CDC-RFA-PS19-1909 FINAL.pdf

Centers for Disease Control

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

National Harm Reduction Technical Assistance and Syringe Services Program (SSP) Monitoring and Evaluation Funding Opportunity

CDC-RFA-PS19-1909

Application Due Date: 06/26/2019

National Harm Reduction Technical Assistance and Syringe Services Program (SSP)

Monitoring and Evaluation Funding Opportunity

CDC-RFA-PS19-1909

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

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-PS19-1909. 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. Notice of Funding Opportunity (NOFO) Title:

National Harm Reduction Technical Assistance and Syringe Services Program (SSP) Monitoring and Evaluation Funding Opportunity 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 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS19-1909

E. Assistance Listings (CFDA) Number:

93.488 F. Dates:

1. Due Date for Letter of Intent (LOI): 05/24/2019

2. Due Date for Applications: 06/26/2019, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

Letter of Intent is requested, but not required. Letters must include the component(s) to which the applicant intends on applying. Please send letters of intent to: harmreduction@cdc.gov.

Please direct any questions regarding the NOFO to harmreduction@cdc.gov. Any questions will not be answered directly, but answers will be published within 48 hours on https://www.cdc .gov/nchhstp/funding/announcements/ps19-1909. Please refer to this webpage for NOFO updates, Q&As and any other information.

3. Date for Informational Conference Call:

05/09/2019 2pm EST.

Dial in numbers:

Country Local/Toll Number Freephone/Toll Free Number

USA 1-517-233-4397 866-796-7163

Participant Passcode: 3869899 https://www.grants.gov https://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 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov https://www.cdc.gov/nchhstp/funding/announcements/ps19-1909%20 https://www.cdc.gov/nchhstp/funding/announcements/ps19-1909%20

G. Executive Summary:

1. Summary Paragraph:

The opioid crisis has had substantial infectious disease consequences, particularly related to injection drug use (IDU). Comprehensive syringe services programs (SSPs), are a proven effective component of community-based programs preventing the spread of infectious disease from IDU. This three-year program will strengthen the capacity and improve the performance of SSPs throughout the United States by supporting enhanced technical assistance (TA) to ensure the provision of high-quality, comprehensive harm reduction services, and supporting the development and implementation of best practices for patient navigation from SSPs to community-based health and social services. Furthermore, this program will improve the capacity of SSPs to conduct process monitoring and evaluation to ensure their program goals and objectives are met, and it will demonstrate the usefulness and feasibility of a national IDU surveillance system to monitor drug use patterns, health consequences of IDU and access to prevention and health services. These strategies and activities will strengthen capacity of organizations to implement comprehensive, sustainable SSPs, improve services provided, and improve national understanding of drug use patterns and access to prevention and intervention services to prevent infectious disease consequences of the opioid crisis.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 2 Organizations may apply for component 1, 2, or both, but must submit a separate work plan and budget for each component. Organizations applying to component 1,Technical Assistance, must conduct activities for demonstration project 1a, Patient Navigation from SSPs. Organizations wishing to apply for component 2, SSP Monitoring and Evaluation, must conduct activities for demonstration project 2a, IDU Surveillance. Separate work plans and budgets are needed for the demonstration projects.

d. Total Period of Performance Funding: $6,925,000 Year one is funded at $4,975,000, with Component 1 funded at $850,000, and Component 2 at $125,000. The demonstration projects are funded in year one for a total of $4,000,000. Years two and three only Components 1 and 2 will be funded, at the same rate as in year one. Total funding available for years 2 and 3 is $975,000 per year.

e. Average One Year Award Amount: $500,000

f. Total Period of Performance Length: 3

g. Estimated Award Date: 09/02/2019

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 NOFO 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 The opioid crisis has led to increases in overdose [1], hepatitis C [2], hepatitis A [3], and hepatitis B virus incidence in persons who inject drugs (PWID) [4, 5]. Steep declines in HIV infection resulting from injection drug use (IDU) have stagnated [6], and increases in endocarditis [7, 8] indicate the need to strengthen interventions that can prevent transmission of infectious disease.

SSPs can provide a range of health and social services that address the comprehensive needs of PWID, including access to sterile syringes, naloxone, testing and treatment for infectious disease, and medication-assisted treatment (MAT) for substance use disorder. The coverage of SSPs in the US is not sufficient [9], and many SSPs are under-resourced and are unable to offer comprehensive services [10]. Public support for these programs is low [11], and despite the ongoing opioid crisis, SSPs have been closed due to public pressure stemming from a lack of support of these programs [14-16].

The Centers for Disease Control and Prevention (CDC) seeks to address the rising rates of infectious disease related to the opioid crisis through a four-part program intended to strengthen the capacity of SSPs to serve PWID, engage them in care, and to contribute surveillance data to inform prevention efforts for PWID. By enhancing the technical assistance provided to SSPs, strengthening referrals from SSPs through patient navigation, improving monitoring and evaluation of SSPs, and demonstrating the usefulness and feasibility of an IDU surveillance system, the capacity of SSPs to effectively prevent injection-related harms among PWID and in their communities will improve.

