Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute on Minority Health and Health Disparities (NIMHD)

Fogarty International Center (FIC)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title
Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC³H-IN) Clinical Research Centers (UG1 Clinical Trial Optional)
Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type
New
Related Notices
  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
  • August 11, 2022 - Notice of Pre-Application Webinar for the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC³H-IN) Funding Opportunity Announcements. See Notice NOT-HD-22-041.

Funding Opportunity Announcement (FOA) Number
RFA-HD-23-013
Companion Funding Opportunity
RFA-HD-23-014 , UM2 Program Project or Center with Complex Structure Cooperative Agreement
Assistance Listing Number(s)
93.865, 93.989, 93.242, 93.279, 93.307
Funding Opportunity Purpose

This FOA invites applications to participate in a research program cooperative agreement to support the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC3H-IN). The Network will expand and/or improve successes achieved by PATC3H to new geographic settings with limited implementation science (IS) research capacity and/or risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users) and stimulate much needed IS research in a neglected area of public health significance: prevention of new HIV infections among adolescents at risk and the identification of, and linkage and retention to care of and long-term viral suppression among youth living with HIV in low-to-middle income countries (LMICs). These settings must have an HIV epidemic density defined by UNAIDS estimates as either a country 1) in which at least 200,000 people are living with HIV and the number has not decreased by more than 5% over the last 2 consecutive years of available data or 2) has an HIV incidence among youth ages 10 to 24 years of 0.01% or more.

The structure of PATC3H-IN shall consist of two highly integrated components - (1) Clinical Research Centers (CRC) (each center will propose a study to be executed in at least 5 research performance sites); and (2) a single Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC).

This FOA solicits applications for Clinical Research Centers (CRC). There is a parallel companion FOA that seeks applications for a single Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) (RFA-HD-23-014).

Key Dates

Posted Date
July 22, 2022
Open Date (Earliest Submission Date)
November 06, 2022
Letter of Intent Due Date(s)

November 06, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable Not Applicable December 06, 2022 March 2023 May 2023 July 2023

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
December 07, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) 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.

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This funding opportunity announcement (FOA) invites applications to participate in a research program cooperative agreement to support the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC3H-IN). The Network will expand and/or improve on successes achieved by its predecessor, PATC3H, to new geographic settings and/or risk populations and stimulate much needed implementation science (IS) research in a neglected area of public health significance: prevention of new HIV infections among adolescents at risk and the identification of, and linkage and retention to care of and long-term viral suppression among youth living with HIV in low-to-middle income countries (LMICs). These settings must have an HIV epidemic density defined by UNAIDS estimates as either a country 1) in which at least 200,000 people are living with HIV and the number has not decreased by more than 5% over the last 2 consecutive years of available data or 2) has an HIV incidence among youth ages 10 to 24 years of 0.01% or more.

Rates of successful achievement of milestones on the HIV prevention and/or HIV care continuum (PHCC) must be improved to address the youth HIV epidemic most effectively. This requires rigorous IS research, the most critically needed next step to optimally differentiating successful interventions to meet the needs of adolescents who typically experience challenges with adherence behaviors and adjusting to health systems not well adept with providing for their care. IS research is the study of methods to promote the integration of research findings and evidence into public health, clinical practice, and community settings. It seeks to understand the behavior of healthcare professionals and other stakeholders as a key variable in the sustainable uptake, adoption, and implementation of evidence-based interventions. PATC3H-IN will establish a network of investigators with expertise on the youth-specific PHCC and in IS research to evaluate promising prevention innovations contextually and developmentally tailored for HIV uninfected at-risk youth, and also treatment and care interventions for youth living with HIV which have demonstrated efficacy and/or effectiveness in adolescent or adult populations.

The Network will conduct coordinated scientific inquiry to (1) improve understanding of the process of integration of research findings and evidence into public health, clinical practice and community settings and elucidate how to sustain uptake, adoption, and implementation of evidence-based interventions for youth who are at risk for or living with HIV in LMICs; (2) increase the scientific capacity and knowledgebase for IS research on at-risk, uninfected adolescents and those living with HIV in new geographies with limited IS research capacity and risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users); and (3) translate findings to inform national and global guidelines on the clinical management of at-risk, uninfected adolescents and those living with HIV in these regions. It is expected that the critical collaborative relationships with policy makers and key stakeholders needed for these applications will also lay the foundation for large scale implementation and sustainability after the grant cycle is over.

This FOA solicits applications for Clinical Research Centers (CRC) to be part of PATC3H-IN. There is a parallel companion FOA that seeks applications for a single Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) (RFA-HD-23-014).

Background

Adolescents and young adults (AYA, 10-24 years old) represent over a quarter of the world’s population and 90% live in LMICs. The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimated 3.9 million people aged 15-24 years old are living with HIV infection. Each day, approximately 1,600 AYA acquire HIV infection and approximately 144 AYA die from an AIDS-related illness. The increasing number of youth coming of age in the next 20 years in LMICs underlines the urgency of HIV prevention and treatment in this demographic group.

Over the past decade, the HIV research arena has experienced numerous triumphs across the PHCC in adults, including several groundbreaking milestones in biomedical prevention of infection as well as the adaptation and implementation of a systematic approach to address and improve health outcomes among those with HIV infection. Noteworthy among these successful interventions, is their dependence on excellent adherence and engagement in care, areas which are particularly challenging for adolescents. Despite the advances made, many of which were undertaken in internationally-based resource constrained settings, adolescent representation in these research activities has been scant to non-existent. This has resulted in tremendous gaps for youth populations affected by HIV in these settings in biomedical prevention interventions and among critical milestones within the youth-specific HIV care continuum which are critical to ensure improved health outcomes.

