RFA-PS-21-002.pdf

Centers for Disease Control and Prevention

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

Program Office

Implementation Research Consortium to Accelerate Impact of Health Department-Delivered HIV Prevention Activities

RFA-PS-21-002

Application Due Date: 01/28/2021

Implementation Research Consortium to Accelerate Impact of Health Department-Delivered HIV Prevention Activities

RFA-PS-21-002

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Notice of Funding Opportunity (NOFO) Title Implementation Research Consortium to Accelerate Impact of Health Department-Delivered HIV Prevention Activities Activity Code U01 – Research Project - Cooperative Agreement

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-PS-21-002

Assistance Listings (CFDA) Number(s) 93.941 93.084 93.943 Category of Funding Activity:

Health NOFO Purpose This NOFO is designed to support research to enhance the implementation of proven HIV prevention interventions by forming a collaborative research infrastructure between experts in the field. The work of the proposed research will support the goals of the Ending the HIV Epidemic national plan. It is anticipated that this NOFO will support four (4) awards for Core Projects and two (2) awards for Collaborative Projects.

Applications for Core Projects should describe plans to conduct an HIV prevention implementation science research project that addresses real-world HIV prevention implementation challenges experienced by health departments and health department implementing partners (e.g., community-based organizations, clinics, etc.) when carrying out evidence-based interventions. Accessing data from health departments and health department partners is essential to this project. Therefore, Principal Investigators are encouraged to create or engage in appropriate partnerships. In response to this NOFO, each Core Project application must describe a detailed research plan and annual budget for years one through five.

In addition to a Core Project, each application should also propose a Collaborative Project.

The Collaborative Project should describe a project working with investigators from multiple institutions (e.g., health departments, academic institutions, or other institutions). Collaborating sites may be identified after award or named at the time of application submission, but study objectives and partner roles and relationships to the grantee and other research partners must be clearly described in the initial application.

Similar to the Core Project, the Collaborative Project should also address real-world HIV prevention implementation challenges experienced by health departments and health department implementing partners. However, the collaborative projects should include: a) multiple institutions, b) creating or engaging in appropriate partnerships (or agree to create/engage the appropriate partnerships, if collaborating sites are identified after the award) to allow for accessing data from health departments and health department partners, and c) study design and data collection methods that are consistent across all collaborating sites using a common protocol. As outlined for the Core Project, the Collaborative Project must describe a detailed research plan and annual budget for years one through five. An applicant must be awarded a Core Project in order to be awarded a Collaborative Project.

Key Dates Publication Date: To receive notification of any changes to RFA-PS-21-002, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 12/17/2020

Application Due Date: 01/28/2021

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 03/23/2021

Secondary Review: 04/27/2021

Estimated Start Date: 09/01/2021

Expiration Date: 01/29/2021

Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

The Research Strategy component of the Research Plan is limited to 25 pages for the entire Research Strategy component of the application (25 pages includes both the Core and Collaborative Project Research Strategy).

Within the total 25-page limit for the Research Strategy of the Research Plan section of the application, the page limit for EACH project is limited as follows:

o Core Project: 15 pages o Collaborative Project: 10 pages

Executive Summary

• Purpose: This NOFO is designed to support research to enhance the implementation of proven HIV prevention interventions by forming a collaborative research infrastructure between experts in the field. The work of the proposed research will support the goals of the Ending the HIV Epidemic national plan. It is anticipated that this NOFO will support four (4) awards for Core Projects and two (2) awards for Collaborative Projects.

• Mechanism of Support: U01 – Research Project - Cooperative Agreement.

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire five (5)-year project period (Core and Collaborative Projects) is $15,000,000. The estimated number of awards will be four (4) for the Core Projects and two (2) for the Collaborative Projects.

Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded, and the number of awards, will depend upon the number, quality, duration and cost of the applications received.

• Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) for the Core Projects is $1,400,000 (with individual awards ranging from $300,000 to $350,000). The estimated total funding (direct and indirect) for the Core Projects, over the entire five (5)-year project period, is $7,000,000. The estimated total funding (direct and indirect) for the first year (12-month budget period) for the Collaborative Projects is $1,600,000 (with individual awards ranging from $750,000 to $800,000 per award. The estimated total funding (direct and indirect) for the Collaborative Projects over the entire five (5)-year project period is $8,000,000. The project period is anticipated to run from 09/01/2021 to 08/31/2026.

• Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement. Please note: Page limits for the Research Strategy section for Core and Collaborative Projects are different and must be followed.

• Eligible Institutions/Organizations. Institutions/organizations listed in Section III. of this announcement are eligible to apply.

• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

• Number of PDs/PIs. Applications may include multiple PDs/PIs (Co-PIs) and, if so, must include a Leadership Plan that describes the roles, responsibilities and working relationships of the identified PDs/PIs (Co-PIs). However, only one PD/PI may be the primary CDC contact for the award and should be listed first in the application; this contact PD/PI must be at the recipient institution and must be indicated as such in the application.

• Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed. One application includes both a Core Project and a Collaborative Project.

• Application Type. New.

• Application Materials. See Section IV.1 for application materials. Please note that

Form F is to be used when completing the application package.

Part 2. Full Text

Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act, Section 301(a) [42 USC 241(a)] and Section 318 [42 USC 247(c)], as amended.

1. Background and Purpose HIV persists as a serious public health challenge in the United States. It has claimed more than 700,000 lives since it was first identified almost 40 years ago [1]. According to CDC, an estimated 1.1 million adults and adolescents in the United States are currently living with HIV, with approximately 15% unaware they have HIV [1-3]. Although HIV infection rates have decreased in the United States, new diagnoses continue in every U.S. state, with 37,881 new diagnoses occurring in 2018 [1, 4]. According to a recent HIV transmission model, approximately 80% of new HIV transmissions in 2016 were from persons either unaware of their HIV infection status (38%), or persons diagnosed with HIV but not in care (43%) [5]. HIV disproportionately impacts African American and Hispanic or Latino populations compared to other races and ethnicities; in 2018, they accounted for 42.8% and 26.2% of HIV diagnoses, respectively [3]. In addition, approximately 66% of HIV diagnoses in 2018 were attributed to male-to-male sexual contact, and from 2014 through 2018, the number of HIV diagnoses for transgender persons (adults and adolescents) increased [3]. In 2018, the highest rate of HIV diagnosis was for persons aged 25–29 years (32.6/100,000), followed by the rate for persons aged 20–24 years (27.9/100,000) [3]. Regionally, the South represented more than 52% of the new HIV diagnoses in the United States in 2018 [3].

Significant achievements have been made in the fight against HIV due to the development of effective biomedical treatment and prevention strategies. The availability of antiretroviral therapy (ART) has helped persons living with HIV achieve viral suppression, improve their health and substantially reduce transmission of the infection to others, such that a person who is properly treated and achieves and maintains viral suppression can expect to achieve a nearly normal lifespan and have effectively no risk of transmitting HIV to their partners. However, not everyone is benefitting from the new treatment and prevention options [1, 6]. Specifically, in 2018, only 79% of blacks/African Americans were prescribed ART, compared with 85% of Hispanics or Latinos and 82% of whites, and an estimated 56% of blacks/African Americans had sustained viral suppression, compared with 67% of Hispanics or Latinos and 69% of whites [7].

Similarly, the use of pre-exposure prophylaxis (PrEP) among high-risk HIV-negative individuals has been successful in reducing HIV transmission. In the United States, approximately 1.1 million persons had indications for PrEP in 2015 [8] and, whereas PrEP use has increased over time, only 18.1% of persons with PrEP indications were prescribed PrEP in 2018 [4]. PrEP coverage (number prescribed/number with indications) is lower among highest priority populations including blacks/African Americans (5.9%) and Hispanics or Latinos (10.9%) as compared to whites (42.1%) [4]. In addition, a meta-analysis found that only 24.5% of men who have sex with men (MSM) who met CDC’s PrEP indications reported ever using it in 2016 [9]. Moreover, compared to other MSM, black MSM were more likely to report barriers to PrEP such as stigma and concerns about efficacy and medical decision-making [10]. Black and Hispanic MSM were significantly less likely than white MSM to be aware of PrEP, to have discussed PrEP with a healthcare provider, or to have used PrEP within the past year [11].

Modeling has been used to indicate the number of persons needed to treat with PrEP in order to prevent one HIV infection. Findings show that universal PrEP use by MSM would be effective in reducing HIV prevalence and incidence among MSM; however, targeted use of PrEP by black and Latino MSM, especially those ≤25 years of age, would have a greater impact on HIV prevention [12].

