ps13-1310 amendment i 02.19.13.doc

AMENDMENT 1- FEBRUARY 12, 2013

1- new Enhanced HIV Testing minimum range added- pgs. 9, 29

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

PART 1. OVERVIEW INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

Funding Opportunity Title: Human Immunodeficiency Virus (HIV) Prevention Projects for the Commonwealth of Puerto Rico and United States Virgin Islands Announcement Type: New Agency Funding Opportunity Number: CDC-RFA-PS13-1310 Catalog of Federal Domestic Assistance Number: 93.939

Key Dates: To receive notification of any changes to CDC-RFA-PS13-1310, 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.

Application Deadline Date: March 27, 2013, 11:59 pm Eastern Standard Time Additional Overview Content: Based on anticipated availability of funds, CDC expects to award up to 8 cooperative agreements under the Categories A and B. The average award will be approximately $225,000, with an individual floor of $200,000 and an individual ceiling of $300,000 (See Section II: Award Information).

Organizations that are funded under this FOA will be required to provide services to the target population specified in their applications. However, no persons will be turned away from services, regardless of their race, ethnicity, or other demographic characteristic. The funding period is up to two years and is based on continued availability of funds. Funding under this FOA cannot be used to implement school-based HIV prevention programs.

All applications submitted in response to this FOA will undergo a structured review. This review will consist of a programmatic and budget assessment to ensure that the proposed project is technically or scientifically sound and the awarded entity is capable of performing the project. Organizations will be provided a copy of the technical/scientific and budget assessment of their application.

Glossary: Definitions for terms and acronyms used frequently throughout the FOA can be found in the FOA Glossary (Attachment I: Glossary of Terms).

Executive Summary:

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year 2013 funds for a cooperative agreement program for community based organizations (CBOs) to develop and implement HIV prevention programs in the following two categories:

Category A: HIV Prevention Programs for the Commonwealth of Puerto Rico

Category B: HIV Prevention Programs for the United States Virgin Islands Organizations should request funding to implement a Comprehensive and Innovative Client- Centered HIV Prevention Program that supports the HIV prevention priorities outlined in their jurisdictional comprehensive HIV prevention plan.

The purpose of this funding opportunity announcement is to implement comprehensive human immunodeficiency virus (HIV) prevention programs to reduce morbidity, mortality, and related health disparities. In accordance with the National HIV/AIDS Strategy (http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf) and High-Impact HIV Prevention (http://www.cdc.gov/hiv/strategy/hihp/index.htm), this FOA focuses on addressing the national HIV epidemic by reducing new infections, increasing access to care, and promoting health equity. The aforementioned will be achieved by enhancing community-based organizations’ capacities to increase HIV testing, link HIV positive persons to medical care, increase referral to partner service, provide prevention services for HIV positive individuals and high risk individuals with unknown/negative serostatus, and increase program monitoring and accountability. Standard performance measures for HIV prevention programs that are consistent with the focus of the National HIV/AIDS Strategy on improving performance and accountability are included in this FOA.

The organization’s Comprehensive and Innovative Client-Centered HIV Prevention Program will consist of the following program components: (1) program promotion (2) client recruitment; (3) addressing health disparities; (4) enhanced HIV testing; (5) strategies to support linkage, re-engagement, and retention in care; and (6) a combination of structural, behavioral, and/or biomedical interventions that supports maximum reach and optimal outcomes.

This opportunity is limited to non-profit organizations (e.g., community, faith-based, and tribal organizations) currently funded under Funding Opportunity Announcement PS08-803: HIV Prevention Projects for the Commonwealth of Puerto Rico and the United States Virgin Islands, these organizations are located in and provide services in the Commonwealth of Puerto Rico or the U.S. Virgin Islands. The following community-based organizations are currently funded under PS08-803 and thus, are eligible to apply for funding under this competing continuation funding opportunity announcement, PS13-1310.

Category A

Commonwealth of Puerto Rico Category B

United States Virgin Islands

Corporation de Salud y Medicina Avanzada (COSSMA)

Estancia Corazon, Inc.

Migrant Health Center, Western Region, Inc.

