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ID#: RFA-AI-12-001 (Reissue of RFA-AI-05-001)     Posted: 27 Feb 2012
Leadership Group for a Clinical Research Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations (UM1)
Deadline: 28 Sep 2012
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Type of Grant: Research
Topics/Fields of Support: Clinical trial site challenges, HIV transmission and acute infection, Pediatric/adolescent infections and trials
National Institutes of Health (NIH, NIAID, NIHCD, NIDCR, 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.

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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.

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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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The purpose of this FOA is to encourage applications for the Leadership Group (LG) for a Clinical Research Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations.  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 Directors/Principal Investigators (PDs/PIs) and senior/key personnel of the affiliated Clinical Trial Units/Clinical Research Sites (CTUs/CRSs) collectively constitute the Clinical Research Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations (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 twoHIV/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.


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.

Among the most significant advances in the field of HIV treatment has been the ability to prevent mother-to-child transmission (MTCT), which is now less than 2 percent in high-income countries.  Even in low-income countries, the use of antiretroviral (ARV) drugs during pregnancy, intrapartum, and after birth including during breast feeding, has reduced MTCT substantially.  UNAIDS estimates that over 340,000 infections in infants are averted each year; nevertheless, over 370,000 infants still become HIV-infected.

Although access to care and treatment services for HIV-infected children in low-income countries is expanding, an estimated 260,000 children died from HIV/AIDS in 2007, adding to more than 4 million children already claimed by the epidemic.  Without treatment, approximately one-half of children who are HIV-infected will die by their second birthday.

The known timing of infection makes infants an important population to study. The timing of intrapartum infant infection can be pinpointed to within a few days, allowing unique research into HIV reservoirs and interventions to prevent their development. The presence of a functional thymus in infants may offer the best opportunity to evaluate immunomodulatory changes that may lead to a functional cure.

Treatment of infants, children, adolescents and pregnant women with HIV or HIV-associated infections presents unique challenges.  Palatable powder or liquid formulations for infants and children can be difficult to manufacture; approximately half of the current oral antiretroviral agents are not available in a pediatric formulation and even fewer have indications or dosing recommendations for infants or young children.  In addition, concerns about teratogenicity prevent or delay clinical trials of many needed medications for pregnant women. The use of biomedical and behavioral interventions to prevent HIV infection cannot be adopted in adolescents until feasibility and acceptability are established in that age group.

The high mortality rate in children with HIV is due in part to their susceptibility to the many childhood infections endemic to geographic areas with high HIV prevalence.  Children are at risk for death due to tuberculosis (TB), or other respiratory and gastrointestinal illnesses.  Some of these illnesses can be prevented or at least ameliorated by vaccines; however, often vaccines are not available or it is unknown whether HIV-infected children should receive the standard vaccination or use an augmented schedule.  In addition, it is unclear if vaccinating HIV-infected pregnant women affects their susceptibility to infection and/or protection for their infants.

Questions still remain about the impact of HIV infection and/or long-term antiretroviral therapy on the growing and developing child. Untreated HIV infection has deleterious effects on growth and development; however, it is unclear how effectively early antiretroviral treatment can ameliorate non-infectious complications of HIV.  While early treatment reduces morbidity and mortality from HIV, treatment is not without consequences.  The total impact of antiretroviral drug exposure perinatally, throughout childhood and during puberty is not known.

In recognition of the frequent occurrence of HIV related oral diseases, both in treated and untreated HIV infected individuals, the NIAID in collaboration with the National Institute of Dental and Craniofacial Research (NIDCR) seeks for the inclusion and implementation of an oral health research agenda, in which clinical interventions are linked to, and integrated within, the HIV/AIDS research priority areas. 

Research Priority Areas

The network will focus its research on infants, children, adolescents and pregnant/postpartum women with HIV or HIV-associated infections, or, in some cases, at high risk for HIV infection.  NIAID’s scientific priority areas to be addressed by the LG of the network in their proposed clinical research agenda include the following (not listed in priority order):

  • Vaccines of high priority to these populations
  • Cure and/or functional cure of HIV
  • Co-infections, co-morbidities and consequences of antiretroviral therapy 
  • Prevention of acquisition of HIV
  • Pharmacology, drug formulations and novel interventions

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

Vaccines of high priority:

  • Safety of licensed and other high priority vaccines
  • Immunogenicity and efficacy in HIV-infected populations compared to HIV-uninfected populations
  • Infant protection through maternal vaccination

Cure and/or functional cure of HIV: utilizing the unique opportunity presented by the known timing of intrapartum transmission to:

  • Quantify viral reservoirs
  • Investigate host, viral or other factors that influence the size of the viral reservoirs
  • Evaluate new therapeutic interventions or combinations of antiretrovirals administered during acute infection to prevent establishment of viral reservoirs

Co-infections, co-morbidities and consequences of antiretroviral therapy:

  • Inflammation, immune activation and senescence related to HIV infection, HIV treatment and co-morbidities, including strategies for amelioration
  • Interventions to prevent and treat co-morbidities, co-infections and adverse antiretroviral consequences, including adverse consequences in HIV-exposed uninfected infants to antiretrovirals to prevent MTCT of HIV
  • Non-invasive, reliable and widely accessible tests and strategies to diagnose TB and other HIV-associated infections in infants and children
  • Evaluation of strategies to prevent MTCT of HIV-associated infections, such as TB and hepatitis

Strategies to prevent acquisition of HIV:

  • Bridging studies evaluating the safety, feasibility, acceptability and efficacy of biomedical and behavioral interventions to prevent HIV infection in adolescents, including but not limited to microbicides, pre-exposure prophylaxis (PrEP) treatment as prevention, test and treat and vaccines
  • Identification of incident infection in pregnant and breastfeeding mothers to prevent transmission to their infants
  • Evaluation of high priority emerging questions related to MTCT

Pharmacology, drug formulations and novel interventions:

  • Determination of the safety, tolerability and optimal dosing of antiretrovirals and medications for prevention and treatment of HIV and HIV-associated infections in the pediatric, adolescents and maternal populations, including the impact of host genetic differences
  • Elucidation of drug-drug interactions involving antiretrovirals and medications to treat co-infections and co-morbidities
  • Evaluation of innovative drug formulations and delivery platforms
  • Evaluation of novel anti-HIV compounds, therapeutic vaccines and other interventions aimed at ameliorating the effects of HIV infection

In relation to the HIV related oral disease research agenda special emphasis will be put on addressing: 1) oral immune activation (IRIS), oral inflammation and oral immune dysregulation; 2) oral mucosal lesions including oral fungal-, HIV- and viral-opportunistic infections as well as eradication of these infections from oral mucosal reservoirs; 3) viral-related tumors and malignancies of the oral cavity

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.


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)


  • 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


  • 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

Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration:  See instructional documents in the NIH Guide Publishing System for the text to insert.

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 Statement, are 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 least four (4) 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.    


NIH encourages inquiries concerning this funding opportunity and welcomes the opportunity to answer questions from potential applicants. 

Additional information and definitions of terms can be found at the following website.   

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936

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

Scientific/Research Contact(s)

Judi Miller, BSN
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5227, MSC-7624
6700B Rockledge Drive
Bethesda, MD 20982-7624 (for Express Mail- 20817)
Telephone:  301-496-1189
FAX:  301-480-4582

Lynne M. Mofenson MD 
Center for Research for Mothers and Children 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD
Room 4B11E, MSC-7510
6100 Executive Boulevard
Rockville, MD 20852-7510
Telephone:  301-435-6870
FAX:  301-496-8678 

Dr. Isaac Rodriguez-Chavez
National Institute for Dental and Craniofacial Research (NIDCR)
Director, NIDCR, DER, AIDS & Immunosuppressive Program
Room 614, MSC 4878
6701 Democracy Boulevard
Bethesda, MD 20892-4878
Telephone: 301-594-7985
FAX: 301-402-3684

Dr. Pim Brouwers
Center for Mental Health Research on AIDS
National Institute of Mental Health (NIMH)
Room 6216, MSC-9619
6001 Executive Boulevard
Bethesda, MD  20892-9619
Telephone:  301-443-4526
FAX:  301-443-9719

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Tina Carlisle
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2121, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone:  301-402-6579
FAX:  301-493-0597

Bryan Clarke
Office of Administrative Management
Eunice Kennedy Shriver National Institutes of Child Health and Human Development
Room 8A01, MSC-7510 
6100 Executive Boulevard 
Bethesda, MD  20892-7510
Telephone:  301-435-6975

Rita Sisco
Division of Extramural Research
National Institute of Mental Health
Room 6120, MSC-9605 
6001 Executive Boulevard
Bethesda, MD  20892-9605
Telephone:  301-443-2805
FAX:  301-480-1956