachment IV), and timeline (Attachment VI) are due with the application and

the final work plan is due to CDC six months after initial funding.

D. Describe and provide a detailed justification for the proposed set of programmatic

activities to address the overarching goals of the demonstration project through

collaboration with local and federal partners. Activities should include required

components as well as additional supplemental and optional components to

achieve multi-level improvements addressing social and structural determinants of

health affecting testing, linkage to, retention in, and re-engagement with care and

providing the greatest impact on the local HIV epidemic among racial and ethnic

minorities. Describe how proposed activities will be coordinated with existing

activities funded by federal, state, and local partners.

E. Describe plans to identify, engage, and coordinate the development of the

demonstration project with key stakeholders and partners, which may include but

49 need not be limited to prevention and care providers from the public and private

sector, community health centers, mental health and substance abuse services,

local communities, other appropriate governmental and non-governmental

entities, local planning groups, and community-based organizations.

F. Describe plans to address capacity building needs during this phase related to the

overarching project goals (i.e., to improve linkage and retention in care outcomes,

to address the initiation of and adherence to ART, and strengthen social support

and services for HIV-positive persons).

G. Describe plans to designate a minimum of 25% of the funding award to support

capacity development and program implementation by CBOs in the jurisdiction.

Capacity building effort should include development of human capital, skills,

partnerships, and infrastructure of community-based organizations within the

jurisdiction, as appropriate, to implement the activities required by the funding

opportunity announcement.

H. Submit a jurisdiction-specific logic model to graphically describe the relationship

between the demonstration project activities and expected outcomes (See sample

logic model in Appendix 1).

I. Monitoring and evaluation description should include details on:

1. Data collection, management, and data analysis

2. Data utilization: how, by whom, and when data will be used to measure

progress toward meeting objectives and to improve program performance

3. Data sharing with participating healthcare/non-healthcare facilities, CBOs

or other service organizations, and key stakeholders, including cost

50 estimates to access nontraditional or private data sources, is such access is

proposed by the applicant

4. Procedures for data security and confidentiality

J. Describe potential ways to expand implementation of the demonstration project

by leveraging existing systems and resources to support the goals of the

demonstration project. Describe how sustainability issues are addressed in the

plan.

K. Agree to collaborate with CDC, federal partners and other technical assistance

entities to provide ongoing training, technical assistance, and consultation to all

staff conducting the demonstration project.

Phases IIA and IIB. Implementation and Evaluation

A. Describe plans to begin implementation of the CDC/federal partner-approved

demonstration project work plan within 6 months of funding.

B. Describe plans to identify, engage, and coordinate the implementation and evaluation

of the demonstration project with key stakeholders and partners, including but not

limited to prevention and care providers from the public and private sector,

community health centers, mental health and substance abuse services, local

communities, other appropriate governmental and non-governmental entities, local

planning groups, and community-based organizations.

C. Describe plans to address major social and structural determinants of health affecting

testing, linkage to, retention in, and re-engagement with HIV care among racial and

ethnic minorities.

51 D. Document collaborations with MOAs. Letters of support can be included if is not

possible to complete MOAs by the application deadline.

E. Describe plans to address capacity building needs during this phase related to the

overarching project goals (i.e., to improve linkage and retention in care outcomes, to

address the initiation of and adherence to ART, and strengthen social support and

services for HIV-positive persons).

F. Describe plans to leverage systems that are in place and existing resources to obtain a

greater return on public health investments that directly address the overarching goals

of the project.

G. Describe plans to collaborate with funded CBOs to ensure successful implementation

of the activities required by the funding opportunity announcement.

H. Describe plans to revise and update the logic model, detailed work plan, and

monitoring and evaluation, and quality assurance activities as needed during the

course of the demonstration project.

I. Describe plans to continue to identify ways to expand implementation of the

demonstration project by leveraging other resources to support the goals of the

demonstration project.

J. Describe plans to ensure that current and new staff have adequate training to

implement activities of the demonstration project.

K. Agree to collaborate with the evaluation team identified by federal partners and

tasked with additional evaluation of grantees’ overall programmatic implementation

of their demonstration project.

52 L. Agree to collaborate with CDC, federal partners and other technical assistance entities

to provide ongoing training, technical assistance, and consultation to all staff

conducting the demonstration project.

M. Agree to participate in efforts to disseminate project findings and lessons learned

within the jurisdiction, and to contribute to dissemination efforts at the local, regional,

and national level.

