ps11-1113 final amend i 04.11.11.doc

AMENDMENT I (04/09/11):

1. Total page limitations increased to 65 pages per Category (p.27).

2. Page limitations for Risk Reduction Interventions and Services section increased to 55 pages (p. 30).

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 Young Men of Color Who Have Sex with Men and Young Transgender Persons of Color

Announcement Type: New Agency Funding Opportunity Number: CDC-RFA-PS11-1113

Catalog of Federal Domestic Assistance Number: 93.939

Key Dates:

Letter of Intent Deadline Date: April 4, 2011, 5:00pm Eastern Standard Time Application Deadline Date: May 17, 2011, 5:00pm Eastern Standard Time Additional Overview Content: Based on anticipated availability of funds, CDC expects to award up to 30 cooperative agreements under the Categories A and B. The average award will be approximately $300,000, with an individual floor of $250,000 and an individual ceiling of $600,000 (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 five years and is based on continued availability of funds. Funding under this FOA cannot be used to implement school-based HIV prevention programs.

Eligible applicants will be reviewed through a two-stage process. In the first stage, all eligible applications will be evaluated by an independent external review panel on the basis of each item referenced in Section IV: Application and Submission Information. In the second stage, the highest ranked applications will then be considered for a pre-decisional site visit (PDSV). Applications will be considered for funding only if they achieve a passing score on the PDSV.

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 announces the availability of fiscal year 2011 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 services for high risk Young Men of Color Who Have Sex with Men (YMSM of color) and their partners regardless of age, gender, and race/ethnicity.

Category B: HIV prevention services for high risk Young Transgender (YTG) persons of color and their partners regardless of age, gender, and race/ethnicity.

NOTE: Throughout this funding opportunity announcement, “young” and “youth” is specifically defined as individuals between the ages of 13 and 29 years.

Applicants should request funding to implement a Comprehensive HIV Prevention Program that supports the HIV prevention priorities outlined in their jurisdiction’s comprehensive HIV prevention plans. The applicant’s comprehensive HIV prevention program for YMSM of color and/or YTG persons of color will consist of the following program components: 1) client recruitment; 2) enhanced HIV testing; 3) risk reduction interventions and services through the implementation of one of the following: Comprehensive Risk Counseling Services (CRCS) with CLEAR: Choosing Life: Empowerment! Action! Results! an effective behavioral intervention (EBI), or an existing, locally developed, theory based intervention; 4) condom distribution; and 5) a coordinated referral network.

This opportunity is limited to non-profit organizations (e.g., community- and faith-based organizations) with experience working with the target populations and providing services to the target populations in the applicant’s service area. In addition, applicants must be located and provide services in one or more of the identified Metropolitan Statistical Areas (MSA): Atlanta-Sandy Springs-Marietta, GA; Austin-Round Rock, TX; Baltimore-Towson, MD; Baton Rouge, LA; Birmingham-Hoover, AL; Boston, Mass-NH; Charlotte-Gastonia-Concord, NC-SC; Chicago, IL-IN-WI; Cincinnati-Middletown, OH-KY-IN; Cleveland-Elyria-Mentor, OH; Columbia, SC; Columbus, OH; Dallas, TX; Denver-Aurora, CO; Detroit, MI; El Paso, TX; Houston-Baytown-Sugar Land, TX; Indianapolis, IN; Jackson, MS; Jacksonville, FL; Kansas City, MO-KS; Las Vegas-Paradise, NV; Los Angeles, CA; Memphis, TN-MS-AR; Miami-Fort Lauderdale, FL; Milwaukee-Waukesha-West Allis, WI; Minneapolis-St. Paul-Bloomington, MN-WI; Nashville-Davidson--Murfreesboro, TN; New Orleans-Metairie-Kenner, LA; New York, NY-NJ-PA; Orlando, FL; Philadelphia, PA-NJ-DE-MD; Phoenix-Mesa-Scottsdale, AZ; Raleigh-Cary, NC; Richmond, VA; Riverside-San Bernardino-Ontario, CA; San Antonio, TX; San Diego-Carlsbad-San Marcos, CA; San Francisco-Oakland, CA; San Jose-Sunnyvale-Santa Clara, CA; San Juan-Caguas-Guaynabo, PR; Seattle, WA; St. Louis, MO-IL; Tampa-St. Petersburg-Clearwater, FL; Virginia Beach-Norfolk-Newport News, VA-NC; Washington, DC-VA-MD-WV.

