CDC-RFA-PS17-1711.pdf

Image Description: Centers for Disease Control

Centers for Disease Control

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

Use of molecular HIV surveillance to identify active HIV transmission networks and implement HIV interventions for Hispanic/Latino men who have sex with men.

CDC-RFA-PS17-1711

Application Due Date: 05/30/2017

Use of molecular HIV surveillance to identify active HIV transmission networks and implement HIV interventions for Hispanic/Latino men who have sex with men.

CDC-RFA-PS17-1711

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.

Application and Submission Information 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-PS17-1711. 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) / Agency for Toxic Substances and Disease Registry

(ATSDR)

B. Funding Opportunity Title:

Use of molecular HIV surveillance to identify active HIV transmission networks and implement HIV interventions for Hispanic/Latino men who have sex with men.

C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg /CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at http://www.cdc.gov/od/science/integrity /docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-PS17-1711

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: 05/30/2017, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

G. Executive Summary:

1. Summary Paragraph:

Hispanic/Latino gay, bisexual, and other men who have sex with men (MSM) in the United States (US) are at elevated risk of HIV. This Funding Opportunity Announcement (FOA) supports demonstration projects to implement an innovative strategy that uses molecular HIV surveillance data (i.e., HIV sequences) to pinpoint networks that include Hispanic/Latino MSM in which active HIV transmission is occurring and deliver a combination of high-impact HIV prevention services to persons in the networks. Activities will be conducted by up to 11 state and local health departments that are directly funded by CDC to conduct HIV surveillance within 6 states with substantial numbers of HIV diagnoses among Hispanic/Latino MSM. Supported activities include analysis of HIV sequence data to identify molecular clusters of active HIV transmission among Hispanic/Latino MSM; use of partner services and other data to assess underlying transmission clusters and HIV risk networks; HIV testing through partner services and social network strategies; linkage to or re-engagement of HIV-positive individuals in HIV care and other services to increase viral suppression and reduce onward HIV transmission; linkage of high-risk HIV-negative individuals to pre-exposure prophylaxis (PrEP); and activities to mitigate the effects of social and structural factors that directly impede access to and participation in HIV-related services by Hispanic/Latino MSM.

https://foa.grantsolutions.gov/www.grants.gov https://foa.grantsolutions.gov/www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf 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

a. Eligible Applicants: Limited

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 11 Up to 11 awards are anticipated.

d. Total Project Period Funding: $21,000,000

e. Average One Year Award Amount: $636,363

f. Total Project Period Length: 3

g. Estimated Award Date: 08/31/2017

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

Part II. Full Text

1. Background

a. Overview HIV diagnoses among Hispanic/Latino gay, bisexual, and other men who have sex with men (MSM) increased by 13% during 2010-2014 and decreased or were stable among white and black/African American MSM, respectively.1 Of all Hispanic/Latino MSM tested for HIV in 2014, 75% knew of their infection,2 well below the National HIV/AIDS Strategy (NHAS) goal of 90% for serostatus awareness among HIV-positive persons.3 Participation by Hispanics/Latinos overall in HIV care is suboptimal: in 2014, 74.3% of Hispanics/Latinos aged ≥13 years in 33 jurisdictions were linked to care within 1 month of their diagnosis (NHAS goal=90%); among those diagnosed with HIV by year-end 2012 who were alive at year-end 2013, 57.7% were retained in care (NHAS goal=90%) and 54.2% were virally suppressed (NHAS goal=80%).4

The number of HIV diagnoses among Hispanic/Latino MSM varies by jurisdiction. Unpublished CDC data indicate that 8 jurisdictions had ≥ 500 HIV diagnoses among these MSM during 2013-2015: Arizona (500 diagnoses); California (4,311); Florida (2,820); Illinois (683); New Jersey (564); New York (1,979); Texas (2,994); and Puerto Rico (802). These jurisdictions accounted for 81% of all HIV diagnoses during these years among Hispanic/Latino MSM in the U.S. and 6 dependent areas.

CDC uses molecular surveillance data to identify networks of persons with active HIV transmission and develop targeted prevention measures. HIV-infected persons are tested for drug resistance as a standard of care to select treatment options. The sequence data generated from these tests are analyzed by CDC and used to identify groups in greatest need of prevention interventions.

