CDC-RFA-PS22-2203 - Modified 10-22-2021.pdf

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- PS22-2203. 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 Young Men of Color Who Have Sex with Men and Young Transgender Persons of Color C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52- 2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr- 46/index.html (See section 45 CFR 46.102(d)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS22-2203

E. Assistance Listings Number:

93.939 F. Dates:

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

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

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.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

2. Due Date for Applications:

11/19/2021 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due 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/ps22-2203/index.html).

G. Executive Summary:

1. Summary Paragraph The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year 2022 funds for a cooperative agreement program for community-based organizations (CBOs) to develop and implement high-impact human immunodeficiency virus (HIV) prevention programs in the following two categories:

Category A: HIV prevention services for Young Men of Color Who Have Sex with Men (YMSM of color) and their partners regardless of age, gender, and race/ethnicity

Category B: HIV prevention services for Young Transgender Persons of Color (YTG persons of color) and their partners regardless of age, gender, and race/ethnicity

NOTE: Throughout this funding opportunity announcement, “young” and “youth” are defined as individuals between the ages of 13-34 years.

The purpose is to implement comprehensive high-impact HIV prevention programs to address health disparities among YMSM of color, YTG persons of color, and their partners with the goal of reducing HIV transmission and HIV-associated morbidity and mortality. This program aligns with the goals of the HIV National Strategic Plan, 2021-2025 (HIV Plan)1, Division of HIV/AIDS Prevention (DHAP) Strategic Plan 2017-20202, and supports the goals of reducing all new HIV infections by 75% by 2025 and 90% by 2030. This program also complements the Ending the HIV Epidemic in the US (EHE)3 initiative and supports the HIV Plan health equity goals of addressing social determinants of health (SDH) and syndemics affecting HIV-related outcomes.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$55,000,000

Category A - $41,250,000 https://www.grants.gov/ https://www.cdc.gov/hiv/funding/announcements/ps22-2203/index.html

Category B - $13,750,000

e. Average One Year Award Amount:

$350,000

f. Total Period of Performance Length:

g. Estimated Award Date:

April 01, 2022

h. Cost Sharing and / or Matching Requirements:

No 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

1. Background

a. Overview For over 40 years, the human immunodeficiency virus (HIV) has affected millions of Americans throughout the United States. In recent years, deaths among persons with HIV (PWH) have declined, while the population of PWH has grown due to the impact of HIV treatment on disease progression and death. According to the CDC, an estimated 1.2 million persons are living with HIV and approximately 13% are unaware they have HIV.4 Unless effectively treated to achieve viral suppression, HIV can be transmitted to others and lead to premature death. However, PWH who use antiretroviral therapy (ART) and reach and maintain an undetectable viral load can have normal life expectancy, improved quality of life, and essentially no risk of transmitting HIV to others through sex.5

Since the late 1980s, CDC has formally partnered with CBOs to expand the impact and reach of HIV prevention in affected communities. Due to their accessibility, history, and credibility in communities, CBOs are recognized and remain important, trusted 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, particularly for people with and at greatest risk for acquiring HIV, including Black/African- American and Hispanic/Latino persons; all races/ethnicities of gay, bisexual, and other men who have sex with men (MSM); people who inject drugs (PWIDs); and transgender persons. This new funding cycle seeks to develop new and enhance existing strategies for CBO HIV prevention programs that aim to achieve the goals and objectives of the HIV Plan by preventing new HIV diagnoses; rapidly diagnosing, linking, and treating PWH to improve HIV-related outcomes; reducing HIV-related disparities and health inequities; and achieving an integrated and coordinated response to address the HIV epidemic for Categories A (YMSM of color) and B (YTG persons of color).

Problem Statement

Despite prioritizing racial/ethnic minority groups in HIV prevention programs, these populations continue to experience the most disproportionate burden of HIV. Black/African-American and Hispanic/Latino persons represent a small percentage of the US population, but accounted for 41% and 29%, respectively of persons newly diagnosed with HIV in 2019.4 While recent HIV trend data indicate reduction or stabilization of new HIV diagnoses among individuals ages > 13 years, persons between ages 13–34 years represented more than 50% of all new HIV diagnoses in 2019.