References

1. CDC. Drug Overdose Death Data, 2016. 2017; Available from: https://www.cdc.gov /drugoverdose/data/statedeaths.html.

2. CDC. Surveillance for Viral Hepatitis — United States, 2016. 2018; Available from: https ://www.cdc.gov/hepatitis/statistics/2016surveillance/commentary.htm.

3. Foster, et al., Hepatitis A Virus Outbreaks Associated with Drug Use and Homelessness - California, Kentucky, Michigan, and Utah, 2017. MMWR, 2018. 67(43): p. 1208-1210.

4. Harris, et al., Increases in Acute Hepatitis B Virus Infections - Kentucky, Tennessee, and West Virginia, 2006-2013. MMWR, 2016. 65(3): p. 47-50.

5. Comer, et al., Notes from the Field: Increase in Acute Hepatitis B Infections - Pasco County, Florida, 2011-2016. MMWR, 2018. 67(7): p. 230-231.

6. CDC Vital signs: HIV and injection drug use. 2016.

7. Collier, et al. Using Population Based Hospitalization Data to Monitor Increases in

Conditions Causing Morbidity Among Persons Who Inject Drugs. J Community Health, 2018. 43(3): p. 598-603.

8. Jackson, et al., Invasive Methicillin-Resistant Staphylococcus aureus Infections Among Persons Who Inject Drugs - Six Sites, 2005-2016. MMWR, 2018. 67(22): p. 625-628.

https://www.cdc.gov/drugoverdose/data/statedeaths.html https://www.cdc.gov/drugoverdose/data/statedeaths.html https://www.cdc.gov/hepatitis/statistics/2016surveillance/commentary.htm https://www.cdc.gov/hepatitis/statistics/2016surveillance/commentary.htm

9. Foundation for AIDS Research (amfAR), Getting to Services: Far, Far Away. 2018.

10. Des Jarlais, et al., Syringe Service Programs for Persons Who Inject Drugs in Urban, Suburban, and Rural Areas - United States, 2013. MMWR, 2015. 64(48): p. 1337-41.

11. McGinty, et al., Public support for safe consumption sites and syringe services programs to combat the opioid epidemic. Prev Med, 2018. 111: p. 73-77.

12. Brazil, Orange County's only needle exhange shuts down after Santa Ana denies permit, in Los Angeles TImes. 2018.

13. Katz, Why a city at the centre of the opioid crisis gave up a tool to fight it, in New York

TImes. 2018.

14. Hedger, 2nd Indiana county ends needle exchange, with 1 official citing moral concerns, in IndyStar. 2017, USA Today.

b. Statutory Authorities Section Sections 301 and 317 (k)(2) of the Public Health Service Act (42 U.S.C. section 241 and 274b), as amended.

c. Healthy People 2020 This NOFO addresses the Health People 2020 focus on substance use (https://www.healthypeo ple.gov/2020/leading-health-indicators/2020-lhi-topics/Substance-Abuse).

Reduce hepatitis B (IID-25: https://www.healthypeople.gov/node/4692/data_details) Reduce new hepatitis C infections: (IID-26: https://www.healthypeople.gov/node/4695/data_ details) Reduce new HIV infections (https://www.healthypeople.gov/node/3522/objectives)

d. Other National Public Health Priorities and Strategies The HHS Strategic Plan, FY 2018-2022: https://www.hhs.gov/about/strategic-plan/strategic-goal -2/index.html HHS Strategy to Combat Opioid Abuse, Misuse and Overdose: https://www.hhs.gov/opioids /sites/default/files/2018-09/opioid-fivepoint-strategy-20180917-508compliant.pdf National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan Through 2020:

https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf-Strategic- Plan-through-2020-508.pdf

e. Relevant Work CDC-RFA-PS14-1403: Capacity Building Assistance (CBA) for High Impact HIV Prevention:

https://www.cdc.gov/hiv/funding/announcements/ps14-1403/index.html and CSTLTS National Partners Cooperative Agreement OT18-1802 "Establishing Performance https://foa.grantsolutions.gov/Syringe%20services%20programs%20serve%20as%20a%20bridge%20to%20other%20health%20services%20including%20HCV%20and%20HIV%20diagnosis%20and%20treatment%20and%20medication-assisted%20treatment%20for%20substance%20use.%20%20The%20majority%20of%20SSPs%20offer%20referrals%20to%20MAT%20,%20and%20people%20who%20inject%20drugs%20(PWID)%20who%20use%20an%20SSP%20regularly%20are%20more%20than%205%20times%20as%20likely%20to%20enter%20treatment%20for%20a%20substance%20use%20disorder%20and%202.8%20times%20as%20likely%20to%20report%20a%20reducing%20or%20discontinuing%20injection%20as%20those%20who%20have%20never%20used%20an%20SSP.