Puerto Rico Community Network for Clinical Research on AIDS (PR CoNCRA)

PS13-1310 is a competing continuation of the currently CDC funded FOA, PS08-803: HIV Prevention Projects for the Commonwealth of Puerto Rico and the United States Virgin Islands, which has ongoing HIV prevention activities conducted solely by non-profit organizations with 501(c)(3) IRS status. Funded PS08-803 CBOs are currently providing HIV prevention services for HIV positive and high risk negative persons at risk for acquiring or transmitting HIV infection who reside in the Commonwealth of Puerto Rico or the U.S. Virgin Islands. Funding for PS13-1310 will support the continued implementation of the current PS08-803 programs to ensure the HIV prevention programs are in support of goals of the National HIV/AIDS Strategy and the High Impact HIV Prevention approach. The two year competing continuation supports alignment of existing programs with National and CDC efforts to maximize resources and streamline programs and the associated reporting requirements. The competing continuation will enable CDC to align its community-based HIV prevention programs allowing for the development of a comprehensive, cost-effective, and streamlined consolidated community-based HIV prevention program model.

This FOA supports a holistic framework that enables NCHHSTP to more comprehensively address the broader, cross-cutting issues of health and wellness by addressing Health Equity, Program Collaboration and Service Integration (PCSI), and Advancing Public Health Approaches to Improve Sexual Health.

Health Disparities

Health disparities in HIV, viral hepatitis, STDs and TB are inextricably linked to a complex blend of social determinants that influence which populations are most severely affected by these diseases. In collaboration with partners and appropriate sectors of the community, organizations 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. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. Organizations 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. (Definitions of health disparity, social determinants of health and health equity are available at http://www.healthypeople.gov/hp2020/advisory/phaseI/glossary.htm).

Program Collaboration and Service Integration (PCSI)

Program collaboration and service integration (PCSI) is a mechanism of organizing and blending interrelated health issues, separate activities, and services in order to maximize public health impact through new and established linkages among programs to facilitate the delivery of services. PCSI focuses on improving collaboration among programs to enhance integrated service delivery at the client level or at point-of-service delivery. The goal of PCSI is to provide prevention services that are holistic, evidence-based, comprehensive, and high quality to appropriate populations at every interaction with the healthcare system. PCSI offers 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. Details of this strategy and approach are outlined in the NCHHSTP PCSI White Paper (http://www.cdc.gov/nchhstp/programintegration/docs/207181-C_NCHHSTP_PCSI%20WhitePaper-508c.pdf).

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, sexual health is not limited to the absence of disease and dysfunction and is an important component of health across the lifespan. It 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.

The holistic health-focused framework supported by NCHHSTP has the potential for reducing the fear, discrimination, and stigma often associated with HIV, STD, viral hepatitis, and TB. The framework enables prevention programs to reach the general public, populations at risk, and health care providers easier. A more holistic and comprehensive health-focused framework also facilitates open and honest societal dialogue around sensitive issues that are critically important to address, including health equity, human sexuality, relationships, and sexual behavior.

Additional information about these imperatives is available on the NCHHSTP website, http://www.cdc.gov/nchhstp.

PART 2. FULL TEXT

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority

This program is authorized under sections Section 317(k) (2) and 318 of the Public Health Service Act (42 U.S.C. Sections 247b (k) (2) and 247(c), as amended.

Background CDC has estimated that approximately 1.2 million (1,148,200) adults and adolescents were living with HIV infection in the United States at the end of 2009, the most recent year for which national prevalence estimates are available.1 From 2006 through 2009, the estimated number of persons living with HIV infection in the United States increased 8%. In 2010, the estimated number of diagnoses of HIV infection in the 46 states and 5 U.S. dependent areas with confidential name-based HIV infection reporting was 48,298. Of these, 47,129 were in the 46 states and 1,169 were in the 5 dependent areas. The cumulative estimated number of deaths of persons with an AIDS diagnosis in the United States and 5 U.S. dependent areas, through 2009, was 641,976. Men who have sex with men (MSM), blacks/African Americans, and Hispanic/Latinos are the groups most affected by HIV infection. Moreover, in 2010, Blacks/African Americans and Hispanics/Latinos accounted for 46% and 20%, respectively, of all estimated HIV diagnoses. The estimated rates of AIDS diagnoses in the Commonwealth of Puerto Rico and the United States Virgin Islands is disproportionately high at 14.9 per 100,000 and 21.6 per 100,000 respectively (CDC HIV Surveillance Report, 2012).2 There is a need to employ a collaborative approach in controlling disease on the individual level while addressing social and environmental factors that contribute to the transmission of HIV. Social determinants of health (SDH) including homelessness, unemployment, and low education levels were found to be independently associated with HIV infection; whereas, environmental factors, such as housing conditions, social networks, and social support are also considered key drivers for becoming infected with HIV, Viral Hepatitis, STDs, and TB.3 Through this competing continuation, CDC is seeking to maintain the fundamental elements that have served this program well since the beginning, while enhancing the program through the incorporation of lessons learned from previous cycles.