In the US, the majority of HIV diagnoses (66%) in 2019 for persons ages >13 years were among MSM. When considering age and race, Black/African American and Hispanic/Latino MSM, ages 25-34 accounted for the largest percentage of HIV diagnoses indicating a continued need for HIV prevention services within these priority populations. Transgender communities are also at increased risk for acquiring HIV. Health departments and scientists report high HIV diagnoses in transgender communities, particularly among racial/ethnic minorities. While transgender populations represented 2% of new HIV diagnoses in 2018, Black/African-American (48%) and Hispanic/Latino (32%) transgender persons collectively comprised 80% of those new HIV diagnoses.6 In addition, a recent CDC study found that these transgender populations represented the majority of persons diagnosed with HIV after receiving an HIV test in the study sample.7

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

c. Healthy People 2030 This NOFO addresses the “Healthy People 2030” focus area of HIV. Sexually Transmitted Infections - Healthy People 2030 | health.gov

d. Other National Public Health Priorities and Strategies This NOFO aligns with the EHE Initiative and CDC 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.

The HIV National Strategic Plan – A Roadmap to End the Epidemic for the United States, 2021-2025 (HIV Plan) – (HIV National Strategic Plan (2021-2025) | HIV.gov)

Ending the HIV Epidemic in the United States – (www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview)

Sexually Transmitted Infections National Strategic Plan for the United States (2021– 2025): Groundbreaking, first ever five-year plan that aims to reverse the recent dramatic rise in STIs in the United States – (https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html)

Viral Hepatitis National Strategic Plan: A Roadmap to Elimination 2021-2025: Provides a framework to eliminate viral hepatitis as a public health threat in the United States by 2030 – (https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html)

Secretary’s Minority AIDS Initiative (MAI) – (www.hiv.gov/federal-response/smaif/overview) https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 http://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview http://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html http://www.hiv.gov/federal-response/smaif/overview http://www.hiv.gov/federal-response/smaif/overview

HIV/AIDS Care Continuum – (www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum)

Division of HIV AIDS Prevention Strategic Plan, 2017-2020 – (https://www.cdc.gov/hiv/pdf/dhap/cdc-hiv-dhap-external-strategic-plan.pdf)

Division of Adolescent and School Health Strategic Plan, 2020-2025 – (https://www.cdc.gov/healthyyouth/about/pdf/strategic_plan/2025/dash-strategic-plan508.pdf)

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan through 2020 – (www.cdc.gov/nchhstp/strategicpriorities/default.htm)

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-PS17-1704, “Comprehensive HIV Prevention Projects for Young Men of Color Who Have Sex with Men and Young Transgender Persons of Color” (www.cdc.gov/hiv/funding/announcements/ps17-1704/index.html)

CDC-RFA-PS21-2102, “Comprehensive High-Impact HIV Prevention Programs for Community-Based Organizations” (www.cdc.gov/hiv/funding/announcements/ps21- 2102/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.

CDC-RFA-PS22-2203 Logic Model: Comprehensive High- Impact HIV Prevention Programs for Young Men of Color Who Have Sex with Men (YMSM) and Young Transgender (YTG) Persons of Color

Strateg ies and Activities

Short-term Outcomes

Intermediate Outcomes

Long-term Outcom es

Prioritized HIV Testing

• Conduct HIV testing among priority populations

• Provide optional services (e.g., Prioritized HIV Testing

• Increased HIV testing among priority populations

• Increased HIV diagnoses among priority

Prioritized HIV Testing

• Increased knowledge of HIV status among

Reduced

HIV

incidence among priority populations http://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum http://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum https://www.cdc.gov/hiv/pdf/dhap/cdc-hiv-dhap-external-strategic-plan.pdf https://www.cdc.gov/healthyyouth/about/pdf/strategic_plan/2025/dash-strategic-plan508.pdf https://www.cdc.gov/healthyyouth/about/pdf/strategic_plan/2025/dash-strategic-plan508.pdf http://www.cdc.gov/nchhstp/strategicpriorities/default.htm http://www.cdc.gov/hiv/funding/announcements/ps17-1704/index.html http://www.cdc.gov/hiv/funding/announcements/ps21-2102/index.html http://www.cdc.gov/hiv/funding/announcements/ps21-2102/index.html

