CDC-RFA-PS22-2209 final (01).pdf

Centers for Disease Control and Prevention

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

Transgender Status-Neutral Community-to-Clinic Models to End the HIV Epidemic

CDC-RFA-PS22-2209

02/25/2022

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- PS22-2209. 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:

Transgender Status-Neutral Community-to-Clinic Models to End the HIV Epidemic 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-PS22-2209

E. Assistance Listings Number:

93.944 F. Dates:

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

01/31/2022 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:

02/25/2022 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 additional information related to this notice of funding opportunity, please visit (https://www.cdc.gov/hiv/funding/announcements/ ps22-2209/index.html).

G. Executive Summary:

1. Summary Paragraph Transgender (TG) persons, especially transgender women (TGW), have a high lifetime risk of acquiring HIV. Black/African American (Black) and Hispanic/Latino (Hispanic) TGW have the highest prevalence of HIV among TG persons. Many TG persons experience poverty, homelessness, stigma, discrimination, and abuse; have mental health and substance use disorders; and need essential support services. In this demonstration project, organizations will be funded to work in transgender health care organizations (TG clinics) in collaboration with transgender-serving community-based organizations (TG CBOs) to develop models for community-to-clinic, status-neutral HIV prevention and care services. Recipients will provide comprehensive, co-located health services including HIV testing, preexposure prophylaxis (PrEP), gender-affirming hormone therapy, primary health care, and navigation. Navigation will be used to link TG persons as needed to services for mental health and substance use disorders and essential support services. Recipients will work with TG CBOs to engage TG persons in HIV testing and education and navigate them to TG clinics. Key outcomes in the project include an increased number of TG persons who initiate, adhere to, and persist with PrEP; increased rates of viral suppression among TG persons with diagnosed HIV; and an increased number of TG persons with unmet needs who receive services for mental health and substance use disorders and other essential support services.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards The number of awards and average award amount will be subject to availability of funds.

d. Total Period of Performance Funding:

$8,000,000

e. Average One Year Award Amount:

$500,000

f. Total Period of Performance Length:

g. Estimated Award Date:

May 13, 2022

h. Cost Sharing and / or Matching Requirements:

https://www.grants.gov/ https://www.cdc.gov/hiv/funding/announcements/ps22-2209/index.html https://www.cdc.gov/hiv/funding/announcements/ps22-2209/index.html

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

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview TG persons, especially transgender women (TGW), have a high prevalence of HIV and lifetime risk of acquiring HIV. In 2019, 625 TGW and 45 transgender men (TGM) were diagnosed with HIV in the United States and 6 dependent areas.1 About half (51%) of these diagnoses were in persons aged 20-29 years. In the 2019-2020 National HIV Behavioral Surveillance Trans cycle, 42% of TGW tested positive for HIV.2 Racial/ethnic disparities in positivity were also found, with positivity rates of 62% among Black TGW and 35% among Hispanic TGW compared to 17% among White TGW.

Despite the disproportionate burden of HIV among TGW, receipt of HIV prevention and care services have been suboptimal. Among TG persons, 92% reported that they were aware of PrEP but only 32% that they have used it.2 In 2019, viral suppression among persons with diagnosed HIV was 67% among TGW.3 Large proportions of TG persons were living at or below the poverty level, experienced homelessness, or exchanged sex for money or drugs.2 Large proportions of TGW also reported verbal or physical abuse, including by a sexual partner, and suicidal ideation and behavior.2 Substance use is prevalent in TG populations.4 All of these factors impact access to and utilization of HIV prevention and care services by TG persons. In addition, some clinical staff might lack TG cultural awareness, and this can be a barrier to TG persons remaining engaged in health care.

Feminizing or masculinizing gender-affirming hormone therapy was reported by 72% of TGW, with an additional 20% wanting to take hormones.2 Many TG persons seek hormone therapy at TG clinics that serve as centers of excellence for TG health and well-being. These encounters provide opportunities for HIV education and counseling, HIV testing and risk assessment, status-neutral HIV services, sexually transmitted infection (STI) testing, and other health care services.