https://foa.grantsolutions.gov/Syringe%20services%20programs%20serve%20as%20a%20bridge%20to%20other%20health%20services%20including%20HCV%20and%20HIV%20diagnosis%20and%20treatment%20and%20medication-assisted%20treatment%20for%20substance%20use.%20%20The%20majority%20of%20SSPs%20offer%20referrals%20to%20MAT%20,%20and%20people%20who%20inject%20drugs%20(PWID)%20who%20use%20an%20SSP%20regularly%20are%20more%20than%205%20times%20as%20likely%20to%20enter%20treatment%20for%20a%20substance%20use%20disorder%20and%202.8%20times%20as%20likely%20to%20report%20a%20reducing%20or%20discontinuing%20injection%20as%20those%20who%20have%20never%20used%20an%20SSP.

https://www.healthypeople.gov/node/4692/data_details https://www.healthypeople.gov/node/4695/data_details https://www.healthypeople.gov/node/4695/data_details https://www.healthypeople.gov/node/3522/objectives https://www.hhs.gov/about/strategic-plan/strategic-goal-2/index.html https://www.hhs.gov/about/strategic-plan/strategic-goal-2/index.html https://www.hhs.gov/opioids/sites/default/files/2018-09/opioid-fivepoint-strategy-20180917-508compliant.pdf https://www.hhs.gov/opioids/sites/default/files/2018-09/opioid-fivepoint-strategy-20180917-508compliant.pdf https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf-Strategic-Plan-through-2020-508.pdf https://www.cdc.gov/nchhstp/docs/NCHHSTP-Strategic-Plan-through-2020-508.pdf-Strategic-Plan-through-2020-508.pdf https://www.cdc.gov/hiv/funding/announcements/ps14-1403/index.html

Standards for Syringe Services Programs"

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

i. Purpose This NOFO supports the implementation of two program components: 1) nationwide technical assistance for syringe services programs and 2) implementation of a national monitoring and evaluation program for SSPs; and two demonstration projects that are required Year 1 activities under each component. Together, these components will enable a supportive structural environment in order to reduce the infectious disease consequences of the opioid crisis.

ii. Outcomes The program is expected to demonstrate measurable progress toward addressing short-term and intermediate outcomes that appear bolded in the logic model. The section entitled CDC Evaluation and Performance Measurement Strategy further describes the outputs and indicators that quantify program outcomes. A summary of short-term and intermediate outcomes to be measured and reported by funding recipients is as follows:

Component 1: Harm Reduction Technical Assistance Short-term Outcomes:

Strengthened capacity of organizations to implement comprehensive syringe services programs (SSPs) to prevent the infectious disease consequences of injection drug use

(IDU)

Intermediate Outcomes:

Improved sustainability of SSPs Improved implementation of SSPs Improved linkage to medication-assisted treatment from SSPs Improved screening and linkage to care for infectious disease at SSPs

Demonstration project 1a: Patient Navigation pilot project Short-term outcomes:

Strengthened connections from SSP to other community programs Strengthened capacity of SSPs to support PWID seeking access to MAT and infectious disease care

Component 2: Monitoring and Evaluation Short-term Outcomes:

Improved national data from SSPs Improved ability of SSPs to conduct monitoring and evaluation activities

Intermediate outcomes:

Improved implementation of SSPs Improved capacity of CDC and partners to monitor SSP services and program needs in the US Improved capacity of CDC to support and sustain SSPs

Improved capacity of SSPs to measure their local impact

Demonstration project 2a: IDU Surveillance pilot project Short term outcomes:

Strengthened capacity of SSPs to contribute to a national surveillance system Strengthened capacity of SSPs to monitor local drug use

iii. Strategies and Activities This program will strengthen SSPs nationwide by providing technical assistance and monitoring and evaluation to improve their capacity to serve the needs of persons who inject drugs. Through demonstration project activities, it will also improve understanding of the needs, risk behaviors, and prevalence of infectious disease among PWID in various locales. The activities and strategies will build a stable foundation for programs by establishing a network of regional experts, a system for continual improvement, and resources and tools to ensure quality service delivery nationwide.

Available funding and required activities are categorized as follows: Component 1: technical assistance for SSPs, and demonstration project 1a: patient navigation from SSPs to care.

Component 2: SSP monitoring and evaluation; and demonstration project 2a: IDU surveillance.

Applicants may apply for component 1 and 2, if desired, but must submit separate work plans for each component. Those applying to component 1 will undertake activities listed for demonstration project 1a, patient navigation. Those applying to component 2 will undertake activities listed for demonstration project 2a, IDU surveillance.