By direction of the President, the U.S. Department of Health and Human Services (HHS) launched The Ending the HIV Epidemic: A Plan for America (EHE) in 2019 to address this ongoing public health crisis, with the goals of first reducing numbers of incident infections in the United States by 75% within 5 years, and then by 90% within 10 years [1]. With the advances made in biomedical and scientific research over many years, substantial important treatment and prevention tools are now available to end the HIV epidemic. Thus, the emphasis of the initiative is not in developing new tools; rather it is in scaling up existing ones (e.g., rapid tests, treatment as prevention [TasP], PrEP, etc.) for individuals and communities who need them but are not being reached. Specifically, in addition to working to accelerate progress by directing new funds to those communities affected by HIV in a phased approach, starting with the areas with the highest burden, EHE is focusing on four strategic pillars including:

diagnosing all individuals with HIV as early as possible after infection; treating HIV infection rapidly and effectively to achieve sustained viral suppression; preventing at-risk individuals from acquiring HIV infection, including the use of PrEP; and rapidly detecting and responding to emerging clusters of HIV infection to further reduce new transmissions (https://www.hiv.gov /federal-response/ending-the-hiv-epidemic/overview). Although this project is not funded with EHE dollars, the intent is to align the research projects with EHE goals.

Achieving EHE goals will require leveraging highly successful programs, including critical scientific advances in HIV prevention, diagnosis, treatment, and outbreak response, and coordinating resources across funded entities. Success will also require dedicated partnerships between researchers and multiple stakeholders including city, county, tribal, and state health departments and other agencies to implement and enhance the uptake and effectiveness of evidence-based interventions, including interventions currently available in the continuum of HIV testing, prevention, and care, to maximize community impact (https://www.hiv.gov/federal -response/ending-the-hiv-epidemic/overview).

CDC recently released two funding announcements for the initial phase of EHE - RFA-PS-19- 1906: "Strategic Partnerships and Planning to Support Ending the HIV Epidemic in the United States" and RFA-PS-20-2010: "Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States". Both funding announcements are directed to health departments (HDs) for planning for, and implementation of, evidence-based and innovative strategies that expand prevention, care, and treatment programs to individuals and communities with highest burden of HIV.

Transferring Evidence-Based Interventions (EBIs), and evidence-informed strategies, into practice settings is often fraught with challenges, and these challenges limit successful implementation and ultimately reduce the impact of the interventions on prevention [13].

Barriers to successful implementation can be posed by resource allocation, organizational structure, intervention adaptability, and the capacity of systems, providers, or operational tools needed to target EBIs and evidence-informed strategies to the persons at highest risk for HIV.

Implementation science is an approach to understanding the magnitude of, determinants of, and strategies most helpful to close the gap between evidence and implementation of effective interventions as routine health practices in real-world settings. Generalizable knowledge generated from implementation research is essential to the effective planning, design, and delivery of HIV prevention and care services at the local level that are vital to the EHE’s success. Science advanced by this NOFO will serve to foster implementation science and generalizable knowledge within the testing, treatment, and prevention pillars of EHE.

References

1. Fauci, A.S., et al., Ending the HIV Epidemic: A Plan for the United States. JAMA, 2019. 321(9): p. 844-845.

2. Dailey, A.F., et al., Vital Signs: Human Immunodeficiency Virus Testing and Diagnosis Delays - United States. MMWR Morb Mortal Wkly Rep, 2017. 66(47): p. 1300-1306.

3. Centers for Disease Control and Prevention. HIV Surveillance Report, 2018 (Updated);

vol.31. http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published May 2020. Accessed July 7, 2020.

4. Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data — United States and 6 dependent areas, 2018. HIV Surveillance Supplemental Report 2020;25(No. 2).

http://www.cdc.gov/hiv/library/reports/ hiv-surveillance.html. Published May 2020.

Accessed July 7, 2020.

5. Li, Z. et al., Vital Signs: HIV transmission along the continuum of care — United States, 2016. Morbidity and Mortality Weekly Report 2019;68(11):267–272.