HIV testing identifies HIV-negative persons who should be assessed for PrEP and nonoccupational postexposure prophylaxis (nPEP) indications,5,6 and if indicated, offered and prescribed PrEP or nPEP. Patients who seek care in TG clinics for gender-affirming services such as hormone therapy can be assessed for PrEP indications and offered PrEP. HIV testing can also identify persons with HIV for rapid antiretroviral therapy (ART) initiation.

TG CBOs might be better poised than TG clinics to reach TG persons who are not already engaged in HIV prevention or care services for HIV education and counseling, HIV testing, and referral to TG clinics for PrEP, nPEP, ART, gender-affirming services, and other health care services.

In the demonstration project, organizations will be funded to work in TG clinics in collaboration with TG CBOs to develop holistic community-to-clinic service models to provide health care and wellbeing services for TG men and women that include co-located HIV prevention and care;

gender-affirming services including hormone therapy and other procedures; STI testing and treatment; hepatitis testing, treatment, and vaccination; preventive health care; and chronic disease care. Navigation will be provided to support use of any needed mental health and substance use disorder services and essential support services. All services will be culturally and linguistically responsive for TG persons to ensure that they feel welcomed, heard, and cared for.

The recipients will also participate in a national learning collaborative to share lessons learned and best practices for TG clinic and TG CBO partnerships to provide status-neutral, community-to-clinic services for TG persons.

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

c. Healthy People 2030 This program specifically addresses or contributes to multiple objectives included in Healthy People 2030:

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

• Increase knowledge of HIV status (HIV-02)

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

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

• Increase viral suppression (HIV-05).

For additional details on the Healthy People 2030 goals listed above, visit:

https://health.gov/healthypeople/search?query=hiv

d. Other National Public Health Priorities and Strategies This program specifically addresses or contributes to the following:

HIV National Strategic Plan (2021-2025) https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025

Ending the HIV Epidemic in the U.S. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview

National Center for HIV, Viral Hepatitis, STD, and TB Prevention’s (NCHHSTP) Strategic Plan https://www.cdc.gov/nchhstp/strategicpriorities/default.htm

e. Relevant Work CDC-RFA-PS15-1509 “Targeted Highly-Effective Interventions to Reverse the HIV Epidemic

(THRIVE)”

CDC-RFA-PS16-003 " Evaluating Locally-Developed or Adapted (Homegrown) Combination HIV Prevention Interventions for Transgender Persons who have Sex with Men"

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://health.gov/healthypeople/search?query=hiv https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.cdc.gov/nchhstp/strategicpriorities/default.htm

CDC-RFA-PS18-1802 “Integrated HIV Surveillance and Prevention Programs for Health Departments” CDC-RFA-PS21-2102 “Comprehensive High-Impact HIV Prevention Programs for Community-Based Organizations”

CDC-RFA-PS19-1904 “Capacity Building Assistance (CBA) for High Impact HIV Prevention Program Integration”

CDC-RFA-PS20-2010 “Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the U.S.”

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities Short-term Outcomes Intermediate Outcomes

Long-Term Outcomes

Provide integrated HIV testing, status-neutral HIV prevention and care services, & comprehensive TG health services to TG persons through TG CBO and clinic collaboratives

Develop collaborations between TG clinics, TG CBOs, and HIV clinics

Implement HIV testing and status-neutral HIV prevention and care services in TG clinics

Support use of mental health and substance use disorder services & other essential support services by TG persons

Identify needs and support linkage to services

Provide services that are culturally and linguistically responsive for TG persons, especially for Black and Hispanic persons

Participate in a national learning collaborative to share best practices and lessons learned for community-to-care, status-neutral, comprehensive HIV & other services for TG persons

Increased availability of HIV testing for TG persons

Increased awareness of HIV status among TG persons

Increased access to STI testing and treatment for TG persons

Increased capacity of TG clinics to provide or link to HIV prevention and care services as well as provide comprehensive TG health services

