CDC-RFA-PS-24-0026 (Final).pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STDS AND TB PREVENTION

Implementation of Community Health Worker-Mediated Services for Re-Engagement to Care and Outreach for Persons with HIV in Rural Communities (REACH: Rural Re-Engagement and

Care using CHWs for Persons with HIV)

CDC-RFA-PS-24-0026

01/05/2024

Table of Contents 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 Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA-PS- 24-0026. 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:

Implementation of Community Health Worker-Mediated Services for Re-Engagement to Care and Outreach for Persons with HIV in Rural Communities (REACH: Rural Re-Engagement and Care using CHWs for Persons with HIV) 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 purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS-24-0026

E. Assistance Listings Number:

93.940 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.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l)

F. Dates:

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

11/13/2023

2. Due Date for Applications:

01/05/2024 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

Topic: Informational Webinar NOFO PS24-0026

Time: November 15, 2023 12:00 PM Eastern Time (US and Canada)

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G. Executive Summary:

1. Summary Paragraph Persons with HIV (PWH) living in rural communities, where the population is <50,000 persons, may have limited access to HIV care providers and may need to travel long distances to visit an experienced HIV care provider. Additionally, Black and Hispanic/Latino PWH may experience structural barriers such as racism and lack of access to language translation services that may make it challenging to adhere to routine HIV care and treatment services. These barriers can be exacerbated in rural communities. In this demonstration project, recipients will be funded to collaborate with HIV care providers to identify PWH in rural communities not in care or not virally suppressed and to implement a Community Health Worker (CHW)-mediated model of re-engagement to care and outreach services for PWH in rural communities. Recipients will employ and train CHWs to facilitate re-engagement of PWH who are not in care and outreach to those who are not virally suppressed to provide services that may include anti-retroviral treatment (ART) delivery, sample collection for standard HIV laboratory testing, transfer of self-collected specimens, as well as provide transportation services, arranging and scheduling telehealth visits and/or in person visits with an HIV medical provider and other providers (mental health, primary care) and offer evidence-based medication adherence support.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$10,500,000

e. Average One Year Award Amount:

$500,000

f. Total Period of Performance Length:

3 year(s)

g. Estimated Award Date:

April 01, 2024 https://cdc.zoomgov.com/skype/1609071574

h. Cost Sharing and / or Matching Requirements:

No No cost sharing or matching funds are required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability are strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview In rural communities, PWH may face challenges in accessing consistent HIV care services. In these rural communities, PWH may also experience health care provider shortages and have fewer providers with expertise in treating HIV. Transportation challenges, where some patients have to travel long distances for care, may also exist. Additionally, Black/African American (hereafter referred to as Black) and Hispanic/Latino communities are disproportionately affected by HIV compared with other racial/ethnic groups. In 2021, Black Americans represented 12% of the US population, but 40% of PWH;Hispanic/Latino people represented 19% of the population, but 29% of PWH. Racism, poverty, residential segregation and stigma continue to drive health disparities and make it more difficult for Black and Hispanic/Latino communities to access HIV testing, prevention, and care services. These disparities are especially seen in many of the priority Ending the HIV Epidemic (EHE) phase I rural states located in the South. This demonstration project will focus on persons disproportionately affected by HIV including cis-gender Black men and women; Hispanic/Latino people; gay, bisexual and other men who have sex with men (hereafter referred to as MSM); and transgender women. Previous studies have shown community-based or home-based delivery of care is an effective approach to re-engage PWH back into HIV clinical care. This strategy was studied primarily internationally with results showing that community-based delivery of ART significantly increased viral suppression.

However, in the US, this model, which may include home visits, has not been implemented as part of routine treatment and care services.

CHWs are frontline public health workers who are trusted members of the community and have a uniquely close understanding of the community served. This trusting relationship enables the CHW to serve as a liaison between health/social services and the community. A CHW approach was assessed as part of the EHE pilot jumpstart initiative which found that CHWs were successful in East Baton Rouge, LA, by facilitating access to HIV treatment for priority populations. Additionally, the use of CHWs has been successful and cost-effective for certain chronic health conditions, particularly when working with low-income persons; people who are medically underserved, and racial/ethnic minority communities to promote disease management in these populations. This demonstration project will provide quantitative and qualitative data on the effectiveness and implementation of a CHW home-based approach to facilitate re-engagement in care and outreach to PWH. The approach aims to improve retention in care and sustained viral load suppression among PWH living in rural communities, to benefit both individual health and reduce community-level HIV transmission.