Component 1: National Harm Reduction TA Recipient will collaboratively develop and deliver a national comprehensive technical assistance program to increase harm reduction knowledge, skills and competencies of staff supporting existing SSPs to local health departments or community based organizations wishing to develop and implement SSPs. Technical Assistance will address, among other topics: providing comprehensive services to persons who inject drugs as described by CDC (https://www.cdc.gov /hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf), linkage to care, monitoring and evaluation, building local champions and stakeholder support, delivering services in rural and suburban areas, and working with law enforcement. In addition to providing technical assistance, the recipient will build a technical assistance toolkit that will be publically available to all SSPs working to deliver effective services in a variety of settings with different levels of resources and local service availability. Recipient will also develop a national training network to support sustainable regional and local expertise to provide ongoing technical assistance.

All component 1 applicants must implement the following activities:

In partnership with CDC, annually develop and implement a work plan for developing and delivering technical assistance based on needs of local health departments and community-based organizations. Technical assistance will address the need to effectively plan, integrate, implement, sustain and expand harm reduction programs and services throughout the United States, in urban, rural and suburban areas. Technical assistance services will include mentoring, consultation, demonstration, skills building, information on best practices and emerging issues, https://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf https://www.cdc.gov/hiv/pdf/risk/cdc-hiv-syringe-exchange-services.pdf resource development and sharing, and opportunities for reciprocal learning among peers through the establishment of a national training network. TA services, products, and materials must be culturally, linguistically, and educationally appropriate to meet the technical assistance needs of harm reduction organizations, and local health departments.

This funding helps state and local health departments, or community based organizations to grow and improve their SSPs. For the purposes of this NOFO, technical assistance is defined as providing in-person, online, peer-to-peer or other support to implement, expand or sustain a harm reduction program. TA will also come in the form of resources, manuals, tools or other documents that provide support to organizations. Models of TA are variable, and might include:

Trainings Consultations Developing Resources

In-person Site visits Manuals

Regional/national meetings Phone calls Evaluation tools

Webinars Emails Templates

Train-the trainer Models of successful programs

Readiness tools

Activities must include:

1. Develop a system for SSPs nationwide to request TA; provide TA to requesting organizations; conduct monitoring and evaluation activities of TA provided.

2. Provision of technical assistance to local health departments, community-based organizations or other groups seeking to establish a SSP in urban, suburban and rural areas of the United States

3. Develop a national training network for SSPs

4. Create of a harm reduction technical assistance toolkit

5. Develop training curricula, materials and toolkit must cover, among other topics:

delivering services within a harm reduction framework, providing comprehensive services to persons who inject drugs, PWID cultural competency, linkage to care and building community health systems, monitoring and evaluation, building local champions and stakeholder support, addressing syringe litter in communities, delivering services in rural and suburban areas, creating a supportive policy environment, and working with law enforcement.

6. Use evidence-informed models for instructional design and adult learning techniques to develop and deliver all training. Products should be carefully developed to ensure that they contain scientifically sound, grammatically correct, and clear language. Training curricula, products, and materials should be fully 508-compliant (https://www.hhs.gov /web/section-508/index.html), formatted, and edited.

7. In partnership with CDC, engage intended audiences in the development of technical assistance curricula, products, and materials.

8. Submit all developed technical assistance products, and materials (e.g., PowerPoint https://foa.grantsolutions.gov/%201.https%20:/www.hhs.gov/web/section-508/index.html https://foa.grantsolutions.gov/%201.https%20:/www.hhs.gov/web/section-508/index.html presentations, implementation manuals, storyboards, learning guides, outlines, etc.) for consideration to be included in final toolkit developed through this NOFO

9. Per CDC guidance, routinely exchange information and work closely with other recipients under this NOFO, and communications group contracted by CDC to support harm reduction communications, to identify technical assistance needs and develop final products.

10. Use feedback from CDC, SSPs and other recipients under this funding opportunity to inform continuous improvement of training.

11. Conduct a timely post-technical assistance activity evaluation of services with quantifiable (e.g. number of people/programs served, topics covered) and qualitative (e.g.

quality of TA provided, needs met, further information needed) data to determine status and challenges related to organizational implementation of harm reduction strategies.

12. Conduct monitoring, evaluation, and reporting activities as described in the funding opportunity.

13. Promote technical assistance program and services.

14. Participate in all post-award meetings, conference calls, and other activities to enhance communication, coordination, and collaboration among any other recipients.

Demonstration Project 1a: Patient Navigation from an SSP Successful recipient of Component 1 will pilot a 1-year program providing patient navigators at 8 SSPs to link clients with opioid use disorder to MAT, and to programs offering care and treatment for infectious disease associated with injection drug use, including viral hepatitis and HIV. At a minimum, 20% of SSP clients will engage with a patient navigator, and 50% of those clients will successfully attend at least one appointment at a linked program.

In partnership with CDC, recipient will develop and implement a work plan for developing and delivering a patient navigation program at 8 SSPs. The primary focus of the SSP patient navigation program is to successfully link clients of SSPs to community-based programs that address the medical and psychosocial needs of PWID, to effectively track navigation work and outcomes, and to develop guidance on replicating successes that can be used in the Harm Reduction TA toolkit that will result from this funding opportunity.