6. Gant, Z., et al., HIV Care Outcomes Among Hispanics or Latinos with Diagnosed HIV Infection - United States, 2015. MMWR Morb Mortal Wkly Rep, 2017. 66(40): p.1065- 1072.

7. Centers for Disease Control and Prevention. Behavioral and Clinical Characteristics of Persons with Diagnosed HIV Infection — Medical Monitoring Project, United States, 2018 Cycle (June 2018–May 2019). HIV Surveillance Special Report 25.

https://www.cdc.gov/hiv/library/reports/ hiv-surveillance.html. Published May 2020.

Accessed July 7, 2020.

8. Smith, D.K., et al. Estimates of adults with indications for HIV pre-exposure prophylaxis by jurisdiction, transmission risk group, and race/ethnicity, United States, 2015. Annals of Epidemiology 2018;28(12):850–857.

9. Kamitani, E., et al., Increasing prevalence of self-reported HIV preexposure prophylaxis use in published surveys: a systematic review and meta-analysis. AIDS, 2018. 32(17): p.

2633-2635.

10. Lelutiu-Weinberger, C. and S.A. Golub, Enhancing PrEP Access for Black and Latino Men Who Have Sex With Men. J Acquir Immune Defic Syndr, 2016. 73(5): p. 547-555.

11. Kanny, D., et al., Racial/Ethnic Disparities in HIV Preexposure Prophylaxis Among Men Who Have Sex with Men - 23 Urban Areas, 2017. MMWR Morb Mortal Wkly Rep, 2019. 68(37): p. 801-806.

12. Elion, R.A., et al., Estimated Impact of Targeted Pre-Exposure Prophylaxis: Strategies for Men Who Have Sex with Men in the United States. Int J Environ Res Public Health, 2019. 16(9).

13. Riley, W.T., Behavioral and Social Sciences at the National Institutes of Health:

adoption of research findings in health research and practice as a scientific priority.

Transl Behav Med, 2017. 7(2): p. 380-384.

Health Equity:

The program supports efforts to improve the health of populations disproportionately affected by HIV/AIDS, viral hepatitis, sexually transmitted diseases (STDs) and TB by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National HIV/AIDS Strategy available at https://www.whitehouse .gov/administration/eop/onap/nhas.

Health disparity is a particular type of health difference that is closely linked with social or economic disadvantage based on racial or ethnic group, religion, socioeconomic status, gender, mental health, cognitive, sensory, or physical disability, sexual orientation, geographic location, or other characteristics historically linked to discrimination or exclusion [HP 2020 - http://www .healthypeople.gov/2010/hp2020/advisory/PhaseI/glossary.htm]. 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 severely affected by these diseases.

Social determinants are the economic and social conditions that influence the health of individuals, communities and jurisdictions and 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 disadvantage. It requires:

• Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and

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

Programs should use data, including social determinants data, to identify communities within their jurisdiction 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, programs should consider social determinants of health in the development, implementation, and evaluation of program specific efforts and use culturally appropriate interventions that are tailored for the communities for which they are intended.

Healthy People 2030 and other National Strategic Priorities This announcement aims to accelerate evidence-informed decision making and performance improvements to HIV prevention strategies. Several Healthy People 2020 (HP 2020) objectives are supported through this NOFO. The HP 2020 objectives supported by this announcement include:

Reduce new HIV infections

• HIV-1 Reduce the number of new HIV diagnoses

• HIV-2 Reduce the number of new HIV infections among adolescents and adults

• HIV-3 Reduce the rate of HIV transmission among adolescents and adults

• HIV-4 Reduce new AIDS cases among adolescents and adults

• HIV-5 Reduce new AIDS cases among adolescent and adult heterosexuals

• HIV-6 Reduce new AIDS cases among adolescent and adult men who have sex with men

• HIV-7 Reduce new AIDS cases among adolescents and adults who inject drugs

• HIV-8 Reduce perinatally acquired HIV and AIDS cases

• HIV-24 Reduce the percentage of young gay and bisexual males in grades 9 through 12 who engage in HIV-risk behaviors

Increase HIV testing and prevent HIV risk

• HIV-9 Reduce the proportion of persons with a diagnosis of Stage 3 HIV (AIDS) within 3 months of diagnosis of HIV infection

• HIV-13 Increase the proportion of persons living with HIV who know their serostatus