In this demonstration project, recipients will be funded to work with HIV clinical providers to develop a CHW-mediated approach to re-engagement to care for PWH not in care and outreach https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/jurisdictions/phase-one/ for PWH not virally suppressed in rural communities. The services CHWs may provide include ART delivery, sample collection for standard HIV laboratory testing, transfer of self-collected specimens, transportation services, arranging and scheduling telehealth visits with the HIV medical providers and with other providers (mental health, primary care) and offering evidence-based medication adherence support. All services will be culturally and linguistically responsive to the population served.

b. Statutory Authorities Section 318(b-c) of the Public Health Service Act (42 USC § 247c(b-c)), as amended, and the Consolidated Appropriation Act of 2016 (Pub. L. 114-113).

c. Healthy People 2030 This program specifically addresses or contributes to multiple objectives included in Healthy People 2030. The topic area of Sexually Transmitted Infections will also be supported.

• Reduce the number of new HIV infections (HIV-01)

• Reduce the number of new HIV diagnoses (HIV-03)

• Increase linkage to HIV medical care (HIV-04)

• Increase viral suppression (HIV-05).

• Reduce the rate of mother-to-child HIV transmission — HIV06

d. Other National Public Health Priorities and Strategies This NOFO aligns with the EHE Initiative and CDC Division of HIV Prevention (DHP), Strategic Plan to (1) reduce the number of people newly diagnosed with HIV; (2) increase access to care and optimize health outcomes for people with HIV; and (3) reduce HIV-related and associated health disparities.

• Ending the HIV Epidemic: A Plan for America

• National HIV/AIDS Strategy (2022-2025)

• National HIV/AIDS Strategy Implementation Plan (2022-2025)

• CDC Division of HIV Prevention Strategic Plan Supplement: An Overview of Refreshed

Priorities for 2022–2025

• CDC National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)

Strategic Plan 2022-2026

• The HHS Strategic Plan FY 2022 – 2026

• HIV Care Continuum

e. Relevant Work CDC-RFA-PS18-1802 “Integrated HIV Surveillance and Prevention Programs for Health Departments”

CDC-RFA-PS20-2010 “Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States” https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://files.hiv.gov/s3fs-public/2022-09/NHAS_Federal_Implementation_Plan.pdf https://www.cdc.gov/hiv/division-of-hiv-prevention/strategic-plan/index.html https://www.cdc.gov/hiv/division-of-hiv-prevention/strategic-plan/index.html https://www.cdc.gov/nchhstp/strategicpriorities/default.htm https://www.cdc.gov/nchhstp/strategicpriorities/default.htm https://www.hhs.gov/about/strategic-plan/2022-2026/index.html https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-term Outcomes Intermediate Outcomes

Long-Term Outcomes

Provide comprehensive HIV testing, care & treatment services to PWH not in care or not virally suppressed in rural communities using Health Department-assigned Community Health Worker (CHW)

• Develop partnerships with HIV clinics

• Identify patients out of care or not virally suppressed

• Assign CHW to re-engage patient with HIV care provider and implement home-based delivery

Provide services that are culturally and linguistically responsive for PWH in rural communities

Support use of mental health, substance use disorder, & other essential support

• Increased re-engagement to HIV care and treatment services by CHWs for PWH not in care in rural communities

• Increased outreach to HIV care and treatment services by CHWs for PWH in care but not virally suppressed in rural communities

• Increased ART (re)-initiation by PWH in rural communities

• Increased linkage to mental health, substance use disorder, and other essential support services for PWH in rural communities

• Increased cultural awareness among CHWs

• Increased persistence with ART by PWH in rural communities

• Increased retention in HIV care among PWH in rural communities

• Increased viral suppression among PWH in rural communities

• Increased sustained viral suppression among PWH in rural communities

• Increased receipt of mental health, substance use disorder, and other essential support services for PWH with need for services in

• Collaborative, sustainable

CHW-

mediated service model for PWH in rural communities

• Decreased HIV incidence among persons living in rural communities

• Decreased HIV-related morbidity and mortality among persons living in rural communities

• Decreased cost of providing HIV testing, care & treatment services among PWH living in rural communities

• Decreased experienced stigma and medical mistrust among persons living in rural communities services by re-engaged PWH