This competing continuation funding opportunity announcement is targeted to groups at risk for HIV infection in the Commonwealth of Puerto Rico and the United States Virgin Islands.

Purpose

The purpose of the program is to:

· Support the development and implementation of high impact, comprehensive community-based HIV prevention programs to achieve maximum impact on reducing new HIV infections via provision of services to persons at high risk for transmitting and acquiring HIV in the Commonwealth of Puerto Rico and the U.S. Virgin Islands;

· Increase the number of HIV positive persons in the Commonwealth of Puerto Rico and the U.S. Virgin Islands who are aware of their HIV status and linked to and re-engaged in care, treatment, and other essential support services;

· Build the capacity of CDC-funded CBOs to support the delivery of scalable, cost-effective, and evidence based comprehensive community-based HIV Prevention Programs for persons at high risk for acquiring or transmitting HIV in the Commonwealth of Puerto Rico and the U.S. Virgin Islands; and

· Promote collaboration and coordination of HIV prevention and care efforts among CBOs, health departments, and other service providers.

Objectives

The objectives of this program are to:

· Reduce HIV transmission.

· Ensure early diagnosis of HIV infection.

· Increase the use of evidence-based, structural, and biomedical interventions for HIV prevention.

· Increase the number of individuals at high risk for HIV infection who receive appropriate HIV prevention services and become aware of their serostatus.

· Increase access to quality HIV medical care and ongoing HIV prevention services for persons who are living with HIV.

· Complement HIV prevention activities and program models supported by state and local health departments.

· Increase outreach and education efforts to individuals at high risk for acquiring and transmitting to encourage them to know their HIV status, engage in behaviors that reduce their risk of becoming infected with HIV and transmitting HIV if currently infected.

This program addresses the “Healthy People 2020” focus area(s) of HIV prevention.

This program also aligns with the National HIV/AIDS Strategy (NHAS) and High-Impact HIV Prevention (HIP). Specifically, reducing new HIV infections through the implementation of a combination of scientifically proven, scalable, and cost-effective interventions and strategies is a primary goal that has been identified in the NHAS and HIP. Preventing HIV infections among high risk populations been identified as a targeted strategy in achieving this goal. This program addresses NHAS priority recommendations and strategies including:

· Intensify HIV prevention efforts in communities where HIV is most heavily concentrated.

· Expand targeted efforts to prevent HIV infection using a combination of effective, evidence-based approaches.

· Educate all Americans about the threat of HIV and how to prevent it.

This program is inclusive of the five major considerations of the HIP approach:

· Effectiveness and cost

· Feasibility of full-scale implementation

· Coverage of the target populations

· Interaction and targeting

· Prioritizations

The NHAS Federal Implementation Plan outlines specific steps to be taken by federal agencies to support the high-level priorities outlined in the Strategy. This program specifically addresses steps related to the NHAS goal of reducing new HIV infections, such as:

· 1.1 Allocation of public funding to geographic areas consistent with the epidemic.

· 1.2 Target high-risk populations.

· 1.2.1 Prevent HIV among gay and bisexual men and transgender individuals.

· 1.2.2 Prevent HIV among Black Americans.

· 1.2.3 Prevent HIV among Latino Americans.

· 1.4 Enhance program accountability.

· 2.1 Design and evaluate innovative prevention strategies and combination approaches for preventing HIV high risk communities.

· 2.3 Expand access to effective prevention services.

Comprehensive and Innovative Client-Centered HIV Prevention Program Overarching Project Framework

Community-Based Organizations (CBOs) are uniquely positioned to complement and extend the reach of HIV prevention efforts implemented by state and local health departments to support the optimization of services across public, private, and other 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 CBOs must develop a work plan that includes (1) all required components listed below, and (2) any additional supplemental components or other approaches the organization selects to help achieve the overarching goals of the project. Specifically, the organization’s Comprehensive and Innovative Client-Centered HIV Prevention Program model will consist of the following program components: (1) program promotion; (2) client recruitment; (3) addressing health disparities; (4) enhanced HIV testing; (5) client centered program model inclusive of strategies to support linkage, re-engagement, and retention in care of HIV positive individuals; and (6) combination of structural, behavioral, and/or biomedical interventions that supports maximum reach and optimal outcomes. Funded organizations 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, grantees should examine and evaluate approaches that include the required components and those additional supplemental 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 organization’s jurisdiction. This framework acknowledges that prevention and care/treatment synergistically contribute to reducing HIV-related morbidity, mortality, and related health disparities among racial and ethnic minorities in the United States.