Program Collaboration and Service Integration (PCSI)

This program supports NCHHSTP’s overarching goal calling for program collaboration and service integration (PCSI). The rationale for PCSI is to maximize the health benefits that persons receive from prevention services by increasing service efficiency; maximizing opportunities to screen, test, treat, or vaccinate those in need of these services; improving the health among populations negatively affected by multiple diseases; improving operations through the use of shared data; and enabling service providers to adapt to, and keep pace with, changes in disease epidemiology and new technologies.

This announcement encourages and supports integration of diagnostic and prevention services for the Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV), hepatitis B virus, (HBV), sexually transmitted diseases (STD); and/or tuberculosis (TB) because of CDC’s greater understanding of the extent to which:

· STDs increase the risk for HIV infection.

· 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 theses 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 (for example, HIV/TB can be deadly, and TB accelerates HIV disease progression).

· Populations disproportionately affected by HIV are also disproportionately affected by infections with TB, HCV, HBV, and STDs.

Details of this strategy and approach are outlined in the NCHHSTP White Paper which can be found at http://www.cdc.gov/nchhstp/programintegration.

Reducing Health Disparities

The program supports efforts to improve the health of populations disproportionately affected by HIV/AIDS, viral hepatitis, STDs, and TB by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National HIV/AIDS Strategy (NHAS).

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. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. (See Attachment I: Glossary of Terms for definitions of health disparity, social determinants of health and health equity.).

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

Improving the Health and Well-being of MSM in the U.S.

Improving the health and well-being of gay and other MSM in the U.S. by promoting health equity and reducing HIV, STD, and viral hepatitis transmission is an important priority for NCHHSTP. Major social and structural barriers affect physical and mental health and limit the delivery, effectiveness, and impact of current prevention efforts. These barriers include stigma, homophobia, discrimination, racism, poverty, substance abuse, incarceration, and homelessness. Left unaddressed, these underlying barriers will continue to compromise the lives and the potential of current and emerging generations of gay, bisexual, and other MSM.

The 2010 NHAS identifies MSM as a priority population and also prioritizes the importance of “working together to advance a public health approach to sexual health that includes HIV prevention as one component.” Sexual health can be considered to be a state of physical, emotional, mental, and social, well-being in relation to sexuality. It is inextricably bound to both physical and mental health and is not limited to the absence of disease and dysfunction, and its importance extends across the lifespan. It includes the ability to understand and weigh the risks, responsibilities, outcomes, and impacts of sexual actions and to practice abstinence when appropriate, and requires a positive and respectful approach to sexuality and sexual relationships, and a respect for sexual rights.

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/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP):

· Decrease the annual HIV incidence rate.

· Decrease the rate of HIV transmission by HIV-infected persons.

· Decrease risky sexual and drug-using behaviors among persons at high risk for acquiring HIV.

· Increase the proportion of HIV-infected people in the United States who know they are infected.

· Increase the proportion of HIV-infected persons who are linked to prevention and care services

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 More than 25 years into the AIDS epidemic, over 576,000 Americans have lost their lives to AIDS. CDC estimates that 56,300 new HIV infections occurred in the United States in 2006. An estimated 1 million people in the United States are living with HIV/AIDS, and an estimated 21% do not realize that they are infected.1 The epidemic continues to have a disproportionate impact on racial/ethnic minorities, particularly African Americans, and gay and bisexual men.