The context of HIV care varies incredibly due to resources, healthcare provision and policies and geographical settings. Striving for healthy outcomes during adolescence must encompass consideration of the complex developmental, psychosocial and cultural issues facing children and adolescents at risk of HIV and with HIV as they transition to adulthood. Recently, several investigators have tailored some successful adult interventions to young people and demonstrated preliminary effectiveness among AYA in some sub-Saharan African countries with their large scale effectiveness trials ongoing; However, many gaps remain unfulfilled in LMICs across the world, especially where training in and capacity for IS research is very limited to non-existent.

IS research that advances and optimizes the successful implementation of interventions with demonstrated efficacy and/or effectiveness in addressing the health needs of AYA who are at risk for or living with HIV in these settings are a critically needed. There is also an urgent need for training researchers who are adept in caring for adolescents impacted by HIV but have limited knowledge or local capacity to conduct rigorous IS research to develop and test interventions that can achieve long-term viral suppression among youth living with HIV and reduce onward transmission to and acquisition of HIV in at-risk youth. HIV researchers must possess the capacity for evaluating scalable and sustainable efficacious interventions that can be successfully implemented by programs serving these vulnerable young populations in LMICs globally.

Network Structure and Mission

Essential Features of PATC3H-IN

PATC3H-IN is a cooperative, multi-component project grant that is newly composed of Clinical Research Centers (CRC) and a Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) (see companion RFA-HD-23-014), which will work collaboratively to achieve the mission of PATC3H-IN. The Network will expand and/or improve on successes achieved by its predecessor, PATC3H, to new geographic settings and/or risk populations and stimulate much needed implementation science (IS) research in the prevention of new HIV infections among adolescents at risk and the identification of, and linkage and retention to care of and long-term viral suppression among youth living with HIV in low-to-middle income countries (LMICs). PATC3H-IN will establish a network of investigators with multidisciplinary expertise on the youth-specific PHCC and in IS research, whose mission will be to evaluate promising prevention innovations contextually and developmentally tailored for HIV uninfected at-risk youth, and treatment and care interventions for youth living with HIV which have demonstrated efficacy and/or effectiveness in adolescent or adult populations and to translate them into public health practices.

The structure of PATC3H-IN will consist of multiple interdependent functional components: (1) Clinical Research Centers (CRC), (2) a single Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC), and (3) a Scientific Leadership Committee (SLC). The SLC will be responsible for PATC3H-IN governance, oversight and coordination, and will develop and implement the network research agenda, convening working groups as needed, prioritizing emerging research projects, efficiently managing the development of clinical protocols, implementing and completing clinical trials and ensuring timely publication and communication of results.

Clinical Research Centers (CRC)

Clinical Research Centers will conduct clinical research and clinical trials, including implementation, effectiveness, and hybrid implementation-effectiveness studies at their participating Clinical Research Performance Sites (CRPS). The goal of studies proposed by Clinical Research Centers should be to improve health outcomes across all milestones on the PHCC for at-risk AYA and those living with HIV. PHCC health outcome milestones, among at-risk uninfected AYA, include proportions who are tested for HIV, assessed for risks and prevention needs, linked to and engaged in prevention services, prescribed biomedical prevention interventions (e.g. topical or oral PrEP), adherent to PrEP, and retested HIV negative, and among youth with HIV, include proportions who are diagnosed with HIV, linked to and retained in HIV care and achieved long-term viral suppression. Relevant implementation outcomes such as penetration, scalability, and sustainability should also be considered.

Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC)

A single Coordination, Translation and Advanced Methods and Analytics Center will manage logistics, stakeholder engagement, and dissemination of findings and products from PATC3H-IN. It will also provide data infrastructure support across PATC3H-IN and will conduct foundational research to support the work of the clinical sites, including modeling studies, national surveys, and/or systematic collection and analysis of relevant policies and laws. This will include establishing infrastructure to support research education and rapid response and emerging research pilots (ERPs). Additional information about this component can be found at: [RFA-HD-23-014].

Scientific Leadership Committee (SLC)

The Scientific Leadership Committee (SLC) will be responsible for PATC3H-IN governance, oversight and coordination, and will develop and implement the network research agenda. The SLC will provide the necessary multidisciplinary expertise to set, prioritize and manage the PATC3H-IN scientific agenda. It will draw on the statistical and data management leadership and coordination expertise in CTAMAC to design and implement future research solicited to address emerging scientific priorities during the project cycle. The PATC3H-IN research agenda will ensure capacity for rapid response to evolving scientific priorities through recurring competitive open solicitations for Emerging Research Pilots (ERPs). These solicitations will be developed and published by the CTAMAC in collaboration with NIH project scientists and supported by the coordination and operational infrastructure of the CTAMAC, which will 1) receive and convene reviews for applications, 2) coordinate and support application prioritization by the SLC, and 3) implement funded meritorious research through CRC-supported Clinical Research Performance Sites (CRPS) after approval by the NICHD Director or her designee. Finally, the ERPs will be conducted through the site consortia’s multidisciplinary, cross-sectoral collaborative relationships with various participant recruitment venues in their communities (e.g. academic, clinic, health department, community-based organizations, online, social media and other virtual health platforms, etc.).

The SLC will include a single representative from each CRC, up to three from the CTAMAC, two site coordinators, two youth advisory board members and the NIH Project Scientists. A chairperson of the SLC will be appointed by NICHD, as will any additional members the institute has deemed necessary after awards are issued.