Personalized Cognitive Counseli ng)

Status Neutral8 Comprehensive High Impact HIV Prevention (HIP) Prevention & Essential Services

• Screen, provide, or refer clients to prevention and essential support services

• Refer to or provide integrated STI and viral hepatitis screenings

• Refer to or provide HIP behavioral interventions (Optional)

• Offer condoms to ALL clients

Prevention Services for Persons regardless of HIV Status

• Screen, provide, or refer clients to antiretrovirals (ARVs) for HIV treatment or prevention (PrEP/nPEP)

• Link clients to high quality medical services for HIV treatment or prevention

• Link or re-engage clients out of HIV treatment or prevention care

• Refer clients with HIV or qualifying STI to Partner population clients unaware of their HIV status

Status Neutral Comprehensive

HIP

• Increased access to prevention and essential support services

• Increased receipt of integrated screenings

• Increased access to condoms

• Increased screenings, referrals, and linkage to PrEP and HIV treatment services

• Increased linkage to HIV care among persons with newly diagnosed HIV ≤30 day

• Increased re-engagement to HIV care among persons with previously diagnosed HIV, not in care ≤30 days

• Increased access to Partner Services among persons with newly diagnosed HIV or qualifying STI

• Increased access to appropriate medication adherence services

Collaborations, Promotion, and Recruitment

• Increased access to safe spaces among priority populations priority populations

Status Neutral Comprehensive

HIP

• Increased engagement in prevention and essential services

• Increased use of condoms

• Increased PrEP use

• Increased viral suppression among persons with

HIV

Collaboration, Promotion, and Recruitment

• Increased use of safe spaces among priority populations to address SDH-related barriers

Reduced death rate among priority populations with diagnosed

HIV

infection

Reduced

HIV-

related disparities in incidence, morbidity, and viral suppression among priority populations

Improved health outcomes for ALL persons regardless of HIV status

Services

• Provide/refer clients to appropriate medication adherence services

• Offer or refer clients to comprehensive SSP (if indicated)

Collaborations, Promotion, and Recruitment

• Establish service agreements with medical care, prevention and essential support service providers

• Conduct program promotion and outreach

• Designate a safe space for priority populations

• Address social determinants of health

i. Purpose This NOFO addresses the national HIV epidemic by implementing CDC’s comprehensive high-impact HIV prevention approach that reduce new HIV infections, increase access to HIV care and prevention services, and promote health equity among YMSM of color, YTG persons of color, and their partners. This will be achieved by enhancing CBO’s capacity to increase HIV testing and integrated STI/viral hepatitis screenings, linkage to HIV prevention and care services, and providing/referring clients to essential support services, regardless of HIV status, and increase program monitoring and accountability.

ii. Outcomes The program is expected to demonstrate measurable progress among its priority populations (i.e., YMSM of color, YTG persons of color) 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:

Prioritized HIV Testing

Increased HIV testing among priority populations

Increased HIV diagnoses among persons in the priority populations who are unaware of their HIV status

Status Neutral Comprehensive High-Impact HIV Prevention Prevention and Essential Support Services

Increased access to prevention and essential support services by priority populations Increased receipt of integrated STI/VH screenings and services Increased access to condoms among priority populations

Prevention Services for Persons regardless of HIV Status

Increased screenings, referrals and linkage to pre-exposure prophylaxis (PrEP) and HIV treatment services among priority populations

Increased linkage to HIV care among persons with newly diagnosed HIV ≤30 days Increased re-engagement to HIV care among persons with previously diagnosed