Assess cost-effectiveness of CHW-mediated re-engagement and outreach to HIV care and treatment services for PWH in rural communities and clinical staff

• Increased understanding of best practices and lessons learned by providers of

CHW-

mediated re-engagement and outreach to HIV care and treatment services for PWH in rural communities rural communities

• Decreased enacted, anticipated, internalized, and perceived stigma experienced by PWH in rural communities

• Improved health equity

i. Purpose This NOFO will fund recipients to work with HIV care providers to develop a CHW-mediated approach to re-engagement to care and outreach services for PWH in rural communities. CHWs will provide services that may include, but are not limited to, ART delivery, sample collection for standard HIV laboratory testing, transfer of self-collected specimens, transportation services, arranging and scheduling telehealth visits with the HIV medical providers and with other providers (mental health, primary care) and offering evidence-based medication adherence support.

ii. Outcomes As depicted in the logic model (bolded outcomes), the recipient will be expected to demonstrate progress in the following:

Short-Term Outcomes

• Increased re-engagement to HIV care and treatment services for PWH not in care in rural communities

• Increased outreach to HIV care and treatment services for PWH in care but not virally suppressed in rural communities

• Increased ART (re)-initiation by PWH in rural communities

• Increased linkage to mental health, substance use disorder, and other essential support services for PWH in rural communities

• Increased cultural awareness among CHWs and clinical staff

• Increased understanding of best practices and lessons learned by providers of CHW-mediated re-engagement and outreach to HIV care and treatment services for PWH in rural communities

Intermediate Outcomes

• Increased persistence with ART by PWH in rural communities

• Increased retention in HIV care among PWH in rural communities

• Increased viral suppression among PWH in rural communities

• Increased sustained viral suppression among PWH in rural communities

• Increased receipt of mental health, substance use disorder, and other essential support services for PWH with need for services in rural communities

• Decreased enacted, anticipated, internalized, and perceived stigma experienced by PWH in rural communities

iii. Strategies and Activities Overview

CDC will work in partnership with recipients to develop CHW-mediated re-engagement to care and outreach services for PWH living in rural communities. Each recipient will work with clinical sites to enroll a minimum of 100 PWH who are not in care or have an HIV viral load (VL) that is not suppressed during a one-year enrollment period. Not in care will be defined as:

(1) a person who has not received HIV medical care (either no medical appointments or no CD4/VL measured) for more than 12 months or (2) a person with an unsuppressed viral load (>200 copies of HIV/ml) on last measurement. The recipient (i.e., Health Department will establish a new or use an existing data sharing agreement with HIV clinical providers and if needed also their local/state health department (H D). Providers will use their electronic medical records (EMRs) to identify persons with HIV who are not in care or not virally suppressed on last measurement. Recipients (HDs) will work with the provider to make sure the data on the patient is most accurate and up to date. This will be done by trying to match the patient information from the EMR with the HIV surveillance data from the HD. A HD assigned CHW will be utilized to contact these patients and implement CHW-mediated home visits that may include setting up telemedicine care, providing ART delivery (e.g., use of mail order prescription delivery) and assisting with laboratory monitoring program for the patient that includes CD4/VL testing, as well as coordinating other needed health and social services. More specifically, the recipient will need to train CHWs and/or any additional team staff to deliver, in a timely manner, HIV care and treatment services which may include but not limited to: plasma specimens (trained in phlebotomy) for viral load and other laboratory testing such as STI and hepatitis testing, transfer of self-collected specimens, provide transportation services, arrange and schedule telehealth visits with the HIV medical providers and other providers (mental health, primary care) and provide evidence-based medication adherence support. Depending on need, these services should be done at least on a quarterly basis and will be developed with cultural and linguistic responsiveness for PWH living in rural communities.

The recipient and the clinical provider will create a structured data dictionary and develop a data management plan. The recipients will assess the needs for data collection to accurately monitor and evaluate key outcomes with technical assistance from CDC as needed. Data collection may include development of surveys/interviews and data collection tools for a standardized approach in data collection from all recipients of the NOFO. Recipient led user satisfaction surveys may be administered to patients and providers to collect qualitative data to assess the quality, acceptance, and overall impressions of the Community Health Worker-mediated re-engagement to care and outreach services to measure program performance. All data will be analyzed to assess program performance and determine whether the intended outcomes are being met. Cost data may also be collected to identify costs associated with implementing CHW-mediated re-engagement to care and outreach services for PWH home visit in rural communities.

