December 28, 2022
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
PAR-20-106 - Centers for AIDS Research (P30 Clinical Trial Not Allowed)
PAR-20-107 - Developmental Centers for AIDS Research (P30 Clinical Trial Not Allowed)
PAR-17-237 - Centers for AIDS Research (P30 Clinical Trial Not Allowed)
PAR-17-238 - Developmental Centers for AIDS Research (P30 Clinical Trial Not Allowed)
PAR-20-307 - Developmental AIDS Research Centers on Mental Health and HIV/AIDS (P30 Clinical Trial Optional)
PAR-20-308 - NIMH AIDS Research Center on Mental Health and HIV/AIDS (P30 Clinical Trial Optional)
PAR-18-832 - NIMH AIDS Research Center on Mental Health and HIV/AIDS (P30 Clinical Trial Optional)
PAR-18-833 - Developmental AIDS Research Centers on Mental Health and HIV/AIDS (P30 Clinical Trial Optional)
PAR-15-196 - Developmental AIDS Research Centers on Mental Health and HIV/AIDS (P30 Clinical Trial Optional)
PAR-15-197 - NIMH AIDS Research Center on Mental Health and HIV/AIDS (P30 Clinical Trial Optional)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
The overall objective of this Notice of Special Interest (NOSI) is to highlight interest in administrative supplement applications from eligible investigators to support (1) projects that conduct implementation research around evidence-based HIV interventions, care, and treatments tailored to communities disproportionately impacted by HIV; (2) Coordination, Consultation, and Data Management Center (CCDMC); and (3) Regional Consultation Hubs (RCHs). Collaborative and synergistic partnerships are critical in developing and defining approaches and models to scale up comprehensive, integrated interventions to expand testing, prevention, and treatment that optimize adherence, retention, and health outcomes, particularly in communities at highest risk for HIV infection.
Background and Goals
Despite scientific advances in HIV prevention, treatment, and care, 34,800 cases of HIV in the United States (U.S.) were diagnosed in 2019, and disparities have been persistent, particularly for racial and ethnic minorities and gay, bisexual, and other men who have sex with men. The tools to end the HIV epidemic are available, but better implementation strategies are needed to reach the right people at the right time and place. The overall objective of the Ending the HIV Epidemic in the United States (EHE) initiative is 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.
In 2019, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary of Health launched EHE to leverage critical scientific advances in HIV prevention, diagnosis, treatment, and care through the successful programs, resources, and infrastructure of the Center for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), and Indian Health Service (IHS). The EHE initiative focuses on the four pillars – Diagnose, Treat, Prevent, and Respond - that are the key strategies to the EHE initiative that together can end the HIV epidemic in the U.S.
The role of the NIH, as a research platform in the EHE initiative, is to support implementation research to inform HHS and partners on evidence-based practices and effectiveness. NIH-supported implementation research is critical to demonstrate the most effective strategies to adopt and integrate evidence-based HIV services, interventions, and policies to support the most affected populations. The success of this EHE initiative depends on collaborative and synergistic partnerships to develop and define approaches and models to scale up comprehensive, integrated interventions to expand testing, prevention, and treatment that optimize adherence, retention, and health outcomes, particularly in communities at highest risk for HIV infection. Projects funded under this initiative will create generalizable and actionable implementation knowledge and enhance the implementation science (IS) knowledge base needed for the EHE initiative.
Scope of Interest
The administrative supplements under this NOSI will support EHE initiative through:
The CCDMC and RCHs will coordinate, collaborate, collect, and assemble data on progress from EHE projects funded under this NOSI. Thus, the recipients of EHE administrative supplements funded through this NOSI will be required to collaborate with and provide information requested by the NIH through the CCDMC and assigned RCHs on a regular basis. Information related to progress will be collected through data requests administered by the RCHs and harmonized by the EHE CCDMC for the NIH. Project recipients will further be expected to utilize the RCHs for IS consultation and technical assistance for their projects. Each project funded under this NOSI will be assigned to an RCH through a systematic process at the beginning of the project year.
Several critical principles should guide these efforts:
EHE Scientific Priorities for FY23 are described below.
Each Center is allowed to submit a maximum of three applications total (i.e., any combination of three out of the four priorities) for project priorities 1. a through d. Information on maximum funding and number of years allowed is located within the Budget and Funding Information section below. Clinical trials are not allowed in CFAR applications according to NIAID clinical trials policy. However, clinical trials are allowed in NIMH ARC applications.
Objective: Using syndemic theory and approaches to (a) increase focus on intersecting diseases and social conditions that exacerbate health inequities, and (b) enhance the evidence base for effective successful approaches to assess, monitor, and intervene with respect to these intersections for optimal outcomes in HIV prevention or treatment.