HIV, not in care ≤30 days Increased access to Partner Services among persons with newly diagnosed HIV or qualifying STI Increased access to appropriate medication adherence services Increased access to safe spaces among priority populations

iii. Strategies and Activities Applicants are required to provide a comprehensive plan for HIV prevention services for priority populations–young men of color who have sex with men (YMSM) or young transgender persons of color (YTG) and their partners, regardless of HIV status. The applicant organization’s High- Impact HIV Prevention program plan for YMSM of color and YTG persons of color must consist of all the following program strategies:

Prioritized HIV Testing Status Neutral Comprehensive High-Impact HIV Prevention for Priority Populations o Prevention Services for Persons Regardless of HIV Status Prevention Services for Persons at Increased Risk for Acquiring HIV Prevention and Medication Adherence Support Services for Persons with

HIV

o Status Neutral Prevention & Essential Services

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

This program will support the national implementation of high-impact HIV prevention programs by CBOs under the two core funding categories described below.

Category A: HIV prevention services for Young Men of Color Who Have Sex with Men (YMSM of color) and their partners regardless of age, gender, and race/ethnicity.

Category B: HIV prevention services for Young Transgender Persons of Color (YTG of color) and their partners regardless of age, gender, and race/ethnicity.

NOTE: Throughout this NOFO, “young” and “youth” are specifically defined as individuals between the ages of 13 and 34 years.

Applicants may only apply for funding under one category. CDC will not consider any application applying for two categories.

*Applicants are required to provide status neutral HIV prevention services for priority populations and their partners.

Project Structure There will be two phases of the project: a development phase lasting no longer than 6 months from the start of Year 1 (April 1, 2022 – September 30, 2022), followed by ongoing program implementation, monitoring, and evaluation.

Development Phase (April 1, 2022 – September 30, 2022): Recipients will collaborate with CDC as well as community, local, and state partners to finalize required or recommended activities of their programs. 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/DHP 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/DHP to revise and finalize their evaluation plan as described later in the Applicant Evaluation and Performance Measurement Plan (EPMP) 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 are expected to work with CDC/DHP to proactively develop a capacity building/technical assistance/training needs plan.

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 October 1, 2022 through March 31, 2027.

o During Year 1 only (April 1, 2022 – March 31, 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 (virtually or in-person) that support the prevention approaches described in this NOFO, as communicated by CDC in advance of the meetings throughout the performance period.

o Recipients must develop proactive capacity building assistance/technical assistance (CBA/TA) plans annually in collaboration with CDC.

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

Justification of Need Since there is no singular HIV prevention approach that will work effectively to address the overarching goals of this program, applicants should assess and consider approaches that when combined will have the greatest public health impact. The combined activities should also have the greatest potential to address the social and structural determinants of health that are known to create the most significant barriers to HIV testing; linking, retaining and re-engaging clients into HIV medical care; and accessing prevention and essential support services in the organization’s jurisdiction. Services should account for the synergies of syndemic conditions (e.g., STIs, viral hepatitis, injection drug/substance use) and should be delivered in a status neutral way to avoid promulgating institutionalized HIV status-related stigma. This framework acknowledges that prevention and care/treatment together contribute to reducing HIV-related morbidity, mortality, and health disparities among racial and ethnic minorities in the United States and the Commonwealth of Puerto Rico.

All applicants must incorporate the following general requirements into their proposed programs:

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

Applicants must use the most current local and/or state HIV epidemiologic and surveillance data, Health Resources and Services Administration (HRSA) Ryan White program data, and/or HIV needs assessment data to provide the information requested in this section. CDC recommends that applicants use the local and/or state health department as their primary source of this data whenever possible.

More specifically, applicants must conduct the following:

Define the specific service area(s) 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.

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 HIV testing; linking, retaining, and re-engaging clients with care; and accessing prevention and essential support services.

Develop a client-centered, status neutral, high-impact HIV prevention (HIP) program that includes a combination of strategies and services to continually engage priority populations who could benefit from the reduction of barriers to accessing HIV medical care and other prevention and essential support services. The program model should include strategies and services to engage priority populations regardless of HIV status.

Visit the following websites for additional information on HIP strategies and services:

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

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(s); 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.