1. In partnership with CDC, determine metrics to be collected in patient navigation program

2. In partnership with CDC, identify 8 SSPs that will participate in this demo project. All participating SSPs must be located in areas where accessing MAT is possible, with support from a patient navigator. Participating SSPs must not have a patient navigation program already in place, but should have the capacity to start one quickly once resources have been made available.

3. Implement and monitor a patient navigation program focused on linking SSP clients to MAT, and care and treatment of infectious disease

4. Develop guidance on replicating successes in other locations

5. Conduct monitoring, evaluation, and reporting activities as described in funding opportunity.

Component 2: SSP Monitoring and Evaluation Successful applicant will develop and implement monitoring and evaluation program for SSPs.

The primary focus of the SSP monitoring and evaluation component is to address a lack of metrics on which SSPs should monitor their ability to effectively serve persons who inject drugs and prevent transmission of infectious disease resulting from injection drug use. Work under this component will include: developing a directory of all SSPs nationwide, identifying metrics to be collected across SSPs, working with SSPs to establish monitoring and evaluation program, and the publication of an annual national SSP report.

Note: To prevent duplication of services and leverage existing federally funded training, the development and delivery of training should occur in coordination, communication and collaboration with the Developing Performance Standards for SSPs (CSTLTS National Partners Cooperative Agreement OT18-1802 "Establishing Performance Standards for Syringe Services Programs") The SSP monitoring and evaluation toolkit will include metrics to be collected, best practices for data collection, tracking SSPs and the services they offer, and resource development and sharing.

All products, and materials must be culturally, linguistically, and educationally appropriate to meet the communications needs of harm reduction organizations, and state and local health departments.

1. Engage at least 80% of SSPs nationwide (as identified by the North American Syringe Exchange Network:https://www.nasen.org/map/) to participate in monitoring and evaluation program

2. In partnership with CDC, and aligned with SSP Performance Standards created through CSTLTS National Partners Cooperative Agreement OT18-1802 "Establishing Performance Standards for Syringe Services Programs", work with SSPs to collect routine client-level data, including basic demographic information, number of syringes distributed and returned, services used, and primary drug(s) of choice, at each client encounter as part of local process monitoring. SSPs will share daily or periodically.

3. In partnership with CDC and national subject matter experts, conduct organizational-level analyses to understand barriers to data collection at SSPs and how they can be addressed

4. In partnership with CDC and national subject matter experts, develop guidance on monitoring and evaluation for SSPs

5. Monitor and track SSPs in the U.S., including openings and closings, locations, and services offered

6. Recipient is responsible for managing SSP data: working with sites to conduct data cleaning, conducting data reconciliation, and identifying errors. Recipient will combine and analyze data sets and provide combined data set to CDC.

7. Support local program evaluation/outcome monitoring at SSPs nationwide. Biannually, work with SSPs to gather information from a SSP clients, focusing on how the local program succeeds in meeting the needs of their clients, measuring client satisfaction, and gaps in services.

8. Work with SSPs to collect summarized data from individual organizations and produce an annual national SSP report

9. In partnership with CDC, and any other recipients of this funding opportunity, and communications group contracted by CDC to support harm reduction communications, and contribute monitoring and evaluation materials to the development and maintenance of harm reduction technical assistance toolkit of all final training curricula, products, and materials.

https://foa.grantsolutions.gov/%20https:/www.nasen.org/map/

10. Per CDC guidance, routinely exchange information and work closely with any other recipients under this funding opportunity to identify technical assistance needs, improve monitoring and evaluation processes and develop final products.

11. Use feedback from CDC, harm reduction programs and other recipients under this funding opportunity to inform continuous improvement of monitoring and evaluation program.

12. Conduct monitoring, evaluation, and reporting activities as described in the funding opportunity.

13. Participate in all post-award meetings, conference calls, and other activities to enhance communication, coordination, and collaboration among all recipients.

Demonstration Project 2a: IDU Surveillance pilot project Successful recipient to component 2 will collaboratively develop and implement a one-year pilot project conducting surveillance of injection drug use by implementing a customizable electronic data capture system and conducting in-depth surveys of persons who inject drugs and drug use trends through SSPs.The primary focus of the surveillance pilot component is to develop and pilot a surveillance system that collects information on substance use and injection use trends and risk behaviors through the deployment of a customizable technology solution designed to capture self-reported client data from individuals engaging with SSPs as well as to collect in-depth information from a subset of SSP clients and their drug-using peers on their drug use practices, experiences with overdose, infectious disease and bacterial infections, unmet needs, and ideas for addressing syringe litter in communities, among other issues.