CDC first began formally partnering with community-based organizations (CBOs) in the late 1980s to expand the reach of HIV prevention efforts. CBOs were, and continue to be, recognized as important partners in HIV prevention because of their history and credibility with the target populations; they have access to groups that may not be reached by other applicants or strategies. Over time, CDC’s program for HIV prevention by CBOs has grown in size, scope, and complexity, responding to the changes in the epidemic, including the introduction of new tools for prevention.

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.2 Through this new cycle, 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 funding opportunity announcement is targeted to groups especially at risk for HIV infection: Young Men of Color Who Have Sex with Men (YMSM of color) and Young Transgender (YTG) persons of color and their partners.

Men Who Have Sex with Men (MSM)

In 2006, MSM accounted for more than half (53%) of all new HIV infections in the United States, and MSM with a history of injection drug use (MSM-IDU) accounted for an additional 4% of new infections. At the end of 2006, more than half (53%) of all people living with HIV in the United States were MSM or MSM-IDU. Since the beginning of the US epidemic, MSM have consistently represented the largest percentage of persons diagnosed with AIDS and persons with an AIDS diagnosis who have died. Young people in the United States are at persistent risk for HIV infection; youth, or young people, are defined as persons who are 13 to 29 years of age.

This risk is especially notable for youth of minority races and ethnicities. Continual HIV prevention outreach and education efforts are required as new generations replace the generations that benefited from earlier prevention strategies. Young Men Who Have Sex with Men (YMSM), especially those of minority races or ethnicities, are at high risk for HIV infection. In the seven (7) cities that participated in CDC’s Young Men’s Survey during 1994 -1998, 14% of African American MSM and 7% of Hispanic MSM aged 15-22 years were infected with HIV.

In the US, about 16% of persons diagnosed with HIV in 2007 were aged 13-24 years, and three quarters of them were male. The majority of 13-29 year old males diagnosed with HIV in 2008 were blacks/African Americans (64%), followed by whites (18%), and Hispanics/Latinos (16%). In 2008, the diagnosis rate was four times greater among Hispanics/Latinos than whites.

In 2006, there were more new HIV infections (52%) among young black MSM (aged 13-29 years) than any other racial or ethnic age group of MSM. The number of new infections among young black MSM was nearly twice that of young white MSM and more than twice that of young Hispanic/Latino MSM.

Among all Hispanic/Latino MSM in 2006, the largest number of new infections (43%) occurred in the youngest age group (13-29 years), though a substantial number of new HIV infections (35%) were among those aged 30-39 years.

Complacency about HIV, specifically among MSM, may play a key role in perceived HIV risk, due to limited experience directly related to the severity of the early AIDS epidemic. Additionally, challenges for many MSM include maintaining safe behaviors over time, underestimating personal risk, and the false belief that because of treatment advances, HIV is no longer a serious health threat. Social and economic factors, such as homophobia, stigma, and the lack of access to health care may potentially increase risk behaviors or serve as potential barriers to accessing and receiving HIV prevention services by some MSM. There is an urgent need to expand access to proven HIV prevention interventions for gay and bisexual men, as well as to develop new approaches to fight HIV in this population.3 Transgender (TG) Persons

While state and local health departments have the option to and several do collect HIV surveillance data on transgender persons, the data is limited to the local level. CDC’s National Monitoring and Evaluation system (NHME) is able to capture Transgender specific HIV testing data such as “sex assigned at birth” and “current gender identity”; however, these data are not currently available. The limited data that CDC does have on infections among transgender persons points to heightened HIV positivity for transgender persons.