Funded organizations (grantees) are required to provide comprehensive HIV prevention services for HIV positive individuals and high risk negative individuals. Organizations may allocate up to 25% of the total award for the development and implementation of a Comprehensive and Innovative Client-Centered HIV Prevention Program for high risk negative individuals.

Program Implementation

Recipient (Grantee) Activities

A. General

All grantees must:

1. Establish and maintain a Consumer Advisory Board (CAB) comprised of members of the target population to assist with programmatic decision-making (e.g., program planning, implementation). Members of the target population must comprise at least 75% of the CAB membership. Remaining members must have HIV prevention and/or care experience and experience working with the target population. The CAB must be used throughout the project period to ensure services are responsive to the needs of the target population.

2. Ensure that services are culturally sensitive and relevant.

3. Implement a recruitment and retention strategy to include a social networking component known to be effective within the target population, with internet and other media-based strategies designed to reach persons at greatest risk for HIV acquisition or transmission. Traditional targeted outreach methods of recruitment and retention (e.g., street outreach) may also be used. Additional suggested strategies to promote programs and enhance recruitment include, but are not limited to, social marketing, peer networking, and STD clinic referrals. The grantee must seek input from the CAB and members of the target population on selecting appropriate recruitment and retention strategies and determining the appropriate use of incentives.

4. Develop and implement a staff development plan designed to promote and sustain peer leadership from within the target population of service. Grantees are expected to hire direct service staff reflective of the target population with minimally twelve months’ experience working with the target population.

B. HIV Prevention Risk Reduction Strategies and Services

All organizations are required to implement a Comprehensive and Innovative Client-Centered HIV Prevention Program that is composed of a combination of structural, behavioral, and/or biomedical interventions that supports maximum reach and optimal outcomes. Additionally, organizations are required to meet and/or exceed 80% of the required program SMART objectives.

1. Program Promotion and Client Recruitment

All funded organizations should 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 promote testing, linkage to, retention in, and re-engagement with care.

Organizations should collaborate with other organizations or agencies that have an established history working with the target population and can conduct outreach activities to recruit high-risk individuals at greatest risk for HIV acquisition or transmission (e.g., social networking component, internet-based outreach). The program must seek input from the CAB on selecting the appropriate program promotion and recruitment strategies and determining the appropriate use of incentives (i.e., monetary and non-monetary) for the program.

Client recruitment is essential to the success of an HIV prevention program. Moreover, use of internet and other media-based social marketing approaches to promote awareness of the HIV prevention program specifically within social networks persons at greatest risk for HIV acquisition or transmission are required.

Organizations should prioritize existing social media efforts that can be tailored to their jurisdiction’s specific requirements from CDC’s Act Against AIDS campaign (http://www.actagainstaids.org/about/index.html) as well as the more targeted campaigns from this effort, such as: (a) Testing Makes Us Stronger (www.hivtest.org/stronger) (b) Take Charge. Take the Test (http://www.actagainstaids.org).3

2. Enhanced HIV Testing

HIV testing is an essential part of a comprehensive HIV prevention program. Funded organizations will be required to implement enhanced HIV testing utilizing a brief risk reduction intervention, i.e., Personalized Cognitive Counseling (PCC), RESPECT and other strategies as determined by CDC as they become available, when appropriate and after completion of a risk assessment. Enhanced HIV testing personnel will be required to be trained in the effective behavioral interventions, Personalized Cognitive Counseling (PCC) and 2-session RESPECT (http://www.effectiveinterventions.org/en/Interventions).

Specifically, enhanced HIV testing with PCC is to be used with individuals who are identified as repeat testers, when appropriate. Repeat testers are described as individuals who have previously been tested and have engaged in unsafe sexual behaviors since the receipt of their last HIV test result. Enhanced HIV testing with RESPECT is to be implemented with individuals who are not identified as repeat testers.

Organizations applying for Category A or B that will be implementing Enhanced HIV testing primarily in a CBO clinical setting must provide enhanced HIV testing to a minimum of 700-1000 members of the target population annually. Organizations applying for Category A or B that will be implementing enhanced HIV testing primarily in a CBO non-clinical setting must provide enhanced HIV testing to a minimum of 400-600 members of the target population annually. Organizations applying for Category A or B that will be implementing enhanced HIV testing in a CBO non-clinical and clinical setting must provide enhanced HIV testing to a minimum of 600-900 members of the target population annually. Organizations are expected to establish their testing objectives based upon the size of the service area and the capacity of the organization to reach the target populations. The enhanced HIV testing program under Category A and B is required to reach and maintain a previously undiagnosed seropositivity rate between the minimum ranges of 2.0% - 4.0% on an annual basis.

