hrsa-25-059 FINAL.pdf

Notice of Funding Opportunity

Application due March 18, 2025

HIV/AIDS Bureau Division of Policy and Data

Improving Mental Health and Engagement in Care Among People with HIV — Evaluation Provider Opportunity number: HRSA-25-059

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 7

Program description 9

Step 2: Get Ready to Apply 24

Get registered 25

Find the application package 25

Application writing help 25

Step 3: Prepare Your Application 27

Application contents and format 28

Step 4: Learn About Review and Award 39

Application review 40

Selection process 46

Award notices 47

Step 5: Submit Your Application 48

Application submission and deadlines 49

Application checklist 50

Step 6: Learn What Happens After Award 52

Post-award requirements and administration 53

Contacts and Support 57

Endnotes 60

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks)

You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days)

You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date

Applications are due by 11:59 p.m. Eastern Time on March 18, 2025.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/

Jump to a step

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 7

Program description 9

Basic information Health Resources and Services Administration (HRSA)

HIV/AIDS Bureau

Division of Policy and Data

Adapting interventions to better serve people with co-occurring HIV and mental health conditions

Have questions? Go toContacts and Support.

Key facts

Opportunity name:

Improving Mental Health and Engagement in Care Among People with HIV — Evaluation Provider Opportunity number:

HRSA-25-059

Announcement version:

New Federal assistance listing:

93.928 Statutory authority:

42 USC §§ 300ff-54(b) and 300ff-101 (§§ 2654(b) and 2691 of the Public Health Service Act); and Consolidated Appropriations Act, 2024, Pub. L. 118-47, Division D, title II.

Key dates

NOFO issue date:

January 16, 2025

Informational webinar:

February 6, 2025

Application deadline:

March 18, 2025

Expected award date:

August 1, 2025

Expected start date:

August 1, 2025

Summary This four-year funding opportunity is supported by the HRSA Ryan White HIV/AIDS Program (RWHAP) Part F: Special Projects of National Significance (SPNS) Program.

This funding uses implementation science to adapt and evaluate the implementation of interventions that better serve people with co-occurring HIV and mental health conditions The focus is on people with HIV who are out of care or experiencing barriers to retention in care, and who also have mental health conditions. This initiative is for people who are RWHAP eligible.

This RWHAP SPNS initiative funds one implementation technical assistance provider (ITAP) and one evaluation provider (EP). The EP is funded under this opportunity. The ITAP is funded separately under a companion NOFO and is responsible for identifying the intervention strategies and selecting and issuing subawards to the implementation sites. The ITAP and EP are required to co-lead the initiative. HRSA HAB encourages you to read and familiarize yourself with the program expectations of the companion NOFO, HRSA-25-058 (ITAP).

The funded EP will:

• Collaborate with the ITAP to identify mental health interventions that the implementation sites will then adapt and implement. This collaboration will ensure alignment with the evaluation.

• Collaborate with the ITAP to select up to 10 implementation sites.

• Develop and lead a multisite evaluation grounded in implementation science (as defined in this NOFO) to assess implementation, including:

◦ Adaptations.

◦ Barriers and facilitators.

◦ Implementation strategies.

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Step 1: Review the Opportunity 5 https://www.govinfo.gov/content/pkg/USCODE-2011-title42/html/USCODE-2011-title42-chap6A-subchapXXIV.htm https://www.govinfo.gov/content/pkg/USCODE-2011-title42/html/USCODE-2011-title42-chap6A-subchapXXIV.htm https://www.govinfo.gov/content/pkg/USCODE-2011-title42/html/USCODE-2011-title42-chap6A-subchapXXIV.htm https://www.govinfo.gov/content/pkg/USCODE-2011-title42/html/USCODE-2011-title42-chap6A-subchapXXIV.htm https://www.govinfo.gov/app/details/PLAW-117publ328 https://www.govinfo.gov/app/details/PLAW-117publ328 https://www.govinfo.gov/app/details/PLAW-117publ328 https://ryanwhite.hrsa.gov/about/parts-and-initiatives/part-f-spns https://ryanwhite.hrsa.gov/about/parts-and-initiatives/part-f-spns https://targethiv.org/library/topics/eligibility https://grants.gov/search-results-detail/354787

◦ Cost.

◦ Other outcomes.

• Provide evaluation-specific technical assistance (TA) to implementation sites.

• Coordinate closely with the ITAP to ensure that the evaluation plan is reflected in their TA activities.

• Collaborate with the ITAP in developing and implementing a communications and dissemination plan for the initiative, including by helping create user-friendly multimedia materials.