N. Agree to attend one grantee meeting each year with other funded grantees during

Years 1, 2, and 3. All grantee meetings will take place in Atlanta, GA, and the grantee

should allocate funds for the Project Director, evaluator, and one other key staff

person to attend one 2-day meeting per year.

Personnel

A. Include a staffing plan that is appropriate and sufficient to accomplish the

program goals and clearly defined staffing roles.

B. Describe plans to maintain appropriate and sufficient staffing in relation to staff

persons' respective roles and responsibilities in implementing the demonstration

project. Describe plans to hire new personnel (if needed).

C. Include a plan to attend grantees meeting with other funded grantees during Years

1, 2, and 3.

D. Provide a plan for training, technical assistance, and consultation to all staff

conducting the demonstration project.

Budget  The budget justification will not be counted in the stated page limit. In accordance with Form CDC 0.1246E (www.cdc.gov/od/pgo/forms/01246.pdf),

53 applicants are required to provide a line item budget and narrative justification for all requested costs that are consistent with the purpose, objectives, and proposed program activities. The budget and budget justification should be placed in the application’s attachments and named as Budget and Budget Justification. Within the budget, include the following: o A detailed, line-item budget and justification (also known as a “budget

narrative”).

o A line-item breakdown and justification for all personnel; that is name,

position title, actual annual salary, percentage of time and effort, and

amount requested).

o A line-item breakdown and justification for all contracts, including:

o Name of contractor and/or consultants.

o Applicant affiliation (if applicable).

o Nature of services to be rendered.

o Relevance of service to the project or justification for use of a consultant.

o Period of performance (dates) or number of days of consultation (basis for

fees).

o Method of selection (for example, competitive or sole source).

o Description of activities.

o Target population.

o Itemized budget and expected rate of compensation (for example, travel,

per diem, and other related expenses); list a subtotal for each consultant in

this category.

. If the above information is unknown for any contractor/consultant

at the time the application is submitted, the information may be

54 submitted at a later date as a revision to the budget if the applicant

is selected for funding.

o Funds must be included for two to three persons to attend one meeting per

year convened by CDC with all grantees.

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:  Organizational Chart  Resumes or Curriculum Vitas of key staff  Letters of support from key collaborators  Project Logic Model  Indirect Cost Rate Agreement  Timeline

Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named:

OtherNarrativeAttachments Attachment I Organizational chart.pdf

OtherNarrativeAttachments Attachment II Resumes.pdf

OtherNarrativeAttachments Attachment III Letters of support.pdf

OtherNarrativeAttachments Attachment IV Project logic model.pdf

OtherNarrativeAttachments Attachment V Indirect Cost Rate Agreement.pdf

OtherNarrativeAttachments Attachment VI Timeline.pdf

No more than 6 electronic attachments should be uploaded per application. Additional requirements for additional documentation with the application are listed in Section VII. Award Administration Information; subsection entitled “Administrative and National Policy Requirements.”

Funding Restrictions

Restrictions, which must be taken into account while writing the budget, are as follows:

55  Grantees may not use funds for research.

 Grantees may not use funds for clinical care (for example, treatment of HIV,

STDs, viral hepatitis, TB, or TB infection; vaccination against Hepatitis A or B).

 Grantees may not use funds for clinical mental health or substance abuse

treatment including medications.

 Grantees may not use funds for; 1) human resources used specifically to distribute

needles or syringes; 2) delivery modes, e.g., vehicles or rent for fixed sites used

specifically for distributing needles or syringes; 3) purchase of needles or

syringes.

 Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of

furniture or equipment. However, such proposed spending may be appropriate for

this FOA and must be clearly identified in the budget. If the purchase of furniture

or equipment (items of cost more than $5,000 and more than two years of use) is

proposed, justification and itemization of costs will be required in the budget.

 The direct and primary grantee in a cooperative agreement program must perform

a substantial role in carrying out project objectives and not merely serve as a

conduit for an award to another party or provider who is ineligible (i.e., pass-

through of funds to an ineligible organizations is restricted).

 Reimbursement of pre-award costs is not allowed.

 Supplanting of federal funds is restricted. Federal funds must be used to

supplement existing funds for program activities and must not replace those funds

that have been appropriated for the same purpose.

56  If requesting indirect costs in the budget, a copy of the indirect cost rate

agreement is required. If the indirect cost rate is a provisional rate, the agreement

should be less than 12 months of age. The indirect cost rate agreement should be

uploaded as a PDF file with "Other Attachment Forms" when submitting via

Grants.gov.