• HIV-14 Increase the proportion of adolescents and adults who have been tested for HIV in the past 12 months

• HIV-16 Increase the proportion of substance abuse treatment facilities that offer

HIV/AIDS education, counseling, and support

• HIV-17 Increase the proportion of sexually active persons who use condoms

• HIV-18 Reduce the proportion of men who have sex with men (MSM) who reported unprotected anal intercourse with a partner of discordant or unknown status during their last sexual encounter

Increase access to care and improve health outcomes for people living with HIV

• HIV-10 (Developmental) Increase the proportion of HIV-infected adolescents and adults who receive HIV care and treatment consistent with current standards

• HIV-11 Increase the proportion of persons surviving more than 3 years after a diagnosis with AIDS

• HIV-12 Reduce deaths from HIV infection

• HIV-19 Increase the percentage of persons with newly diagnosed HIV infection linked to HIV medical care (had a routine HIV medical visit) within one month of their HIV diagnosis

• HIV-20 Increase the percentage of newly diagnosed persons with diagnosed HIV infection who are retained in continuous HIV medical care

• HIV-21 (Developmental) Increase the proportion of persons with an HIV diagnosis in medical care who were prescribed antiretroviral therapy for the treatment of HIV infection at any time in the 12-month measurement period

• HIV-22 Increase the percentage of persons with diagnosed HIV infection who are virally suppressed

• HIV-23 (Developmental) Reduce the proportion of persons with an HIV diagnosis receiving HIV services who were homeless or unstably housed in the 12-month measurement period

Public Health Impact This program would establish a research consortium coordinated with health department programming and associated collaborative partnerships to efficiently conduct HIV prevention implementation research with real-world HIV prevention implementation challenges experienced by health departments and health department implementing partners in mind.

Implementation science is a key element of the EHE initiative, emphasizing the need to learn how to best implement existing tools and effective interventions in a way that decreases new HIV infections in jurisdictions and states with greatest HIV burden. Whereas individual program evaluation and demonstration projects help to improve programs, and can identify lessons that worked in that program, they do not produce generalizable knowledge; in part, because they do not employ the study designs or collect the data needed to do so. A research consortium with Core and Collaborative Projects will allow for more efficient and strategic evaluation of implementation strategies that best facilitate dissemination and adoption of effective HIV prevention tools.

By identifying best practices for implementing and disseminating effective HIV prevention strategies, the proposed research consortium can have a major public health impact in HIV-vulnerable populations and communities. First, by focusing on implementation science, the research consortium should inform how best to deliver evidence-based strategies that will improve service delivery to consumers and increase access to, and uptake of, effective strategies. Second, a research consortium where researchers can work together to identify critical HIV prevention needs of health departments and their implementation partners across their communities, and the most appropriate ways to address those needs, increases the chances of asking relevant scientific questions that will have a public health impact. Third, using a research consortium model can also lead to future and sustainable collaborations that will inform research-to-practice models and foster quality improvement of programs. Finally, because the multi-site findings from the Collaborative Projects may be more generalizable than a single-site study, the potential for greater public health impact is substantially increased by making the findings more useful to health departments, HIV prevention researchers, and Federal agencies.

Relevant Work This NOFO builds on previously funded programs including:

1. RFA-PS-18-1802: Integrated HIV Surveillance and Prevention Programs for Health Departments (https://www.cdc.gov/hiv/funding/announcements/ps18-1802/index.html)

2. CDC HIV Prevention Demonstration Projects with Health Departments (https://www.cdc .gov/hiv/research/demonstration/)

3. NIMH/CDC collaboration on PrIDE: RFA-PS-15-1506 (https://grants.nih.gov/grants/guide /pa-files/PA-16-199.html)

2. Approach Applications may include multiple PDs/PIs (or Co-PIs) and, if so, must include a Leadership Plan that describes the roles, responsibilities and working relationships of the PDs/PIs (or Co- PIs). However, only one PD/PI may be the primary CDC contact for the award; this contact

PD/PI must be at the recipient institution and must be indicated as such in the application.

Each application MUST address a Core Project and a Collaborative Project in a single application. Each Core Project and each Collaborative Project and its accompanying budget must be clearly identified in the application using clear headings/identifiers (see Section IV.2 of this NOFO for more detailed information regarding application format).