This project has four strategies: (1) To provide comprehensive HIV care and treatment services, and testing services (CD4 and viral load), to PWH not in care and/or not virally suppressed living in rural communities by using a health department-assigned CHW; (2) To support use of mental health and substance use disorder services and other essential support services by re-engaged PWH living in rural communities; (3) To assess cost-effectiveness of CHW-mediated re-engagement and outreach to HIV care and treatment services for PWH living in rural communities; and (4) To provide services that are culturally and linguistically responsive for persons, especially for Black and Hispanic/Latino persons living in rural communities to reduce stigma.

Note that all required activities should be implemented according to CDC-approved protocols and procedures. Applicants are expected to describe how they will implement the strategies and activities below.

Strategy 1. Provide comprehensive HIV care and treatment services, and testing services to PWH not in care and/or not virally suppressed living in rural communities by using a health department-assigned CHW.

• Recipients will collaborate with HIV clinics and/or providers who routinely provide care to HIV patients to identify 100 PWH not in care or not virally suppressed located in rural communities where population is <50,000 persons.

o Develop a data-sharing partnership between health departments and HIV clinics and care providers.

o In HIV clinics, develop/ensure electronic health record (EHR) capability to identify persons living in rural communities.

o Health departments and clinics should engage with their state office of rural health in their state.

o HIV care providers will identify patients no longer engaged in care which are defined as a person who has not received HIV medical care (either no medical appointments or no CD4/VL measured) for more than 12 months OR with a detectable viral load on last measurement and transmit that list to health department.

o Match patient EMR data with HIV surveillance data; use the most accurate data on the patient and update patient information accordingly.

o Recipients and HIV care providers will develop plan for efficient use of available resources for HIV, STI, and hepatitis testing; mental health and substance use disorder services; and other essential support services.

o Recipients and HIV clinics will partner with pharmacies to provide ART to PWH not in care or not virally suppressed located in rural communities. Rural communities may also include frontier areas that are remote and sparsely populated rural areas which are isolated from population centers and services. There is not a standard definition of rural, however the CDC National Center for Health Statistics (NCHS) has developed a six-level urban-rural classification scheme for U.S. counties and county-equivalent entities. The most urban category consists of “central” counties of large metropolitan areas and the most rural category consists of nonmetropolitan “noncore” counties. The NCHS scheme is available at: https://www.cdc.gov/nchs/data_access/urban_rural.htm. Additionally, the Office of Management and Budget (OMB), Health Resources and Services Administration (HRSA) and the US Census have their own methodologies for defining urban-rural. Recipients will work with CDC on developing a standard method for defining rural communities.

o Determine insurance coverage for ART or eligibility for the AIDS Drug Assistance Program (ADAP) in each jurisdiction.

o Identify novel or latest HIV treatment options including long acting injectables.

o Recipients will o Hire and train CHWs in engaging PWH o Assign CHWs to locate, contact and re-engage PWH who are not engaged in care or conduct outreach to those that are not virally suppressed.

▪ Set up an initial in-person visit or a home-based telemedicine visit with the

HIV care provider.

o Recipient will o Provide specialized training to CHWs that will include, but is not limited to,

▪ Certification as a Phlebotomy technician

▪ Proper handling and transportation of laboratory specimens.

▪ Understanding basic HIV care management

▪ Familiarization with evidence-based ART adherence interventions.

▪ Understanding of insurance and billing services.

▪ Additional training including on motivational interviewing and/or client-centered approach and assisting a client with using telemedicine for accessing HIV care and treatment.

o On a quarterly basis or depending on need, CHWs may o Deliver a 3-month supply of ART or connect patient with mail-order delivery of prescriptions. Treatment options such as long-acting injectables may be supported by in person visit with the HIV provider.

o Collect specimens for routine laboratory testing that include viral load, CD4, and STI testing, as appropriate.

o Transfer specimens to laboratory.

o Arrange and schedule follow-up telehealth visits with the HIV medical providers.