 Projects that involve the collection of information from 10 or more individuals

and are funded by a grant/cooperative agreement will be subject to review and

approval by the Office of Management and Budget (OMB) under the Paperwork

Reduction Act.

Applicants can obtain guidance for completing a detailed justified budget on the CDC

Web site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

Additional Submission Requirements

Electronic Submission

Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC, Procurement and Grant Office, Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 Email:[email protected] Monday-Friday 7:30am -4:30pm for further instruction.

Note: Application submission is not concluded until successful completion of the validation process. 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. Applicants are strongly encouraged to check the status of their application to ensure submission of their application package is complete and no

57 submission errors exists. To guarantee that you comply with the application deadline published in the Funding Opportunity Announcement, applicants are also strongly encouraged to allocate additional days prior to the published deadline to file their application. Non-validated applications will not be accepted after the published application deadline date.

In the event that you do not receive a “validation” email within two (2) business days of application submission, please contact Grants.gov. Refer to the email message generated at the time of application submission for instructions on how to track your application or the Application User Guide, Version 3.0 page 57.

Applications must be submitted electronically at www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully made available to CDC for processing from Grants.gov on the deadline date. The application package can be downloaded from www.Grants.gov. Applicants can complete the application package off-line, and then upload and submit the application via the Grants.gov Web site. The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than PDF may result in the file being unreadable by staff.

Applications submitted through Grants.gov (http://www.grants.gov), are electronically time/date stamped and assigned a tracking number. The AOR will receive an e-mail notice of receipt when Grants.gov receives the application. The tracking number serves to document submission and initiate the electronic validation process before the application is made available to CDC for processing.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800- 518-4726 or by email at [email protected]. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

Organizations that encounter technical difficulties in using www.Grants.gov to submit their application must attempt to overcome those difficulties by contacting the Grants.gov Support Center (1-800-518-4726, [email protected]). After consulting with the Grants.gov Support Center, if the technical difficulties remain unresolved and electronic submission is not possible to meet the established deadline, organizations may submit a request prior to the application deadline by email to the GMO/GMS [See Section VII “Agency Contacts”], for permission to submit a paper application. An organization's request for permission must: (a) include the Grants.gov case number assigned to the inquiry, (b) describe the difficulties that prevented electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted

58 to the GMO/GMS at least 3 calendar days prior to the application deadline. Paper applications submitted without prior approval will not be considered.

If a paper application is authorized, the applicant will receive instructions from PGO TIMS to submit the original and two hard copies of the application by mail or express delivery service.

Intergovernmental Review Executive Order 12372 does not apply to this program.

V. Application Review Information

Eligible applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the CDC-RFA- PS12-1210. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

EVALUATION CRITERIA Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff and for responsiveness jointly by NCHHSTP and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified if the application did not meet submission requirements.

A complete application will include the following:  Project abstract  Project narrative including a detailed work plan that describes demonstration project activities (required and supplemental/optional components, as appropriate)  Jurisdiction-specific logic model(s)  Monitoring and evaluation plan  Line-item budget with justification  Organizational chart  Resumes or curriculum vitas of key staff  Letters of support or MOAs from key collaborators  Indirect cost rate agreement  Timeline

An Objective Review Panel will be led by CDC with representation from CDC and collaborating federal agencies. The review will be conducted based on the evaluation criteria listed in Section V of the FOA. Funding is competitive and based on application strengths. Applications will be reviewed against the following criteria:

59 Phase I. Development (45 points)

A. Does the applicant describe the current activities and challenges for: 1) HIV testing in

clinical and non-clinical settings, 2) immediate linkage to care; 3) retention in and re-

engagement with care among racial and ethnic minorities in the jurisdiction?

B. Does the applicant describe the major social and structural determinants of health

affecting testing, linkage to, retention in, and re-engagement with HIV care among

racial and ethnic minorities in the jurisdiction?

C. Did the applicant provide a detailed work plan that describes demonstration project

activities as well as monitoring and evaluation, and quality assurance activities?

D. Does the applicant describe and justify the proposed set of programmatic activities to

meet the overarching goals of the demonstration project through collaboration with

local, state, and federal partners?