This FOA supports demonstration projects to use molecular HIV surveillance data to pinpoint networks that include Hispanic/Latino MSM in which active HIV transmission is occurring, and target high-impact HIV prevention services for persons in these networks. Networks with active transmission include persons with diagnosed HIV infection who have genetically similar HIV strains (i.e., molecular clusters); HIV-negative persons at risk for acquiring HIV, and persons with undiagnosed HIV infection. Persons with diagnosed HIV include those who have never been linked to or have fallen out of HIV care, and those in care who may or may not be virally suppressed. Persons with undiagnosed HIV-infection in transmission and risk networks can be identified through use of the proven strategies of partner services and social network testing. 5

FOA-supported activities include: use of HIV sequence data to identify molecular clusters with active HIV transmission; use of partner services and other data to assess underlying transmission clusters and HIV risk networks; HIV testing through partner services and social network strategies; linkage to or re-engagement of HIV-positive individuals in HIV care and other services to increase viral suppression and reduce HIV transmission; linkage of high-risk HIV-negative individuals to pre-exposure prophylaxis (PrEP) and other prevention services; and activities to mitigate the effects of social-structural factors that directly impede participation by Hispanic/Latino MSM in HIV prevention and related services.

References:

https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/hiv-data-trends-fact-sheet-508.pdf1.

https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-hssr-nhbs-msm-2014.pdf2.

https://www.aids.gov/federal-resources/national-hiv-aids-strategy/nhas-update.pdf3.

https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol -21-4.pdf

4.

AJPH 2013 Oct;103(10):1851-6.5.

b. Statutory Authorities This program is authorized under section 318(c) of the Public Health Service Act, 42 U.S.C. section 247c(c), as amended.

c. Healthy People 2020 This FOA addresses the "Healthy People 2020" focus area of HIV. https://www.healthypeople.gov/2020 /topics-objectives/topic/hiv/objectives

d. Other National Public Health Priorities and Strategies This FOA supports the following national strategies:

The National HIV/AIDS Strategy: http://www.aids.gov/federal-resources/national-hiv-aids-strategy /overview/

1.

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

2.

HIV Care Continuum Initiative: https://www.aids.gov/federal-resources/policies/care-continuum/3.

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

CDC Winnable Battles: http://www.cdc.gov/winnablebattles/index.html5.

e. Relevant Work This FOA builds upon the following HIV prevention programs:

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/annoucements/ps12 -1210/index.html

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

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.”

https://www.cdc.gov/hiv/funding/announcements/ps15-1506/ https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-21-4.pdf https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-21-4.pdf https://www.healthypeople.gov/2020/topics-objectives/topic/hiv/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/hiv/objectives http://www.aids.gov/federal-resources/national-hiv-aids-strategy/overview/ http://www.aids.gov/federal-resources/national-hiv-aids-strategy/overview/ http://www.cdc.gov/hiv/pdf/policies_DHAP-strategic-plan.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.hhs.gov/ash/ohaidp/initiatives/ http://www.cdc.gov/winnablebattles/hiv/index.html

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

Image Description: Logic%20Model%20CDC%2DRFA%2DPS17%2D1711.jpg

i. Purpose The purpose of this FOA is to support eligible applicants for using molecular HIV surveillance data to pinpoint networks of active HIV transmission that include Hispanic/Latino MSM and implement high-impact interventions for them. Required activities include identifying molecular clusters and assessing transmission and risk networks; HIV testing; linking/re-engaging HIV-positive persons in care; linking high-risk HIV-negative persons to PrEP; and mitigating the effects of social-structural factors that directly impede access to and participation in HIV-related services by Hispanic/Latino MSM.

ii. Outcomes Awardees are expected to demonstrate measurable progress toward achieving the short-term and intermediate outcomes depicted in the FOA logic model. Indicators that quantify these outcomes are described in the section entitled CDC Evaluation and Performance Measurement Strategy.