There is evidence that suggests HIV positivity is high among male-to-female (MTF) TG persons, especially African Americans. In 2008, a meta-analysis was performed on studies on MTFs; 28% tested positive, 12% self-reported as HIV-positive; HIV positivity among African Americans (56%) was >3 times higher than among Latinos (16%) or whites (17%); HIV risk behaviors were common among all male-to-female transgender persons.4

The lack of progress in HIV prevention for transgender persons can be attributed to the complexity of the epidemic affecting this population, specifically the occurrence of multiple public health problems directly related to HIV risk among transgender persons.5 Similar social and environmental factors that contribute to the transmission of HIV among MSM are also prevalent among transgender populations. Additionally, social and environmental factors affecting TG persons are related to poor mental health, substance use, violence and victimization, discrimination, and economic hardship. HIV prevention interventions for transgender persons require a multi-layered structured approach to address HIV prevention needs in this population.

Continual outreach and education is required as new generations replace the generations that benefitted from earlier prevention efforts. Testing should be encouraged and prevention programs should improve methods for reaching persons unaware of their HIV status, especially those in populations disproportionately at risk.

Purpose

The purpose of the program is to:

· Support the development and implementation of effective community-based HIV Prevention Programs that serve Young Men of Color Who Have Sex with Men (YMSM of color) and Young Transgender (YTG) persons of color and their partners at high risk for acquiring or transmitting HIV.

· Increase the number of YMSM of color and YTG persons of color who are aware of their HIV status and linked to care, treatment, and prevention services.

· Build the capacity of CDC-funded CBOs delivering selected structural interventions, behavioral interventions, outreach or enhanced HIV Testing to YMSM of color and/or YTG persons of color and their partners at high risk for acquiring or transmitting HIV.

· Ensure provision of HIV prevention and care services.

· Promote collaboration and coordination of HIV prevention efforts among CBOs, health departments, and private agencies.

NOTE: Throughout this funding opportunity announcement, “young” and “youth” is specifically defined as individuals between the ages of 13 and 29 years.

Objectives

The objectives of this program are to:

· Reduce HIV transmission.

· Ensure early diagnosis of HIV infection.

· Increase the use of evidence-based 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 YMSM of color and YTG persons of color 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). Specifically, reducing new HIV infections is a primary goal that has been identified in the NHAS. Preventing HIV infections among gay and bisexual men and transgender persons has been identified as a targeted strategy in achieving this goal. This program addresses NHAS priority recommendations and strategies including:

· Recommendations for essential prevention activities and services provided to gay and bisexual men.

· Recommendations for HIV prevention approaches for transgender persons.

· Integration of HIV prevention and care services.

· Address deficiencies in directing the needed proportion of resources to gay and bisexual males and transgender populations within racial/ethnic groups heavily impacted.

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.

· 1.3 Address HIV prevention in Asian American and Pacific Islander and American Indian and Alaska Native populations.

· 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.

Program Implementation

Recipient Activities

Funding Categories: Funding will be made available for activities under two categories.

· Category A: HIV prevention services for high risk YMSM of color and their partners regardless of age, gender, and race/ethnicity.

· Category B: HIV prevention services for high risk YTG persons of color and their partners regardless of age, gender, and race/ethnicity.

NOTE: Throughout this funding opportunity announcement, “young” and “youth” is specifically defined as individuals between the ages of 13 and 29 years.

Note: Organizations may apply for up to two categories, Category A and/or Category B. Under categories A and B, applicants may be required to implement or adapt (when appropriate) CDC program models, including DEBIs (See Attachment II: Procedural Guidance), to achieve effectiveness with YMSM of color and/or YTG persons of color. For an electronic version of the Procedural Guidance for Community-Based Organizations go to http://www.cdc.gov/hiv/topics/prev_prog/ahp/resources/guidelines/pro_guidance/pdf/ProceduralGuidance.pdf.

In addition, applicants applying for two categories must submit a separate project proposal and a detailed line-item budget and justification (with a sub-budget provided for each program model, e.g., Many Men Many Voices; CRCS; and CTR) for each category in which funding is being requested.