External Scientific Advisory Board (ESAB)

An independent external advisory board (ESAB), or an equivalent body of investigators who are not current collaborators of the funded programs, is expected to be constituted by the PD/PI(s) of the CTAMAC in consultation with the SLC. The advisory board will meet at least biannually to review the progress in achieving the goals of all research projects participating in the program at a PATC3H-IN meeting coordinated by the CTAMAC. Following these meetings, the ESAB will make recommendations in writing to PATC3H-IN and the SLC for the continuation or re-direction of any or all projects and activities.

Semi-Annual Programmatic Meetings

A one or two-day semi-annual meeting will be held at a location at or near Bethesda, MD or at another NICHD-approved site or may be held virtually as needed.

NIH PATC3H-IN Management and Oversight Committee (NIH PMOC)

PATC3H-IN is co-funded by multiple NIH Institutes, however, NICHD administers the award. Thus, PATC3H-IN will be programmatically managed by the NIH PMOC, which will consist of the NICHD program director, and the Program Official, and a representative from each NIH institute.

Clinical Research Centers (CRC): Objectives and Scope

All applicants for the Clinical Research Centers must carefully review the companion PATC3H-IN FOA for the Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) (UM2) [RFA-HD-23-014] to understand the complete mission of PATC3H-IN.

Definitions

Clinical Research Performance Site (CRPS)

Clinical Research Center applications must propose a multisite research project to be executed in five or more geographically distinct clinical research performance sites (i.e., five or more communities). A clinical research performance site (CRPS) is defined as a partnership between a national and/or regional health ministry or other local health authority and one or more community-based HIV-related service providers (e.g., hospital, clinic, non-government organization (NGO) or other relevant service provider). The health authority or authorities and the service provider must engage with a shared population of AYA who live or receive services in a defined geographic area (i.e., community). Each of the five proposed clinical research performance sites must be geographically distinct and non-overlapping from the perspective of the population of patients engaging with services and must possess multidisciplinary, cross-sectoral collaborative relationships with various participant recruitment venues in their communities (e.g. academic, clinic, health department, community-based organizations, online, social media and other virtual health platforms, etc.).

 

Community-Based HIV-Related Services Definition

For the purposes of this FOA, a community-based HIV-related service provider is inclusive of any setting, academic or non-academic, where an at-risk AYA or patient living with HIV may engage with medical or behavioral health services that provide primary preventive measures, including PrEP, and/or HIV treatments and address myriad psychosocial determinants impacting health outcomes, including but not limited to mental illness, substance use and other service needs. This includes, but is not limited to HIV service providers, integrated primary HIV care and behavioral health settings, and other settings where HIV-related services are provided to at-risk AYA or patients living with HIV with co-existing needs (e.g. office-based opioid agonist treatment providers, behavioral health service providers, needle exchange sites, housing providers, opioid treatment programs, etc).

Scientific Objectives of the CRC

Applications for the Clinical Research Centers (CRC) will be solicited to (1) improve understanding of the process of integration of research findings and evidence into public health, clinical practice and community settings and elucidate how to sustain uptake, adoption, and implementation of evidence-based interventions for youth who are at risk for or living with HIV in LMICs; (2) increase the scientific capacity and knowledgebase for IS research on at-risk, uninfected adolescents and those living with HIV in new geographies with limited IS research capacity and risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users); and (3) translate findings to inform national and global guidelines on the clinical management of at-risk, uninfected adolescents and those living with HIV in these regions. It is expected that the critical collaborative relationships with policy makers and key stakeholders needed for these applications will also lay the foundation for large scale implementation and sustainability after the grant cycle is over.

Applications proposing studies focused on new geographic settings with limited IS research capacity (e.g. outside of South Africa) and/or risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users) will receive additional program priority.

Applications proposing interventions that incorporate evidence-based efficacious innovations addressing the youth-specific PHCC such as long-acting injectable, implantable or other sustained release platforms of antiretrovirals for prevention and treatment of HIV will receive additional program priority.

Additionally, applicants should:

  • Propose IS research to improve the adoption, implementation and sustainment of evidence-based HIV prevention and care interventions aimed at improving health outcome milestones on the PHCC for at-risk AYA and those living with HIV within one or more LMICs.
    • Develop and test implementation strategies for evidence-based HIV prevention or HIV care interventions.
    • Advance the knowledge base around sustainment of evidence-based HIV prevention and care interventions.
    • Improve health equity among traditionally underserved populations through IS.
    • Scale up evidence-based HIV prevention and care interventions across systems and communities.
    • Advance the science of intervention adaptation in the context of clinical and community settings.
  • Propose to include implementation measures as at least one of the primary outcome measures (e.g., adoption, affordability, fidelity, penetrance, scale-up, sustainability, etc.).
  • Incorporate IS frameworks or theories to guide the design and/or evaluation of implementation strategies.
  • Be encouraged to propose effectiveness-implementation hybrid designs.
  • Provide evidence of capacity for recruitment and successful engagement of adolescents and young adults at-risk of and/or living with HIV within clinical or community settings in research activities or capacity to engage clinics, community based organizations, or other organizations if they are the target of the research.
  • Provide evidence that (a) the proposed HIV IS research is aligned with the designated LMIC's scale-up efforts for AYA HIV prevention and care, and (b) there is adequate funding and other material public and/or private support to ensure that the designated LMIC's scale-up efforts will proceed or continue to proceed as planned after NIH-support is completed.
  • Propose an adolescent HIV research partnership with the Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA), where geographically appropriate - to conduct research and capacity-building activities - that includes representatives from one or more academic institutions, government agencies, and non-governmental agencies.
  • Propose a plan for building adolescent HIV IS research capacity in one or more LMICs in order to (a) conduct IS research and (b) use science-based methods and information to develop adolescent HIV prevention and care policies and programs.