Expected Short-term outcomes (years 1 and 2) include the following:

Increased internal and external partnerships to support HIV prevention activities Increased ability to identify and respond to ongoing molecular clusters and underlying transmission clusters and HIV risk networks that include Hispanic/Latino MSM Increased knowledge of HIV status among Hispanic/Latino MSM Increased linkage to and re-engagement in HIV care among HIV-positive Hispanic/Latino MSM Increased linkage to PrEP-related services by high risk HIV-negative Hispanic/Latino MSM Increased knowledge and clinical management skills by providers about PrEP for HIV prevention with Hispanic/Latino MSM Increased knowledge about PrEP for HIV prevention among HIV-negative Hispanic/Latino MSM at high risk for HIV infection

Expected Intermediate outcomes (year 3) include the following:

Decreased time between HIV diagnosis among Hispanic/Latino MSM and engagement in HIV care Increased retention of HIV-positive Hispanic/Latino MSM in HIV care Increased prescription of PrEP by providers to HIV-negative Hispanic/Latino MSM Increased PrEP uptake among high risk HIV-negative Hispanic/Latino MSM Increased uptake by Hispanic/Latino MSM of HIV prevention services in addition to PrEP (e.g., HIV testing, condom use) and in HIV care

iii. Strategies and Activities Demonstration project awardees are required to implement all of strategies and activities listed below.

1. Create new or expand existing partnerships within the health department and between health departments and local (e.g., community-based) organizations to support project activities

Develop agreements (e.g., Memorandums of Understanding [MOUs]/Memorandums of Agreement [MOAs]) and procedures for data sharing between HIV surveillance and HIV prevention staff within health departments.

Develop agreements and procedures with local organizations (e.g., community-based organizations, clinics, etc.) that create new partnerships or expand and strengthen existing partnerships to support planned project activities.

Develop agreements and procedures that will enable applicants in states with health departments that are independently-funded by CDC for HIV surveillance to collaborate with the other health department(s) to implement the required project activities throughout the state. Activities will include, but are not limited to sharing, analyzing, reviewing, and interpreting molecular and transmission cluster data and intervening as appropriate. Attach MOUs or MOAs to the application, documenting the intention to collaborate on the project.

Ensure that all agreements address security and confidentiality standards for HIV data described in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention’s (NCHHSTP) Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action, 2011 https://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf

2. Use molecular HIV surveillance data and CDC tools to identify molecular clusters that include Hispanic/Latino MSM; use partner services and other data to assess underlying transmission clusters and HIV risk networks

Receive training on the use of CDC tools to identify molecular clusters of active HIV transmission Implement strategies to improve the collection of HIV sequence data from laboratories Identify molecular clusters of active HIV transmission that include Hispanic/Latino MSM Review and analyze data (e.g., partner services data and other data) to identify other persons that may be part of the transmission clusters, for whom sequence data are not available Develop approaches for improving the integration and management of data from disparate systems Design high-impact HIV prevention activities that address features of the identified molecular clusters of active HIV transmission and the associated social and sexual risk networks that include Hispanic/Latino MSM Comply with security and confidentiality standards for HIV data as described in the NCHHSTP Data Security and Confidentiality Guidelines Follow the HIV Surveillance Technical Guidance for HIV Surveillance Programs for HIV surveillance activities

3. Deliver high-impact prevention services to identified Hispanic/Latino MSM and others in their networks, including HIV testing, linkage to or re-engagement in care, and pre-exposure prophylaxis (PrEP)

HIV Testing

Train or retrain, as needed, health department and partner organization staff on HIV testing guidelines, policies, cultural competency, and the use of partner services and the social network HIV testing strategy to reach Hispanic/Latino MSM and persons in their networks Identify high risk HIV-negative and HIV-positive individuals within Hispanic/Latino MSM sexual/social networks Identify other individuals (e.g., friends, sex or drug partners, etc.) who are members of social networks within which active HIV transmission occurs, who are at risk of HIV and who would benefit from HIV testing

Linkage to or Re-Engagement in Care

Link to HIV care those Hispanic/Latino MSM who are newly and previously diagnosed with HIV and other HIV-positive persons in their networks who are not in care Re-engage in HIV care those Hispanic/Latino MSM and other persons in their networks who had been in care and had fallen out of care https://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf

PrEP and other Prevention Services

Develop and implement PrEP-related policies, standard operating procedures (SOPs), protocols, and/or MOUs/MOAs; train health department staff Train providers in clinical management procedures and skills Link high-risk HIV-negative persons to PrEP and other prevention services

4. Identify and prioritize social-structural factors that negatively affect participation by Hispanic/Latino MSM in HIV prevention and care services and implement activities to mitigate the effects of identified factors