Increased PrEP initiation by PrEP-eligible TG persons

Increased nPEP initiation by nPEP-eligible TG persons

Increased rapid ART initiation by TG persons with diagnosed HIV

Increased linkage to HIV care among TG persons with diagnosed HIV

Increased linkage to mental health, substance use disorder, and other essential support services by TG persons with need for services

Increased TG cultural and linguistic responsiveness for TG persons by all CBO and clinical staff

Increased understanding of best practices and lessons learned by providers of community-to-care comprehensive TG health services

Increased adherence to PrEP by TG persons

Increased persistence with PrEP by TG persons

Increased retention in HIV care among TG persons with diagnosed HIV

Increased viral suppression among TG persons with diagnosed HIV

Increased receipt of mental health, substance use disorder, and other essential support services by TG persons

Decreased

HIV

transmission among populations of TG persons

Decreased

HIV

incidence among TG persons

Decreased HIV-related morbidity and mortality among TG persons

i. Purpose This NOFO will fund organizations to work in TG clinics and partner with TG CBOs to develop community-to-clinic models for integrated status-neutral HIV prevention and care services, gender-affirming services including hormone therapy, and primary health care. Navigation will also be used to link TG persons to services as needed for mental health and substance use disorder and other essential support services. These models will increase use of HIV prevention and treatment by TG persons to decrease HIV transmission and improve overall health and wellbeing.

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

Short Term Outcomes

Increased capacity of TG clinics to provide or link to HIV prevention and careservices as well as provide comprehensive TG health services

Increased PrEP initiation by PrEP-eligible TG persons Increased nPEP initiation by nPEP-eligible TG persons Increased rapid ART initiation by TG persons with diagnosed HIV Increased linkage to HIV care among TG persons with diagnosed HIV Increased linkage to mental health, substance use disorder, and other essential support services among TG persons with need for services

Intermediate Outcomes

Increased adherence to PrEP by TG persons Increased persistence with PrEP by TG persons Increased retention in HIV care among TG persons with diagnosed HIV Increased viral suppression among TG persons with diagnosed HIV

iii. Strategies and Activities CDC will work in partnership with recipients to develop community-to-clinic integrated and holistic models to provide co-located services for TG persons. Status-neutral services include HIV testing, gender-affirming services including hormone therapy and other procedures, STI testing and treatment, hepatitis testing and treatment, preventive health care, chronic disease care, mental health and substance use disorder services need assessments and linkage to services, and social service need assessment and linkage to services. Co-located health services have been associated with persons remaining engaged in health care and better health outcomes. These services will be developed with cultural and linguistic responsiveness for TG persons.

This project has four strategies: (1) To provide integrated HIV testing, status-neutral HIV prevention and care services, and comprehensive TG health services to TG persons through TG CBO and clinic collaboratives; (2) To support use of mental health and substance use disorder services and other essential support services by TG persons with needs for these services; (3) To provide services that are culturally sensitive for TG persons, especially for Black and Hispanic persons; and (4) To support development of and participation in a national learning collaborative to share lessons learned and best practices for TG clinic and TG CBO partnerships to provide community-to-clinic, status-neutral, comprehensive services for TG persons

Note that all activities need to be implemented according to CDC-approved protocols and procedures.

Strategy 1. Provide integrated HIV testing, status-neutral HIV prevention and care services, and comprehensive TG health services to TG persons through TG CBO and clinic collaboratives

Recipients will identify TG CBOs and other entities that serve the needs of TG populations and will o Lead development of collaborations between TG clinics, TG CBOs, and HIV clinics to engage TG persons in the community in HIV prevention and TG health services o Consult with health departments for optimal collaboration and efficient use of available resources such as HIV, STI, and hepatitis testing; local PrEP Medication Assistance Programs (MAPs) and other PrEP programs; PrEP navigation; mental health and substance use disorder services; and other essential support services

Recipients will o Conduct HIV testing in both TG CBOs and TG clinics

Conduct Ag/Ab HIV testing Conduct STI testing and treatment Conduct hepatitis testing, treatment, and vaccination o Provide status-neutral HIV services If tested negative for HIV:

Assess for PrEP or nPEP indications If PrEP or nPEP indicated, initiate PrEP or nPEP If tested in TG CBO, navigate to TG clinics for PrEP and nPEP services Train providers in TG clinics to provide PrEP and nPEP care Provide PrEP and nPEP care Use CDC-developed algorithms to identify TG persons in clinical care who might need frequent HIV testing and PrEP Support PrEP and nPEP adherence through patient navigation, adherence counseling, or other strategy Support PrEP persistence through patient navigation, adherence counseling, or other strategy

If diagnosed with HIV:

Train providers in TG clinics to provide rapid initiation of first line

ART and HIV care Provide rapid ART initiation

Provide HIV care in the TG clinic or link to an HIV clinic Identify practice models for HIV care integrated in TG clinics, which may include:

o Hiring an infectious disease clinician in TG clinics o Assessing cost and revenue generation associated with hiring a full-time or part-time HIV care provider in the TG clinic o Training or telementoring TG clinicians to provide HIV care

Develop protocols for nursing support and telemedicine Support ART adherence through patient navigation, adherence counseling, or other strategy o Provide comprehensive health and well-being services Feminizing and masculinizing gender-affirming services including hormone therapy Education, counseling, and linkage to other gender-affirming procedures STI testing and treatment Hepatitis testing, treatment, and vaccination Primary health care Preventive care (e.g., vaccinations) Chronic care (e.g., diabetes care) Referrals to specialty care as needed o Increase financial access of TG persons to health care services Expand enrollment in health insurance if eligible, including Medicaid Develop protocols for the use of MAPs and local PrEP programs

Include protocols for starter packs for PrEP, nPEP, and ART while awaiting MAP approval

Develop and implement strategies to remove barriers to accessing mental health and substance use service

Other collaborative activities recipients may engage in to improve access of TG persons to HIV prevention and TG health services include o Provide training/telemedicine support for clinicians in HIV clinics who want to provide gender-affirming hormone therapy to TG persons o Provide training/telemedicine support for clinicians who practice in geographic areas remote from a TG clinic to provide gender-affirming hormone therapy, PrEP care, and ART and HIV care

Recipients may fund collaborating TG CBOs with up to 20% of its funds to o Implement evidence-based models in CBOs for community outreach to engage

TG persons for HIV testing and prevention, such as conducting community outreach events and implementing snowballing incentive programs for referral of peers for HIV testing and status-neutral HIV services o Support TG CBOs to provide HIV and PrEP education, counseling, HIV testing, and HIV self-test kits o If HIV testing is occurring in TG CBOs, implement evidence-based models in TG CBOs for navigation of TG persons to TG clinics for PrEP; to TG clinics or HIV clinics for ART; and to mental health and substance use disorder services, and other essential support services

Strategy 2. Support use of mental health and substance use disorder services and other essential support services by TG persons to address social determinants of health

Recipients will collaborate to support receipt of mental health and substance use disorder services and other essential support services by TG persons o Identify service providers in the TG clinics or community o Identify client need for mental health or substance use disorder services

Support linkage to needed mental health or substance use disorder services o Identify client need for essential support services (e.g., health insurance, housing, food assistance, child care, transportation, legal services, job training, employment assistance) to address social determinants of health Support linkage to needed essential support services

Strategy 3. Provide services that are culturally sensitive for TG persons and for Black and Hispanic persons

Provide TG cultural awareness training for all CBO staff, PrEP and ART clinical providers, navigators, and all other staff o Include training for all clinical providers on gender-affirming hormone therapy, surgery and procedures, and sexual health care

Recruit project staff with experience and cultural awareness in providing care for TG persons

In TG and HIV clinics, develop/ensure electronic health record (EHR) capability to identify persons by their affirmed gender and appropriate name

Strategy 4. Participate in a national learning collaborative for recipients to share lessons learned and best practices for community-to-care, status-neutral, comprehensive TG service models

Recipients will participate in a new national learning collaborative to share lessons learned and best practices with other TG CBOs and TG clinics in the United States

