cdc-rfa-ps-15-1506.pdf

Centers for Disease Control and Prevention

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

Health Department Demonstration Projects to Reduce HIV Infections and Improve Engagement in HIV

Medical Care among Men Who Have Sex with Men (MSM) and Transgender Persons

CDC-RFA-PS15-1506

Health Department Demonstration Projects to Reduce HIV Infections and Improve Engagement in HIV Medical Care among Men Who Have Sex with Men (MSM) and Transgender Persons

CDC-RFA-PS15-1506

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-PS15-1506. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) B. Funding Opportunity Title:

Health Department Demonstration Projects to Reduce HIV Infections and Improve Engagement in HIV Medical Care among Men Who Have Sex with Men (MSM) and Transgender Persons C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc.gov/od/science /integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-PS15-1506

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.940 F. Dates:

1. Due Date for Letter of Intent (LOI): N/A

2. Due Date for Applications: [Insert 60 days from date of publication], 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: N/A

G. Executive Summary:

1. Summary Paragraph:

Gay, bisexual and other men who have sex with men (MSM) remain the population most heavily affected by HIV infection in the United States (US). Transgender persons and other populations with ongoing risk behavior are also at high risk for HIV infection. [Note: In this announcement, transgender persons include individuals who identify their gender as transgender and have sex with men.] High-impact HIV prevention approaches need to be implemented by state, local and territorial health departments to reduce new HIV infections among these populations. Pre-exposure prophylaxis (PrEP) is a potent new prevention tool for HIV-negative MSM, transgender persons, and other populations with ongoing risk behavior who are at substantial risk of acquiring infection (http://www.cdc.gov/hiv/pdf/PrEPguidelines2014.pdf). Another potent prevention tool is the use of antiretroviral treatment to suppress HIV-1 viral load to improve health outcomes and reduce transmission risk among people living with HIV (PLWH). The importance of HIV treatment has increased focus on interventions and public health strategies designed to link , engage and re-engagePLWH in healthcare. “Data to Care” is a strategy for identifying diagnosed PLWH who are not in HIV medical care. The purpose of this Funding Opportunity Announcement is to support health departments in the US to implement PrEP and Data to Care demonstration projects prioritizing MSM and transgender persons at high risk for HIV infection, particularly persons of color, recognizing that the population with the highest incidence of HIV in the U.S. is young African American MSM.

a. Eligible Applicants: Limited https://foa.grantsolutions.gov/announcementmodule/www.grants.gov https://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov http://www.cdc.gov/hiv/pdf/PrEPguidelines2014.pdf

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 24

d. Total Project Period Funding: $125,000,000

e. Average One Year Award Amount: $2,900,000

f. Number of Years of Award: 3

g. Estimated Award Date: 08/01/2015

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program.Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview

State, local and territorial health departments in the US are implementing high impact HIV prevention programs to reduce new HIV infections among populations of gay, bisexual, and other men who have sex with men (MSM) and transgender persons. Additional effort is needed to realize the benefits of new prevention strategies that have the potential to significantly reduce new HIV infections and increase viral suppression among MSM and transgender persons.

Pre-exposure prophylaxis (PrEP) is a potent new prevention tool for MSM without HIV but who are at substantial risk of acquiring HIV infection. The daily use of oral, antiretroviral medication (PrEP) with co-formulated tenofovir disoproxil fumarate and emtricitabine (marketed as Truvada®) is proven to significantly reduce the risk of HIV acquisition among sexually active adults. In July 2012, the US Food and Drug Administration approved an HIV prevention indication for Truvada, and in May 2014 CDC published Public Health Service clinical practice guidelines for provision of PrEP to persons at substantial risk of HIV acquisition through sexual or injection routes of transmission as part of a package of HIV prevention clinical services. It is critical for health departments to address barriers to and facilitate broader awareness, support and capacity for the scale-up of PrEP services for MSM and transgender persons at high risk for HIV infection, particularly persons of color, recognizing that the population with the highest incidence of HIV in the U.S. is young African American MSM.

