CDC-RFA-PS21-2102.pdf

Centers for Disease Control and Prevention

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

Comprehensive High-Impact HIV Prevention Programs for Community-Based Organizations

CDC-RFA-PS21-2102

Application Due Date: 11/20/2020

Comprehensive High-Impact HIV Prevention Programs for Community-Based Organizations

CDC-RFA-PS21-2102

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 "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- PS21-2102. 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:

Comprehensive High-Impact HIV Prevention Programs for Community-Based Organizations 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)).

New-Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS21-2102

E. Assistance Listings (CFDA) Number:

93.939 F. Dates:

1. Due Date for Letter of Intent (LOI): 09/30/2020

2. Due Date for Applications: 11/20/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

To obtain a schedule of the pre-application and technical assistance activities or additional information related to this notice of funding opportunity, please visit (https://www.cdc.gov/hiv /funding/announcements/ps21-2102/index.html).

G. Executive Summary:

1. Summary Paragraph:

The CDC announces the availability of fiscal year 2021 funds for a cooperative agreement program for community-based organizations (CBOs) to develop and implement high-impact human immunodeficiency virus (HIV) prevention programs.

CBOs are uniquely positioned to complement and extend the reach of HIV prevention efforts implemented by state and local health departments. They support the optimization of services across public, private, and other community-based organizations to achieve objectives of increased identification of HIV diagnoses, referral for pre-exposure prophylaxis (PrEP) and non-occupational post-exposure prophylaxis (nPEP) services, earlier entry to HIV care, and 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/hiv/funding/announcements/ps21-2102/index.html https://www.cdc.gov/hiv/funding/announcements/ps21-2102/index.html increased consistency of care.

By direction of the President, the Department of Health and Human Services (DHHS) has set an ambitious goal of reducing all new HIV infections by 75% in 5 years and by 90% by 2030. This CBO program aligns with the pillars of the nation’s Ending the HIV Epidemic Initiative (EHE):

A Plan for America – Diagnose, Treat, Prevent, and Respond, and employs CDC’s High-Impact Prevention approach.(https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview)

a. Eligible Applicants: Limited

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 90

d. Total Period of Performance Funding: $210,000,000

e. Average One Year Award Amount: $470,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 07/01/2021

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 For more than 35 years, HIV has affected millions of Americans of whom more than 700,000 have died. In recent years, deaths among persons with HIV have declined, while the number of people with HIV has increased. According to CDC, an estimated 1.1 million persons are living with HIV and approximately 15% are unaware they have HIV. [1, 2] Unless effectively treated to achieve viral suppression, HIV can be transmitted to others and leads to premature death.

However, persons with HIV who use antiretroviral therapy (ART) and reach and maintain an undetectable viral load in their blood can have a nearly normal life expectancy and have effectively no risk of transmitting HIV to others through sex.[3] Since the late 1980s, CDC has formally partnered with CBOs to expand the impact and reach of HIV prevention in affected communities. Because of their accessibility, history, and credibility in the community, CBOs are recognized and remain important partners in providing comprehensive high-impact HIV prevention services. Building individual competencies, organizational capacities, and supportive structural environments among these partners are key strategies for the effective promotion, delivery, and sustainability of HIV prevention programs and services, https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview particularly for people with and at greatest risk for acquiring HIV, including Blacks/African- Americans; Hispanics/Latinos; all races/ethnicities of gay, bisexual, and other men who have sex with men (MSM); people who inject drugs (PWIDs); and transgender persons. Through this new funding cycle, CDC is seeking to develop new and enhance existing strategies for community-based HIV prevention programs that aim to achieve these goals in alignment with the Ending the HIV Epidemic Initiative by diagnosing HIV as early as possible; treating HIV quickly and effectively; preventing new HIV cases; and responding quickly to HIV clusters and prevent new cases.

b. Statutory Authorities This program is authorized under Sections 301 and 318 of the Public Health Service Act; 42 USC Sections 241 and 247c, as amended.

c. Healthy People 2030 This NOFO addresses the "Healthy People 2030" focus area of HIV. Healthy People HIV

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

Ending the HIV Epidemic: A Plan for America - (https://www.hiv.gov/ending-hiv-epide mic

Secretary’s Minority AIDS Initiative (MAI) - https://www.hiv.gov/federal-response/smaif /overview

CDC Winnable Battles - https://www.cdc.gov/WinnableBattles/index.html The National HIV/AIDS Strategy for United States: Updated to 2020 - https://www.cdc

.gov/nchhstp/strategicpriorities/docs/nchhstp-strategic-plan-through-2020-508.pdf ;

HIV/AIDS Care Continuum: https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)

Strategic Plan through 2020: https://www.cdc.gov/nchhstp/strategicpriorities/

All NOFO activities must be consistent with current and future CDC-supported programmatic guidance, scientific advances, and recommendations.