E. Does the applicant address all required components?

F. Does the applicant describe plans to identify, engage, and coordinate the development

of the demonstration project with key stakeholders and partners, including but not

limited to prevention and care providers from the public and private sector,

community health centers, mental health and substance abuse services, social

services, local communities, governmental and non-governmental entities, local

planning groups, and community-based organizations? Does the applicant describe

how proposed activities will be coordinated with existing activities funded by federal,

state, and local partners?

60 G. Does the applicant describe plans to address capacity building needs in this phase

related to the overarching project goals (i.e., to improve linkage and retention in care

outcomes, to address the initiation of and adherence to ART, and strengthen social

support and services for HIV-positive persons)?

H. Does the applicant describe plans to designate a minimum of 25% of the funding

award to support capacity development and program implementation by CBOs in the

jurisdiction?

I. Did the applicant submit a jurisdiction-specific logic model to graphically describe

the relationship between the demonstration project activities and expected outcomes?

J. Does the M&E plan include details on:

1. Data collection, management, and data analysis

2. Data utilization: how, by whom, and when data will be used to measure

progress toward meeting objectives and to improve program performance

3. Data sharing with participating healthcare/non-healthcare facilities, CBOs or

other service organizations, and key stakeholders, including cost estimates to

access nontraditional or private data sources, if such access is proposed by the

applicant

4. Procedures for data security and confidentiality

K. Does the applicant describe potential ways to expand implementation of the

demonstration project by leveraging existing systems and resources to support the

goals of the demonstration project? Does the applicant describe how sustainability

issues are addressed in the plan?

61 L. Did the applicant agree to collaborate with CDC, federal partners and other technical

assistance entities to provide ongoing training, technical assistance, and consultation

to all staff conducting the demonstration project?

Phase IIA and Phase IIB Implementation and Evaluation (45 points)

A. Does the applicant describe plans to begin implementation of the CDC/federal

partner-approved demonstration project work plan within 6 months of funding?

B. Does the applicant describe plans to identify, engage, and coordinate the

implementation and evaluation of the demonstration project with key stakeholders

and partners, including but not limited to prevention and care providers from the

public and private sector, community health centers, mental health and substance

abuse services, local communities, governmental and non-governmental entities, local

planning groups, and community-based organizations?

C. Are the collaborations documented with letters of support or MOAs?

D. Does the applicant describe plans to address major social and structural determinants

of health affecting testing, linkage to, retention to, and re-engagement with HIV care

among racial and ethnic minorities?

E. Does the applicant describe plans to address capacity building needs in this phase

related to the overarching project goals(i.e., to improve linkage and retention in care

outcomes, to address the initiation of and adherence to ART, and strengthen social

support and services for HIV-positive persons)?

62 F. Does the applicant describe plans to leverage systems that are in place and existing

resources to obtain a greater return on public health investments that directly address

the overarching goals of the project?

G. Does the applicant describe plans to collaborate with funded CBOs to ensure

successful implementation of the activities required by the funding opportunity

announcement?

H. Does the applicant describe plans to revise and update the logic model, detailed work

plan, and monitoring and evaluation, and quality assurance activities as needed during

the course of the demonstration project?

I. Does the applicant describe plans to continue to identify ways to expand

implementation of the demonstration project by leveraging other resources to support

the goals of the demonstration project?

J. Does the applicant describe plans to ensure that current and new staff have adequate

training to implement activities of the demonstration project?

K. Does the applicant agree to collaborate with the evaluation team identified by federal

partners and tasked with additional evaluation of grantees’ overall programmatic

implementation of their demonstration project?

L. Does the applicant agree to collaborate with CDC, federal partners and other

technical assistance entities to provide ongoing training, technical assistance, and

consultation to all staff conducting the demonstration project?

M. Does the applicant agree to participate in efforts to disseminate project findings and

lessons learned within the jurisdiction, and contribute to dissemination efforts at the

local, regional, and national level?

63 N. Does the applicant agree to attend one grantee meeting each year with other funded

grantees during Years 1, 2, and 3?

Personnel (10 points)

A. Does the applicant include a staffing plan that is appropriate and sufficient to

accomplish the program goals and clearly defined staffing roles?

B. Does the applicant describe plans to maintain appropriate and sufficient staffing in

relation to staff persons' respective roles and responsibilities in implementing the

demonstration project? Does the applicant describe plans to hire new personnel (if

needed)?

C. Does the applicant include a plan to attend grantees meeting with other funded

grantees during Years 1, 2, and 3?

D. Does the applicant provide a plan for training, technical assistance, and consultation

to all staff conducting the demonstration project?