Another potent prevention tool involves antiretroviral medication to suppress HIV-1 viral load, improve health outcomes and reduce transmission risk among people living with HIV (PLWH). The importance if antiretroviral treatment has increased focus on interventions and public health strategies designed to link, engage and re-engage persons living with HIV in health care, with the ultimate outcome of suppressing HIV viral load, decreasing morbidity and increasing survival. To increase viral suppression, more people who are diagnosed with HIV will need to be retained in HIV medical care and receive antiretroviral treatment. There is a need for health departments to implement public health strategies for improving linkage, engagement and re-engagement of MSM and transgender persons who are not in care. Data to Care is a public health strategy for identifying these individuals. Data to Care is based on the use of surveillance data to intervene directly in disease control. Data to Care programs use laboratory reports received by a health department's HIV surveillance program, and a range of other data sources as markers of HIV care, and analyze these reports to confidentially identify HIV-diagnosed individuals who are not engaged in HIV medical care or have not achieved viral suppression. Several state health departments have taken steps toward initiating a Data to Care program, and a few have reported successful implementation of Data to Care activities. It is important that these efforts be expanded and that other state, local and territorial health departments scale up and implement this promising public health strategy to improve outcomes along the HIV continuum of care and prevent new HIV infections.

The purpose of this FOA is to support awards for up to 24 health departments in the United States to implement PrEP and Data to Care demonstration projects prioritizing MSM and transgender persons at high risk of HIV infection, particularly persons of color. Health departments that are funded under this FOA will be required to prioritize their services to these populations. Services may also be provided for persons at substantial risk for HIV (for PrEP) or persons who have HIV and are not virally suppressed or have ongoing risk behavior (for Data to Care) who are not MSM or transgender.

b. Statutory Authorities

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

c. Healthy People 2020

This FOA addresses the "Healthy People 2020" focus area of HIV. http://www.healthypeople.gov/2020/topic sobjectives2020/overview.aspx?topicid=2.

d. Other National Public Health Priorities and Strategies

1. The National HIV/AIDS Strategy: http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf

2. CDC Division of HIV/AIDS Prevention (DHAP) Strategic Plan: http://www.cdc.gov/hiv/pdf/policies_D HAP-strategic-plan.pdf

3. Executive Order (July 15, 2013): http://www.whitehouse.gov/the-press-office/2013/07/15/executive-order -hiv-care-continuum-initiative

4. Minority AIDS Initiative (MAI): http://www.hhs.gov/ash/ohaidp/initiatives/

5. CDC Winnable Battles: http://www.cdc.gov/winnablebattles/hiv/index.html

6. Affordable Care Act: http://aids.gov/federal-resources/policies/health-care-reform

7. The Rehabilitation Act and the Americans with Disabilities Act (ADA): http://www.ada.gov/cguide.htm

8. Standards for Privacy of Individually Identifiable Health Information: http://privacyruleandresearch.nih.gov

9. This FOA supports a holistic framework that enables NCHHSTP to 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. Additional information about these imperatives is available: http://www.cdc.gov/nchhstp

e. Relevant Work

This FOA builds upon current HIV prevention programs, projects, and technical assistance efforts including:

CDC-RFA-PS-12-1201, “Comprehensive HIV Prevention Programs for Health Departments” http://www.cdc .gov/hiv/policies/funding/announcements/ps12-1201/index.html

CDC-RFA-PS10-10181, “Enhanced Comprehensive HIV Prevention Planning and Implementation for Metropolitan Statistical Areas Most Affected by HIV/AIDS” http://www.cdc.gov/hiv/prevention/demonstration/echpp/ http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=2 http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=2 http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf http://www.cdc.gov/hiv/pdf/policies_DHAP-strategic-plan.pdf http://www.cdc.gov/hiv/pdf/policies_DHAP-strategic-plan.pdf http://www.whitehouse.gov/the-press-office/2013/07/15/executive-order-hiv-care-continuum-initiative http://www.whitehouse.gov/the-press-office/2013/07/15/executive-order-hiv-care-continuum-initiative http://www.hhs.gov/ash/ohaidp/initiatives/ http://www.cdc.gov/winnablebattles/hiv/index.html http://aids.gov/federal-resources/policies/health-care-reform http://www.ada.gov/cguide.htm http://privacyruleandresearch.nih.gov/ http://privacyruleandresearch.nih.gov/ http://www.cdc.gov/nchhstp http://www.cdc.gov/hiv/policies/funding/announcements/ps12-1201/index.html http://www.cdc.gov/hiv/policies/funding/announcements/ps12-1201/index.html http://www.cdc.gov/hiv/prevention/demonstration/echpp/

CDC-RFA-PS-12-1210, “Secretary’s Minority AIDS Initiative Funding for Care and Prevention in the United States (CAPUS) Demonstration Project” http://www.cdc.gov/hiv/policies/funding/announcements /ps12-1210/index.html

CDC-RFA-PS13-1302, “ National HIV Surveillance System (NHSS)” http://www.cdc.gov/hiv/policies/fundi ng/announcements/ps13-1302/index.html