• Collaborate with the ITAP in developing and implementing a communications and dissemination plan for the initiative, including by helping create user-friendly multimedia materials.

Funding details Application type: New

Expected total available FY 2025 funding: $1,000,000

Expected number and type of awards: 1 cooperative agreement

Funding range per award: up to $1,000,000 for 1 award

The program and award depend on the appropriation of funds and are subject to change based on the availability and amount of appropriations.

We plan to fund one awards in four 12-month budget periods for a total 4-year period of performance of August 1, 2025, to July 31, 2029, at $1,000,000 per budget year.

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Eligibility Who can apply Eligible applicants include domestic entities eligible for funding under Ryan White HIV/ AIDS Program Parts A - D of Title XXVI of the Public Health Service (PHS) Act.

Types of eligible organizations These types of domestic* organizations may apply:

• Public and nonprofit private entities.

• State and local governments.

• Academic institutions.

• Local health departments.

• Nonprofit hospitals and outpatient clinics.

• Community health centers receiving support under Section 330 of the PHS Act.

• Faith-based and community-based organizations.

• Indian Tribes or Tribal organizations with or without federal recognition.

“Domestic” means the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, or the Republic of Palau.

Individuals are not eligible applicants under this NOFO

Completeness and responsiveness criteria We will review your application to make sure it meets these basic requirements to move forward in the competition.

We will not consider an application that:

• Is from an organization that does not meet all eligibility criteria.

• Requests funding above the award ceiling shown in the funding range.

• Is submitted after the deadline.

Application limits You may not submit more than one application. If you submit more than one application, we will only accept the last on-time submission.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

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Cost sharing This program has no cost-sharing requirement. If you choose to share in the costs of the project, we will not consider it during merit review. We will hold you accountable for any funds you add, including through reporting.

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Program description Purpose This initiative has the following three objectives:

• Objective 1: Support a national cohort of implementation sites to adapt and implement culturally responsive interventions to engage and retain people with co-occurring HIV and mental health conditions in HIV primary care and mental health services.

• Objective 2: Evaluate the implementation of interventions using implementation science frameworks. The EP will document and share evaluation findings throughout the initiative to support successful implementation. The evaluation will assess:

◦ Intervention adaptations.

◦ Barriers and facilitators to implementation.

◦ Implementation strategies.

◦ Cost.

◦ Other implementation, client, and service outcomes.

• Objective 3: Create and disseminate user-friendly multimedia materials to support other RWHAP organizations in replicating effective interventions.

This RWHAP SPNS initiative funds one ITAP and one EP. The ITAP is funded separately under a companion NOFO. The ITAP and EP are required to co-lead the initiative. Full information on objectives and requirements can be found in the program objectives and requirements section.

This initiative focuses on people with HIV and mental health conditions who are out of care or experiencing barriers to retention in care. You and the ITAP may identify additional priority populations, including those identified by the National HIV/AIDS Strategy (NHAS) [PDF], when you are selecting the implementation sites.

Learnings from this initiative will help the RWHAP determine what intervention strategies work to engage people with HIV in care and improve mental health and HIV outcomes in different settings among different priority populations. The EP and ITAP will document and widely share lessons learned with the RWHAP community and beyond to help other organizations replicate these interventions to improve mental health and quality of life among people with HIV in their own settings.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 9 https://files.hiv.gov/s3fs-public/NHAS-2022-2025.pdf https://files.hiv.gov/s3fs-public/NHAS-2022-2025.pdf

Mental health and HIV People with HIV are more likely to have one or more occurring mental health conditions, compared to people without HIV. Mental health conditions include depression, anxiety, and post-traumatic stress disorder. Some populations who are disproportionately impacted by HIV experience increased mental health disparities, including priority populations as defined by the National HIV/AIDS Strategy (NHAS) (2022–2025). Untreated mental health conditions among people with HIV results in reduced quality of life and poorer health outcomes, including low rates of viral suppression and mortality.

Untreated mental health conditions also contribute to lower engagement in HIV care.

Approximately 21 percent of people with HIV in the United States were out of care between 2018 and 2020. Compared to people with HIV in care, those who are out of care are more likely to report mental health symptoms as a barrier to HIV care. They also self-report poorer health and more unmet non-HIV medical and mental health service needs. It is estimated that 60 percent of HIV transmissions result from people with HIV who are out of care.

Although this initiative focuses on mental health, it is important to highlight the complex relationship between mental health, substance use, stigma, and the social determinants of health. Mental health and substance use conditions often mutually reinforce each other, resulting in poorer health outcomes such as low rates of viral suppression and increased rates of hospitalization. In addition, many factors can contribute to the prevalence of mental health conditions among people with HIV at the biological, individual, social, and structural levels.