Syndemic theory emphasizes that adverse interactions between diseases and social conditions contribute to an excess burden of disease in a population. HIV and its common comorbid conditions such as viral hepatitis, sexually transmitted infections (STIs), and substance use and mental health disorders can be seen as an outcome of social inequities and disproportionately impact racial, ethnic, sexual, and gender minoritized populations. These same intersecting social determinants and co-morbid diseases can also affect optimal HIV prevention access, including PrEP, mental health, and substance use services that include syringe services and drug treatment.
Addressing a syndemic problem requires either interventions to account for these factors to successfully overcome and connect to HIV prevention and treatment (and other health care services), and/or interventions and strategies to alter the structures, systems and settings where care is delivered. Integrated services are one example of a change in service delivery to address multiple conditions. This type of change may be necessary but not sufficient to optimize care outcomes, unless individual and social conditions are also addressed.
Implementation strategies using systems approaches can help to shift perspectives and service delivery from siloed to integrated health care. System interventions such as changes to services reimbursement and novel delivery approaches have demonstrated reductions in health disparities, but many disparities remain. Consequently, there is a need for approaches grounded in syndemic theory that use an intersectional lens, in order to incorporate sufficient attention to multiple intersecting issues.
Other social determinants are known to impede optimal HIV prevention and treatment outcomes, such as economic inequality, unstable housing, and inadequate access to health services. Fear of reporting a positive HIV status may be experienced in many settings where disclosure may lead to stigmatizing attitudes and behaviors. Felt experience of enacted stigma in HIV prevention, HIV treatment, and other medical clinics and public health facilities continues to be a pervasive problem. Service delivery settings that are not welcoming to stigmatized populations can be exacerbated by stigmatizing attitudes, beliefs, and behaviors held by health care and community providers. Additionally, undocumented immigrants may experience worsening health inequities in syndemics with HIV and its comorbid conditions resulting from barriers to care in EHE Phase I jurisdictions where there is a significant increase in immigration.
Proposed projects should address individual, social and cultural factors, social and structural determinants of health and co-morbid diseases. Applicant teams are also encouraged to integrate approaches to explore stakeholder perspectives and experiences on the quality of life in the proposed projects. The proposed projects should be co-designed by a team of CFAR/ARC investigators, community partners, implementing partners, people with lived experience, and other key stakeholders to develop, implement, and evaluate implementation strategies. The application must clearly define the stage of the research project (e.g., planning, intervention and/or implementation strategy). In addition, applicants should articulate how the proposed project fits into a longer timeline of research direction that will ultimately lead to intervention development and delivery, implementation strategies, and public health impact beyond their local community.
Applicants should include a conceptual or logic models and identify key variables to be collected that relate to syndemic production and reduction of disparities.
Applicants should also address co-morbid and/or intersecting individual and social determinants of health in their collaborative planning for intervention development, formative work, pilot intervention and implementation strategy.
Research topics may include, but are not limited to:
Objective: This topic will support research projects designed to further capacitate, field, and scale the routine delivery of HIV testing, prevention, and care services through pharmacists and pharmacy settings in the U.S.
Pharmacies have been valuable resources for delivery of vaccines for influenza and COVID-19 in the U.S. Pharmacies are viewed as neutral, non-stigmatizing locations to access healthcare, and they offer convenient access through extended store hours and co-location in neighborhoods and communities affected by HIV. Therefore, the updated National HIV/AIDS Strategy for 2022-2025 states that “Pharmacists” knowledge and accessibility in nearly every urban and rural community can be leveraged as part of a comprehensive HIV prevention and care strategy to expand access to care and improve population health.”
The existing research literature on HIV service delivery through pharmacies is limited but demonstrates the promise of pharmacy-delivered HIV testing, prevention, and care. Pharmacy programs can support HIV prevention by facilitating access to HIV testing alongside other health screenings. New models to provide pharmacy-based PrEP initiation or PrEP care have been pioneered. Adherence support is also a longstanding specialty of pharmacists and pharmacies, and there are opportunities to use pharmacy monitoring of antiretroviral prescription refills as a timely indicator of HIV care engagement – as well as a catalyst for intervention when needed.
Building models for successful pharmacy-based delivery and support of HIV testing, prevention, and care will require further implementation research and multisectoral collaboration. Central challenges include: creating effective strategies to engage populations placed at risk for HIV or living with HIV within pharmacy settings; developing pharmacist trainings and skill improvement programs to support HIV testing, service delivery, and client interactions; ensuring care linkage and collaboration by forming Collaborative Practice Agreements (CPAs) with local physicians where permitted; conducting pharmacy workflow implementation studies with attention to physical space needs for program administration; and consideration of reimbursement strategies and financing models.