Non-responsive areas:

  • Studies focused primarily in geographic areas representing high-income or more developed countries (based on World Bank definition)
  • Studies that do not propose ongoing engagement with youth and other key stakeholders throughout the study period
  • IS research focused on interventions that do not have demonstrated efficacy on one or more milestones on the HIV prevention or care continua targeted by the application

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NICHD and partner components intend to commit an estimated total of $8,000,000 to fund approximately 4-5 awards for fiscal year 2023, subject to funding availability. Future amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $940,000 per year in direct costs.

Award Project Period

The scope of the proposed project should determine the project period and may be up to 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)

Other

  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Bill G. Kapogiannis, MD
Telephone: 301-402-0698
Fax: 301-496-8678
Email: kapogiannisb@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Facilities & Other Resources: Applicants should provide an explanation of resources available from each project/performance site on the "Facilities and Resources" attachment

Specifically:

  • Data should be presented on the epidemiology of HIV among AYA, including trends in new HIV infections, AIDS-related deaths, proportions achieving success across milestones of the PHCC, or other HIV-related health outcomes for the targeted communities, and special populations, where appropriate (e.g. sexual and gender minorities; commercial sex workers; drug users, etc). The data may be presented broadly for the pool of sites and/or specifically for each proposed site, depending on study design.
  • Capacity to recruit additional sites, if needed, should be described.
  • As noted in the Research Strategy Instructions, for each proposed clinical research performance site (CRPS), letters of support from both the (a) targeted national and/or regional health ministry or other local health authority(ies) and (b) community-based HIV-related service provider entity(ies) should be provided. If a study design proposes recruiting sites during the course of study conduct, strong justifications demonstrating feasibility of recruitment (e.g., letters of support from a state government official overseeing a health system with multiple potential sites) and a strong justification for the selection of this strategy must be included.
    • Letters of support must provide evidence that (1) the proposed HIV IS research is aligned with the designated LMIC's scale-up efforts for AYA HIV prevention and care, and (2) there is adequate funding and other material public and/or private support to ensure that the designated LMIC's scale-up efforts will proceed or continue to proceed as planned after NIH-support is completed.
SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

The Clinical Research Center (CRC) PD(s)/PI(s)

  • should be established investigator(s) with a record of scholarly achievements and publications, demonstrated leadership and administrative capabilities, a proven track record designing and leading multidisciplinary research projects that include multi-site clinical trials, particularly cooperative, pragmatic, randomized clinical trials;
  • will be responsible for the oversight and conduct of research projects across CRC-supported Clinical Research Performance Sites (CRPS);
  • will be responsible for communication and collaboration with the Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) and its associated Cores in implementing collaborative research projects across relevant PATC3H-IN CRC and their CRPS;
  • will participate and collaborate with CTAMAC PD(s)/PI(s) and Core leads and others within the Network to discuss, develop plans for and assist the PATC3H-IN Scientific Leadership Committee in guiding the Network in implementing scientific and administrative decisions;
  • should demonstrate a track record of proactive community engagement in development of research activities and provide plans to ensure that the research proposed will be informed by ongoing community input and to conduct ongoing monitoring for impact the research may have on the community.

Biosketches should describe Senior/Key Personnel recent experience and participation in multi-site randomized clinical trials. Applicants are expected to provide evidence of their unique strengths, accomplishments and capabilities to contribute to shared activities across the PATC3H-IN network. Applicants should provide evidence of expertise in the conduct of clinical trials, particularly cooperative, pragmatic, randomized clinical trials. Persons responsible for participant recruitment, enrollment, data collection and data management should be shown to have extensive experience and high qualifications.

Biosketches must be included for one or more representative senior leaders from (a) a relevant national and/or regional health ministry or other local health authority(ies) and (b) a relevant community-based HIV-related service provider entity(ies) relevant to the proposed study to be included as key personnel. Senior leaders do not have to be from one of the targeted communities (CRPS) if not appropriate for the study design, but should have relevant expertise and demonstrate the ability to provide guidance to the research team on pragmatic and practice-related issues relevant to research in the targeted setting.

PD/PIs, senior investigators, and other investigators with substantial time commitments to PATC3H-IN should expect to actively participate in a wide variety of network activities, including, but not limited to: providing mentorship to participants in the Advanced Methodology and Emerging Science (AMES) Core (see Coordination, Translation and Advanced Methods and Analytics Center FOA for more detail), participating in reviews of network publications, actively engaging in harmonization activities, making data from their study available to others, serving as a reviewer for Emerging Research Pilot proposals supported by the AMES Core (see Coordination and Translation Center FOA for more detail). Participation in such network activities may be included among outcomes that may be tracked and reported to NICHD by the Coordination, Translation and Advanced Methods and Analytics Center.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Requirements for Senior Personnel

  • PD(s)/PI(s) must expend at least two (2.0) person-months effort annually on the award over the entire period of support. In a multi-PI application, at least one PD/PI must commit a minimum of 2.0 person-months annually over the life of the grant award.
  • One or more representative senior leaders from (a) a relevant national and/or regional health ministry or other local health authority(ies) AND (b) a relevant community-based HIV-related service provider entity(ies) should be named as Key Personnel and should each expend a minimum of 0.6 person-months effort annually on the award over the entire period of support.
  • Budgets should include funds for travel for the PD(s)/PI(s), up to two health authority and community agency staff named as key personnel, and one additional project staff to participate in in-person PATC3H-IN Scientific Leadership Committee meetings twice per year, every year of the award, in Rockville, MD. An additional in-person kickoff meeting to be held in the Bethesda/Rockville, MD area should be included in the year one budget of the award.
R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Specific Aims are required

Research Strategy:

Each Clinical Research Center should propose a multi-site research project. All proposed projects must engage five or more performance sites (i.e., communities). The number of sites engaged should be appropriate to the goals of the proposed study and the study should be adequately powered to detect proposed outcomes.