Key definitions For this initiative, the following definitions will be used:

• Implementation science: The study of methods to promote or improve the systematic uptake of effective intervention strategies by public health practice, program, and policy. Intervention strategies may occur at the system, community, organization, and individual levels. At HRSA HAB, successful intervention strategies positively impact health and quality of life for people with HIV.

• Intervention strategies: HRSA HAB categorizes interventions into three levels, based on evidence of demonstrated effectiveness. The three levels are collectively known as “intervention strategies” and include:

◦ Evidence-based interventions: Interventions that are demonstrated to effectively improve health and/or quality of life, based on published research.

These interventions meet the CDC criteria for being evidence-based.

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Step 1: Review the Opportunity 10 https://journals.lww.com/aidsonline/fulltext/2023/02010/the_prevalence_of_mental_health_disorders_in.5.aspx https://journals.lww.com/aidsonline/fulltext/2023/02010/the_prevalence_of_mental_health_disorders_in.5.aspx https://journals.lww.com/aidsonline/fulltext/2019/07150/Mental_health_and_HIV_AIDS__the_need_for_an.1.aspx https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7666642/ https://www.kff.org/hivaids/issue-brief/what-do-we-know-about-people-with-hiv-who-are-not-engaged-in-regular-hiv-care/ https://www.kff.org/hivaids/issue-brief/what-do-we-know-about-people-with-hiv-who-are-not-engaged-in-regular-hiv-care/ https://pubmed.ncbi.nlm.nih.gov/26973741/ https://journals.lww.com/aidsonline/fulltext/2019/07150/Mental_health_and_HIV_AIDS__the_need_for_an.1.aspx https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003128 https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003128

◦ Evidence-informed interventions: Interventions that are demonstrated to effectively show promise, based on published research. Evidence-informed interventions may demonstrate impact and strength of evidence without meeting CDC criteria for being evidence-based.

◦ Emerging interventions: Innovative practices that have not yet been published or do not have extensive evaluation data but have effectively improved health and/or quality of life.

• Implementation strategies: Methods to enhance the adoption or uptake of interventions in specific settings.

• Culturally responsive care: Services that are culturally grounded, attuned, and sensitive to the unique needs of each client and their cultural background.

• Flexible service delivery: The ability to quickly adjust services to meet the unique and evolving needs of clients—such as low-barrier care, street medicine, and nontraditional clinic hours.

• Integrated care: Clinicians’ careful coordination of HIV primary care, mental health care, and supportive services. Clinicians work together systematically and use a multidisciplinary approach to ensure clients receive one consistent message about care and treatment and are included in planning their treatment. See Substance Abuse and Mental Health Services Administration’s 2023-2026 Strategic Plan.

• Mental health: The Substance Abuse and Mental Health Services Administration (SAHMSA) includes our emotional, psychological, and social well-being in its definition of mental health. Mental health affects how we think, feel, and act, and helps determine how we handle stress, relate to others, and make choices.

• Out of care or experiencing barriers to retention in care:

◦ Newly diagnosed with HIV within the past 12 months, or

◦ Diagnosed with HIV more than 12 months ago but not fully engaged in care, either by:

▪ Not having at least two HIV medical care encounters at least 90 days apart within a 12-month measurement year (see HAB performance measure).

▪ Being at risk of disconnecting from care by missing their last appointment in the last six months, leaving incarceration, or having another high-risk factor.

▪ Not being virally suppressed—defined as having a viral load of 200 copies/mL or more—at the time of enrollment (see HAB performance measure).

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 11 https://www.samhsa.gov/about-us/strategic-plan https://www.samhsa.gov/about-us/strategic-plan https://www.samhsa.gov/mental-health https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio/core-measures/annual-retention-in-care https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio/core-measures/annual-retention-in-care https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio/core-measures/hiv-viral-load-suppression https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio/core-measures/hiv-viral-load-suppression

Recovery: SAMHSA’s working definition of recovery is a process of change through which individuals improve their health and wellness, live self-directed lives, and strive to reach their full potential. Recovery signals a dramatic shift to expecting positive outcomes for individuals who experience mental health and substance use conditions or both.

Background The HRSA Ryan White HIV/AIDS Program has five statutory funding parts that provide a comprehensive system of medical care, support, and medications for low-income people with HIV. The goal is better health results, and lower HIV transmission in priority groups.