Design and implement feasible activities to mitigate those social-structural factors that are identified – based on the experiences of health department awardees and local-level partner organizations when serving Hispanic/Latino MSM, and the analysis of jurisdiction-specific data -- as directly impeding participation by Hispanic/Latino MSM in HIV prevention and related services Develop and implement procedures and materials that are culturally and linguistically appropriate for Hispanic/Latino MSM

5. Develop and implement performance measurement and evaluation strategies

Identify and use surveillance and other data sources to implement these performance measurement and evaluation strategies

6. Identify and disseminate promising practices relative to strategies and activities

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

Health department awardees will collaborate as partners with CDC. Awardees must establish, build, and/or maintain working partnerships with CDC-funded health departments within their state and with other CDC awardees (e.g., directly-funded CBOs) to ensure communication, collaboration, and coordination for the effective delivery of high-impact HIV prevention activities that are consistent with CDC standards and guidance. Awardees must obtain letters of support and develop MOAs, MOUs, or other agreements and procedures as appropriate, to ensure collaboration between programs within health departments (e.g., surveillance and prevention) and effective communications and data sharing related to identified clusters of active HIV transmission among Hispanic/Latino MSM and their access to, and participation in, HIV-related services. In states with health departments that are independently-funded by CDC to conduct HIV surveillance, these health departments will develop agreements and procedures for sharing data and working collaboratively to analyze, review, and interpret molecular and transmission cluster data and intervene as appropriate. Applicants must include letters of support and any MOUs and MOAs as attachments to their application, documenting their intention to collaborate on the project. Applicants must attach letters of support as a file named “Letters of Support” and upload it as a PDF file at www.grants.gov. Applicants must attach MOUs and MOAs as a file named “MOUs/MOAs” and upload them as PDF files at www.grants .gov.

b. With organizations not funded by CDC:

Health department awardees funded under this announcement will collaborate as needed with non-CDC funded partner organizations such as HIV and other health care providers, community-based organizations, LGBTQ organizations, private providers, clinics and community health centers. Applicants must provide MOUs, MOAs, or letters of support as evidence of planned collaborations that will contribute to the success of the proposed demonstration projects. Applicants must file the MOU or MOA, as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov.

http://www.grants.gov

2. Target Populations The target populations for this project are Hispanic/Latino MSM living with HIV infection, HIV-negative Hispanic/Latino MSM at risk for acquiring HIV, and persons in their sexual, social, and risk networks.

Disabled individuals within these described categories are also considered to be part of the target populations for this project.

a. Health Disparities The FOA requires that health department awardees focus on Hispanic/Latino MSM, the population for which HIV diagnoses are increasing, by pinpointing networks that include Hispanic/Latino MSM in which active HIV transmission is occurring, and delivering high-impact HIV prevention services to persons in the networks. The FOA requires that awardees implement activities to mitigate the effects of social-structural factors which their experiences and analyses identify as directly impeding access to and participation by Hispanic/Latino MSM in HIV prevention and care services.

Awardees are also required to implement measures to facilitate access to and participation in project activities by Hispanic/Latino MSM who may be disproportionately Spanish speakers, who may have limited spoken or written English capacity and limited health literacy, and who may be socially marginalized and stigmatized due to their ethnicity, participation in male to male sex, and their possible undocumented presence in the U.S., and do so in a manner that is linguistically and culturally competent and respectful of and sensitive to values and norms that are shared widely by Hispanic/Latino persons and the often difficult circumstances of Hispanic/Latino MSM. These measures, and activities implemented by awardees to mitigate the negative effects of social-structural factors on participation by Hispanic/Latino MSM in HIV-related services, will contribute to reducing HIV-related disparities and addressing social determinants that affect these populations.

iv. Funding Strategy Anticipated award levels are based on the relative share of the number of people living with diagnosed HIV at the end of 2014 attributable to each eligible jurisdiction. Awards will be allocated using a funding algorithm which is based on 2014 prevalence data and minimum funding level of $120,000 to support organizational infrastructure for the program.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy The CDC Evaluation and Performance Measurement Strategy will assess achievement of program goals and objectives in terms of process, organizational change, and short-term and intermediate outcomes. Although long-term outcomes are described in the logic model and can logically be expected to occur as a result of projects funded by this FOA, these outcomes may not be observed during the 3-year implementation period.

For this demonstration project: (1) Performance Measurement will include a core set of measures that will be developed and agreed upon by CDC and health department awardees, and (2) a Special Evaluation that will include process and outcome evaluations conducted in each jurisdiction to closely examine an aspect of the project that will help explain changes in outcomes, identify factors that may have impeded or contributed to project success, and/or assess unintended effects, among others.