Organizations must also:

a. Discuss their plans with the state or local health department (See Attachment II: List of HIV testing Requirements).

b. Follow current CDC guidelines and recommendations for HIV testing.

c. Integrate HIV testing into their overall HIV prevention program.

d. Develop strategies to recruit high-risk members of the target population who have not been tested in the past six months or do not know their HIV status.

e. Develop strategies to reduce the target population’s barriers to accessing HIV testing.

f. Ensure that individuals with reactive rapid HIV tests receive confirmatory tests, in accordance with state laws and regulations.

g. Ensure that individuals receive their test results, especially those who test positive.

Individuals recruited by the organization who are previously identified as being HIV positive must be linked directly to the risk reduction and prevention services available for HIV positive individuals. All individuals receiving HIV testing should be referred to additional services, as appropriate and as required by the HIV Prevention Programs for HIV positive Individuals.

A minimum of 90% of all HIV positive individuals (previously and newly diagnosed) must be linked to or re-engaged in to care and to appropriate risk reduction strategies and services for HIV positive individuals as required by the Comprehensive and Innovative Client-Centered HIV Prevention Program. Additionally, the organization must provide documentation of existing established agreement(s) with medical care provider(s) (i.e., community health centers (CHCs), public providers, etc.) describing the specific service agreement between the funded organization and the medical provider.

3. HIV Prevention Programs for HIV Positive Individuals

Organizations are required to develop a Comprehensive and Innovative Client-Centered

HIV Prevention Program model for HIV positive (newly and previously diagnosed) individuals that provide linkage to care and treatment services. Services should include linkage and referral to medical services, a combination of structural, behavioral, and/or biomedical interventions that support a maximum reach and optimal outcomes (e.g., interventions for sero-discordant couples, etc.), social services, and follow-up support to remove barriers to care and treatment.

Additionally, organizations must facilitate the provision of appropriate linkages and referrals for HIV positive individuals and should include the following services and strategies that support:

a. linkage to HIV/AIDS care and treatment services, including direct support and follow-up for re-engagement and retention in care services;

b. linkage to CD4 cell count and viral load screening;

c. linkage to treatment adherence services including, Anti-Retroviral Therapy (ART);

d. referral to Partner Services;

e. screening and treatment for STDs, viral hepatitis, and TB;

f. effective linkage to care models (e.g., ARTAS, navigator models, etc.);

g. enhanced comprehensive approach to clinical (e.g., CHCs, etc.) and non-clinical collaborations, such as network building and inclusion in a medical home model;

h. facilitate service agreements with CHCs and other providers that support the above services; and

i. additional essential support services.

The client centered program model should include a combination of strategies and services to continually engage HIV positive individuals who have not yet accepted their diagnosis and identified and deemed as ready for entry into care and treatment services.

Examples of these services are listed in the Comprehensive Coordinated Referral Network and Client Navigation Services sections of this funding opportunity announcement.

4. HIV Prevention Programs for High Risk Negative Individuals Organizations may allocate up to 25% of the total award for the development and implementation of the required Comprehensive and Innovative Client-Centered HIV Prevention Program model for high risk negative individuals. Services should include linkage and referral to a combination of structural, behavioral, and/or biomedical interventions that support a maximum reach and optimal outcomes (e.g., interventions for sero-discordant couples, etc.), social services, and follow-up support to remove barriers to care and treatment.

Additionally, organizations must facilitate the provision of appropriate linkages and referrals for high risk negative individuals and should include services and strategies that:

a. increase the number of persons who are aware of their HIV status;

b. reduce high risk behaviors;

c. expand medical and essential support service networks;

d. enhance comprehensive approach to clinical (e.g., CHCs, etc.) and non-clinical collaborations such as network building and inclusion in a medical home model;

e. facilitate service agreements with CHCs and other providers that support the above services; and

f. facilitate additional essential support services.