The HIV care continuum is key to the program. It shows the journey of someone with HIV from diagnosis to effective treatment, leading to viral suppression. Achieving viral suppression boosts the patient’s quality of life and prevents HIV transmission.

This continuum also helps programs and planners measure progress and use resources effectively. We require you to assess your outcomes and work with your community and public health partners to improve outcomes across the HIV care continuum. To assess your program, review HRSA’s Performance Measure Portfolio.

Strategic frameworks and national objectives To address health challenges faced by low-income people with HIV, using national objectives and strategic frameworks is crucial. These frameworks include:

• Healthy People 2030

• National HIV/AIDS Strategy (NHAS) (2022–2025)

• SAMHSA Strategic Plan (2023–2026)

• Sexually Transmitted Infections National Strategic Plan for the United States (2021–2025)

• Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021–2025)

These strategies offer guidance on the main principles, priorities, and steps for our national health response. They serve as a blueprint for collective action and impact.

Expanding the effort There have been significant accomplishments:

• From 2018 to 2023, HIV viral suppression among RWHAP patients improved from 87.1% to 90.6%. For more, see the 2023 Ryan White Services Report (RSR).

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Step 1: Review the Opportunity 12 https://www.samhsa.gov/find-help/recovery https://ryanwhite.hrsa.gov/about/parts-and-initiatives https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum/ https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio https://health.gov/healthypeople https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.samhsa.gov/about-us/strategic-plan 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://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/2023-ryan-white-annual-data-report.pdf

• Racial, ethnic, age-based, and regional disparities in viral suppression rates have significantly reduced. For more, see the 2023 Ryan White Services Report (RSR).

• In 2020, the Ending the HIV Epidemic in the U.S. (EHE) initiative launched to further expand federal efforts to reduce HIV transmission. For the RWHAP, the EHE initiative expands the program’s ability to meet the needs of clients, specifically focusing on linking people with HIV who are either newly diagnosed, diagnosed but currently not in care, or are diagnosed and in care but not yet virally suppressed, to the essential HIV care, treatment, and support services needed to help them reach viral suppression.

Using data effectively HRSA and CDC promote integrated data sharing and use for program planning, quality improvement, and public health action.

We encourage you to:

• Follow the Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs.

• Create data-sharing agreements between surveillance and HIV programs.

• Progress toward NHAS goals through integrated data sharing, analysis, and use of HIV data by health departments.

• Complete CD4, viral load, and HIV nucleotide sequence reporting to the state and territorial health departments’ HIV surveillance systems. CDC mandates the reporting of all such data to the National HIV Surveillance System (NHSS).

• Use our interactive RWHAP Compass Dashboard to visualize reach, impact, and outcomes of the Ryan White program and to inform planning and decision making. The dashboard gives you a look at national, state, and metro area data and displays client demographics, services, outcomes, and viral suppression. It also includes data about clients in the AIDS Drug Assistance Program (ADAP).

• Develop data-sharing strategies with other RWHAP recipients and relevant entities to reduce administrative burden.

• Use electronic data sources to verify client eligibility when you can. See Policy Clarification Notice 21-02, Determining Client Eligibility and Payor of Last Resort in the Ryan White HIV/AIDS Program.

Program resources and innovative models We offer multiple projects and resources to help you. A full list of resources is available on TargetHIV. We urge you to learn about them and use them in your project. For some examples, see Helpful websites.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 13 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/2023-ryan-white-annual-data-report.pdf https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview/ending-epidemic-timeline/ https://www.cdc.gov/sti/media/pdfs/PCSIDataSecurityGuidelines.pdf https://www.cdc.gov/sti/media/pdfs/PCSIDataSecurityGuidelines.pdf https://data.hrsa.gov/topics/hiv-aids/compass-dashboard https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-21-02-determining-eligibility-polr.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-21-02-determining-eligibility-polr.pdf https://targethiv.org/help/ta-directory

Program objectives and requirements Overview The ITAP and EP are co-leaders of this initiative. You are required to continuously collaborate and communicate with the EP, as well as with HRSA HAB, to achieve the goals of this program.

The table below shows the requirements for the ITAP and EP for initiative activities.

Details about the EP’s lead activities follow. In consultation with HRSA HAB, the ITAP and EP must collaboratively refine their roles and responsibilities within the first 90 days of the award and develop a comprehensive joint work plan.

Program Objectives (O) and Requirements (R) ITAP EP

O1 Support a national cohort of implementation sites to adapt and implement culturally responsive interventions to engage and retain people with co-occurring HIV and mental health conditions in HIV primary care and mental health services.