COMPREHENSIVE HIGH-IMPACT HIV PREVENTION PROGRAM

Applicants are required to develop and implement a comprehensive high-impact HIV prevention program for the priority population clients who are at increased risk for acquiring HIV or living with HIV. The program should align with the goals and objectives of the HIV Plan which also complements the EHE initiative. In addition to the HIV Plan, the proposed program should be guided by the principles of an HIV status neutral approach and addressing social determinants of health and syndemics adversely affecting HIV outcomes in efforts to promote and achieve health equity among the priority populations. Proposed programs should include the implementation and delivery of strategies and activities that prevent new HIV transmission, link clients to HIV prevention and care services, and refer clients to and provide essential support services that aid in reducing HIV-related disparities and health inequities. Applicants may provide the outlined services in a maximum of three (3) service areas within the applicant's jurisdiction.

Status Neutral Approach8

The status neutral approach highlights HIV testing as a gateway to prevention services and acknowledges that people who benefit from HIV prevention services have similar needs and barriers regardless of the outcome of their HIV test. This approach promotes the same engagement of priority populations in the provision of HIV prevention and care services regardless of HIV status. A status neutral approach can increase efficiency and prevent the establishment of services that continue to promulgate the institutional stigma related to HIV and its intersection with other identities, such as gender, sexual orientation, and race/ethnicity identities. Applicant organizations should include a status neutral approach in their program activities and provision of services to priority populations.

Prioritized HIV Testing HIV testing is an essential component of comprehensive high-impact prevention programs.

Applicants should promote a status neutral approach, where HIV testing serves as an entry point to prevention services, regardless of HIV test result to improve HIV prevention and care outcomes. Applicant organizations are required to develop new or enhance existing HIV testing programs for which at least 75% of the tested persons are of the proposed priority population(s).

Recipients will be required to conduct the following:

Develop new or enhance existing HIV testing programs that prioritize priority population clients who are at greatest risk for acquiring 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 https://www.cdc.gov/hiv/effective-interventions/index.html http://www.cdc.gov/hiv/policies/hip.html priority populations at greatest risk for acquiring HIV and who are unaware of their HIV status; and reduce the priority populations’ barriers to accessing HIV testing and address health inequities among the priority populations disproportionately affected by HIV.

Implement prioritized 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_Implementing_HIV_Testing_in_Noncli nical_Settings.pdf). Prioritized HIV testing efforts should also be conducted in accordance with state and local regulations.

Use the latest HIV testing technology available, preferably 4th generation HIV testing technology, when feasible, throughout the program award.

Establish annual HIV testing objectives for the priority population(s) using local jurisdictional data and/or agency historical data.

o Organizations applying for funding under Category A (YMSM of color) must identify a minimum of eight (8) new HIV diagnoses annually.

o Organizations applying for funding under Category B (YTG persons of color) must identify a minimum of six (6) new HIV diagnoses annually.

Applicant organizations must identify a variety of settings where prioritized testing will be conducted and most effective in identifying members of the priority population(s) 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 used, 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 Large-scale HIV Testing Event(s) – Organizations may participate in a large-scale HIV testing event per budget period that is specifically promoted to YMSM of color or YTG persons of color and provides the organization access to their priority population. Community event(s) should be used to establish a mechanism to engage priority population(s), assist with program collaboration, promotion, and recruitment of priority population(s). The event(s) can occur in collaboration with existing organizations (e.g., local/state health departments, CBOs, etc.) that work with or provide services to the priority population(s). Examples of large-scale HIV testing events include, but are not limited to HIV/AIDS Awareness Days, PRIDE events, House and Ball events, and events sponsored by school-based health programs or other school-based providers.