The approach to this award is multi-fold and includes the following key components. Each component is critical in the successful application and completion of this award.

I. Research Priorities

For both Core and Collaborative Projects, applications should focus on implementation strategies specific to the Diagnose, Treat or Prevent pillars of the EHE initiative and address challenges health departments face in bringing effective prevention to populations in need. Some examples of implementation challenges within the pillars that are of interest might include, but are not limited to: evaluation of different community-based testing strategies or approaches to identifying undiagnosed persons (“diagnose”); strategies to better support re-linking people with HIV back into care or to retaining persons in HIV care (“treat”); or strategies to enhance PrEP uptake and persistence (“prevent”). Cross-cutting issues of interest include, but are not limited to, stigma, approaches for rural or marginalized populations (including homeless populations, young trans women and gay men of color, African American women, people of color in rural areas, aging populations, people who inject drugs), and integrating behavioral/mental health issues. Strategies to enhance program delivery, address health care providers, or structural issues (e.g., improving access to care and treatment, policies to reduce healthcare system barriers, and integrating efforts of surveillance, prevention and treatment of HIV) are also of interest.

Applications should focus on areas where there is capacity to achieve the greatest reach and impact for the populations disproportionately affected by HIV and for whom data indicate are not being sufficiently reached with effective prevention.

II. Guidance for Developing Research Plan and Activities

A. CORE PROJECT. Each Core Project proposal should describe a research project that is designed to be implemented and analyzed by an individual awardee institution.

The Core Project research plan should provide both a high-level overview of the entire (5) five-year project period and a detailed description of the first year of the award. The proposals should include a detailed description of the research goals and objectives.

Proposals should also incorporate an explanation of the relevance to one or more of the research priorities listed above. There should be a clearly described implementation problem/gap and associated research question(s), study design, research methods, and implementation outcomes as well as a logic model provided in the application.

Applications are expected to describe the HIV prevention implementation research issue, why previous implementation approaches have not worked, justify why the proposed approach could work, and propose a timeline. Each application should include a logic model with an outline of the anticipated short-term, intermediate, and long-term project-specific outcomes.

Applications should also make specific reference to the Integrated HIV Prevention and Care plan or any other relevant jurisdictional EHE plan or equivalent (e.g., Getting to Zero plan) for the jurisdiction in which they are working, and how the proposed research ideas support these goals. The proposal should include a work plan that directly responds to issues, strategies and activities outlined in either local EHE or other relevant plans.

Applications should propose specific, measurable, achievable, realistic, and time-based (SMART) process and/or outcomes for the implementation research ideas. In addition, a concise description of how the recipient’s plans to implement and monitor each implementation activity should be included in the work plan. The work plan can be uploaded as a separate attachment to be submitted as part of the application. Name the file "work plan" and upload the document(s) as a PDF file under "Other Attachments".

B. COLLABORATIVE PROJECT. The goal of this project is to build science-based partnerships in order to bridge gaps in implementing evidence-based interventions in HIV prevention.

Collaborative Project proposals should describe a research project that includes more than one institution working together on a common protocol to address common implementation challenges in HIV. The Collaborative Project should consist of one primary recipient institution and one or more subcontracting institution(s). Either the primary institution or one or more of its subcontracting sites should have access to health department data in the implementing jurisdictions needed to perform the objectives of the implementation research study. Collaborating sites may be named at the time of application submission, or identified after award, but study objectives and partner roles and relationships to the grantee and other research partners must be clearly described in the application. If named after award, the collaborating sites may also be institutions funded for a Core Project. The funded recipient for the Collaborative Project will be required to participate in an HIV prevention Implementation Science consortium (see below) and collaborating sites may also participate in the consortium. The collaborating sites must provide a letter of commitment that delineates the expertise, roles, responsibilities, and commitments of each consortium team member before work can commence.

III. Consortium Working Groups

The Consortium will be comprised of representatives from the funded Core and Collaborative Projects. The Consortium will provide scientific support to Core and Collaborative Projects as well as aid in the development of the collaborative research infrastructure. As part of the collaborative research infrastructure, co-investigators with expertise in various fields will be expected to participate in additional working groups to aid the development of research in their respective fields. These working groups may revolve around particular subject matter (e.g., PrEP, Data-to-Care specific workgroups) or programmatic domains (e.g., data sharing or facilitating training). Working Groups will work collaboratively to serve in an advisory role to individual investigators by providing scientific and technical support. Well-developed Working Groups are integral to the Consortium's success but will not serve as an advisory group to CDC.