Work under this component will include two main activities. First, recipient will deploy a customizable electronic data capture system to systematically collect information on substance use and injection risk behaviors among individuals engaging with SSPs with a goal of achieving data collection at minimum 80% of SSPs in the US. Second, recipient will develop, in partnership with CDC, and implement a sampling methodology to select up to 30 SSPs from rural, suburban and urban parts of the U.S. to implement a surveillance survey with 50 SSP clients and 250 of their drug-using peers identified using techniques similar to respondent-driven sampling at each SSP to gather data including, but not limited to, recent drug use (what drugs, how administered, how often), recent experiences with overdose and naloxone, recent screening for and diagnoses of infectious disease, recent diagnoses of endocarditis or other recent experiences with abscess and other bacterial infections. SSPs will also conduct testing including rapid hepatitis C virus (HCV) and HIV tests, and collect dried blood spot specimens for additional testing (e.g., HCV RNA). The recipient for this component will also be awarded work under component 2: SSP Monitoring and Evaluation.

Note: To prevent duplication of services and leverage existing federally funded training, the development and delivery of training should occur in coordination, communication and collaboration with the Developing Performance Standards for SSPs (CSTLTS National Partners Cooperative Agreement OT18-1802 "Establishing Performance Standards for Syringe Services Programs").

1. Engage at least 80% of SSPs nationwide (as identified by the North American Exchange Network: https://www.nasen.org/map/) to participate in pilot surveillance program https://foa.grantsolutions.gov/%20https:/www.nasen.org/map/

2. In partnership with CDC and national subject matter experts, determine client-level metrics to be collected across SSP.

3. In partnership with CDC, develop a survey instrument to collect behavioral data, and develop guidance on collecting client-level data at SSPs. The recipient will conduct this work in compliance with the the Centers for Disease Control and Prevention’s 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 available at http://www.cdc.gov/nchhstp /programintegration/docs/PCSIDataSecurityGuidelines.pdf

4. In partnership with CDC, develop and implement a system to conduct biologic data collection, including HIV and HCV testing, and dried-blood spot specimen collection.

5. In partnership with CDC, ensure all SSPs have a database designed to collect programmatic and client-level data, and resources to perform data collection.

6. Adhere to all local and national guidelines for maintaining HIV data security and confidentiality.

7. Recipient is responsible for managing SSP data: working with sites to conduct data cleaning, conducting data reconciliation, and identifying errors. Recipient will combine and analyze data sets and provide combined data set to CDC.

8. In partnership with CDC, develop a sampling strategy for SSP, SSP clients and their peers. Identify up to 10 SSPs from each area (urban, suburban, rural) for a total of up to 30 SSPs that will each survey up to 300 participants (50 SSP clients and 250 peers) for a total of up to 9,000 participants.

9. Include results from surveillance pilot program in Annual SSP Report published under component 2, SSP monitoring and evaluation.

10. In partnership with CDC, and any other recipients of this funding opportunity, contribute to the development and maintenance of harm reduction technical assistance toolkit of all final training curricula, products, and materials.

11. Per CDC guidance, routinely exchange information and work closely with other recipients under this funding opportunity to identify technical assistance needs and develop final products.

12. Use feedback from CDC, harm reduction programs and other recipients under this funding opportunity to inform continuous improvement of surveillance methods.

13. Conduct monitoring, evaluation, and reporting activities as described in the funding opportunity.

14. Participate in all post-award meetings, conference calls, and other activities to enhance communication, coordination, and collaboration among all recipients.

1. Collaborations

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

Upon funding, recipients will work extensively with CDC to implement an efficient and effective technical assistance program and evaluation program that is consistent with CDC standards and guidance. Recipients are expected to communicate, collaborate and coordinate, including, but not limited to the following:

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

Recipients mutually share materials and products created for technical assistance purposes

Funding recipients consult with CDC subject matter experts, other CDC-funded contractors, and each other to inform subject matter content

Work as a team, all funding recipients develop technical assistance toolkit for implementation and sustainability of harm reduction programs.

In partnership with the CDC, all funding recipients participate in recipient meetings, events, activities, workgroups, committees, etc. as well as promotion of the products and services created under this funding opportunity.

All recipients will work closely with group contracted by CDC to perform harm reduction communications work recipient funded under the SSP Monitoring and Evaluation component will work closely with CSTLTS National Partners Cooperative Agreement OT18-1802 "Establishing Performance Standards for Syringe Services Programs"

In addition, funding recipients will work with CDC-funded health departments and/or CBOs implementing harm reduction programs. recipients must have a history of establishing, building, and/or maintaining these working partnerships to facilitate ongoing development and delivery of their respective services (i.e., technical assistance, and/or SSP monitoring and evaluation).