D. Budget (not scored)

Is the budget for the proposed demonstration project reasonable, clearly justified,

consistent with the demonstrated need and proposed activities, and likely to lead to

successful planning and implementation?

Budget (SF 424A) and Budget Narrative (Reviewed, but not scored)]. Although the budget is not scored applicants should consider the following in development of their budget. Is the itemized budget for conducting the project, and justification, reasonable and consistent with stated objectives and planned program activities? If the applicants requests indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should

64 be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

Review and Selection Process

Review All eligible applications will be initially reviewed for completeness by the Procurement and Grants Office (PGO) staff. In addition, eligible applications will be jointly reviewed for responsiveness by NCHHSTP and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that the application did not meet eligibility and/or published submission requirements.

An objective review panel will evaluate complete and responsive applications according to each item referenced in Section “V. Application and Submission Information.” The panel will assign each application a score using scored evaluation criteria as specified in Section “VI. Application Review Information.” The score will be based on the applicant’s responses to the questions in Section VI. The panel will consist of CDC employees and other federal employees from the collaborating agencies. For CDC employees,100% will be from outside the funding Office and at least 51% will be from outside the funding Center. The objective review process will follow the policy requirements as stated in the GPD 2.04 at http://intranet.hhs.gov/grantsinfo/gpdstable.html.

Selection Applications will be ranked separately for each tier and funded in order by score and rank within each tier as determined by the review panel. From 0 to 4 applicants will be funded in each tier.

VI. Award Administration Information

Award Notices

Grantees will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and e- mailed to the program director. A hard copy of the NoA will be mailed to the recipient fiscal officer identified in the application.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration and Transparency Act requirements.

65 Unsuccessful applicants will receive notification of the results of the application review by mail.

Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate. The following additional requirements apply to this project:  AR-4 HIV/AIDS Confidentiality Provisions  AR-5 HIV Program Review Panel Requirements  AR-6 Patient Care  AR-8 Public Health System Reporting Requirements  AR-9 Paperwork Reduction Act Requirements  AR-10 Smoke-Free Workplace Requirements  AR-11 Healthy People 2020  AR-12 Lobbying Restrictions  AR-14 Accounting System Requirements  AR-16 Security Clearance Requirement  AR-21 Small, Minority, and Women-Owned Business  AR-24 Health Insurance Portability and Accountability Act Requirements  AR-25 Release and Sharing of Data  AR-27 Conference Disclaimer and Use of Logos  AR-29 Compliance with E.O. 13513 Federal Leadership on Reducing Text Messaging While Driving, October 1, 2009.

Additional information on the requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

Reporting

Federal Funding Accountability And Transparency Act Of 2006 (FFATA): Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, www.USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000, including such information as:

66 1. The name of the entity receiving the award 2. The amount of the award 3. Information on the award including transaction type, funding agency, etc. 4. The location of the entity receiving the award 5. A unique identifier of the entity receiving the award; and 6. Names and compensation of highly-compensated officers (as applicable)

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the Central Contractor Registry; and 2) similar information on all sub- awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the Federal Funding Accountability and Transparency Act of 2006, please review the following website: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi? dbname=109_cong_bills&docid=f:s2590enr.txt.pdf .

Each funded applicant must provide CDC with an annual Interim Progress Report submitted via www.grants.gov: 1. The interim progress report is due no less than 90 days before the end of the budget period. The Interim Progress Report will serve as the non-competing continuation application, and must contain the following elements: a. Standard Form (“SF”) 424S Form. b. SF-424A Budget Information-Non-Construction Programs. c. Budget Narrative. d. Indirect Cost Rate Agreement. e. Project Narrative.

Additionally, funded applicants must provide CDC with an original, plus two hard copies of the following reports:

2. Financial status report, no more than 90 days after the end of the budget period. 3. Final performance and financial status* (SF 269) reports, both of which are due no more than 90 days after the end of the project period. Additional guidance on what to include in the final performance report will be provided by CDC approximately 3 months prior to the end of the project period.

*Disclaimer: As of February 1, 2011, current Financial Status Report (FSR) requirements will be obsolete. Existing practices will be updated to reflect changes for implementation of the new Federal Financial Reporting (FFR) requirements.

These reports must be submitted to the attention of the Grants Management Specialist listed in the Section VII below entitled “Agency Contacts”.