▪ Provider will discuss test results and go over any pertinent care needs o Provide evidence-based medication adherence support.

o Identify support service needs that may include mental health, substance use, and other social service needs (e.g., transportation, internet access, education).

o As needed, link patient with support service providers.

o Recipient will provide the following services to patients:

o Comprehensive health and well-being services o Education and counseling https://www.cdc.gov/nchs/data_access/urban_rural.htm https://www.cdc.gov/hiv/effective-interventions/treat/motivational-interviewing/index.html https://www.cdc.gov/hiv/effective-interventions/treat/motivational-interviewing/index.html https://www.cdc.gov/hiv/effective-interventions/treat/telehealth/index.html https://www.cdc.gov/hiv/effective-interventions/treat/telehealth/index.html o STI testing and treatment o As needed, hepatitis testing, treatment, and vaccination o Primary health care o Preventive care (e.g., vaccinations) o Care for chronic medical conditions (e.g., diabetes care) o Referrals to specialty care as needed o Increase financial access of rural PWH to health care services o Expand enrollment in health insurance if eligible, including Medicaid o Develop and implement strategies to remove barriers to accessing mental health and substance use services o Other collaborative activities recipients may engage in to improve access of rural PWH to HIV health services include:

o Provide training/telemedicine support for clinicians in HIV clinics who want to provide care to PWH in rural communities.

o Provide training and support for CHWs to engage and provide HIV services to PWH in rural communities.

o Recipients may fund collaborating HIV clinics with up to 50% of its funds to implement evidence-based models to identify and re-engage PWH in rural communities by utilizing CHWs to directly provide services.

Strategy 2. Support use of mental health and substance use disorder services and other essential support services by re-engaged PWH living in rural communities

• Identify service providers in the proximity of the patient or those who can provide telehealth services.

• Identify client need for mental health or substance use disorder services o Support referral and linkage to needed mental health or substance use disorder services

• Identify client need for essential support services (e.g., health insurance, housing, food assistance, child-care, transportation, legal services, job training, employment assistance) to address social determinants of health o Support referral and linkage to needed essential support services

Strategy 3. Assess cost-effectiveness of CHW-mediated re-engagement and outreach to HIV care and treatment services for PWH living in rural communities

• Recipients will work with CDC health economist on analyzing all relevant cost data in implementing activities, including baseline data and longitudinal data.

Strategy 4. Provide services that are culturally and linguistically responsive for persons, especially for Black and Hispanic/Latino persons living in rural communities, to reduce stigma.

• Provide cultural awareness training for all health department staff, especially CHWs, ART clinical providers, and all other staff.

o May conduct focus groups or surveys among staff, providers, and patients to assess services are being provided using culturally and linguistically appropriate methods.

• Recruit project staff with experience in cultural awareness in providing care especially for Black and Hispanic/Latino PWH living in rural communities.

1. Collaborations

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

CDC expects recipients to establish, build, and/or maintain working partnerships with CDC and other CDC-funded organizations and projects (e.g., directly funded state and local health departments, CBOs, STD programs, Viral Hepatitis and TB programs, Medical Monitoring Project) to ensure communication, collaboration, and coordination for the delivery of a comprehensive and integrated HIV program that is consistent with CDC standards and guidance.

For implementing activities, recipients are expected to collaborate with local HIV clinical providers (e.g., CBOs, tribal governments and/or tribally designated organizations, health departments, medical institutions, federally qualified health centers (FQHCs), LGBT health centers, STD clinics, hospitals, specialty clinics, institutions of higher education, faith-based institutions, correctional institutions, etc.). Recipients may allocate up to 50% of their award to support collaboration with local HIV clinical providers, including those funded by CDC.

Jurisdictions with eligible state and local (city or county) health departments should discuss how the state and local area will collaborate during the project period to ensure appropriate provision of services within the geographic area(s) and document any agreements reached in a letter of agreement/letter of concurrence (LOA/LOC), which should be submitted by both parties as part of their application.

Applicants should establish new or have existing MOAs/MOUs with local HIV clinical providers, CBOs, health departments, and state offices of rural health as evidence of collaboration. The MOA/MOU should be reflective of the services most requested by the priority population. As needed, recipients are encouraged to establish additional collaborations supported by MOAs/MOUs over the course of the period of performance.

When establishing prevention and essential support services MOAs/MOUs, the applicant should consider the following:

· Proximity of the provider to the applicant’s service area.

· The provider’s capacity and history to serve the population(s).

· Payment requirements for services rendered (e.g., Ryan White provider, types of health insurance accepted).

· Types of services accessible for persons with HIV.

· Availability and accessibility of telehealth by the provider if option is requested by the applicant.

Additionally, the MOAs/MOUs must include, but are not limited to, the following:

· Name and address of the provider(s).

· Name, title, and contact information (i.e., primary work address, email, and phone number) for the primary point of contact for the provider.