1. HIV Prevention Programs

A. General

All funded applicants must:

1) Seek to locate program activities in a setting that is a culturally and age-appropriate safe space for the target population. The safe space may be a designated and dedicated space within agency premises or may be located off-site within safe proximity of the applicant’s agency locale. The safe space will serve as an entry point for YMSM of color and/or YTG persons of color and also a locale for project activities. Each safe space should be designed to empower YMSM of color and/or YTG persons of color and to provide HIV/STD risk reduction skills. Ensuring the safety of all youth employed and served by the applicant must be an integral component of the applicant agency’s mission, values, and activities. The safe space must be supported by policies and procedures on discrimination and harassment that support an inclusive, affirming, and non-judgmental HIV prevention program. The safe space must also be supported by clear guidelines about interactions between staff (regardless of their age) and youth served by the agency.

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

3) Ensure that services are culturally sensitive and relevant.

4) 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 applicant must seek input from the Youth Advisory Board and members of the target population on selecting appropriate recruitment and retention strategies and determining the appropriate use of incentives.

5) When persons under the age of 18 years (either paid or volunteer) are involved in program outreach activities, caution and judgment must be used in determining the venues/situations where these workers are placed. Agencies must give careful consideration to the age-appropriateness of the activity or venue. Additionally, agencies must comply with all relevant laws and regulations regarding entrance into adult establishments/environments. Laws and curfews must be clearly outlined in required safety protocols developed and implemented within first 6 months of funding. Agencies are required to create internal policies in compliance with local/state laws and reporting requirements regarding sexual assault, rape, abuse or other illegal sexual activity with a minor. Effective training practices and implementation of policies/protocols must occur in the first 6 months of funding.

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

B. Risk Reduction Interventions and Services

All applicants are required to implement a Comprehensive HIV Prevention Program that is composed of the risk reduction interventions and services listed below. Funding under this FOA cannot be used to implement school-based HIV prevention programs.

1. Program Promotion and Client Recruitment

All funded applicants are required to actively promote their programs, collaborate with other organizations or agencies that have established history working with the target population and could conduct outreach activities to recruit high-risk persons into the grantee’s interventions and services and implement a recruitment strategy to reach persons at greatest risk for HIV acquisition or transmission (e.g., social networking component, internet-based outreach). The program must seek input from the Youth Advisory Board on selecting the appropriate program promotion and recruitment strategies and determining the appropriate use of incentives for the program.

Client recruitment is essential to the success of an HIV prevention program. In addition to traditional outreach, the use of recruitment and retention strategies based on experienced entry into social networks is known to significantly structure or influence the social lives of YMSM of color and YTG persons of color (e.g., the house ball scene, house parties, texting groups, Facebook networks) is required. Moreover, use of internet and other media-based social marketing approaches to promote awareness of the HIV prevention program specifically within social networks of YMSM of color and YTG persons of color are required.

2. Enhanced HIV Testing

HIV testing is an essential part of an 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) or other strategies as determined by CDC and 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 intervention, Personalized Cognitive Counseling (PCC), (http://www.effectiveinterventions.org/en/Interventions/PCC.aspx).

Specifically, enhanced HIV testing with PCC is to be used on 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.

Applicants applying for Category A must provide enhanced HIV testing to a minimum of 600 to 1000 YMSM of color annually. Applicants applying for Category B must provide enhanced HIV testing to a minimum of 75 to 150 YTG persons of color annually. Applicants are expected to establish their testing objectives based upon the size of their MSA and the capacity of the CBO to reach the target populations. The enhanced HIV testing program under both categories is required to reach and maintain a previously undiagnosed seropositivity rate of 4.0% on an annual basis.