e. Relevant Work This NOFO builds upon previous and current HIV prevention programs for community-based organizations, including:

CDC-RFA-PS15-1502, "Comprehensive HIV Prevention Projects for Community-Based Organizations" https://www.cdc.gov/hiv/funding/announcements/ps15-1502/index.html

CDC-RFA-PS17-1704, "Comprehensive HIV Prevention Projects for Young Men of Color Who Have Sex with Men and Young Transgender Persons of Color" https://www https://www.healthypeople.gov/2020/topics-objectives/topic/hiv https://www.hiv.gov/ending-hiv-epidemic https://www.hiv.gov/ending-hiv-epidemic https://www.hiv.gov/federal-response/smaif/overview https://www.hiv.gov/federal-response/smaif/overview https://www.cdc.gov/WinnableBattles/index.html https://www.cdc.gov/nchhstp/strategicpriorities/docs/nchhstp-strategic-plan-through-2020-508.pdf%20 https://www.cdc.gov/nchhstp/strategicpriorities/docs/nchhstp-strategic-plan-through-2020-508.pdf%20 https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum https://www.cdc.gov/nchhstp/strategicpriorities/ https://www.cdc.gov/hiv/funding/announcements/ps15-1502/index.html https://www.cdc.gov/hiv/funding/announcements/ps17-1704/index.html

.cdc.gov/hiv/funding/announcements/ps17-1704/index.html

NOFO activities will support current and future CDC HIV prevention programs and initiatives.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

https://www.cdc.gov/hiv/funding/announcements/ps17-1704/index.html

i. Purpose The NOFO focuses on addressing the national HIV epidemic by reducing new infections, increasing access to care, and promoting health equity in accordance with the Ending the HIV Epidemic: A Plan for America Initiative and CDC’s High-Impact HIV Prevention approach. This will be achieved by enhancing CBOs' capacity to increase HIV testing and referrals to Partner Services, link persons with HIV to HIV medical care and ART, provide/refer prevention/ essential services, including SSPs, for persons with HIV and persons at risk for acquiring HIV, and increase program monitoring and accountability.

ii. Outcomes The program is expected to demonstrate measurable progress among its target populations toward addressing the short-term outcomes depicted in the NOFO logic model. Potential indicators that quantify these outcomes are described in the section entitled CDC Evaluation and Performance Measurement Strategy.

Expected short-term outcomes include the following:

Diagnose

Increased persons who are aware of their HIV status Increased receipt of integrated screenings

Treat

Increased receipt of HIV medical care and ART among persons with newly diagnosed

HIV

Increased receipt of HIV medical care and ART among persons with previously diagnosed HIV, not-in-care

Increased access to Partner Services

Prevent

Increased access to PrEP Increased availability of condoms

iii. Strategies and Activities Applicants are required to provide a comprehensive plan for HIV prevention services for persons with HIV and high-risk HIV-negative persons. The program plan must consist of all required comprehensive HIV prevention core and operational program activities and strategies.

At least 75% of funding must be used to support the comprehensive HIV prevention core program activities and up to 25% of funding may be allocated to support the operational program activities.

Comprehensive HIV Prevention Core Program:

Diagnose (Targeted HIV Testing, Provide and/or Refer to Integrated Screenings) Treat (Linkage to HIV Medical Care, Re-engagement, Partner Services Referral, Medication Adherence (to achieve Viral Suppression)) Prevent (Referrals to PrEP and nPEP, Health Education/Risk Reduction, Condom

Distribution) Respond (Support for Health Department Cluster Detection and Response Activities)

Operational Program:

Program Promotion, Outreach, and Recruitment Community Engagement Group (CEG) HIV Planning Group (HPG)

Applicants must address all strategies and activities delineated above, unless otherwise indicated.

Structure of the Project There will be two phases of the project: a development phase lasting no longer than 6 months from the start of Year 1 (July 1, 2021 - December 31, 2021), followed by ongoing program implementation, monitoring, and evaluation.

Development Phase (July 1, 2021 – December 31, 2021): Recipients will collaborate with CDC as well as community, local, and state partners to finalize the components of their project. During this time, recipients are expected to complete staff hiring processes and attend all required trainings that support the effective implementation of their programs.

During the Development Phase:

o Recipients must work with CDC/DHAP to revise and finalize their detailed Year 1 work plan and five (5) year work plan based on the approved funding amount and program strategies and activities as described later in the Applicant Evaluation and Performance Measurement Plan section of the NOFO.

o Recipients must work with CDC/DHAP to revise and finalize their evaluation plan, as described later in the Recipient Evaluation and Performance Measurement Plan section of the NOFO.

o If recipient is fully staffed during the development phase and the entire 6 months is not needed for program development, full implementation of the approved program is expected during the development phase.

o Recipients will be expected to attend a Recipient Orientation meeting in Atlanta, Georgia, during Year 1 and should allocate funds to support the travel of up to three staff persons to attend the 4- to 5-day meeting.