The overarching questions that the project will assess include the following:

To what extent do grantees successfully collect laboratory HIV surveillance data (i.e., CD4, viral load results, and HIV sequence data) and use it to evaluate the outcomes of linkage to, re-engagement in, and retention in HIV care?

1.

To what extent do grantees successfully use molecular data to identify clusters of active transmission involving Hispanic/Latino MSM?

2.

To what extent do grantees successfully use partner services or other strategies to identify Hispanic/Latino MSM and others in their networks and deliver high-impact HIV prevention services?

3.

To what extent does the project increase knowledge of HIV status among Hispanic/Latino MSM?4.

To what extend do grantees successfully link or re-link HIV-diagnosed Hispanic/Latino MSM into HIV care?

5.

To what extent do grantees successfully link high-risk HIV-negative Hispanic/Latino MSM to PrEP and other prevention services?

6.

To what extent do grantees reduce the effects of social-structural factors that create barriers to HIV prevention services and care among Hispanic/Latino populations in their jurisdictions?

7.

What promising and good practices are identified by grantees relative to the utilization of molecular data to identify HIV transmission clusters; the delivery of high-impact HIV interventions (i.e., HIV testing, Linkage to Care, and PrEP); and efforts at addressing structural factors among Hispanic/Latino

MSM?

8.

To fully address the overarching questions Performance Measurement and a Special Evaluation will be conducted. At a minimum, Special Evaluation will focus on question 7 where there is a need to conduct more rigorous process and outcome evaluations for which CDC will provide guidance.

The following Table includes main outputs, outcomes, and corresponding performance metrics that will help track project progress. This is not an exhaustive list since measures will be finalized in collaboration with selected jurisdictions.

OUTPUTS / OUTCOMES PERFORMANCE MEASURES /

STANDARDS

OUTPUTS

Cluster investigation and intervention protocols and standard operating procedures Health department staff trained in using molecular cluster analysis tools and cultural competence pertaining to Hispanic/Latino MSM Strategies to improve collection of HIV sequence data implemented Molecular clusters of active transmission, including Hispanic/Latino MSM and underlying transmission clusters identified HIV testing using partner services and social network testing strategy Culturally and linguistically appropriate activities, including educational materials, developed for providers and Hispanic/Latino MSM HIV and non-HIV infected Hispanic/Latino MSM HIV referred to HIV care or prevention services, including PrEP Partners of those HIV infected notified of their exposure Social and structural barriers faced by

Number and type of protocols and SOPs on cluster investigation in place Number of health department staff trained in using molecular cluster analysis tools and cultural competency Number of HIV diagnoses that have an HIV sequence Number of identified molecular clusters of active transmission for which underlying transmission networks are identified Number of persons identified and tested through partner services and social network strategy testing Number and type of educational activities delivered to providers and Hispanic/Latino MSM concerning HIV testing, PrEP, HIV care, etc.

Number of HIV and non-HIV infected Hispanic/Latino MSM HIV, respectively, referred to HIV care or prevention services, including PrEP Document describing social-structural factors that create barriers to Hispanic/Latino MSM access to and participation in HIV prevention and care; prioritized factors addressed by

Hispanic/Latino MSM addressed in project activities Monitoring and evaluation plan implemented Implementation challenges identified and addressed Promising practices disseminated project activities, and description of activities implemented to mitigate the negative effects of identified social-structural factors Document identifying project implementation challenges and how they are addressed Report with promising and good practices

SHORT TERM OUTCOMES

Increased internal and external partnerships to support HIV prevention activities Increased ability to identify and respond to ongoing molecular clusters and underlying transmission clusters and HIV risk networks that include Hispanic/Latino MSM Increased knowledge of HIV status among Hispanic/Latino MSM Increased linkage to and re-engagement in HIV care among HIV-positive Hispanic/Latino MSM Increased linkage to PrEP-related services by high risk HIV-negative Hispanic/Latino MSM Increased knowledge and clinical management skills by providers about PrEP for HIV prevention with Hispanic/Latino MSM Increased knowledge about PrEP for HIV prevention among HIV-negative Hispanic/Latino MSM at high risk for HIV infection