CDC-RFA-PS14-1403, “Capacity Building Assistance (CBA) to Improve the Delivery and Effectiveness of Human Immunodeficiency Virus (HIV) Prevention Services for High-risk and/or Racial/Ethnic Minority Populations, Category C: CBA for Health Departments” http://www.cdc.gov/hiv/topics/funding/PS14-1403 /index.htm

CDC-RFA-PS14-1410, “Secretary’s Minority AIDS Initiative Funding to Increase HIV Prevention and Care Service Delivery among Health Centers Serving High HIV Prevalence Jurisdictions” http://www.cdc.gov/hiv /policies/funding/announcements/PS14-1410/index.html CDC–HCVJB2X2–2013-60075, “Data to Care: Providing technical assistance to state and local public health jurisdictions in their use of HIV surveillance data to support continuous, high-quality care for persons living with HIV”

CDC PrEP resources are available online:

Centers for Disease Control and Prevention. Pre-Exposure Prophylaxis (PrEP) Fact Sheet. Available at: http://www.cdc.gov/hiv/prevention/research/prep/.

Centers for Disease Control and Prevention: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2014 Clinical Practice Guideline. Available at: http://www.cdc.gov/hiv /pdf/guidelines/PrEPguidelines2014.pdf .

CDC Data to Care resources are available online:

Data to Care: Using HIV Surveillance Data to Improve the HIV Care Continuum. Available at: http ://www.effectiveinterventions.org/en/HighImpactPrevention/PublicHealthStrategies/DatatoCare.aspx.

Relevant citations:

Centers for Disease Control and Prevention. Estimated HIV incidence in the United States, 2007–2010. HIV Surveillance Supplemental Report 2012; 17(No. 4). http://www.cdc.gov/hiv/topics/surveillance/resources /reports/#supplemental. Published December 2012.

Centers for Disease Control and Prevention. HIV Testing at CDC-Funded Sites, United States, Puerto Rico, and the U.S. Virgin Islands, 2010. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; September 2012: 17.

Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 dependent areas—2011. HIV Surveillance Supplemental Report 2013;18(No. 5). http://www.cdc.gov/hiv/library/reports/surveillance/. Published October 2013.

Accessed 7 August 2014.

Centers for Disease Control and Prevention; US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014: a clinical practice guideline. 2014:1-67. http://www .cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf. Accessed 28 May 2014.

Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med, 2011;365(6)493-505.

Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. Dec 30 2010;363(27):2587-2599.

Grant, RM., Anderson PL, McMahan V, et al. "Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study." The Lancet infectious diseases. 2014. Doi: 10.1016/S1473-3099(14)70847-3.

http://www.cdc.gov/hiv/policies/funding/announcements/ps12-1210/index.html http://www.cdc.gov/hiv/policies/funding/announcements/ps12-1210/index.html http://www.cdc.gov/hiv/policies/funding/announcements/ps13-1302/index.html http://www.cdc.gov/hiv/policies/funding/announcements/ps13-1302/index.html http://www.cdc.gov/hiv/topics/funding/PS14-1403/index.htm http://www.cdc.gov/hiv/topics/funding/PS14-1403/index.htm http://www.cdc.gov/hiv/policies/funding/announcements/PS14-1410/index.html http://www.cdc.gov/hiv/policies/funding/announcements/PS14-1410/index.html http://www.cdc.gov/hiv/prevention/research/prep/ http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf http://www.effectiveinterventions.org/en/HighImpactPrevention/PublicHealthStrategies/DatatoCare.aspx http://www.effectiveinterventions.org/en/HighImpactPrevention/PublicHealthStrategies/DatatoCare.aspx http://www.cdc.gov/hiv/topics/surveillance/resources/reports/#supplemental http://www.cdc.gov/hiv/topics/surveillance/resources/reports/#supplemental http://www.cdc.gov/hiv/library/reports/surveillance/ http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

Herbst JH, Jacobs ED, Finlayson TJ, et al. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: A systematic review. AIDS Behav. 2008;12:1-17.

Johnson AS, Hall HI, Hu X, Lansky A, Holtgrave DR, Mermin J. Trends in Diagnoses of HIV Infection in the United States, 2002-2011. JAMA. 2014; 312(4):432-434. doi:10.1001/jama.2014.8534.

Purcell D, Johnson CH, Lansky A, et al. Estimating the population size of men who have sex with men in the United States to obtain HIV and syphilis rates. The Open AIDS Journal 2012; 6:98–107.

Sevelius JM, et al. HIV/AIDS programming in the United States: Considerations affecting transgender women and girls. Women’s Health Issues. 2011:21-6S; S278-S282.