Ongoing Implementation Phase: It is expected that each recipient will begin programmatic implementation no later than January 1, 2022 through June 30, 2026.

o During Year 1 only (July 1, 2021 – June 30, 2022), recipients will be expected to achieve at least 50% of each NOFO performance measure described throughout the NOFO and approved by CDC.

o Beginning in Year 2, and for all subsequent years (Years 3, 4, and 5), recipients are expected to meet or exceed all NOFO performance measures.

o Recipients must also allocate sufficient funds to enable appropriate program staff to attend all required CDC meetings and trainings that support the prevention approaches described in this NOFO, as communicated by CDC in advance of the meetings throughout the period of performance.

Justification of Need There is no singular approach that will work effectively to address the overarching goals of the project. Applicant must describe the factors that place the target population at high risk of acquiring or transmitting HIV, including concurrent risk transmission with other diseases (i.e., STDs, viral hepatitis, and TB) and social and environmental characteristics. Applicants should provide an overview of how the proposed target population and the community at large have been affected by HIV (e.g., HIV incidence or prevalence; HIV co-morbidity rates with hepatitis, STDs, or TB).

Applicant should access and consider approaches that when combined will have the greatest public health impact. This framework acknowledges that prevention and care/treatment together contribute to reducing HIV-related morbidity, mortality, and related health disparities among racial and ethnic minorities in the United States, the Commonwealth of Puerto Rico, and the U.S.

Virgin Islands.

The applicant should ensure the proposed program aligns with the state or local health department’s Jurisdictional HIV Prevention Plan (e.g., Integrated HIV Prevention and Care Plan, EHE Plan, Getting to Zero Plan). More specifically, the applicant must:

Define the specific service area in which they plan to deliver their program. Local surveillance and epidemiologic data, when available, should be used to identify the proposed service area within the eligible jurisdiction that are disproportionately affected by HIV and where people with and at greatest risk for HIV reside and/or frequent.

Enhance existing and develop new strategies to identify and collaborate with organizations that currently provide similar and/or complementary services in the proposed service area; this may be done in consultation with the Health Department.

Describe how these funds will augment existing HIV prevention services and provide an assurance that the funds being requested will not duplicate or supplant funds received from any other federal or non-federal entity.

Develop an approach that includes the required components and additional components that will, when combined, have the greatest public health impact. These combined activities should have the greatest potential to address the social and structural determinants of health that are known to create the most significant barriers to testing; linkage to, retention in, and re-engagement with care; and prevention and essential support services.

Develop a client centered program model that should include a combination of high-impact prevention (HIP) strategies and services to continually engage persons with HIV and eliminate or reduce barriers to accessing medical care and other prevention and essential support services. Program model should also include strategies and services to engage persons at risk for acquiring HIV. Visit the following websites for additional information on HIP strategies and services: https://www.cdc.gov/hiv/effective-interventi ons/index.html and http://www.cdc.gov/hiv/policies/hip.html.

COMPREHENSIVE HIV PREVENTION CORE PROGRAM:

Organizations are required to develop and implement a Comprehensive HIV Prevention Core Program model for persons with HIV (newly and previously diagnosed) and persons at high risk for acquiring HIV, which enhances existing and establishes new structures that align with and support the Ending the HIV Epidemic Initiative. This includes the implementation and delivery of strategic practices that focus on the diagnosis, treatment for persons with HIV, prevention of new HIV infections, and assisting health departments to rapidly respond to growing HIV clusters to prevent new infections in compliance with the requirements of the NOFO. 75% or more of the award amount must be allocated to the comprehensive HIV prevention core program.

https://www.cdc.gov/hiv/effective-interventions/index.html https://www.cdc.gov/hiv/effective-interventions/index.html http://www.cdc.gov/hiv/policies/hip.html

DIAGNOSE

Required Strategies and Activities:

Targeted HIV Testing Integrated Screening Activities

Targeted HIV Testing HIV testing is an essential part of the Comprehensive HIV Prevention Core Program. Recipients will be required to:

Develop new or enhance existing targeted HIV testing programs aimed at reaching persons who are at greatest risk for HIV and who are unaware of their HIV status.

Integrate HIV testing into the comprehensive high-impact HIV prevention program and the overall mission and operations of the organization’s HIV prevention and care services.

This should include the development of strategies to recruit members of the target population at greatest risk for HIV and who are unaware of their HIV status; and reduce the target population’s barriers to accessing HIV testing and address health inequities among the target population disproportionately affected by the HIV epidemic.