Objectives/Outcomes Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

Implementation Science (IS) Research Issues. As a key component of the EHE initiative, IS research is needed to identify critical implementation strategies to improve the delivery, reach, uptake, fidelity, and sustainability of HIV clinical and behavioral prevention services in order to substantially reduce annual new infections, particularly among those not currently being reached with effective prevention services. Implementation science research evaluates the use of strategies to integrate interventions into real-world settings to improve patient access and use, and subsequently, outcomes. Implementation science research focuses on understanding barriers and facilitators, mechanisms, and processes that affect implementation, and evaluates strategies to improve implementation. Implementation science research assesses the extent to which contextual factors that function as determinants of implementation, such as lack of expertise among staff, can be addressed by a specific implementation strategy. Implementation strategies, in general, are those methods or techniques used to enhance the dissemination, adoption, use/uptake, reach/penetration, fidelity, or sustainability of a program, service, or intervention (hereafter referred to as a public health program). Implementation strategies are typically “independent” of the specific public health programs being implemented, in that they comprise the key elements for integrating or expanding a program within a given setting. Mechanisms of action are processes or events through which an implementation strategy operates, such as a training program to increase staff expertise (strategy) which improves staff knowledge, changes attitudes, or increases self-efficacy and confidence in ability to deliver the program with fidelity.

Implementation outcomes include measures of the extent to which a public health program is adopted and delivered with fidelity in a given setting (see Figure 1).

The logic models depicted in Figure 1 are intended to be examples of appropriate formats; other formats are acceptable.

A wide range of frameworks and models have been developed to structure IS research approaches; online tools can assist applicants (i.e., consortium teams) in identifying the framework(s) most appropriate for their specific research topic (https://dissemination-implementation.org/).

Applications should propose Core and Collaborative Projects that use IS research methods (e.g., approaches, measures) to address implementation challenges that are improved by the understanding of factors that impact HIV prevention programs and services in their jurisdictions. For example, IS research questions related to the Diagnose and Treat pillars of EHE might include identifying which factors affect the extent to which routine opt-out HIV screening in healthcare and other institutional settings is implemented according to operational guidance, is delivered by staff with adequate training and support, does not add undue burden to existing workflows, and is acceptable to the client population and/or mitigates barriers to access that they might otherwise encounter. Such research questions may also focus, for example, on comparing strategies of rapid linkage to HIV medical care for persons newly diagnosed and/or for persons with indications of PrEP. Such studies could examine differences in implementation components, such as specific messages provided to the client, characteristics of the messenger (e.g., experience and skill in communicating with diverse populations), program staffing and resource allocation, and methods of outreach. Additionally, research questions could focus on identifying strategies to improve health equity in terms of accessibility to services for priority groups with disproportionately high HIV burden. These examples of IS research questions serve to illustrate how programs can be strengthened and identified using an IS approach and are not intended to be definitive for the purposes of responding to this funding opportunity. Qualitative measures (e.g., individual interviews and focus groups, content analysis of program documents) and quantitative measures (e.g., electronic medical record abstraction, survey methods, clinical and laboratory assessments of patients) may be used in each research project. Each proposed study will use an IS framework (e.g., Consolidated Framework for Implementation Research [CFIR] [1], Theoretical Domains Framework [TDF] [2], Promoting Action on Research Implementation in Health Services [PARIHS] [3], RE-AIM [4], Proctor Outcomes Model [5,6]) to define the key domains of implementation and measurement. Data should be collected on implementation-relevant strategies, hypothesized mechanisms of change and implementation outcomes (e.g., fidelity to intervention model, uptake of tools by providers, exposure/reach to clients, sustainability/feasibility of the implementation model). Examples of possible IS designs include formative research to further define the implementation barriers or standardize the implementation model, observational studies to understand the critical implementation components involved in a given intervention mode, and between- and within-group (including pre/post) comparisons or controlled trials of different implementation strategies for a public health program, strategy, or service.

References

1. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50.

2. Birken SA, Powell BJ, Presseau J, et al. Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review. Implement Sci. 2017;12(1):2.

3. Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011;6:99.

4. Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013;103(6):e38-46.

5. Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research:

conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65-76.

6. Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B:

Implementation research in mental health services: An emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health 2009, 36:24–34.

Target Population Study outcomes of the award will be assessed at the level of health department staff and systems, HIV prevention community partner staff and systems, and related infrastructure components that influence or impact HIV prevention implementation in the jurisdictions, as appropriate, given the proposed research focus. Target populations will be defined accordingly from this group of entities. Programs conducted by these entities, which the research questions focus on, should serve priority groups identified in local HIV prevention plans (i.e., Integrated HIV Prevention and Care and/or EHE Plans) and reflect the need for the proposed IS research.

Process level assessment inputs for enhancing HIV implementation may include target populations of HD and HIV prevention partner organization staff, and community members intended to eventually benefit from application of implementation research findings.

Collaboration/Partnerships The goal of this NOFO is to build partnerships to bridge the gap between IS research and health department unanswered IS questions. In order to effectively meet this need, consultation and partnership with a state or local health department (HD) is strongly encouraged. Applications should demonstrate an understanding of HD IS needs and processes related to data collection, and applications that include HD representatives as collaborators, or even as co-principal investigators, are strongly encouraged. If multiple PDs/PIs (or Co-PIs) are proposed, the application must include a Leadership Plan that describes the roles, responsibilities, and working relationships of the PDs/PIs (or Co-PIs). Only one PD/PI may be the primary CDC contact for the award, must be at the recipient institution, and the contact must be clearly indicated in the application.

Consortium Collaboration - During the consortium meetings and IS research process, CDC expects recipients to coordinate, as needed, with various relevant groups and stakeholders, including, but not limited, to Health Resources and Services Administration (HRSA) funded entities, sexually transmitted disease (STD) programs, viral hepatitis programs, TB programs, school-based programs, other surveillance programs, laboratory units, other health agencies, tribal governments and/or tribally designated organizations, community-based organizations, community health centers, Bureau of Primary Health Care funded recipients, lesbian, gay, bisexual and transgender (LGBT) health centers, STD and TB clinics, hospitals, specialty clinics, other non-governmental organizations, and criminal justice and correctional facilities implementing comprehensive HIV programs focused on ending the HIV epidemic in the respective jurisdictions.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a five (5)-year research project period. The application should describe specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application’s project plan and describe the development and implementation of project performance measures based on specific programmatic objectives.

The application should include an evaluation plan consistent with the proposed research and the stated purpose and outcomes of this announcement. Among other elements and evaluation activities, the evaluation and performance measurement plan should include the following elements:

Process-level measures: The consortium and jurisdictional teams will be assessed annually for process-level functioning, with member-level feedback applied to improve consortium progress in working together.

Annual site-level reports will be submitted that describe jurisdictional issues and accomplishments, including a summary of jurisdictional successes and lessons learned, and those successes and lessons learned from cross-jurisdictional collaborative activities.

Descriptive data will be included that describe numbers by study for enrollment and completion as well as key findings when available.

Outcome-level measures: Project outcome-level assessment will be IS-related and specific to each study and issues being addressed therein. Examples of implementation outcomes that could be assessed include acceptability or uptake of services by prioritized community members; HIV prevention-related HD or community partner staff perceptions, attitudes, and skills; relationship-level variables between HD staff, partner staff, and key community representatives; infrastructure-level factors such as policies, clinic or center environmental issues, or other physical mechanisms impacting HIV prevention implementation. Applications should include well-defined outcomes in the context of the proposed research focus. Specific outcomes and measures will vary depending on the proposed research questions.

Translation Plan Projects should be designed with valuable tools in mind as products. These products should support implementation of HIV prevention programs and activities that are in alignment with the goals of EHE. Products should be able to be scaled to a broad level beyond the jurisdictions in which the research was conducted. Specifics will vary based on the focus of the proposed research. When feasible, products from completed IS studies shall be shared with others, either through peer-to-peer interactions with other health departments or dispersed through entities and mechanisms available to health departments and HIV prevention professionals in the US (e.g., NASTAD, CDC). To the greatest extent possible, study tools should be created in a format that are easily translated for broader use.

Findings should be disseminated through relevant conference presentations, meetings, and publications.