Number of MOUs/MOAs (as applicable) and minutes from partnership meetings Number of Hispanic/Latino MSM and persons in their networks identified with newly diagnosed HIV infection Number of Hispanic/Latino MSM and persons in their networks diagnosed with HIV and who received results Number of Hispanic/Latino MSM and persons in their networks who are diagnosed with HIV and are linked to HIV care within 30 days of diagnosis Number of high risk HIV-negative Hispanic/Latino MSM and persons in their networks linked to PrEP services Number of providers who attended project trainings to increase their clinical management knowledge Number of high-risk HIV-negative Hispanic/Latino MSM who receive information about PrEP

INTERMEDIATE OUTCOMES

Decreased time between HIV diagnosis among Hispanic/Latino MSM and engagement in HIV care Increased retention of HIV-positive Hispanic/Latino MSM in HIV care Increased prescription of PrEP by providers to HIV-negative Hispanic/Latino MSM Increased PrEP uptake among high risk HIV-negative Hispanic/Latino

MSM

Increased uptake by Hispanic/Latino MSM of HIV prevention services in

Number of days between identification of HIV-diagnosed Hispanic/Latino MSM and persons in their networks and their successful engagement/re-engagement in HIV medical care Number of Hispanic/Latino MSM and persons in their networks diagnosed with HIV and retained into HIV care Number of high-risk HIV-negative Hispanic/Latino MSM and persons in their networks prescribed with PrEP Number of Hispanic/Latino MSM and addition to PrEP (e.g., HIV testing, condom use) and in HIV care persons in their networks using HIV prevention and care services

The CDC strategy will require that awardees allocate 8% of the overall budget to support performance measurement and 5% of the overall budget to support special evaluation of funded activities.

Performance measurement data will allow CDC to assess performance of the overall project and will be reported to and supervised by CDC, which will disseminate data in grantee feedback reports in collaboration with jurisdictions. Jurisdictions will be required to submit data to the National HIV Surveillance System, in progress reports annually, and through EvaluationWeb for HIV test events. Findings will ensure ongoing program and system improvement. CDC will also require the implementation of Special Process and Outcome Evaluations to identify good practices and determine how social and structural factors were successfully addressed. Guidance on both Performance Measurement and Special Evaluation will be provided by CDC on an ongoing basis throughout the project period.

Project data management systems will have security controls for management, operational and technical safeguards needed to protect the confidentiality, integrity, and availability of a federal information system and its information that comply with the National Institute of Standards and Technology (NIST) (http://csrc .nist.gov/groups/SMA/fisma/overview.html). The data management systems will have security plans, including an Information System Security Plan, emergency response capabilities, designated individuals who are responsible for security, reporting to Congress, security awareness training, and regular review of the system as specified in OMB Circular A-130. All data collected will be submitted to the CDC Project Officer using government-provided, encrypted USB. Finalizing the details of the data management plan and systems will be the responsibility of the project officer, the grantee funded to conduct the project, and the partnering entities supplying outcome data.

Awardees will collect all required surveillance and other quantitative and qualitative data using CDC approved applications, and submit the data to CDC according to an established schedule, using CDC-approved systems. Details concerning data management plans and systems will be finalized by the CDC project officer, the awardee, and partner organizations that supply outcome data.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant) Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these FOA funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

http://csrc.nist.gov/policies/FISMA-final.pdf http://csrc.nist.gov/policies/FISMA-final.pdf https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Awardees will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, within the first 6 months of award, as described in the Reporting Section of this FOA.

Awardees will collaborate with CDC to develop a detailed evaluation and performance measurement plan for the entire project within the first six months of the award. The detailed evaluation plan will build on elements described in the initial plan. In addition, awardees will describe baseline and target performance values for each reporting year.

Awardees will address three components in the Evaluation and Performance Measurement Plan.

1. Approach:

Describe engagement of stakeholders (e.g., HIV-STD program staff, community organizations, MSM and Hispanic/Latino advocates, CDC) in Evaluation and Performance Measurement processes.

Describe planned channels to use, and audiences (including the public) to target, for dissemination of Performance Measures and Special Evaluation results.

2. Performance Measurement:

Identify indicators, including those based on surveillance data, to be tracked throughout the project, baseline data, and targets.

State how frequently (e.g., daily, weekly, monthly) data will be collected on each indicator.