Implement targeted HIV testing in non-healthcare settings to identify HIV using multiple strategies and the most current recommendations. Follow current CDC guidelines and recommendations for HIV testing. (https://www.cdc.gov/hiv/pdf/testing/CDC_HIV_Im plementing_HIV_Testing_in_Nonclinical_Settings.pdf). Targeted HIV testing efforts should also be conducted in accordance with state and local regulations.

Utilize the latest HIV testing technology available, when feasible, throughout the program award.

Establish annual HIV testing objectives for the target population using local jurisdictional data and/or agency historical data. Organization must identify a minimum of eight (8) new HIV diagnoses annually.

Organizations must identify a variety of settings where targeted testing will be conducted and most effective in identifying members of the target population with undiagnosed HIV and those who are lost to HIV medical care. Examples include, but are not limited to:

o Onsite testing within the organization o Venue-based testing (e.g., Retail Pharmacy, Substance Use Centers, Clubs/Bars, etc.)

o Mobile/field testing o Self-Testing (Home-based) – If self-testing is utilized, organizations are required to provide specific protocols, in conjunction with the local or state health department, which includes recruitment processes, follow-up, and linkage procedures. https://www.cdc.gov/hiv/testing/self-testing.html o Consider the use and implementation of Social Network Strategy (SNS) to recruit the target population, if feasible. https://www.cdc.gov/hiv/effective-interventions /diagnose/social-network-strategy/index.html?Sort=Title%3A%3Aasc&;Interventi on Name=Social%20Network%20Strategy

Employ repeat testing activities for individuals who report engaging in high-risk behaviors since their last HIV test. Repeat testers are described as individuals who have https://www.cdc.gov/hiv/pdf/testing/CDC_HIV_Implementing_HIV_Testing_in_Nonclinical_Settings.pdf https://www.cdc.gov/hiv/pdf/testing/CDC_HIV_Implementing_HIV_Testing_in_Nonclinical_Settings.pdf https://www.cdc.gov/hiv/testing/self-testing.html https://www.cdc.gov/hiv/effective-interventions/diagnose/social-network-strategy/index.html?Sort=Title%3A%3Aasc&Intervention%20Name=Social%20Network%20Strategy https://www.cdc.gov/hiv/effective-interventions/diagnose/social-network-strategy/index.html?Sort=Title%3A%3Aasc&Intervention%20Name=Social%20Network%20Strategy https://www.cdc.gov/hiv/effective-interventions/diagnose/social-network-strategy/index.html?Sort=Title%3A%3Aasc&Intervention%20Name=Social%20Network%20Strategy previously been tested and have engaged in unsafe sexual behaviors since the receipt of their last HIV test result. Recipient may opt to implement Personalized Cognitive Counseling (PCC), when appropriate with repeat testers, upon receipt of training from a CDC-approved provider. Visit https://www.cdc.gov/hiv/effective-interventions/diagnose /personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&;Intervention Name=Personalized%20Cognitive%20Counseling for additional information.

Serve the identified members of the proposed target population supported by local epidemiologic and surveillance data and the appropriate health department’s Jurisdictional HIV Prevention Plan (e.g., Integrated HIV Prevention and Care Plan, and/or EHE Plans, Getting to Zero Plan) (See Attachment B: Organizational Capacity and Proposed Target Population Worksheet). At least 75% of individuals tested must be considered members of the applicant’s target population.

CDC recognizes that a shift in the community, changes in the prevalence within a jurisdiction, and/or changes in the HIV landscape may require adjustments to the target population (i.e. age range and race/ethnicity) and annual performance measures. Therefore, CDC may allow an organization the flexibility to adjust annual HIV testing objectives and/or strategies throughout the 5-year period of performance, upon discussion and approval with the CDC/DHAP assigned Project Officer.

Large Scale Testing Event

Organizations are required to participate in at least one large-scale HIV testing event per budget period that is specifically promoted to members of the target population and provides the organization access to members of their target population. Examples of large-scale testing events include, but are not limited to,HIV/AIDS Awareness Days, PRIDE weekend events, House and Ball events, and events sponsored by school-based health programs. Exception may be made in cases of unusual risk and large-scale events are not allowed in the jurisdiction within a program year.

The engagement at the community event should be used to establish a mechanism to engage the target population, assist with program promotion and recruitment, and network with members of the target population.

The event can occur in collaboration with existing organizations that work with or provide services to the target population. Recipients should not be the sole sponsor and/or primary organizer of the event.

Optional Targeted HIV Testing Activities Recipients may also implement the following complementary services with the HIV testing program in accordance with the NOFO requirements, as appropriate.