Sweeney P, Gardner LI, Buchacz K, Garland PM, Mugavero MJ, Bosshart JT, et al. Shifting the paradigm:

Using HIV surveillance data as a foundation for improving HIV care and preventing HIV infection. Milbank Quarterly 2013; 91: 558–603.

2. CDC Project Description

a. Approach

i. Purpose

The purpose of this FOA is to support awards for up to 24 health departments in the United States to implement PrEP and Data to Care demonstration projects prioritizing populations of MSM and transgender persons at high risk for HIV infection, particularly persons of color. Health departments funded under this FOA will be required to prioritize their services to these populations. Services may also be provided for persons at substantial risk for HIV (for PrEP) or persons who have HIV and are not virally suppressed or have ongoing risk behavior (for Data to Care) who are not MSM or transgender.

ii. Outcomes

Key outcomes to be expected by the end of the project period are illustrated in the logic models for PrEP support projects (Category 1) and Data to Care projects (Category 2). Potential indicators that quantify these outcomes are described in Section b. Evaluation and Performance Measurement. Only the project period outcomes are listed below.

CATEGORY 1: PrEP SUPPORT DEMONSTRATION PROJECTS TARGETING MSM AND

TRANSGENDER PERSONS AT SUBSTANTIAL RISK OF ACQUIRING HIV

Short-Term Outcomes

Increased capacity of health departments to implement PrEP support activities for MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV at substantial risk for HIV Increased knowledge and awareness of PrEP, and training in clinical management of PrEP for HIV prevention among providers Increased knowledge and awareness of PrEP for HIV prevention among MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV Increased capacity of health departments to integrate services and share data across HIV, STD, and Hepatitis to help identify MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV who can benefit from PrEP

Intermediate Outcomes

Establishment of policies, procedures and protocols to implement PrEP support activities for MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV Increased number of providers trained to offer PrEP to MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV Increased number of MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV who are prescribed PrEP Establishment of policies, procedures and protocols to integrate services and share data across HIV, STD, and hepatitis to help identify MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV who can benefit from PrEP

CATEGORY 2: DATA TO CARE DEMONSTRATION PROJECTS THAT USE SURVEILLANCE

DATA SOURCES TO IDENTIFY MSM AND TRANSGENDER PERSONS NOT IN HIV CARE

Short-Term Outcomes

Increased capacity of health departments to implement Data to Care activities, including:

Confidential list of persons not in HIV medical care from routinely collected HIV surveillance data Processes for integrating existing STD, hepatitis and other surveillance data with lab reporting Agreements for data sharing between health department programs and health care providers when necessary for the purposes of Data to Care Data to Care protocols and standard operating procedures

Increased capacity of health departments to conduct outreach to HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who currently are not in HIV medical care

Intermediate Outcomes

Increased capacity of health departments to use surveillance and other data to accurately identify HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who currently are not in HIV medical care and reside in their jurisdiction Increased capacity of health departments to contact HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are not in HIV medical care Increased capacity of health departments to refer to HIV medical care HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, and who are not in care Increased proportion of all HIV-diagnosed MSM who are virally suppressed Reduced length of time between identification of and the successful engagement or re-engagement in HIV medical care of MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are not in care

iii. Strategies and Activities

CATEGORY 1: PrEP SUPPORT DEMONSTRATION PROJECTS TARGETING MSM AND

TRANSGENDER PERSONS AT SUBSTANTIAL RISK OF ACQUIRING HIV

Applicants should propose support activities to strengthen or enhance the ability to identify MSM and transgender persons who stand to benefit the most from PrEP, refer appropriate candidates to PrEP providers in the jurisdiction, and increase the number of providers knowledgeable and capable of offering PrEP to MSM and transgender persons at high risk for HIV infection, particularly persons of color. PrEP-related activities must be implemented as part of a comprehensive HIV prevention program that includes, when indicated, referral to prevention, screening and treatment services for STD, viral hepatitis, substance abuse, and mental health services.

Funds may not be used for PrEP medications (e.g., Truvada), laboratory testing related to PrEP (for example, creatinine tests, liver function tests, pregnancy tests, and other clinical tests that could result from evaluation of side effects/toxicities), or personnel costs for the provision of PrEP medication and recommended clinical care associated with PrEP. Funds may be used for HIV tests, hepatitis B screening, and STD testing.

However, grantees should coordinate these services and seek payment from other sources, where available.

Possible payment sources that should be explored include Medicaid, Medicare, and private health insurance.

