January 2018 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year 2021 Concepts

Fiscal Year 2019 Concept

Fiscal Year 2019 Small Business Innovation Research (SBIR) Contract Solicitation Topics

HIV Prevention Clinical Trials Leadership and Operations Center (Clinical Trial Required)

Request for Applications—proposed FY 2021 initiative

Contact: Sheryl Zwerski

Objective: The focus of HIV prevention research is to deliver products and strategies that will reduce HIV incidence at the population level. Since it is likely that no one intervention or strategy will meet the needs of all persons at risk of acquiring HIV, multiple prevention options are needed that are effective, desirable, and sustainable.

This initiative will provide scientific leadership and operational management to support a coordinated, multidisciplinary effort to conduct multisite, domestic and international clinical trials directed toward HIV prevention.

Description: The focus of this funding opportunity announcement is the Leadership and Operations Center for the HIV Prevention Clinical Trials Network. The scientific agenda for HIV prevention includes evaluating products and strategies to reduce HIV incidence, focusing on the populations and groups at highest risk of HIV acquisition. HIV prevention products should achieve the goals of safety and high level of effectiveness to prevent HIV acquisition. Additionally, the products or strategies should be designed to fit in to the lives and practices of the target population and address the challenges of adherence.

Product evaluation should include, as appropriate, pharmacokinetic/pharmacodynamic assessments, safety, efficacy, and possibly bridging studies.

End-user preferred characteristics should be determined and considered when developing or testing new HIV products and strategies.

Inclusion of relevant behavioral and social science expertise in study and product design is necessary to enhance uptake and adherence to products and strategies.

Partnerships should be fostered to evaluate the implementation and impact of effective prevention methods on HIV incidence.

Operational principles for the NIH HIV/AIDS Clinical Trials Network include:

  • Implementing and maintaining standardized processes, forms, and project management functions across the network to allocate and track project resources and allow trans-network coordination and reporting. Protocol-based project plans including timelines and resources will allow better forecasting of network activities.
  • Incorporating new researchers, particularly from underrepresented populations and those in resource limited countries, within the context of conducting the network's research agenda.
  • Integrating community participation in network activities, from the scientific agenda to protocol development and community engagement; providing support for network community advisory boards; and providing support for community training and education as needed to ensure the success of the network’s research agenda.

HIV Vaccines Clinical Trials Leadership and Operations Center (Clinical Trial Required)

Request for Applications—proposed FY 2021 initiative

Contact: Mary Marovich

Objective: The focus of this initiative is to provide scientific leadership and operational direction to support coordinated, multidisciplinary efforts to advance the field of preventive HIV vaccine research. HIV vaccine research and development remains a critical high-priority of NIAID DAIDS, with the ultimate objective of identifying safe and globally efficacious preventive vaccines to protect against HIV infection and/or disease progression across the lifespan and for all age and risk groups. The objectives will primarily be addressed through clinical research (primarily, but not exclusively, clinical trials and laboratory evaluation of specimens) directly related to identifying safe and efficacious preventive HIV vaccines, defining the correlates of vaccine protection, and answering additional key clinical and immunologic research questions to expedite vaccine discovery and development.

In addition, this initiative will provide for the collaboration of the preventive HIV Vaccines Leadership and Operations Center (LOC) with other NIH divisions and institutes and centers to evaluate vaccines against other infectious diseases that burden populations impacted by HIV or to meet emerging public health needs. This may include, but is not limited to, tuberculosis and hepatitis C.

Description: The focus of this funding opportunity announcement is the Leadership and Operations Center (LOC) for the HIV Vaccines Clinical Trials Network.