Additionally, each applicant is required to provide linkage to care and treatment services for HIV positive individuals and their partners, including referral to partner services (PS), medical and social services, with follow-up support to remove barriers to care and treatment services, and demonstrated effective linkage to care models (e.g., ARTAS, navigator models). Additionally, applicants must also make appropriate referrals for high risk HIV negative persons with follow-up support to remove barriers to accessing HIV prevention services. Appropriate referrals for HIV positive and/or high risk negative individuals include, but are not limited: (1) linkage to HIV/AIDS care and treatment services, including direct support and follow-up for re-engagement and retention in care services, (2) linkage to CD4 cell count and viral load screening, (3) linkage to treatment adherence services including, Anti-Retroviral Therapy, (4) referral to Partner Services, (5) screening and treatment for STDs, Hepatitis C, and TB, (6) other area CDC funded HIV prevention programs [via state or local health departments and/or directly funded CBOs], (7) Syringe Services Programs, where available and in accordance with CDC/HHS policy, and other programs for active substance users, (8) drug treatment programs, (9) mental health counseling programs experienced with youth and young adults, (10) referral to pre-exposure prophylaxis and post-exposure prophylaxis, where available, (11) housing, (12) basic education continuation-completion services, and (13) employment readiness and referral programs, as appropriate.

Applicants must also:

a) Discuss their plans with the state or local health department (See Attachment IV: 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.

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

3. Interventions and Services (Evidence-Based Interventions or Locally- Developed Interventions or CRCS with CLEAR)

· For Medium Risk Negative Individuals- (See Attachment I: Glossary of Terms, for a detailed definition of Low/Medium risk negatives.) Applicants are required to provide brief risk reduction interventions, access to HIV prevention brochures, pamphlets, and prevention education websites, and referrals to appropriate evidence-based interventions off-site.

· For High Risk Negative Individuals- (See Attachment I: Glossary of Terms, for a detailed definition of high-risk negatives.) Applicants are required to choose to implement one of the following interventions or strategies: 1) Comprehensive Risk Counseling and Services (CRCS) with CLEAR; or 2) a locally developed theory-based intervention; or 3) an effective behavioral intervention (EBI) from the list below:

List of Approved DEBIs

MPowerment d-up: Defend Yourself!

· For HIV Positive Individuals- Applicants are required to choose to implement one of the following interventions or strategies: 1) Comprehensive Risk Counseling and Services (CRCS) with CLEAR; or 2) a locally developed theory-based intervention; or 3) an effective behavioral intervention (EBI) from the list below:

List of Approved DEBIs

Willow ( for YTG only)

Individuals recruited by the applicant 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 Coordinated Referral Network. In addition, a minimum of seventy percent (70%) of all HIV positive individuals (previously and newly diagnosed) must be linked directly to appropriate risk reduction intervention and strategies for HIV positive individuals as required by the Coordinated Referral Network, which would include care.

4. Condom Distribution

Free and accessible condoms are an integral component of the HIV prevention program. Applicants are expected to implement condom distribution programs which increase access to and use of condoms by YMSM of color and YTG persons of color. 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. Applicants are expected to distribute condoms to 100% of HIV positive individuals and high-risk negative individuals.

5. Coordinated Referral Network and Service Integration

Applicants must develop and sustain a coordinated referral network. The Coordinated Referral Network must provide for, as appropriate: (1) linkage to HIV/AIDS care and treatment services, including direct support and follow-up for re-engagement and retention in care services, (2) linkage to CD4 cell count and viral load screening,

(3) linkage to treatment adherence services including, Anti-Retroviral Therapy,

(4) referral to Partner Services, (5) screening and treatment for STDs, hepatitis, including hepatitis B vaccinations, and TB, (6) other area CDC funded HIV prevention programs [via state or local health departments and/or directly funded CBOs], (7) referral to Syringe Services Programs, where available and in accordance with HHS/CDC policy, and other programs for active substance users, (8) drug treatment programs, (9) mental health counseling programs experienced with youth and young adults, (10) referral to pre-exposure prophylaxis and post-exposure prophylaxis, where available, (11) housing, (12) basic education continuation-completion services, and (13) employment readiness and referral programs.