o Consider the use and implementation of Social Network Strategy (SNS) to recruit the priority population(s), if feasible. (https://www.cdc.gov/hiv/effective-interventions/diagnose/social-network-strategy?Sort=Title%3A%3Aasc&Intervention%20Name=Social%20Network%2 0Strategy) 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?Sort=Title%3A%3Aasc&Intervention%20Name=Social%20Network%20Strategy https://www.cdc.gov/hiv/effective-interventions/diagnose/social-network-strategy?Sort=Title%3A%3Aasc&Intervention%20Name=Social%20Network%20Strategy https://www.cdc.gov/hiv/effective-interventions/diagnose/social-network-strategy?Sort=Title%3A%3Aasc&Intervention%20Name=Social%20Network%20Strategy https://www.cdc.gov/hiv/effective-interventions/diagnose/social-network-strategy?Sort=Title%3A%3Aasc&Intervention%20Name=Social%20Network%20Strategy o Serve the identified members of the proposed priority 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 Priority Population Worksheet). At least 75% of individuals tested must be considered members of the applicant’s priority population.

Integrated, Status Neutral Syndemic Screening Activities Recipients should have or establish the capacity to implement various integrated screening activities (e.g., screening for syndemic conditions such as STIs, viral hepatitis, and/or TB), in conjunction with HIV testing for members of their priority population(s) regardless of HIV status. Recipients will be required to provide the following service integration activities:

Support and promote collaboration between HIV, STI, 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 supported by epidemiologic data, and are in accordance with current CDC guidelines and recommendations. Visit https://www.cdc.gov/nchhstp/highqualitycare/guidelines.html and https://www.cdc.gov/tb/publications/guidelines/testing.htm for additional information.

Use up to 5% of the total approved 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 STIs, 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 priority population members who are tested for HIV to get a syphilis serology and screening for urethral and rectal gonorrhea and chlamydia. The applicant can use self-collection of specimens (urine and vaginal/rectal swabs).

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

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 STIs, 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, STI, viral hepatitis, and/or TB) reporting regulations.

For clients who are candidates for hepatitis A or B vaccination (or COVID-19 and other vaccinations, as appropriate), provide referrals to these services.

Periodically review monitoring data to assess the value of continuing screening for other STIs, 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).

https://www.cdc.gov/nchhstp/highqualitycare/guidelines.html https://www.cdc.gov/tb/publications/guidelines/testing.htm

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 and during the Development phase (first six months) of the program, the organization must:

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

Submit the service agreement with the application or during the project development phase.

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.

ALL recipients are expected to refer clients to or provide clients with integrated screening for other STIs, viral hepatitis, and/or TB.

Funds from this NOFO may not be used for clinical services; treatment of HIV, STIs, 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.

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 priority population(s), 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/rr551ra1.htm). The majority of the HIV testing must be conducted in an outreach setting; up to 25% of the HIV testing efforts can be conducted as routine, opt-out HIV testing. FQHCs are also required to conduct prioritized HIV testing in an outreach setting (as outlined above).

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 annual performance measures given the priority population (e.g., Category A or Category B). 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/DHP assigned Project Officer.

Optional HIV Testing Activity 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) o Recipients may opt to implement Personalized Cognitive Counseling (PCC), when appropriate with repeat testers, 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 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5912a1.htm?s_cid=rr5912a1_e http://www.cdc.gov/tb/topic/testing/default.htm#who http://www.cdc.gov/tb/topic/testing/default.htm#who https://www.cdc.gov/mmwr/preview/mmwrhtml/rr551ra1.htm and have engaged in unsafe sexual behaviors since the receipt of their last HIV test result. Visit https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Perso nalized%20Cognitive%20Counseling&;Intervention%20Name=Personalized%20 Cognitive%20Counseling for additional information.

Additional HIV Testing Information In accordance with the guidelines established by the local and/or state health department and CDC data requirements, applicant organizations are required to:

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

Additional information is 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. Coordinate training(s) 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 Prioritized HIV Testing and Partner Services Letter of Agreement.

Work with the local or state health department to collaborate with various entities to support using advances in HIV testing and algorithms to improve the detection of early and acute HIV, when feasible and appropriate, considering the capacity of the recipient.

Report information on HIV diagnoses to your respective health department (e.g., state, local health department’s surveillance program).

Work with health departments to explore opportunities for seeking reimbursement and to determine whether third-party reimbursement makes sense financially, and is 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).