The proposed scientific agenda to further identifying safe and effective HIV vaccines will include:

  • Designing and conducting Phase I and II trials to address scientific questions critical to developing an efficacious preventive HIV vaccine; performing standardized evaluation of candidate vaccines, combinations, immune activators and adjuvants; evaluating the impact of vector immunity; and assessing new and innovative approaches that show promise in preclinical development (e.g., mucosal immunization, mechanisms to enhance innate immunity, novel envelope immunogens, broadly neutralizing antibodies).
  • Designing and conducting Phase IIb and III trials to evaluate whether promising vaccine candidates can prevent HIV infection (and progression of infection); capitalizing on the findings of previous Phase IIb and III studies to advance the development of vaccine and other immune activator regimens, including adjuvants, delivery methods, as well as reagents and their optimal combinations; and optimizing efficient and maximally informative study designs.
  • Assessing immune responses in Phase I and II trials to determine which candidates/combinations are worthy of efficacy testing; developing methods to optimize signal; developing and validating assays for pivotal trials and measuring the breadth of induced immune responses; establishing high-throughput immunogen screening programs; and implementing quality assurance/quality control programs. Whenever possible, design and conduct studies with common protocols, reagents, and assays to permit comparisons of various approaches.
  • Evaluating possible correlates of immune protection in the context of Phase IIb/III trials.
  • Assessing both virus and host genetic variability and their impact on immunogen response and efficacy.

Other goals of the HIV Vaccines LOC include:

  • Collaborating closely with NIH and with other organizations conducting HIV vaccine research to optimize vaccine evaluation and resource utilization.
  • Collaborating with other HIV research networks to maximize efficient use of joint expertise and resources.
  • Optimizing trial designs to accelerate the evaluation and licensing, both domestically and internationally, of preventive HIV vaccines. Enrolling sufficient numbers of women and minorities to assess trends among genders, races, or other host factors across the lifespan; and developing cohorts and collecting epidemiological information necessary to enable the rapid, successful, and cost-effective conduct of efficacy trials.
  • Creating and continuously refining algorithms (e.g., based on preclinical data, expanded response profiles) to compare concepts and vaccine candidates/combinations.
  • Collaborating with other prevention efforts to explore, design, and conduct studies of vaccines in combination with other prevention modalities, as appropriate.
  • Incorporating and fostering research on the epidemiologic and sociobehavioral aspects of vaccine interventions in preventing HIV infection.
  • Developing, implementing, and supporting procedures to ensure that valid data can be employed to license preventive vaccines in at-risk populations.
  • Encouraging ongoing collaboration between clinical researchers and nonhuman primate (NHP) researchers to inform NHP research and, in turn, further inform further human research toward an efficacious preventive HIV vaccine.
  • Providing leadership, expertise, and infrastructure to assess vaccines against other infectious diseases that burden populations impacted by HIV/AIDS.
  • Developing composite protocol budgets that incorporate all leadership and operations costs.
  • Managing protocol implementation funds. Establishing mechanisms for approval and distribution of protocol funds linked to protocol project milestones.
  • Establishing a standing group of collaborators and representatives of academia and industry to regularly review and prioritize studies (concepts) for network consideration.
  • Participating in NIAID organized working groups to coordinate 1) cross-network scientific and operational activities and 2) research communication between basic, preclinical, and clinical researchers (including NHP).
  • Engaging academic and industry partners to develop candidate vaccines to assess different specific scientific hypotheses for prevention and control of HIV infection.

Operational principles for the NIH HIV/AIDS Clinical Trials Network include:

  • Implementing and maintaining standardized processes, forms, and project management functions across the network to allocate and track project resources and allow trans-network coordination and reporting. Protocol-based project plans including timelines and resources will allow better forecasting of network activities.
  • Incorporating new researchers, particularly from underrepresented populations and those in resource limited countries, within the context of conducting the network's research agenda.
  • Integrating community participation in network activities, from scientific agenda to protocol development and community engagement; providing support for network community advisory boards; and providing support for community training and education as needed to ensure the success of the network’s research agenda.