5. Structured Condom Distribution:

Free and accessible condoms are an integral component of the HIV prevention program. Organizations are expected to implement condom distribution programs which increase access to and use of condoms by HIV positive and high risk negative persons residing in Puerto Rico and US Virgin Islands. Effective condom distribution programs should adhere to the following principles: (1) provide condoms free of charge, (2) implement social marketing efforts to promote condom use by increasing awareness of condom benefits and normalizing condom use within communities, and (3) conduct both promotion and distribution activities at the individual, organizational, and community levels. Organizations are expected to distribute condoms to 100% of HIV positive individuals and high-risk negative individuals to whom services are provided. For additional information go to (http://www.effectiveinterventions.org/en/HighImpactPrevention/StructuralInterventions/CondomDistribution.aspx)

6. Service Integration Organizations with existing capacity to conduct integrated screening activities should continue implementing service integration activities; however, all organizations are encouraged to implement integrated screening activities (e.g., screening for STDs, viral hepatitis, and/or TB), after the receipt of appropriate training. Organizations are eligible to utilize up to 5% of the requested total funding amount to enhance support of integrated screening efforts.

a. Organizations proposing to implement integrated screening activities should do the following:

1) Work with STD, hepatitis, and TB programs to design, develop, and implement the activities.

2) Ensure that clients receive their test results, especially those who test positive.

3) Ensure that clients who test positive are linked to medical care and receive timely and appropriate evaluation and treatment.

4) For clients who test positive for other STDs, ensure that partner services are initiated as soon as possible after diagnosis, in accordance with CDC recommendations and state and local requirements.

5) For clients who are candidates for hepatitis A or B vaccination, provide referral or linkage to these services.

6) Periodically review monitoring data to assess the value of continuing screening for other STDs, viral hepatitis, and TB.

b. If proposing to implement integrated screening activities under this program:

1) Funds from this FOA may be used for other screening tests as described above only if the other tests are done in conjunction with HIV screening, are indicated by epidemiologic data, and are in accordance with current CDC guidelines and recommendations.

2) Funds from this FOA may not be used for clinical services (for example, treatment of HIV, STDs, viral hepatitis, TB, or TB infection; vaccination against hepatitis A or hepatitis B). Arrangements for these clinical services should be made through collaboration with STD, hepatitis, and TB programs or other clinical care providers.

c. If an organization is not proposing to implement integrated screening activities, that organization must develop a plan to link HIV positive and high risk negative individuals to local and/or state Health Departments, medical providers, or other service providers to ensure screening for STDs, viral hepatitis, and/or TB.

Funded organizations must develop a referral tracking system to determine and document successfully accessed referral services (e.g., a client referred for medical care is verified to have attended at least one medical appointment).

7. Client Navigation Services Organizations are required to develop or enhance systems for providing client navigation services (assisting patients in obtaining necessary information, support, and skills to access complex medical systems) for HIV positive and high risk negative individuals at all stages of care, treatment, prevention, and essential support services. Navigation should incorporate peer-to-peer services to:

a. support the development of a peer mentoring program that focuses on recruitment and training of peers;

b. provide services that reduce and/or eliminate barriers to care and services, such as accompanying individuals to medical appointments, providing transportation services, etc.; and

c. navigate essential support services that address acceptance, responsibility, behavior change, etc.

C. Enhanced HIV Prevention Planning and Infrastructure

1. Organizational Strategic Plan Strategic planning is a process used to define or enhance an organization’s strategy or direction for future planning. The development of the National HIV/AIDS Strategy and the High-Impact HIV Prevention approach necessitates organizations to realign their HIV prevention programs appropriately to ensure optimization of HIV prevention efforts that scalable, cost-effective, and evidence based.

Within the first three (3) months of funding, organizations must submit a copy of their most recent strategic plan; the strategic plan must have been completed within the last 24 months. If the strategic plan was not completed within the last 24 months, the organization must submit an outline of a strategic plan proposal that describes the strategic planning process in detail and is facilitated by an individual external to the organization.

Organizations that have completed a strategic planning process within the last 24 months, must provide an addendum to the strategic plan that describes the processes to be implemented to refine existing HIV prevention strategies, develop new innovative HIV prevention strategies, and build the capacity of the organization to provide a continuum of HIV prevention and care services that support the comprehensive HIV jurisdictional plan, goals of the National HIV/AIDS Strategy, and High-Impact HIV Prevention.

Organizations that have not completed a strategic planning process within the last 24 months must include a section in the strategic plan that describes the processes to be implemented to refine existing HIV prevention strategies, develop new innovative HIV prevention strategies, and build the capacity of the organization to provide a continuum of HIV prevention and care services that support the comprehensive HIV jurisdictional plan, goals of the National HIV/AIDS Strategy, and High-Impact HIV Prevention.

2. Coordination and Collaboration with Health Departments and HIV Planning Groups (HPG)

Organizations selected for funding must coordinate and collaborate with state and local health departments. Specifically, funded organizations are expected to:

a. Refer HIV-infected clients to Partner Services (PS) provided through the health department, as required by local and/or state regulations.

b. Participate in the state and/or local HIV prevention HPG process.

c. Support the integration of HIV prevention activities with STD, viral hepatitis, and TB screening and prevention services, whenever feasible and appropriate.

d. Establish contact, with other organizations serving populations of interest in the target service area (to facilitate dialogue and explore partnership opportunities related to HIV/STD prevention and health and wellness approaches including sexual health.