This EHE supplement topic therefore calls for two-year implementation research projects co-designed by a team of CFAR/ARC investigators, community partners, implementing partners, people with lived experience, and other key stakeholders to further capacitate, field, and scale the routine delivery of HIV testing, prevention, and care services through pharmacists, pharmacy technicians and pharmacy settings in the United States. Research topics may include but are not limited to:
Objective: Improving linkage and connection to mental health, substance use, social services, housing, job services, HIV care, and any other community resources post-incarceration. The goals are to optimize timely linkage to HIV care, retention, and viral suppression among people living with HIV (PLWH) re-entering their communities.
It is estimated that about 15% (180,000) of the 1.2M people living with HIV (PLWH) in the U.S. have contact with some form of incarceration annually (e.g., pre-trial holding, city jails, and state or federal prisons). These are important opportunities for both HIV testing and HIV care after incarceration for innovative multi-level interventions to enhance timely linkage to HIV care, retention, and viral suppression.
EHE supplements on this topic will support
In addition, intersecting stigmas can adversely affect linkage to community, health, and mental health services among PLWH after incarceration. On its own, being identified as a formerly incarcerated person is already a known barrier to return to community among persons returning from correctional care. Taken together, re-entering their community as PLWH with any other additional intersecting stigmas (e.g., mental illness, substance use, sexual and gender minority status, being homeless) can further disrupt timely return to all health care services. Therefore, projects which also address intersectional sexual and gender minority facilitators and barriers to return to community post-incarceration are encouraged.
Research topics may include, but are not limited to:
Proposed studies should clearly specify next steps for intervention research, in addition to clearly identifying and partnering with the end-users of the knowledge that would be generated (e.g., prevention scientists, public health officials, health departments, justice systems, policy makers, community organizations, etc.). Applicants should thoroughly explain how that knowledge might be used to inform decisions and implement change. The involvement of the end-users is to ensure that the proposed data and methods will be useful. The partnerships with key end-users can be existing, or new relationships initiated based on success of previous stakeholder engagement and preparation to implement proposed work in a new setting.
Objective: Using cluster detection and response strategies to address identified service gaps, reduce HIV-related health disparities, and contain outbreaks.
Cluster detection and response (CDR) offers a strategic framework to guide tailored implementation of proven HIV prevention strategies where transmission is occurring most rapidly. Clusters of rapid HIV transmission can be detected in several ways including provider reporting, partner services, or analysis of case or molecular data from HIV surveillance. The presence of a rapid transmission cluster is an indication that prevention and care services are not reaching people who need them and indicates an opportunity to identify limitations or gaps in services and curate focused and tailored interventions where general population interventions have failed.CDR involves adapting HIV resources and services to those who use them,rather than expectingpeople to adapt to access resources and services in a system that has failed them.
Engagement with both health departments and communities are an integral part of CDR planning and response efforts, including efforts to strengthen HIV prevention and treatment activities. Applications for this topic should propose CDR activities that foster partnerships among health departments, community partners (including but not limited to care, testing, and social services providers), and implementation scientists, and should clearly describe the partnerships, including the roles and responsibilities of individuals and partners across the entire project team. Activities should be proposed in locations where rapid transmission clusters meeting CDC national priority criteria have been recently identified. Applicants are encouraged to consider conducting CDR implementation research across a full range of cluster types, including smaller or larger clusters, clusters primarily among racial and ethnic minority groups, clusters associated with sexual transmission, and clusters among people who inject drugs. The proposed scope of work should include investigating cluster networks; using IS methods including formative/rapid ethnographic assessment to identify and address gaps in critical programs and services, including testing, PrEP, linkage to and retention in care; addressing identified social determinants of health, and advancing health equity.
Applications submitted under this topic may include but are not limited to:
All centers may submit one application for the CCDMC. Only one CCDMC application will be funded.
Supplemental funding will be awarded to support one Coordination, Consultation and Data Management Center (CCDMC). This Center will be expected to function as a supportive resource to EHE projects and Regional Consultative Hubs (RCHs) and provide regular updates on progress and outcomes to NIAID/NIMH Program Officers. The expected functions are described below, as well as expectations.
The CCDMC’s resources are intended to provide the following:
Organization and management
Training and capacity building
All centers may also submit one application for a regional consultation hub (RCH). However, each Center is only allowed to be involved in one RCH. A Center cannot be funded for both a CCDMC and an RCH. However, a Center can apply for both a CCDMC and RCH, but the Center that is selected as the CCDMC will be ineligible to receive funding for an RCH, if both applications are meritorious.
This supplement topic will support CFARs and ARCs that have strong IS expertise to serve as an RCH to provide consultation and technical assistance to EHE project teams and to coordinate and collaborate with the CCDMC. CFAR and ARC investigators are encouraged to collaborate on RCH applications based on IS expertise and are allowed to include IS experts from outside of the Centers and other institutions that are not part of a CFAR/ARC. IS experts are limited to participate as an IS team member on one IS hub application.
Applicants must describe the IS expertise, technical assistance, coaching, training, and consultative services that will be available through the RCH, including RCH team members, their roles and responsibilities and how the IS hub will interact with the CCDMC and CFAR/ARC Administrative Core. The RCH is expected to cover the scope of work described below, and should describe any regional, local, or unique expertise and services that could be provided.
The RCH must provide, at the minimum, the following activities and processes:
Currently funded Centers (not in a no cost extension/bridge year) that are awarded from the Funding Opportunities Announcements (FOAs) listed below are eligible to submit applications for this announcement. There is no restriction on NIH Investigator Status (e.g., Early Stage Investigator, New Investigator, etc.).
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
Administrative supplement requests must be submitted through Grants.gov using electronic submission processes (NOT-OD-20-128). Follow all instructions in the SF424 (R&R) Application Guide to ensure all appropriate required and optional forms are completed, with the following additional guidance:
NOTE: The budget should be appropriate for the work proposed in the supplement request. If funding for travel to a scientific meeting is included, it must be for the purpose of presenting data from this supplement award.
Submit letters of support from all implementing and collaborating partners which describes their roles and responsibilities on the project and how this project supports the local EHE plan.
Letters of support that are the same for all partners may fail to establish a level of credibility, may not show a true commitment to the project, or may fail to demonstrate authentic collaboration.
Describe the IS framework or model utilized to support the logic model and to guide the study design and evaluation methods.
Studies of implementation strategies should build knowledge both on the overall effectiveness of the implementation strategies (implementation outcomes), as well as "how and why" they work (implementation mechanisms). Data on facilitators and barriers (implementation determinants) to program success, mechanisms of action, moderators and mediators of implementation strategies, and implementation outcomes will greatly aid decision-making on which strategies work for which interventions, in which settings, and for what populations. Applicants should therefore incorporate IS theories, models, and/or frameworks appropriate for implementation research to inform study hypotheses, measures, implementation outcomes, and health outcomes if able to be measured.
Another tool that applicants should reference is the Implementation Outcomes Crosswalk, which aims to offer standard measurements of key constructs in the context of HIV services and programs.
Coordination data collection among the projects funded at the CFARs and ARCs is critical for local knowledge to become generalizable implementation knowledge. There is a balance to strike in capturing uniform data across varied contexts and in respecting researcher autonomy to develop metrics that are specific to a given study. HIV IS experts have ascribed relevance ratings to each measure in the Crosswalk across several stages of implementation research.
Applicants are expected to measure, at a minimum, those that are “Required” for the appropriate study stage or otherwise justify why a measure is not applicable for your study. You may also choose additional outcomes apart from those listed in the Crosswalk that are relevant to your research question.
Budget and Funding Information
Funding for supplements will be supported by the NIH. The maximum funding allowed per application is:
Note: The proposed project period of the supplement cannot extend beyond the project period of the parent award.
For the CFARs, funds for these supplements will be provided to the Developmental Core.
Please note that the number of applications that will be funded for this administrative supplement announcement will be based on funding availability, alignment with the local EHE plans, addressing the goals of the EHE initiative including one or more pillars and collaboration with local partners, and program balance.
At the time of submission, both CFAR and ARC Applicants are requested to send an email notification of applications submitted that includes the below information for each:
This information will assist us in planning for the review.
Information should be sent to:
Annalise Schoonmaker, M.S.
National Institute of Allergy and Infectious Disease
Administrative Review Considerations
Applications that are complete and responsive to the announcement will be evaluated for scientific and technical merit, and alignment with the NIH HIV/AIDS research priorities by an internal NIH review group convened by the NIAID in accordance with standard NIH review procedures.
The following criteria apply to all applications, unless noted.
Funding may be requested for any category normally funded by a CFAR/ARC grant that is required to fulfill the goals of the proposed request and must be fully justified.
CFAR Team Lead
Eric Refsland, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIAID EHE Coordinator
Ann Namkung Lee, MPH
National Institute of Allergy and Infectious Diseases (NIAID)
NIMH EHE Coordinator
Christopher Gordon, Ph.D.
National Institute of Mental Health (NIMH)