HIV/AIDS Adult Therapeutics Clinical Trials Leadership and Operations Center (Clinical Trial Required)

Request for Applications—proposed FY 2021 initiative

Contact: Sarah Read

Objective: The focus of this initiative is to provide scientific leadership and operational direction to plan and support coordinated, multidisciplinary efforts to advance the field of HIV adult therapeutics research. HIV/AIDS adult therapeutics research and development remains a critical high priority of NIAID DAIDS, with the ultimate objective of HIV suppression or sustained virologic remission for all age groups. The objectives will primarily be addressed through clinical research (primarily, but not exclusively, clinical trials) directly related to HIV and to answering key clinical research questions to expedite HIV suppression or sustained virologic remission.

In addition, this initiative will provide for the collaboration of the HIV/AIDS Adult Therapeutics Leadership and Operations Center with other NIH divisions and institutes and centers to evaluate co-infections and co-morbidities that burden populations impacted by HIV. This may include, but is not limited to, tuberculosis (TB) or hepatitis B.

Description: The focus of this funding opportunity announcement is the Leadership and Operations Center (LOC) for the HIV/AIDS Adult Therapeutics Clinical Trials Network. Although the focus is interventions for HIV/AIDS and associated complications and co-infections, the group may be asked by NIAID to support additional research for populations impacted by HIV or to meet emerging public health needs.

The scientific agenda for HIV/AIDS Adult Therapeutics will include:

Novel and Durable Interventions for HIV

  • Achieving durable HIV suppression for all adults (including special populations) by investigating:
    • Novel drugs and biologics, including long-acting formulations
    • Novel combinations of biomedical and behavioral interventions
  • With partners, demonstrating effectiveness of these approaches as integrated behavioral, biomedical, and structural interventions

Antiretroviral Therapy-Free Remission

  • Identifying strategies to eradicate HIV or to achieve a sustained virologic remission through:
    • Immune-based interventions including therapeutic vaccines and antibodies
    • Gene/cell therapies
    • Interventions that activate or suppress latent provirus
  • Within the context of clinical trials:
    • Investigate host, viral, or other factors that influence HIV persistence and immune response

Complications and Co-infections

  • Identifying and addressing mechanisms, including those caused by HIV viral replication and persistence of viral products, that lead to host cell and tissue dysfunction
  • Partnering to prevent and treat end-organ disease
  • Exploring curative strategies for hepatitis B co-infection

Tuberculosis (TB)

  • Evaluating novel drugs and combination treatments for drug- sensitive and -resistant TB
    • Including new formulations, delivery routes, and adjunctive host-directed therapies
    • Developing improved treatments for HIV and TB co-infection
  • Improving chemoprevention of TB
  • Evaluating new diagnostics and prognostic biomarkers, with a focus on point-of-care testing and extrapulmonary TB
  • Within the context clinical trials, conducting pathogenesis and translational research
  • With partners, improving therapies for TB in the setting of co-morbidities that worsen TB outcomes

Other objectives of the Adult Therapeutics LOC include:

  • Coordinating with the Statistical and Data Management Centers (SDMC) and Laboratory Centers to plan, prioritize, and implement the network’s research agenda.
  • Providing operational capacity, expertise, and infrastructure to work with affiliated sites and collaborating networks as needed to conduct trials.
  • Expertise to design and implement proof-of-concept through Phase IV clinical trials.
  • Efficient protocol development and implementation processes.
  • Collaborating and partnering with other HIV research groups to maximize efficient use of joint expertise and resources.
  • Using a standardized process for project management plans to allow integration with plans of other network awards including SDMC, laboratory, and Clinical Trials Units.
  • Establishing a standing group of network and non-network collaborators and representatives of academics and industry to regularly assess the strategic vision of the LOC.
  • Participating in NIAID organized working groups to coordinate 1) cross-network scientific and operational activities and 2) research communication between basic, preclinical, and clinical researchers.

Operational principles for the NIH HIV/AIDS Clinical Trials Network include:

  • Implementing and maintaining standardized processes, forms, and project management functions across the network to allocate and track project resources and allow trans-network coordination and reporting. Protocol-based project plans including timelines and resources will allow better forecasting of network activities.
  • Incorporating new researchers, particularly from underrepresented populations and those in resource-limited countries, within the context of conducting the network's research agenda.
  • Integrating community participation in network activities, from scientific agenda to protocol development and community engagement; providing support for network community advisory boards; and providing support for community training and education as needed to ensure the success of the network’s research agenda.