Note: Organizations located in the twelve jurisdictions funded to implement the Enhanced Comprehensive HIV Prevention Planning and Implementation for Metropolitan Statistical Areas most affected by HIV/AIDS project are encouraged to collaborate with the local health department to maximize the impact of HIV prevention activities.

3. Monitoring and Evaluation

a. Develop a Monitoring and Evaluation Plan - Funded organizations must work with CDC to develop and implement a process monitoring plan and conduct routine monitoring and evaluation for each intervention and/or service they provide. For organizations that are selected for funding, CDC will provide a template and technical assistance for developing a process monitoring plan at the time of award. At a minimum, the monitoring plan will include the following:

1) Program goals and measurable objectives.

2) Activities that will be conducted to meet the objectives.

3) Data collection plans, responsible staff, timelines, and tools/data resources (See Attachment XI: M&E Resource Tool).

4) How data will be used, by whom, and when to measure progress towards meeting objectives.

5) Procedures to ensure that data quality and security are consistent with CDC guidelines.

6) A logic model for each strategy and service being implemented

b. Data Collection and Reporting - Organizations selected for funding must collect and report data consistent with CDC requirements. This includes but is not limited to standardized data reporting as described under the OMB ICR #0920-0696. Specifically, funded organizations must do the following:

1) Designate a specific staff person to review program monitoring data at defined intervals in order to assess how well the program is functioning and use this information to continually assess and improve program performance.

2) Collect and report standardized data on the following: (1) budget and other characteristics of the agency; (2) all HIV prevention activities funded under this announcement, including behavioral interventions, CRCS with CLEAR, and enhanced HIV testing; (3) client-level information on demographic and risk characteristics of the grantee’s HIV prevention program clients; (4) aggregate data for outreach and recruitment activities; and (5) other information that may be needed to adequately describe the grantee’s program.

3) Use the CDC-required data reporting software (EvaluationWeb®) or other CDC approved reporting system to report required data electronically unless alternative arrangements have been made in the organization’s jurisdiction for directly-funded CBOs to submit data to CDC through the state’s system.

4) Designate specific staff responsible for management, reporting, use, and security of all data collected for purposes of this program.

5) Report core program performance indicators for HIV prevention activities as specified in CDC’s technical assistance guidelines for HIV prevention program indicators; CDC will provide these guidelines.

6) Ensure that all staff responsible for data collection and management are appropriately trained on the use of CDC-required data reporting software (EvaluationWeb®) or other CDC approved reporting system and on National HIV Monitoring and Evaluation (NHME) data for routine reporting.

7) Designate a specific staff person to review program monitoring data at defined intervals in order to assess how well the program is functioning and use this information to continually assess and improve program performance.

c. Information System and Data Security Requirements - 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 agency is required to comply with the applicable provisions of the Privacy Act and to undertake other safeguards for individuals and establishments against invasion of privacy. To provide these safeguards in performance of the contract, the agency must:

1) Agree to sign a Memorandum of Understanding (MOU) indicating that all information will be adequately protected according to H.19 308(d) Contract Clause for Safeguards for Individuals and Establishments against Invasions of Privacy (See Attachment III: MOU between the Centers for Disease Control and Prevention and Directly Funded Agencies for use of CDC-Licensed or Owned Data Systems).

2) Agree to sign the Rules of Behavior (ROB) document for system administrators and the users (See Attachment IV: Rules of Behavior for use of CDC-Licensed or Owned Data Systems System Administrators).

3) Comply with all federal (i.e., HHS, and/or CDC) information systems and information processing security policies and regulations in performance of the security requirements and deliverables and be bound by the Assurance of Confidentiality (available from the CDC COTR).

4) Develop system rules of behavior for systems under the agency’s responsibility.

5) Conduct a privacy impact assessment (PIA) on all information systems acquired, developed, or used in conjunction with CDC data.

6) Conduct annual reviews and validations of system user accounts to ensure continued need for access to system.

7) Annually review security controls and measures to ensure continued compliance with federal information system and data security regulations and identify security vulnerabilities.