Personalized Cognitive Counseling (PCC)

Recipients may opt to implement Personalized Cognitive Counseling (PCC) only upon receipt of training from a CDC-approved provider. PCC is an intervention designed to reduce sexual risk behaviors among men who have sex with men (MSM) who are repeat testers for HIV. Repeat testers are described as individuals who have previously been tested and have engaged in unsafe sexual behaviors since the receipt of their last HIV test https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling%20 https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling%20 https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling%20 result. Visit https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cogni tive-counseling/index.html?Sort=Priority%3A%3Aasc&;Intervention Name=Personalized %20Cognitive%20Counseling for additional information.

Federally Qualified Health Centers

Applicants that are Federally Qualified Health Centers (FQHCs), if located in a geographic area with high HIV disease burden and provide services to the target population, may opt to implement routine HIV testing within their clinic setting, in accordance with the CDC recommendation (2006 HIV Testing in Healthcare Setting Guidance: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm). The majority of the HIV testing must be conducted in an outreach setting; up to 25% of HIV testing efforts can be conducted as routine, opt-out HIV testing.

Referrals for Persons with HIV Recipients will be required to:

Refer persons with HIV (newly and previously diagnosed) to prevention and essential support services, as described in the Treat and Prevent section, discussed later in the

NOFO.

Integrated Screening Activities Recipients that have the capacity to implement various integrated screening activities (e.g., screening for STDs, viral hepatitis, and/or TB), in conjunction with HIV testing, for members of their target population at greatest risk of acquiring HIV, should implement service integration activities within their organization. Recipients will be required to:

Support and promote collaboration between HIV, STD, viral hepatitis, and/or TB programs through the support and provision of integrated screening activities delivered in conjunction with HIV testing. Funds from this NOFO may be used for other screening tests, including those described below, only if these tests are provided in conjunction with HIV screening, are indicated by epidemiologic data, and are in accordance with current CDC guidelines and recommendations. Visit https://www.cdc.gov/std/tg2015/tg-2015-print.pdf and https://www.cdc.gov/tb/publications/guidelines/testing.htm for additional information.

Utilize up to 5% of the requested total funding amount to implement and/or strengthen and enhance integrated screening activities within the agency.

Collaborate with key staff of the participating facilities to plan, develop, and implement the integrated screening activities for STDs, viral hepatitis, and/or TB.

Collaborate with the STD, hepatitis, and/or TB prevention programs in the jurisdiction to design, develop, and implement proposed screening and treatment services.

Encourage MSM who are tested for HIV to get a syphilis serology and screening for urethral and rectal gonorrhea and chlamydia. The applicant should consider self-collection of specimens (urine and self-collected swabs) to facilitate implementation and reduce costs.

Ensure that clients receive their test results, especially those who test positive.

https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling%20 https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling%20 https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling%20 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm https://www.cdc.gov/std/tg2015/tg-2015-print.pdf%20 https://www.cdc.gov/std/tg2015/tg-2015-print.pdf%20 https://www.cdc.gov/tb/publications/guidelines/testing.htm%20

Ensure that clients who test positive are linked to appropriate medical care and receive timely and appropriate evaluation and treatment.

For clients who test positive for STDs, ensure that Partner Services are initiated as soon as possible after diagnosis, in accordance with CDC recommendations and state and local requirements. Ensure compliance with health department disease (e.g., HIV, STD, viral hepatitis, and/or TB) reporting regulations.

For clients who are candidates for hepatitis A or B vaccination, provide referrals to these services.

Periodically review monitoring data to assess the value of continuing screening for other STDs, viral hepatitis, and TB.

When appropriate and feasible, use all available mechanisms to bill for integrated screening services and obtain reimbursement from third-party payers (e.g., Medicaid, Medicare, private insurance).

If the recipient does not have the capacity to perform integrated screening activities in conjunction with HIV testing, the organization must refer clients for integrated screening. The organization must:

Establish a service agreement with a clinical care provider in the service area.

Submit the service agreement with the application.

Ensure the service agreement clearly describes services offered by the clinical care provider and the agreed upon referral process between the recipients and the clinical provider. This agreement should include how the clinical care provider will confirm receipt of service obtained by the referred client.

Funds from this NOFO may not be used for clinical services; treatment of HIV, STDs, viral hepatitis, and/or TB; vaccination against hepatitis A or hepatitis B; and vaccination against human papillomavirus (HPV).

Visit http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5912a1.htm?s_cid=rr5912a1_e and http ://www.cdc.gov/tb/topic/testing/default.htm#who for additional information.

Additional Information:

In accordance with the guidelines established by the state or local health department and CDC data requirements, organizations are required to:

Develop strategies to collect and report the required CDC HIV testing variables to CDC.

Additional information is located in the Applicant Evaluation and Performance Measurement Section of the NOFO.