· Detailed description of the agreed-upon referral processes for prevention and essential support services between the applicant and the prevention and essential support service provider.

· Process for confirming that the individual accessed the service, in accordance with federal, state, and local policies.

· Signatures from the Business Official for the applicant and the prevention and essential support services provider.

Note: Applicants should submit MOAs/MOUs within a file(s) named “MOUs" and uploaded as a PDF file(s) under "Other Attachments Forms" as a part of your application. Submitted MOAs/MOUs do not count toward the page limit for the Project Narrative.

b. With organizations not funded by CDC:

CDC expects recipients to establish, build, and/or maintain collaborative relationships with organizations not funded by CDC that will support the implementation of the proposed program.

Consideration should be given to developing strategic partnerships with the following types of organizations: federal agencies (e.g., the Health Resources and Services Administration, the Centers for Medicare & Medicaid Services, Substance Abuse and Mental Health Services Administration, Indian Health Service) and their recipients; public health departments; tribal governments and/or tribally designated organizations; local and state education agencies;

colleges and universities; non-CDC funded CBOs; capacity building assistance organizations;

faith-based organizations; for-profit organizations; clinics and hospitals; non-governmental organizations; state and local governments; community advocates; community members;

foundations; and other stakeholders that may have a vested interest in promoting health through HIV prevention, care, and treatment.

For implementing activities, recipients are expected to collaborate with local HIV clinical providers (e.g., CBOs, tribal governments and/or tribally designated organizations, health departments, medical institutions, federally qualified health centers (FQHCs), LGBT health centers, STD clinics, hospitals, specialty clinics, institutions of higher education, faith-based institutions, correctional institutions, etc.). Recipients may allocate up to 50% of their award to support collaboration with local HIV clinical providers, including those not funded by CDC.

Applicants should establish new or have existing MOUs/MOAs with local HIV clinical providers, CBOs, health departments, and state offices of rural health as evidence of collaboration. The MOA/MOU should be reflective of the services most requested by the priority population. As needed, recipients are encouraged to establish additional collaborations supported by MOAs/MOUs over the course of the period of performance.

When establishing prevention and essential support services MOAs/MOUs, the applicant should consider the following:

• Proximity of the provider to the applicant’s service area.

• The provider’s capacity and history to serve the priority population(s).

• Payment requirements for services rendered (e.g., Ryan White provider, type of health insurance accepted).

• Types of services accessible for persons with HIV.

• Availability and accessibility of telehealth by the provider if option is requested by the applicant.

Additionally, the MOAs/MOUs must include, but not be limited to, the following:

• Name and address of the provider(s).

• Name, title, and contact information (i.e., primary work address, email, and phone number) for the primary point of contact for the provider.

• Detailed description of the agreed-upon referral processes for prevention and essential support services between the applicant and the prevention and essential support service provider.

• Process for confirming that the individual accessed the service, in accordance with federal, state, and local policies.

• Signatures from the Business Official for the applicant and the prevention and essential support services provider.

Note: Applicants should submit MOUs/MOAs within a file(s) named “MOUs" and uploaded as a PDF file(s) under "Other Attachments Forms" as a part of your application. Submitted MOAs/MOUs do not count toward the page limit for the Project Narrative.

2. Population(s) of Focus The recipients will focus their activities on all PWH not in care and/or not virally suppressed living in rural communities. Recipients will identify and define geographic service delivery areas based on local municipalities, zip codes, or their own descriptors on which rural communities will be included. This demonstration project will focus on persons disproportionately affected by HIV, which may include cisgender Black women, gay, bisexual and other MSM and transgender persons of any race or ethnicity. However, all PWH living in rural communities will be eligible for these services and could include newly diagnosed or recently diagnosed PWH in rural areas not in care and/or not virally suppressed, who could benefit from using CHWs for continued engagement to HIV care and treatment services.

This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

a. Health Disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Achieving this requires focused and ongoing societal efforts to address historical and contemporary injustices; overcome economic, social, and other obstacles to health and healthcare; and eliminate preventable health disparities.

Broadly defined, social determinants of health are non-medical factors that influence health outcomes. They are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. These forces (e.g., racism, climate) and systems include economic policies and systems, development agendas, social norms, social policies, and political systems. See content below and in other sections (e.g., Approach, Collaborations, Populations of Focus) for information on how this specific NOFO affects social determinants of health.