Applicant organizations must also conduct the following:

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 Prioritized 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.

Prevention Services for Persons Regardless of HIV Status Although services below are differentiated based on HIV status to allow for more clarity for the applicant, the implementation strategy must focus on weaving these services together using a status neutral approach. Applicants should evaluate a combination of approaches that include the required components and additional components that will, when combined, have the greatest https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling&;Intervention%20Name=Personalized%20Cognitive%20Counseling https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling&;Intervention%20Name=Personalized%20Cognitive%20Counseling https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling&;Intervention%20Name=Personalized%20Cognitive%20Counseling https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling&;Intervention%20Name=Personalized%20Cognitive%20Counseling https://www.cdc.gov/hiv/effective-interventions/diagnose/personalized-cognitive-counseling/index.html?Sort=Priority%3A%3Aasc&Intervention%20Name=Personalized%20Cognitive%20Counseling&;Intervention%20Name=Personalized%20Cognitive%20Counseling public health impact. Navigation support services align with the goals and objectives of the HIV Plan and the use of HIV navigators for linkage and re-engagement activities to HIV medical care and pre-exposure prophylaxis (PrEP) as an evidence-based strategy should be implemented as a component of the applicant’s program.

Prevention Services for Persons at Increased Risk for Acquiring HIV In support of achieving the national goals of preventing and reducing HIV transmission among priority population(s) and reducing HIV-related disparities, recipients will be required to conduct the following activities for clients at increased risk for acquiring HIV to increase access to PrEP and non-occupational post-exposure prophylaxis (nPEP) services, including screening, referrals, linkage to PrEP or nPEP provider, and prescribing PrEP and nPEP:

Assess and refer persons with a non-reactive HIV test result, who are at increased risk for acquiring HIV, to PrEP and nPEP services, in accordance with CDC guidance (https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf).

Support the awareness and uptake of PrEP and nPEP services among priority population(s)

Provide and/or refer at least 90% of YMSM of color and YTG persons of color to PrEP services within 30 days for clinical evaluation

Use or establish a referral network of PrEP and nPEP clinical service providers to support referrals and provision of PrEP and nPEP services

Use existing resources in the jurisdiction to identify and/or develop a referral network for PrEP and nPEP provides. Examples may include, but not limited to, preplocator.org, PrEP provider directories, Ready-Set-PrEP, PrEP warmlines, TelePrEP or other existing resources in jurisdiction.

Coordinate a navigation plan to ensure clients are appropriately referred and linked to PrEP and nPEP services

Establish Service Agreement with a PrEP Provider (See Attachment E: Linkage to HIV Medical Care and PrEP Provider Plan)

In addition, applicants will be required to provide the following:

At least one MOA/MOU with the application for PrEP service provider(s) proximal to the organization’s service area(s) and have capacity and history of providing services to the priority population(s). MOA/MOU must be updated, valid, and submitted annually.

Service agreement must describe the agreed upon referral and linkage process to PrEP and nPEP services and include the process for confirming that services were accessed as well as the specific role of the partner/collaborator.

Prevention Services for Persons with HIV To achieve the national goal of improving HIV-related outcomes for PWH, recipients will be required to conduct the following activities for clients with HIV:

Linkage to and Re-engagement in HIV Medical Care Partner Services Referrals Medication Adherence Support to Achieve Viral Suppression https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf

Establish Service Agreement with an HIV Medical Care Provider (See Attachment E:

Linkage to HIV Medical Care and PrEP Provider Plan Template)

Linkage to HIV Medical Care Recipients will be required to conduct the following linkage to HIV medical care activities:

Link at least 90% of persons newly diagnosed with HIV to HIV medical care and ART initiation immediately, but no later than 30 days after 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 services and referral to or provision of 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 use 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 barriers to medical care and 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 and PrEP Provider Plan Template)

Service Agreement with an HIV Medical Care and PrEP Provider(s) Applicants must establish a service agreement with an HIV Medical Care and PrEP Provider(s) to maintain the continuity of status neutral service provision.