Coordinate with the local or state health department regarding HIV testing plans, to include trainings and process for referring clients to Partner Services, and training to support the confirmation of persons newly diagnosed with HIV, identified by the CBO for Partner Services. Confirmation of the coordination with the state or local health department must be provided via Attachment C: Health Department Targeted HIV Testing and Partner Services Letter of Agreement.

Work with the local or state health department to collaborate with various entities to support utilizing advances in HIV testing and algorithms to improve the detection of early http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5912a1.htm?s_cid=rr5912a1_e%20 http://www.cdc.gov/tb/topic/testing/default.htm%23who%20 http://www.cdc.gov/tb/topic/testing/default.htm%23who%20 and acute HIV, when feasible and appropriate, considering the capacity of the recipient.

Work with health departments to explore opportunities for seeking reimbursement and to determine whether third-party reimbursement makes sense financially, when appropriate and feasible. Organizations with the capacity to bill and obtain reimbursement are expected to use all available mechanisms to obtain reimbursement for HIV testing from third-party payers (e.g., Medicaid, Medicare, private insurance).

Applicants must also:

Ensure that the proposed HIV testing activities meet all local, state, and federal requirements for HIV testing. If required by state or local regulations, the organization must arrange for physician oversight of the HIV testing program. (See Attachment C:

Health Department Targeted HIV Testing and Partner Services Letter of Agreement)

If physician oversight is required, the applicant must submit a signed Physician Oversight Letter of Intent with the application for funding. (See Attachment D: Letter of Intent from a Physician for State Regulations and HIV Testing Activities)

If conducting rapid HIV testing, submit a copy of the current Clinical Laboratory Improvement Amendments (CLIA) certificate with the application.

TREAT

Required Strategies and Activities:

Linkage to HIV Medical Care Re-engagement to HIV Medical Care Partner Services Referrals Medication Adherence (to achieve Viral Suppression) Prevention and Essential Support Services

Linkage to HIV Medical Care Recipients will be required to:

Link persons with newly diagnosed HIV to HIV medical care and ART initiation immediately, but not greater than 30 days of diagnosis.

Develop a navigation program that engages clients from the time of notification of diagnosis to the client’s first HIV medical care appointment.

o Employ at least one trained HIV Navigator (a minimum of 0.5 FTE) within the agency to help facilitate the coordination of the organization’s linkage to HIV Medical Care plan activities. The hiring, training and development of navigators (e.g., community health workers, peer advocates, outreach workers) will help facilitate access to linkage, re-engagement, and retention in medical care and refer or provide prevention and essential support services.

o Develop or enhance systems for assisting persons with HIV with navigating services (i.e., obtaining necessary information, support, and skills to access complex medical systems) at all stages of care, treatment, prevention, and essential support services. If needed, organization may utilize telehealth as an option for Linkage to HIV Medical Care services.

o Provide navigation services (e.g., accompanying persons to medical appointments, providing or referring to prevention and essential support services) that reduce and/or eliminate barriers to medical care that address acceptance, responsibility, and behavior change.

Submit a Linkage to HIV Medical Care Program Plan with the application. The Linkage to HIV Medical Care Program Plan must include detailed information about the linkage program to include staff responsible for linking clients to HIV medical care, the organization’s linkage to care process (method and timeframe for linking clients to care within the allotted 30 day requirement), provider(s) associated with the linkage to care program, a process for securing multiple communication methods to contact clients, etc.

(See Attachment E: Linkage to HIV Medical Care Program Plan Template)

See Additional Program Information for specific details regarding the Service Agreement with the HIV Medical Care Providers.

Optional Linkage to HIV Medical Care Activities Recipients may opt to implement a CDC approved linkage to HIV Medical Care strategy listed below or utilize the CBO’s existing linkage to HIV medical care program. See https://www.cdc .gov/hiv/effective-interventions/treat/index.html for additional information regarding Linkage to Care strategies.

o Anti-Retroviral Treatment and Access to Services (ARTAS) o HIV Navigation Services – STEPS to Care o Stay Connected (Clinics Only)

Re-engagement to HIV Medical Care Recipients will be required to:

Re-engage persons with previously diagnosed HIV into HIV medical care and ART when it is determined that the individuals are not currently in HIV medical care, immediately but not greater than 30 days.

Support state and/or local health departments with Data-to-Care efforts. Applicants should work with the jurisdiction’s state and/or local health department to follow-up and/or link persons that are out of care utilizing the health department Not-In-Care (NIC) list.

The organization’s client centered program model for viral suppression activities should include a combination of high-impact prevention strategies and activities to continually engage persons with HIV. This will include referring to partner services, medication adherence activities, and referring and/or providing prevention and essential support services as deemed appropriate for the target population and in compliance with the requirements of the NOFO.