A health disparity is a preventable difference in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by populations that have been socially, economically, geographically, and environmentally disadvantaged. Health disparities are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these diseases and conditions.

This project supports efforts to improve the health of populations disproportionately affected by HIV, but also viral hepatitis, sexually transmitted diseases (STDs), and tuberculosis (TB) by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity.

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

iv. Funding Strategy Recipients are expected to significantly contribute to the implementation of required activities in the NOFO. However, recipients may propose to use up to 50% of their award to fund collaboration with an HIV clinic(s) to implement activities. Subcontracted HIV clinics may receive funding if there is no programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to CDC or another funding source in the same fiscal year. See the “Duplication of Effort” section of the NOFO for more information.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Recipients should include measurable goals and aims based on a three (3)-year project period.

The application should describe SMART project objectives for each activity described in the application’s project plan and describe the development and implementation of project performance measures based on specific program objectives.

CDC staff will not be engaged in the programmatic activities but will provide technical assistance and support to the recipient as needed. CDC will neither interact with program participants nor their identifiable information. The recipient will be solely responsible for defining the scope, methods, and data collection design.

In developing the evaluation and performance measurement plans, recipients should ensure ability to demonstrate appropriate and successful implementation of the strategies and activities;

progress in achieving outcomes; and understanding the barriers to progress during the period of performance. Recipients are to develop a plan to use performance measurement and evaluation data to improve processes to achieve intended outcomes. Recipients may also conduct special evaluations as needed throughout the period of performance using existing or newly collected data that will be useful in implementing program objectives for their community. Key evaluation questions and data sources for such evaluations will be determined throughout the period of performance to appropriately meet the specific evaluation requirements in the project.

Special evaluation studies, such as formative surveys, interviews, or focus groups with PWH or providers in HIV clinics may also be conducted for information to optimize service models to meet the needs of PWH in rural communities. CDC staff will provide technical assistance and support to the recipient as needed.

A data management plan is required and should include:

• A description of the data to be collected or generated in the proposed project

• The standards to be used for the collected or generated data

• Mechanisms for, or limitations to, providing access to the data, including a description of the provisions for the protection of privacy, confidentiality, security, and intellectual property, or other rights

• Statement of the use of data standards that ensure all documentation that describes the method of collection, and what the data represent

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified

• Other additional requirements based on the program

• Report on trainings of staff to improve cultural and linguistic responsiveness for PWH by

HIV clinics and CBOs

The application should show need based on epidemiologic data in their jurisdictions and demonstrate that the proposed clinical sites use an EHR in their patient care to facilitate collection of longitudinal data to calculate outcome measures in order to evaluate recipient performance and progress toward intended outcomes. Person-level longitudinal data may include demographic characteristics and self-reported sexual and injection drug use behaviors of clients and information about their encounters with HIV clinics, CBOs, and other clinics or organizations and re-engagement, retention, and receipt of services. These data will be linked at the person-level with health care data extracted from EMR in HIV clinics. All data linkages will be conducted by the recipient and the HIV clinic and de-identified data will be transmitted from the recipient to CDC at least every 6 months to inform quality improvement activities.

Recipients should work with their HIV clinic partner(s) and as needed include CDC for technical assistance to include the following information at baseline and every 6 months as process measures for the proposed strategies and activities:

Provide comprehensive HIV testing, care & treatment services to PWH not in care or not virally suppressed in rural communities using Health Department-assigned CHW

• Report on status of collaborations between and among health department, HIV clinic(s), and CBOs.

• Report on numbers of PWH identified as not in care and/or not virally suppressed.

• Report the number of CHWs assigned to re-engage patient with HIV care provider and implement home-based delivery

• Report on trainings of staff to improve cultural and linguistic responsiveness for PWH by

HIV clinics and CBOs

• Report number of trainings provided to key staff to decrease enacted, anticipated, internalized, and perceived stigma experienced by PWH in rural communities

• Report best practices and lessons learned by providers of CHW-mediated re-engagement and outreach to HIV care and treatment services for PWH in rural communities

Support use of mental health, substance use disorder, & other essential support services by re-engaged PWH

• Report of numbers of PWH with mental health disorders, substance use disorders, and other essential support service needs and referral and linkage to appropriate services by the HIV clinic and CBOs

Assess cost-effectiveness of CHW-mediated re-engagement and outreach to HIV care and treatment services for PWH in rural communities

• Report all relevant cost data in implementing activities, including baseline data and longitudinal data.