Specifically, referral networks for HIV positive individuals must include: (1) linkage to HIV/AIDS care and treatment services, including direct support and follow-up for re-engagement in care services, (2) linkage to treatment adherence services, (3) referral to Partner Services (PS), and (4) demonstrated effective linkage to care models (e.g., ARTAS, navigator models).

Applicants with existing capacity to implement integrated screening activities (e.g., screening for STDs, viral Hepatitis, and/or TB) should continue implementing service integration activities and are eligible to utilize up to 5% of the requested total funding amount to enhance these efforts.

a) If proposing to implement integrated screening activities, applicants 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 implementing 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.

Funded applicants 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).

6. Monitoring and Evaluation

a) Develop a Monitoring and Evaluation Plan- Funded applicants 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 applicants 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, proposed staffing, timelines, and tools.

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.

b) Data Collection and Reporting- Applicants selected for funding must collect and report data consistent with CDC requirements. {See Attachment V: PS11-1113 National HIV/AIDS Monitoring and Evaluation (NHME) Data Set.} This includes but is not limited to standardized data reporting as described under the OMB ICR #0920-0696. Specifically, funded applicants must do the following:

1) Collect and report standardized data on the following: 1) budget and other characteristics of the applicant 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.

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

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

4) Report core program performance indicators for HIV prevention activities as specified in CDC’s technical assistance guidelines for HIV prevention program indicators. The data needed for calculating these indicators are included in the required variables listed in item (1) above. CDC will provide these guidelines.

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

6) 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 VI: 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 VII: Rules of Behavior for use of CDC-Licensed or Owned Data Systems System Administrators).

3) Ensure all employees sign a Non-Disclosure Agreements (NDA) and submit the NDA to CDC prior to the commencement of work. (See Attachment VIII: Contractor’s Pledge of 308(d) Confidentiality Safeguards for Individuals and Establishments Against Invasion of Privacy).

4) 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). (See Attachment IX: Security Summary for NHME).

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

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

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

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

9) 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- Applicants selected for 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- Applicants 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.

7. Staffing

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

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

b) Delivery of the intervention(s) or strategies.

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 youth program settings (e.g., safe space) venues and locales, and staffing of youth program services and activities.

g) Developing and ensuring that data security and confidentiality guidelines meet the federal requirements and 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.

8. Staff Development

Applicants 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 youth 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. As a part of their training staff and agency volunteers, if applicable, must read the assurance of confidentiality and sign confidentiality pledges. Specifically, each employee of the agency must sign the Non-Disclosure Agreements (Attachment VIII: Contractor’s Pledge of 308(d) Confidentiality Safeguards for Individuals and Establishments Against Invasion of Privacy). The training should be conducted annually for all agency personnel who have access to and review aggregate and client level data.

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

9. Coordination and Collaboration with Health Departments and Community Planning Groups (CPG)

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

a) Refer HIV-infected clients to Partner Services (PS) provided through the health department.

b) Participate in the state and/or local HIV prevention community planning group 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 geographical area (e.g., schools, youth-serving organizations, GLBT health organizations, faith-based organizations, juvenile detention) to facilitate dialogue and explore partnership opportunities related to HIV/STD prevention and health and wellness approaches including sexual health.

Note: Applicants 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.

10. Additional Required Grantee Activities for HIV Prevention Programs

a) Within the first six months of funding, applicants selected for funding must work with CDC-funded CBA providers to develop and implement a Strategic Plan for Enhanced CBO Capacity. This tailored plan will assess and define the CBO’s capacity building goals, objectives, activities, timelines, and roles and responsibilities of the provider and recipient 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 six months of funding, participate in CDC-approved trainings. In particular, grantees must participate in CDC-approved trainings on data collection and submission, HIV testing and/or CRCS prior to the implementation of program activities.

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

1) Have at least one YMSM of color and/or YTG persons of color, actively…