Early activities for all proposed demonstration projects include: create new or expand existing partnerships with community-based organizations, LGBT organizations, private health care providers, clinics and community health centers including STD clinics that serve MSM and transgender persons; identify and convene Community Advisory Boards to inform program planning and implementation processes; develop provider buy-in and support; develop local evaluation framework for activities; and assure compliance with CDC/NCHHSTP Security and Confidentiality Guidelines across all programs.

Example PrEP support activities that can be implemented by health departments include:

Training for clinicians about PrEP including its safety and efficacy, for whom it is indicated, and recommended clinical procedures either directly or in collaboration with local partners (for example, HIV/STD Prevention Training Centers, HRSA funded AIDS Education and Training Centers, PrEP Warmline) Training for counselors about PrEP and methods to support medication adherence and maintain sexual risk reduction practices The development of policies that support the use of PrEP as an HIV prevention tool in accordance with clinical guidelines Create or identify educational materials including online and mobile tools for providers and consumers describing the safety and effectiveness, recommended clinical practices for providing PrEP-related clinical care, and the local availability of PrEP providers Develop and conduct media campaigns for providers and consumers to increase awareness of PrEP availability in the local area Using disease intervention specialists (DIS) to refer consumers to PrEP services when indicated, consistent with PrEP Guidelines Provide screening for indications for PrEP (i.e., level of risk for HIV acquisition) as a routine procedure in conjunction with receiving HIV-negative test results and provision of other offers of services and screening for STDs.

Enhance PrEP activities through integration with STD and hepatitis screening services Referral of consumers to PrEP providers in the local area Develop procedures for health department staff to help providers and consumers navigate public and private programs that provide or reimburse for PrEP

CATEGORY 2: DATA TO CARE DEMONSTRATION PROJECTS THAT USE SURVEILLANCE

DATA SOURCES TO IDENTIFY MSM AND TRANSGENDER PERSONS NOT IN HIV CARE

Applicants should propose activities that support expanding or enhancing their ability to use HIV surveillance data and other data sources, as appropriate, to improve clinical outcomes along the HIV continuum of care for MSM and transgender persons. These activities use lab reports received by a health department’s surveillance system as markers for HIV care. Health departments should use these data to generate lists of individuals that may not have been linked to or who may have dropped out of HIV medical care. Several strategies, including conferences with health care providers and clinic staff, can occur to determine which names on the list are likely not in HIV care and should be prioritized for outreach. To improve outcomes along the continuum of HIV care for MSM and transgender persons who have sex with men, applicants should propose activities that use available data to improve identification, linkage to care, or re-engagement in care among persons not in care. These are key antecedents to improve HIV viral suppression among persons in care.

Funds may not be used for clinical care or HIV medications (antiretroviral therapy).

Early activities for all proposed demonstration projects include: create new or expand existing partnerships with community-based organizations, LGBT organizations, private health care providers, clinics and community health centers; identify and convene Community Advisory Boards to inform program planning and implementation processes; develop provider buy-in and support; develop local evaluation framework for activities; assure compliance with CDC/NCHHSTP Security and Confidentiality Guidelines across all programs; and review of state and local laws and regulations affecting collection and use of HIV surveillance data (for Data to Care activities).

Example activities that can be implemented by health departments in support of Data to Care include:

Develop organizational procedures, policies and protocols to use HIV surveillance data, as needed, to engage or re-engage HIV-diagnosed MSM, transgender persons, and other persons who have HIV and are not virally suppressed or have ongoing risk behavior in HIV medical care so they can achieve HIV viral suppression Develop confidential list of persons not in HIV medical care from routinely collected HIV surveillance data Develop agreements for data sharing across programs when necessary for the purposes of Data to Care Enhance Data to Care activities through integration with STD and Hepatitis surveillance data and referrals via existing programs to help identify MSM, transgender persons, and other persons not in HIV care who have HIV and are not virally suppressed or have ongoing risk behavior Enhance capacity to implement Data to Care activities through staff training, hiring new staff or redirecting staff activities, working with community-based organizations, or other efforts that build capacity to implement robust Data to Care activities Other activities can include:

Review state and/or local laws and regulations affecting collection and use of HIV surveillance data and other data sources as appropriate Community engagement activities to share plans for Data to Care, gather input on the program from affected communities, and to enlist support for the Data to Care activities Collaborate with local providers and organizations to develop and/or improve procedures to share data including across program areas when necessary Use of HIV surveillance data to help identify persons not in care and prioritize them for engagement or re-engagement in care activities Activities that match lists of patients not in HIV care with lists of persons with recent STD, Hepatitis or TB infections to prioritize outreach.