Recipients will support other TG CBOs and TG clinics to provide HIV status-neutral, community-to-clinic comprehensive services for TG persons

1. Collaborations

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

Recipients are required to collaborate with local TG CBOs to provide outreach to TG populations to engage them in HIV testing; HIV and PrEP education and counseling; and linkage to TG clinics. Recipients are required to collaborate with state or local health departments in their jurisdiction for optimal and efficient use of available resources such as HIV, STI, and hepatitis testing, treatment, and vaccination; state and local PrEP Medication Assistance Programs (MAPs) and other PrEP programs; navigation services; mental health and substance use disorder services and other essential support services; and training for PrEP and ART clinical service provision; and training for navigation. Recipients may provide up to 20% of their award to the collaborating TG CBO(s) to provide outreach to TG populations to engage them in HIV testing; HIV and PrEP education and counseling; linkage to TG clinics; and data collection for evaluation. TG CBOs may receive funding if they are not funded for similar activities through other CDC programs, or if funded but require additional resources for evaluation activities.

Applicants are required to obtain MOUs/MOAs from CBOs and health departments as evidence for the collaboration, must file the MOU/MOA, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov. The MOA/MOU should be reflective of the services most requested by the priority population. Recipients are encouraged to establish additional collaborations supported by MOAs/MOUs over the course of the period of performance.

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

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

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

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

· Types of services accessible for persons with HIV and HIV-negative persons at increased risk of acquiring HIV.

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

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

· Name and address of the provider(s).

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

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

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

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

b. With organizations not funded by CDC:

Recipients are required to collaborate with local TG CBOs for TG outreach. Recipients may provide up to 20% of their award to the TG CBO to provide outreach to TG populations to engage them in HIV testing; HIV and PrEP education and counseling; linkage to TG clinics; and data collection for evaluation.

http://www.grants.gov

Applicants are required to obtain MOUs/MOAs from CBOs as evidence for the collaboration, must file the MOU/MOA, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov. The MOA/MOU should be reflective of the services most requested by the priority population. Recipients are encouraged to establish additional collaborations supported by MOAs/MOUs over the course of the period of performance.

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

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

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

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

· Types of services accessible for persons with HIV and HIV-negative persons at increased risk of acquiring HIV.

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

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

· Name and address of the provider(s).

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

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

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

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

2. Target Populations The recipients will focus their activities on transgender women, especially Black and Hispanic TGW, to achieve the greatest impact on HIV prevention and care and health equity for TG populations.

Clinical organizations that serve TG persons in the 50 jurisdictions included in Phase 1 of the Ending the HIV Epidemic in the U.S. (EHE) initiative, listed in the table below, are encouraged to apply (https://ahead.hiv.gov). More than half of U.S. HIV diagnoses in 2016-2017 were in these 50 jurisdictions, so resources allocated to these disproportionately affected communities can most effectively support ending the HIV epidemic.

U.S. counties and jurisdictions included in Phase 1 of the Ending the HIV Epidemic in the U.S. initiative

Arizona Illinois North Carolina Maricopa County Cook County Mecklenburg County California Indiana Ohio Alameda County Marion County Cuyahoga County https://ahead.hiv.gov

Los Angeles County Louisiana Franklin County Orange County East Baton Rouge Parish Hamilton County Riverside County Orleans Parish Pennsylvania Sacramento County Maryland Philadelphia County San Bernadino County Baltimore City Tennessee San Diego County Montgomery County Shelby County San Francisco County Prince George’s County Texas Florida Massachusetts Bexar County Broward County Suffolk County Dallas County Duval County Michigan Harris County Hillsborough County Wayne County Tarrant County Miami-Dade County Nevada Travis County Orange County Clark County Washington Palm Beach County New Jersey King County Pinellas County Essex County Washington D.C.

Georgia Hudson County Puerto Rico Cobb County New York San Juan Municipio Dekalb County Bronx County Fulton County Kings County Gwinnett County New York County

Queens County

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

A health disparity occurs when a health outcome occurs to a greater or lesser extent between populations. Health disparities in HIV, viral hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these infections and diseases.