Lead Support

R1.1 Select and adapt interventions to engage and retain the priority population in HIV primary care and mental health services.

Lead Support

R1.2 Select and issue subawards to up to 10 implementation sites. Lead Support

R1.3 Train and monitor implementation sites on adhering to and adapting the intervention. Monitor compliance with federal regulations.

Lead Limited support [1]

R1.4 Coordinate and facilitate multisite meetings. Lead Support

O2 Evaluate the implementation of interventions using implementation science frameworks.

Support Lead

R2.1 Develop and implement a multisite evaluation plan grounded in implementation science.

Support Lead

R2.2 Develop and implement a process and digital platform for collecting and reporting implementation, service, client, and cost data.

Support Lead

R2.3 Provide implementation science and evaluation-related TA to implementation sites.

Limited support

Lead

O3 Create and disseminate user-friendly multimedia materials to help other RWHAP organizations replicate effective interventions from the initiative.

Lead Support

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R3.1 Develop a communications and dissemination plan and produce user-friendly multimedia replication materials.

Lead Support

Details of the EP requirements The objectives and program requirements are based on the overarching initiative. This section provides details on objectives and program requirements that the EP will lead or support.

Objective 1 You will support the following objectives and program requirements led by the ITAP, which are detailed in the companion NOFO (HRSA-25-058).

Requirement 1.1, Support: Select and adapt interventions to engage and retain the priority population in HIV primary care and mental health services.

• You will conduct a literature review of relevant interventions.

Requirement 1.2, Support: Select and issue subawards to up to 10 implementation sites.

• You will collaborate with HRSA HAB and the ITAP to develop and implement a competitive application process to select implementation sites.

Requirement 1.3, Limited support: Train and monitor implementation sites on adhering to and adapting the interventions. Monitor compliance with federal regulations.

• You will collaborate with the ITAP to help the implementation sites develop logic models for their approach. These models will clearly outline the core elements, implementation strategies, and potential barriers and facilitators to successful implementation.

• You will coordinate with the ITAP and HRSA HAB (as needed) to monitor each implementation site, including by making annual site visits to ensure compliance with federal requirements, monitor implementation progress, and provide TA. The ITAP will develop a site visit protocol to guide the content and focus of the site visits, and you will provide input on evaluation-related items.

◦ Site visits also serve as an opportunity for you to thoroughly collect and document information on intervention adaptations, implementation strategies, and barriers and facilitators to implementation.

Requirement 1.4, Support: Coordinate and facilitate multisite meetings.

• You will help the ITAP and HRSA HAB facilitate at least two multisite meetings per year. You should plan to hold these meetings at HRSA headquarters or in the

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Washington, DC, metropolitan area. The meetings must include at least two representatives from your organization, the ITAP, HRSA HAB, and each implementation site.

• You will also help the ITAP coordinate at least two work planning meetings per year between your organization, the ITAP, and HRSA HAB.

Objective 2 Requirement 2.1, Lead: Develop and implement a multisite evaluation plan grounded in implementation science.

• You will coordinate with HRSA HAB to develop and implement a multisite evaluation plan grounded in validated implementation science frameworks.

• You must receive appropriate ethics approval for conducting this evaluation.

• You should consider HRSA HAB’s implementation science framework (HAB IS) when developing the evaluation plan (see Psihopaidas 2020). HRSA HAB IS is intended to be a scaffolding upon which specific frameworks, measures, and concepts from implementation science are built to develop a robust, tailored evaluation framework.

• Your evaluation should include implementation, service, and client outcomes, as well as implementation strategies (see Proctor 2011 and Proctor 2023). You should select validated quantitative measures for implementation, client, and service outcomes, and cite them.

• You will also conduct a cost analysis of the implementation of the selected interventions.

Evaluation methods

You should incorporate both quantitative and qualitative data collection, analysis, and reporting. Quantitative, qualitative, and mixed methods analysis can be used based on the specified evaluation question.

• Quantitative methods can be useful for understanding the effects of an intervention on client outcomes, for example. Quantitative measures can also be used to track implementation—for example, the number of staff trainings.

• Qualitative methods can provide a deeper understanding of barriers and facilitators to implementation, why and how adaptations are made, and why certain implementation strategies are used, for example. Additionally, qualitative inquiry can provide a more nuanced understanding of clients’ perceptions of their care and experiences.

• Mixed methods integrate both quantitative and qualitative data and analysis.

Requirement 2.2, Lead: Develop and implement a process and digital platform for collecting and reporting implementation, service, client, and cost data.