Other potential activities are discussed at http://www.effectiveinterventions.org/en/HighImpact Prevention/PublicHealthStrategies/DatatoCare.aspx

1.Collaborations

a. With CDC-funded programs:

http://www.effectiveinterventions.org/en/HighImpactPrevention/PublicHealthStrategies/DatatoCare.aspx http://www.effectiveinterventions.org/en/HighImpactPrevention/PublicHealthStrategies/DatatoCare.aspx

Health department awardees are required to collaboratively partner with CDC. In addition, awardees should collaborate with other CDC-funded programs, where appropriate, to apply programmatic successes and lessons learned.

b. With organizations external to CDC:

For PrEP support projects, health departments should partner with HIV and other health care providers and organizations with experience providing medical care, reaching and engaging the target populations in the jurisdiction.

For Data to Care projects, health departments should partner with key HIV and other health care providers, and other engagement and re-engagement programs in the jurisdiction.

For all projects, health departments should create new or expand existing partnerships (as needed) with community-based organizations, LBGT organizations, private providers, clinics, and community health centers. Health departments should also identify and convene Community Advisory Boards.

2. Target Populations

Health departments should focus their activities on gay, bisexual, and other men who have sex with men (collectively referred to as MSM), and transgender persons at high risk for HIV infection, particularly persons of color. Applicants should describe how the work plan will impact the local HIV epidemic among these populations.

a. Inclusion

All applicants should design their program so that it is accessible and available to participants regardless of age, race/ethnicity, sexual orientation, gender identity, or socio-economic status. Additionally, all grantees should provide programs and services to multiple underserved populations including but not limited to racial/ethnic minorities, individuals with disabilities, and individuals with limited English proficiency. All applicants' activities should result in measurable improvements among target populations.

iv. Funding Strategy (for multi-component FOAs only)

N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Evaluation and performance measurement will demonstrate achievement of the work plan outcomes and show effective implementation of the program activities implemented by the health departments. Evaluation findings can be used by awardees and CDC to ensure continuous program and system improvement, help create an evidence-base for program activities to expand or enhance HIV prevention activities for MSM and transgender persons, and assess which activities are scalable and effective in various contexts.

The CDC strategy for monitoring and evaluating program and awardee performance will involve process and outcome data and will be consistent with the logic models (Categories 1 and 2) and approach presented above.

Awardees will be responsible for monitoring and evaluation of their own programs for continuing quality improvement. The CDC strategy will require the following from awardees: use approximately 10% of the overall budget to support local program evaluation of funded activities; collaborate with CDC in development of evaluation plans and data collection activities as appropriate; participate in data collection activities as appropriate; submit progress reports; conduct real-time documentation and tracking of program activities using existing health department and partnering agency IT applications; and periodic data entry and electronic submission of data and reporting information.

When possible, program effectiveness will primarily be assessed using short-term and intermediate outcome measures. Where appropriate, outcomes can be calculated using existing HHS-supported data sources (e.g., HIV case surveillance and HIV testing). CDC will also require the collection and reporting of data from health department staffs, and staff from partnering agencies (as appropriate) to measure additional program processes and outcomes. Guidance on program monitoring and evaluation and performance measures will be provided by CDC on an ongoing basis throughout the project period.

As stated above, the CDC evaluation strategy will assess grantees’ achievement of program goals in terms of process, organizational change, and short-term and intermediate outcomes. Cost indicators will also be collected. Indicators aligning with short-term and intermediate project outcomes are listed for each activity.

CATEGORY 1: PrEP SUPPORT DEMONSTRATION PROJECTS TARGETING MSM AND

TRANSGENDER PERSONS AT SUBSTANTIAL RISK OF ACQUIRING HIV

SHORT-TERM OUTCOMES:

Outcome: Increased capacity of health departments to implement PrEP support activities for MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV

Indicator: Developing draft policies, protocols and procedures, memoranda of agreement, and establish partnerships with key stakeholders to support PrEP activities

Outcome: Increase knowledge and awareness of PrEP, and training in clinical management of PrEP for HIV prevention among providers

Indicator: Creation or identification of educational materials and tools for providers, provision of clinical training to providers, and media campaigns as indicated by counts of materials/tools, trainings, media events

Outcome: Increase knowledge and awareness of PrEP for HIV prevention among MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV

Indicator: Creation or identification of educational materials and tools for consumers and media campaigns as indicated by counts of materials/tools and media events Indicator: Dissemination of educational materials and tools for consumers and media campaigns as indicated by counts of media events and dissemination activities

Outcome: Increased capacity of health departments to integrate services and share data across HIV, STD, and Hepatitis to help identify MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV who can benefit from PrEP