The research strategy section should be organized as follows:

Section A: Research Project Design

Applicants are requested to develop and propose a research concept that lays out a theoretically grounded, hypothesis-driven study design to address gaps along the HIV prevention and/or HIV care continuum (PHCC) for AYA populations in LMICs. Applications should advance delivering or optimizing evidence-based interventions to prevent and treat HIV infection among AYA populations in these regions.

Applications are expected to include services delivered in communities as a primary target, thus applications should involve stakeholders and clinical research performance sites from both (a) targeted national and/or regional health ministry or other local health authority(ies) and (b) community-based HIV-related service providers. A focus on community-based settings is inclusive of transitions from local health authorities to communities, so may include, for example, a focus on continuing care that began on entry into the public health system through HIV and/or sexually transmitted infection testing and resuming or maintaining care at the community-based HIV-related service provider.

Applicants are encouraged to consider relevant issues such as comorbid mental health and physical health issues, polysubstance use, trauma-informed approaches, etc. Designs may engage a variety of community-based HIV-related service providers who provide services targeting common comorbid issues. Primary outcomes must include HIV-specific youth health outcomes on the PHCC.

Applications should provide a detailed overview of the research design and sample of the proposed study. This overview should include:

  • A discussion of the significance of the proposed research to define HIV-negative adolescents at highest risk of HIV seroconversion, including any special populations whose behaviors may pose a particularly high risk, and the critical steps along the HIV prevention continuum that will advance effective interventions to reduce HIV infections in these youths. Additionally, among adolescents living with HIV, a discussion of the importance of youth-specific research interventions that will inform best practices to improve health outcomes along the HIV care continuum.
  • A detailed description of the proposed research project, including a clear specification of the proposed collaboration within the CRPS between the health authority(ies) and the community-based HIV-related service provider.
  • A description and justification for the target study population(s) for the research question(s) posed and any interventions being tested. Include a discussion of generalizability of the study results, as well as a discussion of efforts that will be made to recruit adequate numbers of high-risk groups, such as adolescent girls and young women and/or special populations of at-risk youth who are often marginalized [e.g. young men who have sex with men (YMSM), transgender youth (TGY) and youth who engage in transactional sex (YCSW) or use substances].
  • A description of the age range to be recruited and enrolled, with a rationale provided that addresses the ethical, legal and regulatory considerations needed to enroll persons under the local age of majority. This includes attention to local laws and policies regulating the participation of minors in research and the provision of clinical services to such youth, with appropriate consideration of issues such as cognitive capacity, truly informed consent, and autonomy, and the appropriate roles of parents and/or guardians. Age ranges should reflect local epidemiology; the existence of legal or policy protections for younger youth should not deter sampling of epidemiologically justified populations.
  • A rigorous study design, appropriate to the goals of the proposed research, including plans for how interventions and assessments will be grounded in an understanding of an adolescent's developmental trajectory and stages, and how they will address an adolescent's evolving cognitive and decisional capacity, judgement, emotional development, social competence, risk and health seeking behaviors, and contextual factors such as sex role, community norms and familial expectations. The plans should also detail how these impact health outcomes along the youth-specific PHCC.
  • Plans to determine the status across the PHCC of an individual (discrete, non-duplicated) study participant, and if appropriate, of the cohort, both at enrollment and during follow-up (e.g. HIV education, testing, re-testing, access/linkage and adherence to pre-exposure prophylaxis (PrEP) and/or other prevention services, linkage to care among youth with positive HIV test, care engagement, drop-out and re-engagement, adherence to ART, viral suppression, etc). Include a description of the methods to be used and appropriate validation plans, as needed. Applicants are encouraged to explore the pros and cons of different innovative approaches with respect to feasibility, cost, and accuracy among other parameters.
  • Description of study outcomes. As described above, primary study outcomes must include HIV-specific youth health outcomes on the PHCC and at least one must include an implementation science measure (e.g., adoption, affordability, fidelity, penetrance, scale-up, sustainability, etc.). Applicants are strongly encouraged to define outcomes across a full continuum of care, using standardized measures that leverage the concept of a cascade of care that incorporates behavioral health services and medical therapies for the prevention and treatment of HIV and its comorbid conditions in AYA. Economic outcomes are also strongly encouraged.
  • For work proposing to develop, test, evaluate and/or refine strategies of dissemination and implementation of evidence-based practices to improve outcomes along the youth-specific PHCC, a clear description of the conceptual models appropriate for dissemination and implementation (D & I) research that will be used and how potential mediators and moderators that may explain the impact of D & I strategies on improving these outcomes will be identified and measured. Include a description of how strategies will be adapted for youth developmental trajectory and local context, and a description of how program costs and other economic outcomes will be incorporated into evaluations that will help address scalability and sustainability.
  • A description and statistical evaluation of the sample size needed to test the study hypothesis and study the individual and contextual factors associated with health outcomes or milestones across the entire spectrum of the PHCC.
  • A strong justification for the selected follow-up period. Applicants are strongly encouraged to plan for follow-ups for one year or longer in both effectiveness and implementation studies.
  • A brief description of proposed clinical research performance sites, including: (1) Detailed plans for ensuring high rates of recruitment and retention; and (2) Justification of the selected number of sites including power analyses appropriate to targeted outcomes and study design. Please see notes below for additional guidance regarding proposed clinical research performance sites.
  • Potential sustainability of the proposed intervention. The research project should be of sufficient priority to these stakeholders that that there is potential for positive findings from the study to be sustainably incorporated into standard practice after the study concludes.