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• You will provide a secure digital platform so all sites can report all data to you. You will train and support evaluation staff at the implementation sites and monitor data collection and quality. You will also provide technical input, oversight, and support to the sites to complete any required institutional review board (IRB) or other approvals needed to collect and report evaluation data.

Data security

• You will electronically receive, store, manage, and maintain de-identified client-level data, which the implementation sites will collect and report to you.

• The implementation sites will submit data to you through a secure data portal that you will design and maintain.

• You will coordinate efforts to ensure the privacy and confidentiality of all data submitted, collected, and stored, under all applicable laws and regulations.

• You will monitor the quality and completeness of submitted data.

• You will help the implementation sites assure the privacy and confidentiality of study participants’ protected health information.

Requirement 2.3, Lead: Provide implementation science and evaluation-related TA to implementation sites.

• You will provide training and ongoing support to the implementation sites’ data management staff to meet the requirements of the evaluation. When new evaluation staff are hired at implementation sites, you will make sure there is a process to train them.

• You will attend site visits with the ITAP to capture and document intervention adaptations, implementation strategies, and barriers and facilitators to implementation.

• You may support the ITAP and implementation sites to develop, review, and refine site-specific logic models.

• You will support all implementation sites in interpreting and reporting on all evaluation-related data, including performance measures.

Evaluation Measures

You must include the following measures from HAB’s Performance Measure Portfolio:

• Client engagement and retention.

• Antiretroviral therapy adherence.

• Viral suppression.

Include other measures specific to your evaluation questions such as:

• Client demographics.

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Step 1: Review the Opportunity 17 https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio

• Biomedical and mental health indicators.

• Indicators of stigma.

Your key performance measures must also assess implementation and include process analysis and cost analysis.

Process analysis is a systematic method of examining how work is done. It will assess implementation of the interventions, including:

• Uptake.

• Engagement of clients in the interventions.

• Implementation strategies.

• Facilitators and barriers to implementation.

A cost analysis study (or cost-effectiveness study, if feasible) will measure the labor and programmatic costs and expenditures incurred by each implementation site to determine how easily the intervention can be replicated in RWHAP and other health care settings.

Objective 3 You will support the following objectives and program requirements led by the ITAP, which are detailed in the companion NOFO (HRSA-25-058).

Requirement 3.1, Support: Develop a communications and dissemination plan and produce user-friendly multimedia replication materials.

You will help the ITAP, in coordination with HRSA HAB, to develop and implement a communication and dissemination work plan and timeline for disseminating evaluation findings and replication materials. This plan will outline how you and the ITAP will create, review, and promote materials and strategies that will help other organizations replicate successful interventions from this initiative.

• You will produce manuscripts in collaboration with implementation sites and HRSA HAB to describe the design and outcomes of the project.

• Along with the ITAP, you will review all draft dissemination products to ensure rigor, quality, and consistency before they are submitted to HRSA HAB for review.

• Along with the ITAP, you will manage the completion of all dissemination products through the HRSA clearance process in collaboration with your HRSA project officer.

The communication and dissemination plan will include:

• Publication and dissemination committee: Your organization, along with HRSA HAB staff and implementation site representatives, will participate in this committee. The committee will generate study questions, topics for presentations

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 18 and publications, concept sheets and analyses, and a dissemination plan for the initiative’s products.

• Dissemination products and strategies: These will include user-friendly multimedia materials that describe findings from the initiative. They should include materials aligned with RWHAP service categories [PDF] so they can easily be replicated. You will work with the ITAP to ensure that evaluation findings are included in the dissemination products.

• Project websites: You will collaborate with the ITAP and HRSA HAB to develop and maintain a public, project-specific page on TargetHIV.org to communicate about the project.

Key personnel HIV and mental health expertise are critical to this initiative. People with lived experience, mental health professionals, and other key partners must be a part of the ITAP, EP, and implementation site teams.

When possible, consider hiring individuals with lived experience into key roles. Lived experience includes people living with HIV, people in recovery with mental health and/ or substance use conditions, or people who have changed their behaviors to reduce the risk of HIV. Lived experience, along with other relevant personal or professional expertise, is acceptable instead of education, as appropriate.

Timeline of lead activities This chart shows a high-level anticipated timeline of lead activities for this project.

Year Lead: ITAP Lead: EP

Year 1 • Develop joint work plan with

EP.

• Coordinate and co-facilitate project planning meetings.

• Conduct a comprehensive search to select mental health interventions.

• Develop a technical assistance plan, including process for TA tracking.

• Select and issue subawards to implementation sites.

• Develop a communications and dissemination plan.