Short-term outcomes

Outcome: Increased re-engagement to HIV care and treatment services by CHWs for PWH not in care in rural communities

Measures:

• Number of PWH that were identified as not in care by the HIV clinic/provider

• Number of PWH that were contacted by the CHW

• Number of PWH that scheduled an appointment with the CHW (telehealth or in-person).

• Number of PWH that successfully met their appointment with the CHW (telehealth or in-person).

• Number of PWH that scheduled their next appointment with an HIV provider (re-engagement to HIV care and treatment services).

• Number of PWH linked to HIV clinic (in-person or telehealth)

Outcome: Increased outreach to HIV care and treatment services by CHWs for PWH in care but not virally suppressed in rural communities

Measures:

• Number of PWH that were identified in care but not virally suppressed by HIV clinic/provider

• Number of PWH that were contacted by the CHW

• Number of PWH that scheduled an appointment with the CHW (telehealth or in-person).

• Number of PWH that successfully met their appointment with the CHW (telehealth or in-person).

• Number of PWH provided evidence-based medication adherence support by CHW and/or their HIV provider.

Outcome: Increased ART (re)-initiation by PWH in rural communities

Measures: Number of PWH who (re)-initiated ART with an ART prescription.

Outcome: Increased linkage to mental health, substance use disorder, and other essential support services for PWH in rural communities

Measures:

• Number of PWH with unmet mental health support service needs

• Number of PWH with unmet substance use disorder support service needs

• Number of PWH provided assistance to link to mental health support services

• Number of PWH provided assistance to link substance use disorder support services

• Number of PWH with unmet other essential support service needs that include but are not limited to:

o Number of PWH needing HIV education and counseling o Number of PWH needing STI testing and treatment o Number of PWH needing hepatitis testing, treatment, and vaccination o Number of PWH needing Primary health care o Number of PWH needing Preventive care (e.g., vaccinations) o Number of PWH needing Chronic care (e.g., diabetes care) o Number of PWH needing Referrals to specialty care as needed o Number of PWH needing comprehensive health and well-being services

• Number of PWH provided assistance to link to other essential support service needs that include but are not limited to:

o Number of PWH linkage assistance to HIV education and counseling o Number of PWH linkage assistance to STI testing and treatment o Number of PWH linkage assistance to hepatitis testing, treatment, and vaccination o Number of PWH linkage assistance to Primary health care o Number of PWH linkage assistance to Preventive care (e.g., vaccinations) o Number of PWH linkage assistance to Chronic care (e.g., diabetes care) o Number of PWH linkage assistance to Referrals to specialty care as needed o Number of PWH linkage assistance to comprehensive health and well-being services

Outcome: Increased cultural awareness among CHWs and clinical staff

Measures: Number of CHWs and clinical staff provided trainings on cultural and linguistic responsiveness for PWH

Intermediate outcomes:

Outcome: Increased persistence with ART by PWH in rural communities

Measures: Number of persons persisted with ART (i.e. at least 2 separate ART prescriptions at least 3 months apart within 12 months)

Outcome: Increased retention in HIV care among PWH in rural communities

Measures: Number of persons retained in HIV care (i.e. 2 clinic and/or telehealth visits with lab measurements at least 3 months apart within 12 months)

Outcome: Increased viral suppression among PWH in rural communities

Measures: Time to viral suppression among persons who received ART based on last VL test.

Outcome: Increased sustained viral suppression among PWH in rural communities

Measures: Number of persons with two consecutive suppressed viral load results at least 3 months apart within 12 months.

Outcome: Increased receipt of mental health, substance use disorder, and other essential support services for PWH with need for services in rural communities

• Number of PWH receiving mental health support service needs

• Number of PWH receiving substance use disorder support service needs

• Number of PWH receiving other essential support service needs that include but not limited to o Number of PWH receiving HIV education and counseling o Number of PWH receiving STI testing and treatment o Number of PWH receiving hepatitis testing, treatment, and vaccination o Number of PWH receiving Primary health care o Number of PWH receiving Preventive care (e.g., vaccinations) o Number of PWH receiving Chronic care (e.g., diabetes care) o Number of PWH receiving Referrals to specialty care as needed o Number of PWH receiving comprehensive health and well-being services

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 for continuous program quality improvement, including, as applicable to the award, how findings will contribute to reducing or eliminating health disparities and inequities.

• How key…