Section B: Justification of Proposed Clinical Research Performance Sites (CRPS)

A minimum of five clinical research performance sites (CRPS) are required. Letters of Support and required details for each research performance site should be provided in Project/Performance Site Location section. The following guidelines should be followed with respect to selecting CRPS:

  • A CRPS is defined as a geographically distinct area, and must include: (a) a national and/or regional health ministry or other local health authority(ies) and (b) one or more community-based HIV-related service providers. Definitions of the scope of the CRPS are outlined in Part 2, Section I of this announcement.
  • If there is any ambiguity with regard to the geographic distinctness of the proposed CRPS, applicants must provide a clear justification for their site selection approach.
  • Although a minimum of five CRPS must be engaged, the actual number of CRPS should be justified scientifically based on power analyses and sample size appropriate to the design and outcomes of interest in the proposed study.
  • In general, it is expected that applicants will be able to pre-specify all expected CRPS. If there is a compelling reason why this cannot or should not be done, applicants should provide similar detail to that described below regarding potential sites and what approach will be used in ultimately selecting sites.
  • Additional detail should be included on planned performance sites as detailed in the SF424(R&R) Project/Performance Site Locations

Section C: Clinical Research Center (CRC) Collaboration Capacity

The research strategy section on CRC collaboration capacity should propose:

  • A partnership on adolescent HIV research with the Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA), where geographically appropriate, to conduct research and capacity-building activities and that includes representatives from one or more academic institutions, government agencies, and non-governmental agencies.
  • A plan for building adolescent HIV IS research capacity in one or more LMICs in collaboration with the Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) and its Cores in order to (a) conduct IS research and (b) use science-based methods and information to develop adolescent HIV prevention and care policies and programs.
  • Plans for community engagement that describe the experience, expertise, and track record of working collaboratively with communities and community-based organizations and that demonstrate how communities of youth, and adults as appropriate, will be actively engaged in all aspects of the research. Establishment and support of regular meetings of a CRC Youth Advisory Board (YAB) or equivalent will be required. Must include plans for development and structure of the CRC YAB, representation from each participating CRPS, and how the CRC YAB will be used, how often they will meet, and how they will meaningfully contribute to the research of the CRC and to the PATC3H-IN network, through participation on the network-wide PATC3H-IN YAB with support from the CTAMAC.

Applicants should also include a general discussion of the CRC capacities to engage with the rest of the PATC3H-IN network, including capacity to:

  • Participate in data harmonization and other collaborative efforts within the network;
  • Contribute unique expertise and research capacity to the network; and
  • Demonstrate a track record of collaboration in similar multi-site and multi-center efforts.
  • If multiple organizations will collaborate as part of the proposed Clinical Research Center, a plan for collaboration within the center must be presented as well.
  • Commit to provide CTAMAC accurate data to facilitate the ability of the CTAMAC to provide NICHD with accurate data-driven updates of network progress.

Letters of Support: For each proposed clinical research performance site (CRPS), letters of support from both the (a) targeted national and/or regional health ministry or other local health authority(ies) and (b) community-based HIV-related service provider entity(ies) should be provided. If a study design proposes recruiting sites during the course of study conduct, strong justifications demonstrating feasibility of recruitment (e.g., letters of support from a state government official overseeing a health system with multiple potential sites) and a strong justification for the selection of this strategy must be included.

Letters of support must provide evidence that (1) the proposed HIV IS research is aligned with the designated LMIC's scale-up efforts for AYA HIV prevention and care, and (2) there is adequate funding and other material public and/or private support to ensure that the designated LMIC's scale-up efforts will proceed or continue to proceed as planned after NIH-support is completed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD requires that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, are expected to include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. This plan must include procedures, milestones, and timelines to make the data and bio specimens available for access and analysis by the research community as appropriate. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses.Information about DASH may be obtained at https://dash.nichd.nih.gov/.

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

Does the Center address questions that will improve rates of prevention of new HIV infections among adolescents at risk and the identification of, and linkage and retention to care of and long-term viral suppression among youth living with HIV in low-to-middle income countries (LMICs)? Does the Center address scalable, generalizable HIV treatment and prevention models in community settings? Does the Center generate novel information about how to improve collaborations between (a) national and/or regional health ministry or other local health authority(ies) and (b) community-based HIV-related service providers to improve public health outcomes? Does the research plan address potential sustainability?