Indicator: Developing draft policies, protocols and procedures for integrating and sharing data across HIV, STD and Hepatitis for referring MSM, transgender persons, and other persons at substantial risk for acquiring HIV

INTERMEDIATE OUTCOMES:

Outcome: Establishment of policies, procedures and protocols to implement PrEP support activities for MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV

Indicator: Final written policies, procedures and protocols (e.g., health departments, clinics, health care providers) to support provision of PrEP to MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV

Outcome: Increased number of providers trained to offer PrEP to MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV

Indicator: Number of providers trained by the health departments or their agents to offer PrEP to MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV

Outcome: Increased number of MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV who are prescribed PrEP

Indicator: Number of MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV who are prescribed PREP

Outcome: Establishment of policies, procedures and protocols to integrate services and share data across HIV, STD and Hepatitis to help identify MSM and transgender persons at high risk for HIV infection, particularly persons of color, and other persons at substantial risk for HIV who can benefit from PrEP

Indicator: Final written policies, procedures and protocols (e.g., health departments, clinics, health care providers) to support integrating services and data sharing across HIV, STD and Hepatitis

CATEGORY 2: DATA TO CARE DEMONSTRATION PROJECTS THAT USE SURVEILLANCE

DATA SOURCES TO IDENTIFY NEWLY-DIAGNOSED MSM AND TRANSGENDER PERSONS

NOT IN HIV CARE

SHORT-TERM OUTCOMES:

Outcome: Increased capacity of health departments to implement Data to Care activities for HIV diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who currently are not in HIV medical care

Indicator: Development of procedures to create confidential list of persons not in HIV medical care from routinely collected HIV surveillance data; processes for integrating existing STD, Hepatitis and other surveillance data with lab reporting; agreements for data sharing between health departments and health care providers when necessary for the purposes of Data to Care;

and Data to Care protocols and standard operating procedures

Outcome: Increased capacity of health departments to conduct outreach to HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who currently are not in HIV medical care

Indicator: Number of staff trained to conduct outreach to HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who currently are not in HIV medical care

INTERMEDIATE OUTCOMES:

Outcome: Increased capacity of health departments to use surveillance and other data to accurately identify HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who currently are not in HIV medical care and reside in their jurisdiction

Indicator: Prioritized list of HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are accurately identified as not in HIV medical care

Outcome: Increased capacity of health departments to contact HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are not in HIV medical care

Indicator: Proportion of identified HIV-diagnosed MSM, transgender persons, and other persons

Indicator: Proportion of identified HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are not in HIV medical care successfully contacted by health department

Outcome: Increased capacity of health departments to refer to HIV medical care HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are not in care

Indicator: Proportion of identified HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are not in care that are referred to HIV medical care

Outcome: Increased proportion of all HIV-diagnosed MSM who are virally suppressed

Indicator: Proportion of HIV-diagnosed MSM who are virally suppressed

Outcome: Reduced length of time between identification of and the successful engagement or re-engagement in HIV medical care of HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are not in care

Indicator: Proportion of identified HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are not in care successfully engaged or re-engaged in HIV medical care within 90 days of being identified as not in care Indicator: Number of days between identification of HIV-diagnosed MSM, transgender persons, and other persons who have HIV but are not virally suppressed or have ongoing risk behavior, who are not in care and their successful engagement or re-engagement in HIV medical care

ii. Applicant Evaluation and Performance Measurement Plan

The health department awardee will collaborate with CDC to further develop and implement performance measurement standards that are based on its specific programmatic objectives.

The health department awardee will be required to provide descriptions of the development and implementation of program activities in annual progress reports and other formats as required by CDC. The CDC will provide the template and guidance for these reports.

Post-award, a more detailed evaluation and performance measurement plan for the entire project will be developed by awardees in collaboration with CDC. This more detailed evaluation plan will build on elements stated in the initial plan. In addition to the items in the initial plan, awardees will:

Describe baseline and target performance for each reporting year. Targets should demonstrate adequate progress toward meeting or exceeding national goals identified in the NHAS as well as CDC goals;

Describe the frequency that monitoring and evaluation and performance data are to be collected, keeping in mind CDC data submission requirements and local data use for routine project oversight;

Describe the data system to be used for local data management and use; CDC will specify the system to be used for submission of required data;

Describe how program monitoring data will be used for continuous quality improvement;

Describe dissemination channels and populations (including public dissemination) of local evaluation findings; and Describe other information requested, as determined by the CDC program.