Partner Services Referrals Partner Services are a broad array of services that should be offered to persons with HIV or other STDs and their sexual or needle-sharing partners. By identifying infected persons, confidentially notifying their partners of their possible exposure, and providing infected persons and their partners a range of medical, prevention, and psychosocial services, Partner Services can improve https://www.cdc.gov/hiv/effective-interventions/treat/index.html the health outcomes not only of individuals, but of communities as well.

Recipients will be required to:

Refer 100% of persons with newly diagnosed HIV to Partner Services.

Ensure that clients who test positive for HIV, are referred immediately, but not greater than 30 days after diagnosis, in accordance with CDC recommendations and state and local requirements.

Ensure persons with previously diagnosed HIV are also referred to the health department immediately upon identification.

Medication Adherence (to achieve Viral Suppression) Medication Adherence services are required to support direct observation, maintenance on ART, and overall achievement of viral suppression.

Recipients will be required to:

Implement medication adherence interventions to further strengthen their high-impact HIV prevention program.

Provide or refer all persons with HIV (newly and previously diagnosed) to medication adherence services and interventions based upon the identified needs of the client.

Submit a service agreement upon award, if the organization will be referring for any of the medication adherence services.

Optional Medication Adherence Intervention Strategies

Recipients may opt to implement a CDC approved linkage to medication adherence intervention strategy listed below or utilize the CBO’s existing medication adherence support program. See https://www.cdc.gov/hiv/effective-interventions/treat/index.html for additional information regarding Medication Adherence strategies.

o Partnership for Health (Medication Adherence) o Stay Connected

In anticipation of continuous advancements in the availability of medication adherence and strategies, recipients may opt to implement new CDC supported interventions and strategies as they become available, with prior written approval from CDC.

Prevention and Essential Support Services Recipients are required to provide or refer clients to prevention and essential support services that align with CDC’s high-impact prevention goals. This can include training and development of navigators (e.g., community health workers, peer advocates, outreach workers) to provide or refer prevention and essential support services for increasing access to and retention in HIV medical care. The goal is to eliminate or reduce barriers to accessing HIV medical care and other prevention and essential support services.

Recipients will be required to:

Develop or enhance processes for assisting clients with navigating services (obtaining necessary information, support, and skills to access complex medical systems) for all persons with HIV.

Develop and implement a process for providing and/or referring clients to prevention and essential support services for persons with HIV.

Provide and/or refer all persons with newly diagnosed HIV to prevention and essential support services, based on the identified needs of the client.

Establish collaborations supported by service agreements over the course of the 5-year period of performance. Applicants should submit one established MOA/MOU or service agreement (internal and/or external to organization) with a prevention and essential support services provider with the application. The agreement(s) should be reflective of the services most commonly identified by the target population. The MOA/MOU should be uploaded as a PDF in other attachments and named "PESS MOA".

Use PS21-2102 funds to help navigate clients to the following prevention and essential support services that may include, but are not limited to:

o Health benefits navigation and enrollment (e.g., Insurance navigation and enrollment) o Evidence-based risk reduction interventions o Behavioral health services (e.g., Mental health counseling and services, Substance use treatment services, SSPs) o Social services (e.g., Transportation services (to and from HIV prevention and essential support services and medical care appointments), Employment services, Basic education continuation and completion services, Food Banks, Food Programs, including Supplemental Nutrition Assistance Program (SNAP), and Comprehensive sexual health education, including HIV education (e.g., risk reduction programs, school-based HIV prevention providers)) o Housing

See Additional Program Information for specific details regarding the MOA/MOU for Prevention and Essential Support Services.

PREVENT

Required Strategies and Activities:

Referrals to PrEP and nPEP Condom Distribution Prevention and Essential Support Services Risk Reduction Behavioral Interventions (Optional)

Referrals to PrEP and nPEP Recipients will be required to:

Support the awareness and uptake of PrEP and nPEP services.

Refer persons with a non-reactive test result and who are at high-risk for acquiring HIV to

PrEP and nPEP services, in accordance with CDC guidance.

Support efforts to increase access to PrEP and nPEP services.

Utilize or establish a referral network of PrEP and nPEP clinical service providers to referrals of high-risk HIV-negative persons to these providers.

o May utilize existing resources in the jurisdiction to identify and/or develop a referral network for PrEP and nPEP providers, if available (Examples include, preplocator.org, PrEP Warm lines, TelePrEP or existing resources within the jurisdiction).

Coordinate a navigation plan to ensure clients are appropriately referred and linked to PrEP and nPEP services. Services may be incorporated into the PS21-2102 HIV Medical Care plan.

Condom Distribution Free and accessible condoms are an integral component of an HIV prevention program. Recipients will be required to:

Implement condom distribution as a structural intervention to increase access to and use of condoms by persons with HIV and persons at high risk of acquiring HIV.

Offer condoms to 100% of persons with HIV and persons at greatest risk of acquiring

HIV.