8) Develop policies and procedures that clearly describe the physical security of the facility/facilities that will be used during the project; the procedures for protection, controlling, and handling data during performance of the project including any development and testing activities; any required limitations on employees concerning the reproduction, transmission, or disclosure of data and project information; the physical storage procedures to protect data; the procedures for the destruction of source documents and other contract-related waste material; and personnel security procedures.

d. Quality Assurance - Organizations selected for funding within the first 6 months of funding must develop, implement, and maintain a quality assurance plan to monitor program activities, consistently review and use program data on a routine basis to improve the program, and plan for future programs. The plan should be written and include processes to ensure the following:

1) Interventions and services are delivered in an appropriate, competent and sensitive manner, and policies and procedures supporting appropriate culturally sensitive service delivery are made available to all program staff.

2) Interventions are being delivered with fidelity (e.g., observation of staff) and

3) Interventions and services are meeting the needs of the target population (e.g., client satisfaction surveys).

4) Client Records and Program Data Management - Organizations selected for funding must develop systems for maintaining client records and managing program data related to the intervention, including assuring client confidentiality and adhering to policies and practices for data security and Web-based reporting.

4. Staffing

Organizations selected for funding must ensure that the program is adequately staffed for the following:

a. Planning and oversight of the intervention(s) or strategies.

b. Delivery of the strategies and services.

c. Collecting, entering, analyzing, and using standardized program monitoring data and program performance indicators related to the intervention(s) or strategies and reporting data and indicators to CDC.

d. Quality assurance activities that will be conducted for each of the intervention(s) or strategies.

e. Maintenance of client records and management of program data related to each of the intervention(s) or strategies.

f. Consistent, culturally sensitive, and age-appropriate staffing of program services and activities, including settings, venues, and locales where services will be provided.

g. Developing and ensuring that data security and confidentiality guidelines meet the federal requirements, continually consulting with CDC and annually reviewing security controls and measures to ensure continued compliance with federal information system and data security regulations and identifying security vulnerabilities.

5. Staff Development

Organizations selected for funding must ensure that program staff is adequately trained on the following:

a. Culturally sensitive and age-appropriate planning and oversight of the agency’s prevention program.

b. Delivering the intervention(s) or strategies and related skills, such as group facilitation, program monitoring and evaluation.

c. CDC data collection, data use, and reporting requirements.

d. Conducting quality assurance for each of the intervention(s) or strategies.

e. Appropriately accessing identifiable and confidential information. Training should be conducted annually for all agency personnel who have access to and review of aggregate and client level data.

f. Developing sensitivity and skills to interact with individuals who are at high risk of acquiring or transmitting HIV.

6. Additional Required Grantee Activities for HIV Prevention Programs

a. Within the first three (3) months of funding, organizations selected for funding must work with CDC-funded Capacity Building Assistance (CBA) providers, as identified by the Division of HIV/AIDS Prevention, Capacity Building Branch, to develop and implement a Strategic Plan for Enhanced CBO Capacity. This tailored plan will assess and define the organization’s capacity building goals, objectives, activities, timelines, and roles and responsibilities of the provider and grantee of CBA services and will describe an ongoing program improvement process which will include use of program monitoring and evaluation data as described above.

b. Within the first three (3) months of funding, participate in CDC-approved trainings. In particular, organizations must participate in CDC-approved trainings on data collection and submission, HIV testing, etc.

c. Within three (3) months after being selected for funding, a statement must be provided that the agency agrees to:

1) Develop a formal agreement, such as a memorandum of agreement (MOA), with each collaborating agency serving persons identified through the program. The direct and primary grantee in a cooperative agreement program must perform a substantial role in carrying out project outcomes and not merely serve as a conduit for an award to another party or provider who is ineligible.

2) Grantees are required to submit fully executed MOAs and/or Service Agreements with each subcontracted agency describing, at a minimum, the roles and responsibilities, key contact personnel for both the grantee and the subcontracted agency(s), and agreed upon program deliverables.

d. Submit a copy of the proposed material to CDC's Grants Management Office for approval if the organization plans to use materials and include the name or logo of either CDC or the Department of Health and Human Services (HHS).

e. Convene a local materials review panel or utilize the local health department materials review panel to comply with CDC’s Assurance of Compliance with the Requirements for Contents of AIDS Related Written Materials Form (Attachment V: CDC Form 0.1113 Assurance of Compliance with the Requirements for Contents of AIDS-Related Written Materials). The current guidelines and the form may also be downloaded from the CDC website: http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm.

f. Submit any newly-developed public information resources and materials to the CDC National Prevention Information Network (NPIN) so they can be added to the database and accessed by other organizations and agencies. NPIN can be accessed through the following link: http://www.cdcnpin.org/scripts/index.asp.

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

CDC Activities

a. Collaborate with grantees and provide technical…