Paperwork Reduction Act (PRA) applicability will depend upon the evaluation and reporting methods to be used for each activity.

c. Organizational Capacity of Awardees to Execute the Approach

All applicants must demonstrate their existing or forthcoming capacity to successfully execute all proposed strategies and activities to meet program requirements. Applicants should address infrastructure (the applicant organization’s physical space and equipment), workforce capacity and competence, expertise and experience related to all program focus areas, information and data systems, and electronic information and communication systems to implement the award. Applicants must provide evidence of program management/staffing plans, performance measurement, evaluation, financial reporting, management of travel requirements, and workforce development and training. Applicants are encouraged to provide additional information that demonstrates their capacity to efficiently manage fiscal mechanisms (e.g., subcontracts and hiring new staff) in support of the project.

For PrEP support projects, applicants must have demonstrable capacity to coordinate and facilitate development of trainings, policies, educational materials, social media campaigns, integration with other screening services, and referral of eligible clients to PrEP providers.

For Data to Care projects, applicants must have demonstrable capacity to coordinate and facilitate project activities that support the use of HIV surveillance data to identify patients who may have never linked to care or who have fallen out of HIV care as indicated by missing lab data.

Applicants must have complete HIV laboratory reporting of CD4 and viral load test results, defined as follows:

i. The jurisdiction’s laws or regulations require the reporting of all CD4 and viral load results to the state or city health department.

ii. A minimum of 95% of HIV-related test results from laboratories that perform HIV-related testing for each area are being reported to the state or city health department.

iii. The jurisdiction is reporting at least 95% of all CD4 and viral load test results to CDC as of January 2014 (as outlined in the 2012 Monitoring Report, published in November 2014).

Note: Complete HIV laboratory reporting should be consistent with the definition as defined in CDC’s HIV Surveillance Supplemental Report, Volume 18, Number 2 entitled “Monitoring Selected National HIV Prevention and Care” Objectives by Using HIV Surveillance Data—United States and 6 U.S.

Dependent Areas—2010 (pages 9 -10). Available at: http://www.cdc.gov/hiv/library/reports/surveillance /2010/surveillance_Report_vol_18_no_2.html

In addition, the applicant must demonstrate capacity to safeguard data. In accordance with H.19 308(d) Contract Clause for Safeguards for Individuals and Establishments against Invasions of Privacy and with Subsection (m) of the Privacy Act of 1974 (5 U.S.C. 552a) and Section 308(d) of the Public Health Service Act (42 U.S.C. 242m), the applicant is required to comply with the applicable provisions of the Privacy Act and to undertake other safeguards to protect individuals and establishments against invasions of their privacy.

To successfully meet these requirements over the course of this cooperative agreement, the grantee must:

1. Comply with all federal (i.e., HHS, and/or CDC) information systems and information processing security policies. For example, local policies and procedures should clearly describe required physical security attributes of all facilities; procedures for protecting, controlling, and handling data during performance of the project, including any development and testing activities; required limitations on employees with respect to the reproduction, transmission, or disclosure of data; physical storage procedures to protect data; procedures for the destruction of source documents and other contract-related waste material; and personnel security procedures.

2. Ensure that data collection, entry, management, submission, analysis, use, and dissemination procedures are consistent with CDC security and confidentiality guidelines, as outlined above.

3. Ensure data security and confidentiality policies are in place and conform with NCHHSTP Data Security and Confidentiality Guidelines. MOAs should include a certification statement agreeing that these policies will be in place before project activities are implemented.

4. Procedures for electronic and physical data security and data sharing must be reviewed and approved by the http://www.cdc.gov/hiv/library/reports/surveillance/2010/surveillance_Report_vol_18_no_2.html http://www.cdc.gov/hiv/library/reports/surveillance/2010/surveillance_Report_vol_18_no_2.html

4. Procedures for electronic and physical data security and data sharing must be reviewed and approved by the applicable Overall Responsible Party(s) (ORPs). If more than one ORP is at the health department, the HIV Surveillance Program’s ORP should review and approve all procedures for data sharing.

5. Develop and maintain ‘Rules of Behavior’ for persons who have access to data systems under the agency’s responsibility. State and local data system rules of behavior need to be responsive to CDC data security policies.

6. The applicant should sign and submit to CDC an interagency MOU regarding protection of sensitive data collected for this program. This MOU will be provided to grantees on receipt of award or shortly thereafter.

http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf

7. Ensure all agency personnel having access to identifiable and confidential information receive appropriate annual training and sign confidentiality pledges (Non-Disclosure Agreement). CDC will provide on-line training materials.

8. Conduct a privacy impact assessment (PIA) on all information systems acquired, developed, or used in…