Describe how performance measures data will be managed and by whom; information system(s) that will be used; plans to ensure quality of performance measures data, how frequently results will be reported and to whom, keeping in mind CDC data submission requirements and the use of local data for routine project oversight.

Describe how performance measurement results will be used.

3. Special Evaluation

List up to 3 evaluation questions for which a Special Evaluation will be conducted to determine how well social and structural factors were successfully addressed in this project to ameliorate barriers to HIV prevention services and care among Hispanic/Latino MSM populations in selected jurisdictions Identify how findings of Special Evaluation will be utilized by health department and other stakeholders.

Paperwork Reduction Act (PRA) may be applicable depending on the evaluation and reporting methods used for the project.

c. Organizational Capacity of Awardees to Implement the Approach All applicants must demonstrate their existing capacity to successfully execute all proposed strategies and activities to meet the FOA requirements. Applicants should address infrastructure (the applicant organization’s physical space and equipment), workforce capacity and competence, expertise and experience related to all strategies and activities that are described in the FOA narrative and logic model, information and data systems, and electronic information and communication systems to implement the award.

Applicants must provide evidence of security and confidentiality verification from CDC, 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. Applicants must also demonstrate their capacity to provide, and their successful experience providing, services to Hispanic/Latino individuals who are Spanish speakers, who may have limited spoken or written English capacity and limited health literacy, and who may be socially marginalized and stigmatized due to their ethnicity, participation in male to male sex, and their possible undocumented presence in the U.S., in a manner that is linguistically and culturally competent and respectful of and sensitive to values and norms that are shared widely by Hispanic/Latino persons and the often difficult circumstances of Hispanic/Latino gay, bisexual and other men who have sex with men.

Applicants must submit as attachment CVs/resumes of proposed staff and organizational charts for health departments. Applicants must name these files as "CVs/Resumes" or "Organizational Charts" and upload them at www.grants.gov.

d. Work Plan Applicants must develop a work plan that describes how proposed activities will contribute to achieving the short and intermediate outcomes outlined in the accompanying logic model. Applicants should cite available local epidemiologic data, cost data or other sources for articulating how the proposed approach will have the greatest impact for their jurisdiction.

Activities in this Funding Opportunity Announcement should expand or enhance current activities or in other ways increase their impact in their jurisdiction in improving HIV outcomes for Hispanic/Latino MSM. To this end, applicants should also explain how the proposed work plan will further extend or leverage other funded activities.

Applicants are required to provide a work plan that provides both a high-level overview of the entire three-year project period and a detailed description of the first year of the award. The work plan should incorporate all FOA-related program strategies and activities. Applicants should describe how they plan to monitor each activity.

Note: Post-award, proposed work plan activities may be adjusted in consultation with CDC to better address the overarching goals of the project.

The applicant should address the following outline in their work plan:

Three-Year Overview of Project Work Plan:

Intended outcomes for the entire three-year project period Year 1 Detailed Work Plan:

Program strategies and activities Outcomes aligned with program strategies and activities Timeline

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that awardees are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with awardees on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

No additional guidance.

f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE

AGREEMENTS)

In a cooperative agreement, CDC staff members are substantially involved in program activities above and beyond routine grant monitoring. CDC activities for this program are as follows:

A. Provide or facilitate consultation and technical assistance to awardees on all aspects of the implementation of the funding program as well as all protocols, procedures, and instruments related to the plan, both directly and through CDC’s network of awardees and partners.

B. Work with awardees to address various training, capacity building and technical assistance needs that are crucial to the successful execution of the plan, and that are not addressed by other funding sources.

C. Provide specific training, capacity building, and technical assistance on the use of CDC-approved tools for conducting molecular cluster analyses.

D. Monitor awardee progress with implementing planned activities and developing and conducting monitoring and evaluation activities through consultation via site visits, email, telephone conference calls, and review of progress reports, periodic updates, and other data reports.

E. Provide requirements and expectations for standardized and other data reporting and support monitoring and evaluation activities with technical assistance, web-based training on M&E, M&E-related materials such as data collection tools, and on-line TA via the National HIV Monitoring and Evaluation Service Center as appropriate.

F. Facilitate necessary CDC and other clearances.

G. Plan, convene, and facilitate joint awardee meetings during the project period.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program

Support to Awardees Section.