Regarding other CDC-funded programs, recipients should identify and address technical assistance opportunities for appropriate program coordination and service integration of prevention. recipients are expected to collaborate as directed with recipients of CDC-RFA-PS14- 1403 Capacity Building for High-Impact HIV Prevention, CDC-RFA-17-1702 Improving Hepatitis B and C Care Cascades, and CDC-RFA-17-1703 Strengthening Surveillance in Jurisdictions with High Incidence of Viral Hepatitis.

b. With organizations not funded by CDC:

Recipients are expected to collaborate and partner closely with SSPs nationwide in order to accomplish all NOFO activities. Recipients are expected to establish, build and/or maintain collaborative relationships that will support the implementation of their proposed activities related to their funded component. Consideration should be given to developing, building and/or maintaining relationships with the following types of organizations: syringe services programs, organizations offering medication-assisted treatment, organizations providing other services to persons who inject drugs, health departments, faith-based organizations partnering with harm reduction organizations, law enforcement, clinics, hospitals, tribal organizations, and other recipients of federal dollars directed at serving persons who inject drugs.

Proposals relying on work completed by or through another organization must submit MOUs with their application to demonstrate existing capacity.

2. Target Populations For purposes of this NOFO, the target population is comprised of the interdisciplinary harm reduction workforce (e.g., health care professionals, outreach workers, counselors, administrators) within current and future harm reduction organizations and their local partner organizations (e.g., healthcare organizations and CBOs), stakeholders (e.g. health officials, law enforcement, policy makers and community members), and PWID, and their drug using peers who may be at risk for IDU. Successful applicants must execute program deliverables in a manner that is available, accessible, and acceptable regardless of age, race, ethnicity, gender identity, sexual orientation, geography, socioeconomic status, disability status, primary language, health literacy, and other relevant social dimensions.

a. Health Disparities Persons who inject drugs experience considerable health disparities, from having high mortality due to overdose, and a higher risk of transmission of viral hepatitis, HIV or other infections resulting from injection drug use. They experience high rates of stigma in medical settings1, which are compounded by frequent experiences of violence, incarceration, sexual trauma and marginalization from within and outside of the system2. Harm reduction programs have been shown to be places where persons who inject drugs can access necessary services, including sterile injection equipment and safe disposal of used equipment, access to medication-assisted treatment, screening for infectious disease and linkage to care, and vaccination for hepatitis A and B, among other services. Harm reduction programs, by definition, provide these services in a non-judgmental manner, meeting people who inject drugs ‘where they’re at’, thus addressing the barriers that more traditional health care services can present for this population. This NOFO will help quantify a normally hidden population to better characterize their needs and will improve the local and national understanding of health disparities in this historically marginalized group.

Recipients will use culturally and linguistically appropriate messages, strategies and intervention which address social determinants of health, reduce health disparities and promote health equity.

1.Paquette, C.E., et al. (2018). Stigma at every turn: Health services experiences among people who inject drugs. Int. J. of Drug Policy, 57, pp. 104-110

2.Kidorf, et al. (2004). Prevalence of psychiatric and substance use disorders in opioid abusers in a community syringe exchange program.Drug and Alcohol Depedence, 74(2), pp.115-122.

iv. Funding Strategy It is anticipated that component 1 will be funded at $2.55 million, and component 2, $375,000.

Demonstration project 1a will be funded for one year only at $1,000,000. Demonstration project 2a will be funded for one year only at $3,000,000.

Component 1: $850,000/year for three years Component 1a: $1,000,000 for one year Recipient for Component 1 will also conduct all activities under Demonstration Project 1a, Patient Navigation at SSPs.

Component 2: $125,000/year for three years Component 2a: $3,000,000 for one year

Recipient for Component 2 will also conduct all activities under Demonstration Project 2a, IDU surveillance.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy CDC will monitor and evaluate overall program performance (i.e. all Recipients combined);

program performance by component; and program performance of each Recipient. Recipients will be expected to document implementation of their work plan. Recipients will track, collect and submit the required quantitative and qualitative performance data (i.e. output and outcome indicators) via quarterly performance reports. CDC will use monitoring and evaluation findings to document project status and completion, ensure continuous project improvement and fiscal accountability, and create an evidence base to inform strategies and activities for future harm reduction programs.

CDC will assess recipients’ progress toward achieving short-term and intermediate outcomes. In addition to the above data sources submitted by Recipients, CDC will use other sources including but not limited to assessment of technical assistance recipients after technical assistance delivery, post-training evaluations, training recipient demographic and organizational data, and data gathered from monitoring and evaluation programs, and patient navigation project. Data collection requirements during the period of performance will be subject to review and approval by the Office of Management and Budget (OMB).

The data collected are used for monitoring, evaluation, accountability and improvement of recipient work in accomplishing programmatic goals. CDC will review the data to monitor the recipient performance and accomplishment of work plan outcomes and activities, to assess individual recipients’ progress toward achieving outputs, accomplishment of short-term and intermediate outcomes identified in the program logic model, to identify challenges and potential solutions and to improve program performance. CDC will review the data to monitor recipient performance by component. CDC will only collect data that will be analyzed and used.