Social determinants are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life risks and outcomes (https://www.cdc.gov/socialdeterminants/index.htm). These include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic challenges. It requires:

Continuous efforts focused on elimination of health disparities, including disparities in health and in living and working conditions that influence health, and https://www.cdc.gov/socialdeterminants/index.htm

Continuous efforts to maintain a desired state of equity after health disparities are eliminated.

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

iv. Funding Strategy The number of awards and amount of each award will be subject to the availability of funds.

Funding will be made available for organizations to work in TG clinics in collaboration with TG CBOs. Recipients may fund their collaborating TG CBOs with up to 20% of their award. TG CBOs may receive funding if they are not already funded for similar activities through another CDC program, or if funded but require additional resources for evaluation activities.

Applicants that are not TG clinics are required to identify the TG clinic where the work will occur and must submit a letter from the director (or another official) at the clinic indicating their support of the application and plans to implement proposed activities.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

CDC will collaborate with recipients to develop evaluation and performance measurement plans to ensure appropriate and successful implementation of the strategies and activities; progress in achieving outcomes; and understanding the barriers to progress during the period of performance. CDC will collaborate with recipients to develop a plan to use performance measurement and evaluation data to improve processes to achieve intended outcomes.

Recipients may also be expected to participate in special evaluations as needed throughout the period of performance using existing or newly collected data. Special evaluation studies, such as formative surveys, interviews, or focus groups with TG persons or providers in TG CBOs and TG clinics may be conducted for information to optimize service models to meet the needs of TG persons. Key evaluation questions and data sources for such evaluations will be determined throughout the period of performance to appropriately meet the specific evaluation requirements in the project.

A data management plan is required and should include:

A description of the data to be collected or generated in the proposed project The standards to be used for the collected or generated data Mechanisms for, or limitations to, providing access to the data, including a description for the provisions for the protection of privacy, confidentiality, security, and intellectual property, or other rights

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

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

Other additional requirements based on the program

CDC will request de-identified person-level longitudinal data at baseline and every 6 months from recipients, collected and stored through EHRs and then deidentified and transmitted to CDC. These data will allow CDC to calculate process and outcome measures in order to evaluate recipient performance and progress toward intended outcomes. These data will be used to develop dashboards with calculated outcome measures that serve as feedback to programs to guide ongoing quality improvement activities. The dashboards will help ensure success by providing program effectiveness information that can be helpful to manage the project and ensure progress towards achieving intended outcomes. The information is also helpful to determine applicability of evidence-based approaches for different populations, settings, and contexts as a component of ongoing quality improvement. Extraction of data from EHR allows data collection to be efficient and timely. Data collection and transmission to CDC every 6 months has been found in a previous demonstration project (CDC-RFA-PS15-1509) to be an effective approach to support ongoing quality improvement and to facilitate program success. It also supported recipients to monitor the quality of activities provided by their contractors, facilitating any necessary changes to ensure achieving intended outcomes. The data will be de-identified and comply with the NCHHSTP Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs.

For client demographic and behavioral information, the date of data collection should be included. For services provided by the TG clinic, TG CBO, or other entity or organization, the date of service should be included. Person-level longitudinal data will include demographic characteristics and self-reported sexual and injection drug use behaviors of clients and information about their encounters at TG clinics, TG CBOs, HIV clinics, and other clinics or organizations to understand TG persons enrolled in the project and linkage and receipt of services. These data will be linked at the person-level with health care data extracted from EHR in TG clinics and HIV clinics. All data linkages will be conducted by the TG clinic and de-identified data will be transmitted to CDC at least every 6 months to inform quality improvement activities.