 

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this FOA:

Is the time commitment of the PD/PI (s) and the investigators with decision making authorities appropriate for the stated study goals? Is there clear description of roles for each major key personnel involved in the research site? Are Key Personnel from relevant (a) national and/or regional health ministry or other local health authority(ies) AND (b) community-based HIV-related service provider entity(ies) included? If key personnel do not have a history of collaboration, is an appropriate plan in place to ensure successful coordination and communication?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

Does this design test interventions or strategies that are potentially generalizable to other communities or settings? Does this design test a practice or intervention that is widespread, but for which limited evidence is available?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Is there sufficient access to the appropriate population(s)? Does the application include an appropriate plan to insure that the study includes discrete, non-duplicated subjects living in the geographic area of interest?

Is the study design rigorous and appropriate to the level of evidence for the targeted intervention? Are there appropriate methods of assessing the HIV health outcomes along the PHCC of the adolescent participants? Will the proposed research strategy lead to enrollment and retention of adequate numbers of high-risk groups targeted by this FOA (AGWY, YMSM, TGY, YCSW, and adolescents who use substances)? Will the proposed approach support a statistically significant study of the individual and contextual factors associated with various health outcomes along the PHCC for at-risk, uninfected adolescents and youth living with HIV?

Are the approaches likely to result in scalable and efficient study designs? What is the prospect for implementation and sustainability after the grant cycle has ended? Do plans for IS research capacity building sufficiently demonstrate how PATC3H-IN infrastructure, including collaboration with the Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) and its Cores, will be leveraged to advance the mission of the network in one or more LMICs?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA:

What is the prospect of successful achievement of study outcomes given the description and justification provided for the proposed geographically distinct CRPS? Is there sufficient evidence provided in the letters of support to demonstrate that the proposed HIV IS research is aligned with the designated LMIC's scale-up efforts for AYA HIV prevention and care?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council (NACHHD). The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Compliance with data and resource sharing policies.
  • NIH discretion with application selection to ensure a synergistic and equitable range of topics specific to this FOA are addressed (i.e., prevention approaches and specific parts of the continuum of care, diverse populations, and geographic distribution) and which have maximal likelihood of scalability and sustainability of impact.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
 

The PD(s)/PI(s) will have the primary responsibility for:

PATC3H-IN Clinical Research Center (CRC)

The PATC3H-IN CRC will consist of the Principal Investigator(s), project manager, and staff deemed necessary to carry out the mission of the CRC. The CRC project manager will coordinate the activities of the CRC and all affiliated CRPS at the direction of the Principal Investigator. The CRC will be responsible for:

  • Organizing a local Executive Committee for day-to-day management of the study
  • The planning, direction, execution and monitoring of the proposed research, including: definition of objectives and approaches; implementation; data management, storage and analysis, interpretations and publication of results
  • Provide training, including the development and updating of study manuals of operation, to all personnel related to acceptable quality control and quality assurance procedures at all participating CRPS as well as protocol-training where indicated
  • Provide on-site monitoring for those studies being performed at a particular CRPS on a schedule dictated by the SLC, its authorized subcommittee or NICHD, as needs arise
  • Organizing and supporting a local CRC Youth Advisory Board (YAB) or equivalent to regularly contribute to the research of the CRC and to the PATC3H-IN network, including logistical support in-person PATC3H-IN meetings.
  • Ensuring cooperation and coordination with the Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC). This includes ensuring progress on recruitment, data cleaning, and other activities is reported in a timely fashion.
  • Serving as a member of the PATC3H-IN Scientific Leadership Committee (SLC) and participating in required activities, including primary responsibility for organizing regular conference calls and 1-2 annual PATC3H-IN face-to-face meetings to focus on study initiation, progress and results.
  • The management of plans for study participants at any stage across the PHCC (e.g. referrals for adolescents who seroconvert during the project for HIV treatment, including the care provider or providers to which they will be referred and a description of how they will be followed to obtain information on their subsequent treatment for HIV and tracking of their PHCC outcomes; referrals for high-risk exposures among HIV-uninfected youth to HIV prevention services like post-exposure ART prophylaxis (PEP) and/or PrEP and descriptions of how their PHCC outcomes will be tracked). These plans should include necessary and relevant collaborations and agreements with local and national agencies to facilitate the successful achievement of the research objectives. Information about management status of all subjects on study is also required in annual progress reports
  • Collaboratively building adolescent HIV IS research capacity in one or more LMICs in partnership with the Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) and its Cores
  • Collaboratively plan and conduct all recurring SLC and PATC3H-IN meetings and work with the PATC3H-IN SLC and NIH to assemble and convene the PATC3H-IN External Scientific Advisory Board (ESAB) at least annually
  • Making drafts of manuscripts available for review (electronically) to the NIH Project Scientists and other NIH staff at the time they are circulated to coauthors and when the final manuscripts are submitted for publication. This ensures the program can maintain an up-to-date summary of program accomplishments and can prepare for press releases of findings, if warranted
  • Working with the PATC3H-IN SLC and CTAMAC to produce and maintain documentation of Network manual of operations which includes but is not limited to standard operating procedures, publications and data sharing policies, and study training manuals. The Network manual will be administratively managed by the CTAMAC.
  • Agreeing to abide by the procedures and policies established by the SLC
  • Work with the CTAMAC to stablish and support a Data and Safety Monitoring Board (DSMB) when instructed by NICHD
  • Participating in the overall coordination of NIH research efforts on AYA and HIV in LMIC settings; this participation may include collaboration and consultation with other NIH awardees, the appropriate sharing of information, data, and research materials, and participation in NIH efforts to standardize and harmonize pre-clinical and clinical data collection.
  • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Project Scientists will represent each of the institutes co-sponsoring the FOA.