CDC will use the data to produce reports on the program’s accomplishments, achievement of key indicators and outcomes, feedback reports, and other monitoring and evaluation reports.

Evaluation findings can be used by recipients and CDC to ensure continuous program and system improvement, help create an evidence base for CBA strategies, demonstrate the value of the NOFO and assess which strategies are effective and scalable. CDC may report findings at national and regional conferences, online, in peer-reviewed journals, and in other public forums.

Recipients will be expected to demonstrate measurable progress toward achieving outputs and the short-term and intermediate outcomes that are bolded in the logic model. For each component, CDC will work with recipient to finalize their detailed work plan, evaluation and performance management plan (EPMP), including a data management plan in accordance with CDC program guidance. A list of outputs, outcomes and performance measures is present in the EPMP. As part of their proposed EPMP, applicants must provide a proposed DMP describing:

the process of retrieving and collecting data (as appropriate); how data will be analyzed and interpreted for continuously monitoring, refining and panning programmatic activities to address all CDC required outputs, outcomes, and performance measures; how and for whom data reporting and programmatic accomplishments will be developed and disseminated; how recipient will provide public access to data; and how data will be stored, archived, and preserved long-term, in accordance to CDC standards.

Recipients will be required to submit a more detailed EPMP, including a DMP, within the first 6 months of award, as described in the reporting section of this NOFO.

Component 1: Technical Assistance

Strengthened capacity of SSPs with identified technical assistance needs o Indicator: Of the programs with identified technical assistance needs, the proportion of programs that received technical assistance

Demonstration Project 1a: Patient Navigation Programs at SSPs

Strengthened connections from SSP to other community programs Indicator: Participating SSPs describe partnerships built with programs providing MAT and care and treatment for infectious disease to support this program Strengthened capacity of SSPs to support PWID seeking access to MAT and infectious disease care Indicator: Participating SSP report on hiring patient navigator o Indicator: Number of MAT or ID care linkages

Component 2: SSP Monitoring and Evaluation

Improved data from syringe services programs o Indicator: Percentage of SSPs nationwide provided in quarterly reports (Target:

80%) Improved ability of SSPs to conduct monitoring and evaluation activities o Indicator: Percentage of SSPs nationwide for which data were collated to highlight areas that need improvement (Target: 80%)

Demonstration Project 2a: IDU surveillance

Strengthened capacity of SSPs to monitor local drug use o Indicator: Percentage of SSPs nationwide with client-level data reported on local drug use (Target: 80%) Improved capacity of SSPs to collect and monitor client-level data o Indicator: Percentage of SSPs nationwide that use database developed to collect surveillance data and reporting to Recipient (Target: 80%)

Strengthened capacity of SSPs to track the negative sequelae of IDU such as overdose and infectious disease experienced by PWID o Indicator: Percentage of SSPs nationwide that report on the negative sequelae experienced by their clients (Target: 80%)

Recipients will be expected to document technical assistance services and other outputs, and progress on demonstration projects. CDC will provide a tool that recipients can use to provide quarterly updates. Information will be requested that includes, but is not limited to, the following:

Component 1: Harm Reduction Technical Assistance

Curricula, materials and products reviewed by CDC TA delivery and tracking information (e.g. method of TA delivery, TA service hours, dates of service, progress notes, action plan) TA recipient and organization information (e.g. TA recipient contact information and positions, organization, services provided) Training recipients assessed for TA for implementation challenges after training Trainee attendance and completion of training Dissemination of training materials Progress toward achieving outputs and the short-term outcomes that are bolded in the logic model

Demonstration Project 1a: Patient Navigation

Materials and products reviewed by CDC Progress towards implementation of navigation program: new hires, development of relationships with programs providing MAT and/or infectious disease care and treatment Success stories Data on uptake of navigation services, successes in getting clients to appointments, barriers to successful linkages Progress toward development of guidance document to support program replicability Progress toward achieving outputs and the short-term outcomes that are bolded in the logic model

Component 2: SSP monitoring and evaluation

Materials and products reviewed by CDC Information about SSPs being monitored and tracked: data being collected, proportion of

SSPs participating, basic data on SSPs (e.g. location, services offered, number of clients served), basic client data (e.g. demographics, HCV/HIV status, primary drug of choice)

Report of barriers to implementation of monitoring and evaluation program from SSPs Progress towards development SSP Annual Report Progress toward achieving outputs and the short-term outcomes that are bolded in the logic model

Demonstration Project 2a: IDU Surveillance

Materials and products reviewed by CDC Progress on implementation of database at all U.S. SSPs Progress on development and dissemination of surveillance guidelines Preliminary surveillance data Progress on survey of SSP clients and their drug-using peers: number surveyed, preliminary results Report of barriers to implementation of surveillance program from SSPs Progress toward achieving outputs and the short-term outcomes that are bolded in the logic model Describe and document organization’s ability to comply with local and national standards for confidentiality and security of HIV surveillance data.

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

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings…