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HIV VACCINE ELECTRONIC (E) RESOURCE
ID#: RFA-AI-12-011(Reissue of RFA-AI-05-001)     Posted: 27 Feb 2012
Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV Infection (UM1)
Deadline: 28 Sep 2012
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Type of Grant: Research
Topics/Fields of Support: Preclinical and clinical vaccine trials
National Institutes of Health (NIH, NIAID, NIDA, NIMH)

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency—making important medical discoveries that improve health and save lives.

Thanks in large part to NIH-funded medical research, Americans today are living longer and healthier. Life expectancy in the United States has jumped from 47 years in 1900 to 77 years today, and disability in people over age 65 has dropped dramatically in the past 3 decades. In recent years, nationwide rates of new diagnoses and deaths from all cancers combined have fallen significantly.

Scientific Leadership

NIH is the largest source of funding for medical research in the world, creating hundreds of thousands of high-quality jobs by funding thousands of scientists in universities and research institutions in every state across America and around the globe.

NIH is made up of 27 Institutes and Centers, each with a specific research agenda, often focusing on particular diseases or body systems. NIH leadership plays an active role in shaping the agency's activities and outlook.

The Office of the Director is the central office at NIH, responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all the NIH components. The NIH Director, with a unique and critical perspective on the entire agency, is responsible for providing leadership to the Institutes and for constantly identifying needs and opportunities, especially for efforts that involve multiple Institutes. The NIH Director is assisted by the NIH Deputy Directors including the Principal Deputy Director, who shares in the overall direction of the agency's activities.

More than 80% of the NIH's budget goes to more than 300,000 research personnel at over 3,000 universities and research institutions. In addition, about 6,000 scientists work in NIH’s own laboratories, most of which are on the NIH main campus in Bethesda, Maryland. The main campus is also home to the NIH Clinical Center, the largest hospital in the world totally dedicated to clinical research.

Successful biomedical research depends on the talent and dedication of the scientific workforce. NIH supports many innovative training programs and funding mechanisms  that foster scientific creativity and exploration. The goal is to strengthen our nation’s research capacity, broaden our research base, and inspire a passion for science in current and future generations of researchers.


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DETAILS

Purpose

The purpose of this FOA is to encourage applications for the Leadership Group (LG) for a Clinical Research Network on Integrated Strategies to Prevent HIV Infection.  The LG will have overall responsibility for: (i) developing, implementing and adapting the network’s clinical research agenda to address NIAID’s HIV/AIDS scientific priorities described below in Part 2, Section I, 3, (ii) overseeing and managing the network’s scientific/clinical research activities and associated laboratory and statistical/data management support functions, (iii) allocating network resources, and (iv) evaluating network performance using a LG proposed/Division of AIDS (DAIDS) approved process and evaluation standards.

The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) and senior/key personnel of the LOC, LC and SDMC together form the LG. The LG coupled with the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) and senior/key personnel of the affiliated Clinical Trial Units/Clinical Research Sites (CTUs/CRSs) collectively constitute the Clinical Research Network on Integrated Strategies to Prevent HIV Infection (herein referred to as the “network”). The three different parts of the LG (LOC, LC and SDMC) will be required to work together collaboratively and with the network-affiliated CTUs/CRSs to carry out the activities that are essential to achieving the network’s clinical research agenda.

Clinical Trial Units (CTUs) provide the scientific and administrative expertise as well as the infrastructure to contribute to NIAID Clinical Research Networks.  A CTU is an organization/institution composed of at least one, but no more than eight CRSs that can contribute to at least two HIV/AIDS Clinical Research Networks.  The CTU PD(s)/PI(s) is/are responsible for all CTU/CRS activities and performance, and also serve(s) as scientific and administrative representative(s) to the CTU’s affiliated network(s).

A Clinical Research Site (CRS) is a component of a CTU and is defined as a discrete location (e.g. hospital, outpatient clinic, community health center, private practice, local health department clinic) with appropriate identified and characterized potential trial participants (e.g. demographics, incidence and prevalence of HIV/AIDS) where participant recruitment and retention, protocol management and other clinical research activities are conducted. The CRS must be staffed by qualified professionals capable of conducting clinical research for one or more clinical research networks in accordance with Good Clinical Practice (GCP), local regulatory requirements, and other applicable NIH requirements.  In addition, each CRS must participate in one or more HIV/AIDS clinical research network(s). The activities of each CRS will be directed by a CRS Leader with the experience and qualifications to oversee clinical activities and the day-to-day clinic operations will be overseen by a CRS Coordinator with relevant clinical research experience and qualifications.  An individual CRS and/or CRS Leader may be proposed in only one CTU application. 

Background

NIAID currently supports six HIV/AIDS clinical research networks: the AIDS Clinical Trials Group (ACTG), the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HVTN), the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), and the Microbicide Trials Network (MTN).

Over the past 30 years, HIV/AIDS research has led to phenomenal scientific advances.  Scientists uncovered the structure and genetic organization of HIV and began to understand the mechanisms by which HIV causes disease.  This understanding led to the development of (i) tests to detect HIV infection, measure HIV viral load and monitor immune function, and (ii) highly active antiretroviral therapies (HAART).

Despite these scientific advances, according to the Joint United Nations Programme on HIV/AIDS (UNAIDS), 33 million people globally are estimated to be living with HIV, of whom 22 million are living in sub-Saharan Africa.  Slightly more than half of all people living with HIV are women and girls.  In sub-Saharan Africa, more women than men are living with HIV, and young women aged 15–24 years are as much as eight times more likely than men to be HIV-infected.

NIAID has supported the development of new strategies to prevent the spread of HIV through the HPTN, the MTN, the IMPAACT, the HTVN and the ACTG networks.  The NIAID research priorities in the area of non-microbicide and non-vaccine prevention have been to identify practical, safe and effective approaches to halt the spread of HIV, especially in domestic and international populations at greatest risk; to develop integrated behavioral and biomedical prevention models that are efficacious, cost-effective, locally-appropriate, and sustainable; and to evaluate the generalizability and scale up potential of integrated prevention programs in different cultural contexts.

To address these broad ranging goals, the HPTN developed and implemented a strategy trial to evaluate the ability of enhanced community-wide testing and counseling to reduce HIV incidence at multiple urban and rural sites in sub-Saharan Africa and Thailand. The HPTN also implemented a trial of medication assisted treatment (buprenorphine/naloxone) and intensive counseling strategy to prevent HIV infection in opiate injectors at multiple sites in Asia.  The HPTN has recently undertaken strategy trials to assess the feasibility of reaching and retaining black MSM and females at high risk of HIV infection in the United States and initiated a district wide test, treat and link to care strategy domestically.   Finally, the HPTN also conducted a trial to evaluate the treatment and prevention benefits of early versus standard initiation of antiretroviral therapy among serodiscordant couples at multiple international sites.  This study revealed a significant benefit in preventing HIV infection of the uninfected partner when the infected partner initiated ART immediately compared to those who delayed ART.

The ultimate goal of HIV prevention research is to reduce incidence at the population level.   Since it is likely that no one intervention or strategy will be completely effective or accepted by all persons at risk of acquiring HIV infection, multiple “prevention packages” (combination strategies) optimized for  specific populations and/or settings must be developed.  The outcomes of highest importance are effectiveness in reducing incidence, feasibility of scale up and sustainability.

Pre-exposure prophylaxis (PrEP) is a specific area where activities must be strengthened and moved forward.  In recent trials TruvadaTM provided 44% efficacy for MSM and 73% efficacy in HIV serodiscordant couples.  The trial in MSM revealed that adherence is even more important than had been previously recognized; drug levels from a random sample of participants in this study indicated that overall adherence was only 50%.  These results reinforce the need to explore better ways of increasing adherence through intermittent dosing, longer acting agents and/or long term delivery systems.

Research Priority Areas:

NIAID’s scientific priority areas to be addressed in response to this FOA include the following two areas (not listed in priority order):

  • Evaluate and optimize integrated strategies to prevent HIV infection.
  • Evaluate and optimize most promising pre-exposure prophylaxis (PrEP) regimens

Examples of research within the priority areas in the LG applications include, but are not limited to the following:

Evaluate and optimize integrated strategies to prevent HIV infection

  • Antiretroviral treatment as prevention
  • Counseling and testing approaches
  • Enhanced linkage to care strategies
  • Male Circumcision
  • Prevention of mother to child transmission
  • Integrated substance use and HIV prevention 

Evaluate and optimize pre-exposure prophylaxis regimens

  • Pharmacokinetic/pharmacodynamic assessment
  • Efficacy
  • Acceptability
  • Bridging studies          
  • Sustained delivery formulations

Adherence to an agent as well as a clinical trial protocol is essential to the success of prevention and treatment-related protocols.  It is therefore expected that protocol teams will seek relevant scientific guidance and expertise at the concept stage in order to assure that state-of-the-art interventions to support adherence and valid assessments to measure adherence are appropriately incorporated. If attention to adherence is considered not critical to the protocol, justification to that effect must be approved by Network Leadership.

Application Requirements

The LG will be responsible for all network activities and will ensure that all the constituent parts of the network fulfill their respective responsibilities in the most efficient and effective manner possible.  Each part of the LG linked application (LOC, LC, and SDMC) is expected to demonstrate scientific leadership, effective management and efficient utilization of resources.

Leadership Time Commitment.  When a single PD/PI is proposed in any of the three LG applications, the PD/PI will be required to devote at least 6 person months effort to the project.  Applications proposing Multiple PD(s)/PI(s) are permitted, but the roles and responsibilities of multiple PD(s)/PI(s) should be clearly delineated and justified.  If two or more PD(s)/PI(s) are named in any application, each PD/PI must devote at least 3.6 person months effort to the project.

The governance and organizational structure of the LG leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD(s)/PI(s) and other collaborators.

Research Agenda.  The LG’s clinical research agenda should be clearly articulated and directly related to achieving NIAID’s scientific priorities.  The LG is required to monitor and evaluate the need to refine and revise the research agenda. As part of this process, the LG is required to actively engage input from researchers and HIV-affected communities.

Governance and Management.  The LOC, LC and SDMC, in their areas of responsibility, must establish and define effective communication and decision making processes, identify clear lines of authority, coordinate and collaborate effectively both within the network and with other NIH-supported networks or other Federal and private sector clinical research programs as appropriate to avoid redundancies and ensure efficiencies.  Governance or management by committees is permitted.  The governance and management should utilize effective approaches to project management, including project plans with identified key milestones; ongoing evaluation of projections against actual data and adjustments to project plans; and development and implementation of contingency plans. In addition, the LOC, LC and SDMC, in their area of responsibility, must establish processes to identify and resolve operational issues and develop training and education programs within the context of the network’s research agenda for network members, including new researchers, particularly from under-represented populations and those in low and middle income countries.

Bylaws, policies and standard operating procedures should not be included in the application, but must be provided, for approval, to NIAID within 90 days of Notice of Award.

Resource Utilization and Allocation.  The LOC, LC and SDMC, in their area of responsibility, must ensure optimal resource utilization and ensure that resource allocation supports the clinical research agenda.

Collaborative Responsibilities. The LG will be strongly encouraged to collaborate with other NIH-supported networks and other Federal and private sector clinical research programs, and to interact with government and non-government organizations, including the private sector, and committees to effectively develop and implement a clinically relevant, interdisciplinary and cost-efficient clinical research network.  Such collaborations and interactions are essential for the development and implementation of a comprehensive research agenda that utilizes the strengths, experience and expertise of the various collaborating organizations.  The sharing of expertise, resources and procedures is expected in key areas, including: development of clinical infrastructure in low-income countries; harmonization of laboratory resources and specimen management; harmonization of common data elements and data entry interfaces; community engagement, including development, training and support of community advisory boards. Examples of additional entities the LG will need to collaborate and/or communicate with include, but are not limited to:  the Adolescent Medicine Trials Network (ATN), the NIAID Strategic Working Group (SWG), Scientific Review Committees (SRCs),  network LG Program Officers (NLGPOs) and Project Scientists, the Division of AIDS (DAIDS) Enterprise System (DAIDS-ES), Office of Clinical Site Oversight (OCSO), the DAIDS Clinical Laboratory Oversight Team (DCLOT), the HIV/AIDS Network Coordination Office (HANC), other HIV/AIDS Clinical Research Network groups and the non-HIV/AIDS Research Network.

ELIGIBILITY

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

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)

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)
  • 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   

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not 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 Statementare allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

When a single PD/PI is proposed in any of the three LG applications, the PD/PI will be required to devote at least 6 person months effort to the project.  If two or more PD(s)/PI(s) are named in any application, each PD/PI must devote at least 3.6 person months effort to the project.  

CONTACT INFORMATION

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

Additional information and definitions of terms can be found at the following website.http://www.niaid.nih.gov/labsandresources/restructuring/pages/default.aspx    

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov 

Scientific/Research Contact(s)

NIAID

Mike Gilbreath, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5249, MSC-7620
6700B Rockledge Drive
Bethesda, MD 20982-7624(for Express Mail- 20817)
Telephone:  301-451-2743 (office)
Email: gilbreathmj@niaid.nih.gov

NIDA

Richard Jenkins, Ph.D.
Prevention Research Branch
National Institute on Drug Abuse (NIDA)
Room 5170, MSC-9589
NSC - Neuro Science Center
6001 Executive Boulevard
Rockville, MD 20852-9589
Telephone:  301-443-1923 
Email: jenkinsri@nida.nih.gov

NIMH

Christopher Gordon, Ph.D.
Prevention Research Branch
National Institute of Mental Health (NIMH)
Room 6212, MSC-9619
NSC - Neuro Science Center
6001 Executive Boulevard
Rockville, MD 20852-9619
Telephone:  301-443-6100
Email: cgordon1@mail.nih.gov 

Peer Review Contact(s)

Peter R. Jackson, PhD
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3133, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (for Express Mail – 20817)
Telephone 301-496-8426
FAX: 301-480-2310
Email:  pjackson@niaid.nih.gov

Financial/Grants Management Contact(s)

Penny Williams 
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 2241, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone:  301-402-5937
FAX:  301-402-0597
Email: plwilliams@mail.nih.gov