The NIH Project Scientist(s) will:

  • Participate in the PATC3H-IN SLC that oversees the establishment, maintenance and collaborative scientific efforts of PATC3H-IN and its progress in achieving program goals
  • Assist the PATC3H-IN SLC in monitoring the progress of ongoing studies, including field data collection, standardization of methods across study sites, and adherence to protocol and quality control measures
  • Work closely with the PATC3H-IN CRC and CTAMAC PD(s)/PI(s), the SLC, and the PD(s)/PI(s) of all PATC3H-IN network components in order to ensure proper conduct of all research activities to achieve the mission of the network
  • Assist the PATC3H-IN SLC in the selection of research topics, and the development or review of protocols for specific studies and interventions
  • Assist the PATC3H-IN SLC in identifying PATC3H-IN resources required for the successful implementation of collaboratively developed research protocols
  • Arrange Program and/or peer review of all new PATC3H-IN protocols developed during the project cycle and, when necessary, the external peer review of the protocols, clearing these studies for implementation
  • Assist in data analyses, interpretation, and publication of study results
  • Assist in identifying the need to terminate or curtail the study (or an individual award) in the event of nonparticipation in the committee/group activities, substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of protocol, or substantive protocol changes without prior approval from NIH Program or the PATC3H-IN SLC.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The duties of the NIH Program Official include:

  • Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines.
  • Phase out or curtail the award (or an individual component of the award) in the event technical performance requirements are not met.
  • Perform other duties required for normal program stewardship of grants.

Areas of Joint Responsibility include:

The PATC3H-IN Scientific Leadership Committee (SLC)

The PATC3H-IN SLC is the primary governing body of the Cooperative and will consist of PD(s)/PI(s) and other representatives from each component the PATC3H-IN network, the NIH project scientists and other scientific experts as agreed to by the SLC, as follows: a single representative from each CRC, up to three from the CTAMAC, two site coordinators, two youth advisory board members and the NIH Project Scientists. A chairperson of the SLC will be appointed by NICHD, as will any additional members the institute has deemed necessary after awards are issued.

The PATC3H-IN SLC will oversee the integration of efforts through leadership, efficient communication, coordination and scientific collaboration across the multiple participating research institutions, as well as close interaction with NIH program staff members. The PATC3H-IN SLC will have the primary responsibility for identifying emerging scientific priorities, defining the collaboration research and capacity building agenda, and implementing these in the network within the guidelines of this FOA. The PATC3H-IN SLC will retain custody of and have primary rights to the data and software developed under such collaborations, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Each full member will have one vote. Each NIH Project Scientist will also have one vote.

Awardee members of the PATC3H-IN SLC will be required to accept and implement policies approved by the PATC3H-IN SLC.

Specifically, the SLC will:

  • Identify adolescent-specific HIV research objectives to address the PHCC
  • Approve the direction of the research effort including any reconfiguration of working groups to better address the direction of the scientific agenda
  • Approve the policies and procedures developed, adopted or revised by the network
  • Critically evaluate and approve the research agenda specific to its scientific merit, feasibility, clinical relevance, and implications as well as advise on the development of implementation strategies
  • Establish timelines for the completion of tasks and monitor progress
  • Execute all Memoranda of Understanding or Agreement with other entities to conduct PATC3H-IN developed or co-endorsed research
  • Coordinate PATC3H-IN collaboration with investigators with funding from sources other than NIH-funded networks
  • Be responsible for the fiscal management and tracking of all network resources, either directly or through establishment of a specific subcommittee tasked with this function in an iterative and continuous manner, through a collaborative effort with the PATC3H-IN CTAMAC
  • Approve use of discretionary funds as recommended by NIH
  • Develop a formal liaison with the Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA), where geographically appropriate, to conduct research and capacity-building activities
  • Supervise progress, with the assistance of the NICHD staff, in identifying resources within PATC3H-IN to support subject recruitment, enrollment, retention, data collection, specimen shipping, and negotiated protocol monitoring costs for PATC3H-IN approved protocols and in recommending to NICHD the use of funds for such support
  • Participate in regular conference calls and attend PATC3H-IN meetings to be held at least semi-annually.
  • Facilitate, with the support of the CTAMAC, development of research protocols, human subjects and other regulatory protocols, data harmonization, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products
  • Adhere to policies and procedures on Data Management, Analysis, and Access: Data generated are the property of the awardee. Research sites must provide requested data to the CTAMAC in a timely fashion in accordance with the policies and procedures established in study protocols and by the SLC. In addition, the CTAMAC and all research sites of the CRC must provide NICHD with access to all data generated under this award, subject to rules specified in any Certificates of Confidentiality obtained by awardees. Data must be shared upon request with the SLC and subcommittees reporting to the SLC when appropriate.
  • Cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care systems engaged in research and beyond

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Bill G. Kapogiannis, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-0698
Email:kapogiannisb@mail.nih.gov

Richard A Jenkins
National Institute on Drug Abuse (NIDA)
Phone: 301-443-6504
E-mail: jenkinsri@mail.nih.gov

Richard Berzon
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: berzonra@mail.nih.gov

Susannah Allison, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: allisonsu@mail.nih.gov

Geetha Parthasarathy Bansal
Fogarty International Center (FIC)
Phone: (301) 496-1653
E-mail: geetha.bansal@nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email:duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Mario Martinez, MPH

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Telephone: 301-402-4078

Email: martinem@mail.nih.gov

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Priscilla Grant
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email:siscor@mail.nih.gov

Bruce R Butrum
Fogarty International Center (FIC)
Phone: 301-451-6830
E-mail: butrumb@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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