Ensure that effective condom distribution programs adhere to the following principles: (1) provide condoms free of charge, (2) implement social marketing efforts to promote condom use by increasing awareness of condom benefits and normalizing condom use within communities, and (3) conduct both promotion and distribution activities at the individual, organizational, and community levels. For additional information and guidance, please visit https://www.cdc.gov/hiv/effective-interventions/prevent/condom-distribution-programs/index.html.

Prevention and Essential Support Services Recipients are required to provide or refer clients to prevention and essential support services that align with CDC’s high-impact prevention goals. This can include training and development of navigators (e.g., community health workers, peer advocates, outreach workers) to provide or refer prevention and essential support services for increasing access to and retention in HIV medical care. The goal is to eliminate or reduce barriers to accessing HIV medical care and other prevention and essential support services.

Recipients will be required to:

Develop or enhance systems for assisting clients with navigating services (obtaining necessary information, support, and skills to access complex medical systems) for all persons at high-risk of acquiring HIV.

Provide and/or refer persons at high-risk of acquiring HIV to prevention and essential support services, based on the identified needs of the client.

Develop and implement a process for providing and/or referring persons at high-risk for acquiring HIV to prevention and essential support services.

Establish collaborations supported by service agreements over the course of the 5-year period of performance. Applicants should submit one established MOA/MOU or service agreement (internal and/or external to organization) with a prevention and essential support services provider with the application. The agreement(s) should be reflective of the services most commonly requested by the target population. The MOA/MOU should https://www.cdc.gov/hiv/effective-interventions/prevent/condom-distribution-programs/index.html https://www.cdc.gov/hiv/effective-interventions/prevent/condom-distribution-programs/index.html be uploaded as a PDF in other attachments and named "PESS MOA".

Use PS21-2102 funds to help navigate clients to the following prevention and essential support services that may include, but are not limited to:

o Health benefits navigation and enrollment (e.g., Insurance navigation and enrollment) o Evidence-based risk reduction interventions o Behavioral health services (e.g., Mental health counseling and services, Substance use treatment services, SSPs) o Social services (e.g., Transportation services (to and from HIV prevention and essential support services and medical care appointments), Employment services, Basic education continuation and completion services, Food Banks, Food Programs, including Supplemental Nutrition Assistance Program (SNAP), and Comprehensive sexual health education, including HIV education (e.g., risk reduction programs, school-based HIV prevention providers)) o Housing

Optional Prevent Activity Risk Reduction Behavioral Interventions Organizations may opt to implement health education and risk reduction behavioral interventions to support recruitment, outreach, and engagement in HIV services for persons with HIV and those at risk for acquiring HIV. See https://www.cdc.gov/hiv/effective-interventions/prevent/index.html for additional information on these approved CDC supported risk-reduction behavioral interventions.

Risk Reduction Behavioral Intervention for Persons with HIV

Optional activities to support recruitment, outreach, and engagement in HIV prevention and care services: Taking Care of Me video, TWIST, PROMISE

Risk Reduction Behavioral Intervention for Persons at risk for acquiring HIV

Optional activities to support recruitment, outreach, and engagement in HIV prevention services: d-Up!, Safe in the City video, Sister to Sister, Sin Buscar Excusas, PROMISE

RESPOND

Recipients should be prepared to assist the state and local health departments in responding to HIV clusters and outbreaks. Such activities may include, but are not limited to:

Tailoring other strategies and activities included in this NOFO (e.g., HIV testing efforts, PrEP awareness, referral to Partner Services) to support cluster response.

Supporting state and/or local health departments with Data-to-Care efforts, to include data sharing for improved program outcomes.

Support health department efforts with cluster response efforts for interrupting HIV transmission, as requested and practical.

Establishing a MOU with health department(s) in support of HIV cluster response https://www.cdc.gov/hiv/effective-interventions/prevent/index.html activities, including data sharing and Partner Services referrals.

For activities across the pillars (Diagnose, Treat, Prevent, and Respond), recipients are required to collaborate with their state and/or local health department(s) to assist with HIV prevention activities within the jurisdiction (such as cluster response activities, following up on clients/persons with HIV identified through Data-to-Care activities, sharing of HIV data, and coordination with Partner Services) and improve outcomes along the continuum of HIV care.

Activities should be in compliance with health department security and confidentiality guidelines.

Activities should be outlined with the letter of support from the health department and MOUs, if applicable. (Attachment C: Health Department Targeted HIV Testing and Partner Services Letter of Agreement) Additionally, to better target HIV prevention activities and strategies to be conducted under this NOFO, recipients should work with their state and/or local health departments to:

Identify specific areas where hard-to-reach populations reside and/or frequent.

Propose activities that use available data, including data on populations experiencing clusters and outbreaks to improve identification, linkage to care, or re-engagement to care among persons not in care.