• Develop joint work plan with

ITAP.

• Co-facilitate project planning meetings.

• Support selection of mental health interventions.

• Support selection of implementation sites.

• Support development of the communications and dissemination plan.

• Develop a multisite evaluation plan grounded in implementation science.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 19 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf#page=4

Year Lead: ITAP Lead: EP

• Submit evaluation protocol for Institutional Review Board (IRB) review and approval.

• Support sites with IRB applications and submissions, as needed.

Years 2 and 3 • Train sites on implementing their selected interventions (year 2 only).

• Coordinate and co-facilitate multisite and project planning meetings.

• Monitor subrecipients, including through an annual site visit.

• Provide TA to sites on adapting and implementing the interventions.

• Develop replication materials and begin disseminating as appropriate.

• Train sites on all aspects of the evaluation.

• Co-facilitate multisite and project planning meetings.

• Lead data collection and, in year 3, analysis for the multisite evaluation.

• Attend annual subrecipient site visits.

• Provide TA to sites on the evaluation.

• Work on publications.

Year 4 • Continue to coordinate and co-facilitate multisite and project planning meetings.

• Continue to monitor subrecipients, including through an annual site visit.

• Provide TA to sites on sustaining the interventions.

• Finalize replication materials and other dissemination products.

• Continue to co-facilitate multisite and project planning meetings.

• Complete data collection for the multisite evaluation.

• Continue to attend the annual subrecipient site visits.

• Continue to provide TA to sites on the evaluation.

• Finalize data analysis and integrate evaluation findings into dissemination products.

• Finalize any publications.

Step 1: Review the Opportunity 20

Award information Cooperative agreement terms

Our responsibilities Aside from monitoring and technical assistance, we also get involved in these ways:

• Facilitate the availability and expertise of key federal partners in planning, developing, and implementing the project, including staff from SAMHSA, the National Institute of Mental Health (NIMH), and other relevant agencies.

• Facilitate effective collaborative relationships with the ITAP, EP, and other relevant partners.

• Provide relevant project information and resources, including TA resource centers.

• On an ongoing basis, review activities, procedures, measures, and tools to accomplish the goals and objectives of this initiative.

• Participate in designing and implementing evaluation tools, evaluation plans, and other project materials.

Review and participate in disseminating project activities, products, findings, best practices, evaluation data, and other information developed as part of this project to RWHAP providers and the broader health care community.

• Coauthor and publish technical manuscripts describing project design, implementation, outcomes, and other topics in scientific journals.

Your responsibilities You must follow all relevant laws and policies. In addition to the requirements and activities mentioned in the program objectives and requirements section, you must also:

• Participate in the National Ryan White Conference on HIV Care and Treatment.

• Share real-time information throughout the duration of the project with implementation sites, the ITAP, and HRSA HAB, including status updates, tools developed to help the sites, and other information about the evaluation.

• Collaborate with assigned HRSA HAB project officers and other HRSA staff as necessary to plan, execute, and evaluate project activities.

• Complete all HRSA HAB reporting requirements.

Step 1: Review the Opportunity 21

Funding policies and limitations

Policies

• We will only make awards if this program receives funding. If Congress appropriates funds for this purpose, we will move forward with the review and award process.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds

◦ Satisfactory progress in meeting the project’s objectives

◦ A decision that continued funding is in the government’s best interest

• If we receive more funding for this program, we consider options such as:

◦ Fund more applicants from the rank order list

◦ Extend the period of performance

◦ Award supplemental funding.

General limitations For guidance on some types of costs we do not allow or restrict, see Project Budget Information in Section 3.1.4 of the Application Guide. You can also see 45 CFR part 75, or any superseding regulation, General Provisions for Selected Items of Cost General Provisions for Selected Items of Cost.

Congress’s current appropriations act includes a salary limitation, which applies to this program. As of January 2025, the salary rate limitation is $225,700. This limitation may be updated.

Program-specific statutory or regulatory limitations You cannot use funds under this notice for the following:

• Charges that are billable to third-party payers such as private health insurance, prepaid health plans, Medicaid, or Medicare.

• To directly provide medical or support services (for example, HIV care, counseling, and testing) that supplant existing services.

• Cash payments to intended recipients of RWHAP services.

• Purchase or construction of new facilities, or capital improvements to existing facilities.

• Purchase or improvement to land.

• Fundraising expenses or lobbying activities and expenses.

• Syringe Services Programs that have not received HRSA’s prior approval or do not comply with HHS and HRSA policy.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 22 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=13 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.aids.gov/federal-resources/policies/syringe-services-programs/

• To develop materials designed to directly promote or encourage intravenous drug use or sexual activity.

• Pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) medications or related medical services. (Please note that RWHAP recipients and subrecipient providers may provide prevention counseling and information to eligible clients’ partners—see RWHAP and PrEP Program Letter, November 16, 2021.)

• International travel.

See Manage Your Grant for other information on costs and financial management.

Indirect costs Indirect costs are costs you charge across more than one project that cannot be easily separated by project. For example, this could include utilities for a building that supports multiple projects.

To charge indirect costs you can select one of two methods:

Method 1 – Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency at time of award.

Method 2 – De minimis rate. Per 2 CFR 200.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs.

This rate is 15% of modified total direct costs (MTDC). See 2 CFR 200.1 for the definition of MTDC. You can use this rate indefinitely.

Program income Program income is money earned as a result of your award-supported project activities. You must use any program income you generate from awarded funds for approved project-related activities Find more about program income at 45 CFR 75.307.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 23 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/hiv-care/prep-dcl-november-2021-508.pdf https://www.hrsa.gov/grants/manage-your-grant https://www.ecfr.gov/current/title-45/part-75#p-75.414(f) https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC)) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.307

Step 2:

Get Ready to Apply

In this step

Get registered 25

Find the application package 25

Application writing help 25

Get registered SAM.gov You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI). SAM.gov registration can take several weeks. Begin that process today.

To register, go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist to find out what you’ll need to register.

When you register or update your SAM.gov registration, you must agree to the financial assistance general certifications and representations. You must agree to those for grants specifically, as opposed to contracts, because the two sets of agreements are different. You will have to maintain your registration throughout the life of any award.

Grants.gov You must also have an active account with Grants.gov. You can see step-by-step instructions at the Grants.gov Quick Start Guide for Applicants.

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov and search for opportunity number HRSA-25-059.

After you select the opportunity, we recommend that you click the Subscribe button to get updates.

Application writing help Visit HHS Tips for Preparing Grant Proposals.

Visit HRSA’s How to Prepare Your Application page for more guidance.

See Apply for a Grant for other help and resources.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 25 https://sam.gov/content/entity-registration https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://www.grants.gov/search-grants https://www.hhs.gov/grants-contracts/grants/get-ready-for-grants-management/tips-for-preparing-grant-proposals/index.html https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://www.hrsa.gov/grants/apply-for-a-grant

Join the webinar For more information about this opportunity, join the webinar on February 6, 2025 from 1:00pm-2:30pm ET.

If you are not able to join through your computer, you can call in:

• Phone number: (833) 568-8864

• Meeting ID: 160 642 1131; Passcode: qEbU09WH

We will record the webinar. If you are not able to join live, you can replay it at TargetHIV.

Have questions? Go to Contacts and Support

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 26 https://hrsa-gov.zoomgov.com/meeting/register/vJItce2qrzopG6_8BLUAHkUeaAScoNvgUfg#/registration https://targethiv.org/calendar/hrsa-25-058-and-059

Step 3:

Prepare Your Application

In this step

Application contents and format 28

Application contents and format Applications include 5 main components. This section includes guidance on each.

Application page limit: 60 pages

Submit your information in English and express whole number budget figures using U.S. dollars.

Make sure you include each of these:

Components Submission format

Project abstract Use the Project Abstract Summary form.

Project narrative Use the Project Narrative Attachment form.

Budget narrative Use the Budget Narrative Attachment form.

Attachments Insert each in the Other Attachments form.

Other required forms Upload using each required form.

Required format You must format your narratives and attachments using our required formats for fonts, size, margins, etc. See the formatting guidelines in Section 3.2 of the Application Guide.

Project abstract Complete the information in the Project Abstract Summary form. Include a short description of your proposed project. Include the needs you plan to address, the proposed services, and the population groups you plan to serve. For more information, see Section 3.1.2 of the Application Guide.

Include the following within the Project Abstract:

• Summary of the project: Provide a brief summary describing the proposed project.

• Goals and objectives: Describe overall project goals and objectives.

• Evaluation questions: Outline proposed multisite evaluation questions.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 28 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=24 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=13

Project narrative In this section, you will describe all aspects of your project. Project activities must comply with the nondiscrimination requirements.

Use the section headers and the order listed.

Introduction See merit review criterion 1: Need

• Briefly describe the purpose of your project.

• Describe the proposed:

◦ Evaluation.

◦ Multisite evaluation questions.

◦ Cost analysis.

◦ Evaluation-related TA.

◦ Publication and dissemination activities.

• Clearly and…