2. Award Mechanism: U62

3. Fiscal Year: 2017

4. Approximate Total Fiscal Year Funding:

$7,000,000

5. Approximate Project Period Funding:

$21,000,000

This amount is subject to the availability of funds.

Estimated Total Funding: $21,000,000

6. Total Project Period Length:

3 year(s)

7. Expected Number of Awards:

Up to 11 awards are anticipated.

8. Approximate Average Award:

$636,363 Per Budget Period

9. Award Ceiling: $1,410,008 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $259,604 Per Budget Period

11. Estimated Award Date: 08/31/2017

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this FOA.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments

Additional Eligibility Category:

Government Organizations:

State governments or their bona fide agents (includes the District of Columbia) Local governments or their bona fide agents

2. Additional Information on Eligibility

Eligibility for this FOA is limited to state and local health departments that have the authority to conduct, and are directly funded by CDC to conduct, HIV surveillance. This program is authorized under section 318(c) of the Public Health Service Act, 42 U.S.C. section 247c(c), as amended.

Applicants must submit documentation demonstrating that they meet both of the following two criteria:

(1) Applicants must be located in a state that has reported at least 500 diagnoses of HIV infection among Hispanic/Latino MSM during 2013-2015. To adequately identify HIV molecular clusters that include Hispanic/Latino MSM and have a sizeable impact on new HIV diagnoses, health departments must be located within a state that reported at least 500 diagnoses of HIV infection among Hispanic/Latino MSM during 2013-2015.

To satisfy the first criterion, applicants must complete the following steps:

(a) Use the CDC-developed Atlas Plus application located at https://gis.cdc.gov/grasp/nchhstpatlas/main .html to derive the number of diagnoses of HIV infection among Hispanic/Latino MSM during 2013-2015 in the applicant’s state. The total number for 2013, 2014, and 2015 must add up to at least 500 diagnoses among Hispanic/Latino MSM.

(b) Submit, as an attachment to their application, a copy of the table that is generated from Atlas Plus that shows the number described in (a) above.

(2) Applicants must have reported HIV sequence data for at least 20% of all HIV diagnoses during 2013-2015. Grantees funded under this program announcement will be required to use HIV sequence data reported to their HIV surveillance program as the primary data source for the analysis of HIV molecular clusters. Identification of molecular clusters relies on (a) collecting HIV sequence data from laboratories as part of routine HIV surveillance activities and (b) demonstrating the capacity to conduct molecular HIV surveillance as evidenced by submission of HIV nucleotide sequence data to CDC for at least 20% of all HIV diagnoses during 2013-2015.

To satisfy the second criterion, applicants must submit, as an attachment to their application, a summary document that provides the following data elements:

(a) The total number of persons who received an HIV diagnosis during 2013–2015 and were residing in the applicant’s jurisdiction (i.e., the area funded to conduct HIV surveillance) at the time of diagnosis;

(b) The number of all HIV diagnoses during 2013-2015 in the jurisdiction that had an HIV genetic sequence;

(c) The percentage of all HIV diagnoses during 2013-2015 in the jurisdiction that had an HIV genetic sequence. The percentage must be at least 20%.

In addition, applicants must submit a copy of “Table 2. Completeness of HIV Sequences among Diagnoses, by Selected Demographic Characteristics,” which is generated by a SAS program that is available to applicants from CDC’s HIV Incidence and Case Surveillance Branch, and which applicants are instructed to use in order to calculate the data elements required for Criterion 2 (a), (b), and (c) above. (Detailed instructions to applicants for accessing the SAS program and preparing documentation for the required attachment are provided below.)

Detailed instructions to applicants:

To provide documentation for the attachment required by the second criterion, applicants must use the CDC-developed SAS program titled Local_MHS_Analysis_201704.sas. The program is available on the HIV Incidence and Case Surveillance Branch (HICSB) SharePoint site (https://partner.cdc.gov/Sites/NCHHS

TP/HICSB).

In their attachment, applicants must provide a summary document that provides the following data elements based on calculations and generated by the above-referenced SAS program, and contained in the SAS output “Table 2. Completeness of HIV Sequences among Diagnoses, by Selected Demographic Characteristics. ” The table must show (1) the total number of persons who received an HIV diagnosis during 2013–2015 and were residing at the time of their diagnosis in the applicant’s jurisdiction (as indicated by Column B, rows 44-46 of Table 2); and (2) the percentage of HIV diagnoses in their jurisdiction with any sequence…