67 VII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For programmatic technical assistance, contact: David W. Purcell Branch Chief, Prevention Research Branch Department of Health and Human Services Centers for Disease Control and Prevention Division of HIV/AIDS Prevention 1600 Clifton Road, MS E-37 Atlanta, GA 30333 Telephone: 404-639-1934 E-mail: [email protected]

For financial, grants management, or budget assistance, contact: Barbara Rene Benyard, Grants Management Officer Department of Health and Human Services CDC Procurement and Grants Office 2920 Brandywine Road, MS E-15 Atlanta, GA 30341 Telephone: 770-488-2757 Fax: 770-488-2868 E-mail: [email protected]

For assistance with submission difficulties, contact: Grants.gov Contact Center Phone: 1-800-518-4726 Email: [email protected] Hours of Operation: 24 hours a day, 7 days a week. Closed on Federal holidays.

For submission questions, contact: Technical Information Management Section Department of Health and Human Services CDC Procurement and Grants Office 2920 Brandywine Road, MS E-14 Atlanta, GA 30341 Telephone: 770-488-2700 Email: [email protected]

CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348

68 VIII. Other Information

For additional information on reporting requirements, visit the CDC website at: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm.

Other CDC funding opportunity announcements can be found at www.grants.gov.

1. National HIV/AIDS Strategy (NHAS): http://www.aids.gov/federal-resources/policies/national-hiv-aids-strategy/what- is-thenhas/strategy.html 2. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention’s (NCHHSTP) Strategic Plan: http://www.nchhstp.cdc.gov/docs/10_NCHHSTP %20strategic%20plan%20Book_semi%20final508.pdf 3. CDC Health Disparities and Inequalities Report — United States, 2011: http://www.cdc.gov/mmwr/pdf/other/su6001.pdf 4. NCHHSTP's Social Determinants of Health White Paper: http://www.cdc.gov/socialdeterminants/docs/SDH-White-Paper-2010.pdf 5. PCSI White Paper: http://www.cdc.gov/nchhstp/programintegration/docs/207181C_NCHHSTP_PC SI%20WhitePaper-508c.pdf 6. Healthy People 2020 – HIV Topic Area: http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx? topicid=22 7. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, 2006: http://www.cdc.gov/mmwr/pdf/rr/rr5514.pdf 8. Revised Guidelines for HIV Counseling, Testing, and Referral, 2001: http://www.cdc.gov/mmwr/pdf/rr/rr5019.pdf 9. Quality Assurance Standards for HIV Counseling, Testing, and Referral Data, 2009: http://www.cdc.gov/hiv/testing/resources/guidelines/qas/ 10. Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988 | Rapid HIV Testing | Testing | Topics | CDC HIV/AIDS: http://www.cdc.gov/hiv/topics/testing/resources/guidelines/qa_guide.htm 11. HIV Testing Implementation Guidance in Correctional Settings, January 2009: http://www.cdc.gov/hiv/topics/testing/resources/guidelines/correctionalsettings/ pdf/Correctional_Settings_Guidelines.pdf 12. Recommendations for Partner Services Programs for HIV Infection, Syphilis, Gonorrhea, and Chlamydial Infection: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr57e1030a1.htm 13. Guidelines for Internet-based Partner Services: http://www.ncsddc.org/upload/wysiwyg/documents/IGPS.pdf 14. Antiretroviral Treatment Access Study (ARTAS) Linkage to Care Intervention: Craw JA, Gardner LI, Marks G, Rapp RC, Bosshart J, Duffus WA, Rossman A,

69 Coughlin SL, Gruber D, Safford LA, Overton, J, Schmitt K. Brief strengths-based case management promotes entry into HIV medical care: results of the Antiretroviral Treatment Access Study-II (ARTAS-II). JAIDS, 2008; 47:597-606. http://www.ncbi.nlm.nih.gov/pubmed/18285714 15. National Standards for Culturally and Linguistically Appropriate Services in Health Care: http://minorityhealth.hhs.gov/assets/pdf/checked/finalreport.pdf 16. Guidelines for Budget Preparation: http://www.cdc.gov/od/pgo/funding/budgetguide.htm 17. Contract Clause for Safeguards for Individuals and Establishments against Invasions of Privacy and with Subsection (m) of the Privacy Act of 1974 (5 U.S.C. 552a) and Section 308(d) of the Public Health Service Act (42 U.S.C. 242m): http://www.justice.gov/opcl/privstat.htm 18. Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuideli nes.pdf

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