CDC will request the following information at baseline and every 6 months from recipients as process measures for the proposed strategies and activities. For aggregate numbers requested, recipients will extract data from their EHR and deidentify and transmit data to CDC for CDC to calculate measures:

Strategy: Provide integrated HIV testing, status-neutral HIV prevention and care services, and comprehensive TG health services to TG persons through TG CBO and clinic collaboratives o Process measures: Report on status of collaborations and linkage processes between TG clinics, TG CBOs, and HIV clinics

Data for CDC to calculate numbers of HIV tests by site and numbers of referrals of TG persons to HIV prevention and care services by TG clinics and CBO

Strategy: Support use of mental health and substance use disorder services and other essential support services by TG persons:

o Process measures: Report on status of identification of mental health, substance use, and other essential support service needs and linkage processes Data for CDC to calculate numbers of TG persons with mental health disorders, substance use disorders, and other essential support service needs and referral and linkage to appropriate services by TG clinics and CBOs

Strategy: Provide services that are culturally and linguistically responsive for TG persons, especially for Black and Hispanic persons o Process measures: Report on trainings of staff to improve cultural and linguistic responsiveness for TG persons by TG clinics and CBOs

Strategy: Participate in a national learning collaborative to share best practices and lessons learned for community-to-car, status-neutral, comprehensive HIV and other services for TG persons o Process measures: Report on attendance and participation in national learning collaborative among participating TG clinics and TG CBOs

CDC will request de-identified person-level longitudinal data, collected and stored through EHRs, at baseline and every 6 months from recipients for CDC to calculate outcome measures for the intended outcomes:

Outcome: Increased capacity of TG clinics to provide or link to HIV prevention services and HIV care as well as provide comprehensive TG health services o Measures:

Data for CDC to calculate number of TG persons encountered by TG CBO and TG clinic Data for CDC to calculate number of TG persons in TG clinic who received gender-affirming hormone therapy, other gender-affirming procedures

Data for CDC to calculate number of TG persons who received primary care services by type of service including vaccinations by type of vaccine, STI testing, positive STI tests by STI and anatomical site, treatment for STIs, and testing for other infections (HBV, HCV)

Data for CDC to calculate number of TG persons encountered who were tested for HIV by site and HIV test result

Data for CDC to calculate number of TG persons tested for HIV who were linked to a TG clinic or HIV clinic by site and HIV test result

Data for CDC to calculate number of TG persons provided navigation to a clinic and accepted or declined navigation

Data for CDC to calculate number of TG persons linked to a TG clinic or HIV clinic using navigation by site and HIV test result

Data for CDC to calculate number of TG persons initiating PrEP, nPEP, and ART at the TG clinic

Outcome: Increased PrEP initiation by PrEP-eligible TG persons o Measures:

Data for CDC to calculate number of TG persons prescribed same-day PrEP

Data for CDC to calculate number of TG persons prescribed PrEP at a later date

Outcome: Increased adherence to PrEP by TG persons o Measure:

Data for CDC to calculate number of TG persons adhered to PrEP

Outcome: Increased persistence with PrEP by TG persons o Measure:

Data for CDC to calculate number of TG persons persisted with PrEP

Outcomes: Increased nPEP initiation by nPEP-eligible TG persons o Measures:

Data for CDC to calculate number of TG persons assessed for nPEP Data for CDC to calculate number of TG persons provided nPEP if eligible

Outcomes: Increased rapid ART initiation by TG persons with diagnosed HIV o Measures:

Data for CDC to calculate number of TG persons tested for HIV with a positive test by site of testing

Data for CDC to calculate number of TG persons provided rapid ART initiation

Data for CDC to calculate number of TG persons received an ART prescription

Outcomes: Increased linkage to HIV care among TG persons with diagnosed HIV o Measures:

Data for CDC to calculate number of TG persons linked to a TG clinic or HIV clinic (if tested in a TG CBO)

Data for CDC to calculate number of TG persons provided navigation to TG clinic or HIV clinic and accepted or declined navigation

Outcomes: Increased retention in HIV care among TG persons with diagnosed HIV o Measure:

Data for CDC to calculate number of TG persons retained in HIV care

Outcomes: Increased viral suppression among TG persons with diagnosed HIV o Measure:

Data for CDC to calculate time to viral suppression among TG persons who received ART

Outcomes: Increased linkage to mental health services by TG persons with needs for services o Measures:

Data for CDC to calculate the number of TG persons with unmet mental health service needs Data for CDC to calculate number of TG persons provided navigation to link to mental health services, and accepted or declined navigation Data for CDC to calculate number of TG persons linked to mental health services

Outcomes: Increased linkage to substance use disorder services by TG persons with needs for services o Measures:

Data for CDC to calculate number of TG persons with unmet substance use service needs Data for CDC to calculate number of TG persons provided navigation to link to substance use disorder services, and accepted or declined navigation

Data for CDC to calculate number of TG persons linked to substance use disorder services

Outcomes: Increased linkage to other essential support services by TG persons with needs for services o Measure:

Data for CDC to calculate number of TG persons with unmet essential support service needs Data for CDC to calculate number of TG persons provided navigation to link to essential support services, and accepted or declined navigation Data for CDC to calculate number of TG persons linked to other essential support services

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

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

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

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additional-requirements/ar-25.html.

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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

All recipients are expected to comply with the NCHHSTP Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs (2011). All standards included in the NCHHSTP Data Security and Confidentiality Guidelines should be implemented by recipients, unless otherwise justified. A Certification of Compliance statement signed by an overall responsible party or parties (ORP) will be submitted annually to the CDC Project Officer at the same time the Annual Performance Report (APR) is submitted.

For information on the data security and confidentiality guidelines and example certification statement, please refer to http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf

c. Organizational Capacity of Recipients to Implement the Approach Applicants should describe their organizational capacity to implement the strategies and activities in the NOFO, including

Capacity for program planning, program evaluation, performance monitoring, financial reporting, budget management and administration, and personnel management. Capacity for program evaluation and monitoring should include demonstration of ability to collect person-level longitudinal clinical data and other information using EHR and data collection systems.

Relevant experience and capacity (management, administrative, and technical) to implement the activities and achieve the project outcomes for the priority population;

experience and capacity to implement the evaluation plan; and a staffing plan and project management structure sufficient to achieve the project outcomes and that clearly defines staff roles. Relevant experience should include demonstration of experience and https://www.cdc.gov/grants/additional-requirements/ar-25.html http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf credibility in providing clinical services to TG persons consistently for at least the last 24 months, with demonstration of the scope of their current work and experience in providing gender-affirming hormone therapy and other healthcare services for TG persons, especially Black and Hispanic TGW Applicants should demonstrate that they provided clinical services for at least 100 TGW in 2019 and served a population comprised of at least 50% Black or Hispanic TG persons in the application narrative. For applicants that are not TG clinics, a letter from the partnering TG clinic indicating their support of the application and plans to implement proposed activities is required.

Applicants should name this letter “Support from partner transgender clinic” and upload as a pdf at www.grants.gov.

A financial management system that will allow proper funds management and segregation of funds by program, and meet the requirements as stated in the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards:

“45 CFR Part 75.302." The financial system should permit the preparation of reports required by general and program-specific terms and conditions; and the tracing of funds to a level of expenditure adequate to establish that such funds have been used according to the federal statutes, regulations, and terms and conditions of the federal award

Ability to manage the required procurement efforts, including the ability to write, award, and manage contracts in accordance with applicable grants regulations

Applicants should provide CVs for key staff and note whether hiring new staff will be required as well as organizational charts. For CVs, applicants must name this file "CVs/Resumes" or "Organizational Charts" and upload it at www.grants.gov.

d. Work Plan Applicants must provide a detailed work plan for the first year of this award and a high level work plan for the subsequent years of the award. The detailed work plan must describe the applicant’s approach to conduct the required strategies and activities and accomplish each process measure. The work plan must also include a timeline and the person responsible for completing each activity. The budget submitted must be consistent with the work plan and include resources needed to conduct these activities.

An example of a work plan format is presented below that demonstrates alignment of the work plan with the logic model and narrative. In this format, the table would be completed for each period of performance outcome. If a particular activity leads to multiple outcomes, it should be described under each outcome measure.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position/Party

Completion Date

1.

2.

3.

4.

5.

6.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

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

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

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

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