HIV/AIDS Clinical Trials Laboratory Centers (Clinical Trial Required)

Request for Applications—proposed FY 2021 initiative

Contact: Daniella Livnat

Objective: The focus of this funding opportunity announcement (FOA) for a Laboratory Center (LC) is to provide a framework for laboratory leadership, structure, and activities that contribute to developing the Networks’ research agenda and execute the laboratory component of the Networks’ clinical research. The LC will be expected to work closely with the Leadership and Operations Centers (LOC) to contribute to the scientific agenda and develop and review the lab components of study protocols; coordinate selection of appropriate testing laboratories with Clinical Trials Units/Clinical Research Sites (CTU/CRS) leaders; and coordinate with the Statistical and Data Management Center(s) (SDMC) to achieve reliable laboratory data capture and export as well as specimen tracking.

Description: This initiative for a Laboratory Center (LC) will:

  1. Implement, coordinate, and oversee laboratory testing in support of the Network research agenda in U.S. and non-U.S. laboratories, including:
    • Clinic-based laboratories associated with CRSs for local specimen processing and testing (e.g., HIV rapid tests, urine hCG)
    • CRS-affiliated clinical laboratories and/or commercial labs for routine clinical testing (e.g., safety tests, various diagnostics)
    • Central/specialized/endpoint laboratories (e.g., immunology, virology, pharmacology, tuberculosis) that use a variety of modern analytic tools (e.g., high-throughput systems biology approaches to study tissue, cells, and plasma/serum coupled with detailed clinical phenotyping; next generation sequencing techniques, immunophenotyping, imaging techniques, quantitative molecular methods for measuring HIV reservoirs)
  2. Ensure, in collaboration with DAIDS-funded laboratory quality assurance contracts (pSMILE, VQA, IQA, CPQA, TBQA, EQAPOL), the ongoing reliability and integrity of protocol-mandated laboratory testing and standards of laboratory operations to allow for the approval of registrational studies by U.S. and non-U.S. regulatory entities. Laboratories will be expected to comply with DAIDS requirements, as appropriate, including participating in External Quality Assurance schemes to assess ability to perform tests correctly, Clinical Laboratory Improvement Amendments certification and/or compliance with Good Clinical Laboratory Practices.
  3. Ensure reliable specimen chain of custody, address shipping challenges, and provide for local and centralized short- and long-term storage of study samples obtained from study participants. The LC, in collaboration with Network Leadership, will promote access to stored specimens for future research by the broader scientific community.
  4. Ensure the use of appropriate, validated, and verified laboratory data capturing and specimen tracking systems according to all regulatory standards.
  5. Support developing and evaluating novel assays for implementation in trial protocols and in ancillary studies (e.g., assays to measure the HIV viral reservoir, identifying immune profiles that correlate with vaccine, determining vaccine response durability, assays for measuring antiviral drugs and biologics, HIV incidence assays/algorithms for measuring impact of prevention tools).
  6. Implement an approach for selecting, determining readiness, and approving laboratories to participate in study protocols.
  7. Develop and implement an approach to ensure reliable testing in back-up laboratories, when needed, and develop and implement an approach for the timely acquisition of external specialized laboratory expertise when needed to support study protocols.

Additionally, the LC will be expected to work closely with the SDMC and LOC to contribute to its scientific agenda and review the lab components of study protocols; coordinate with CTU/CRS leaders the selection of appropriate testing laboratories; and coordinate with the SDMC(s) to achieve reliable laboratory data capture and export as well as specimen tracking.

There will be the expectation of centralizing testing in support for one or more Networks’ studies when appropriate, and harmonizing lab-related requirements and processes in support of the Networks (e.g., laboratory approval process).

HIV/AIDS Clinical Trials Statistical and Data Management Centers (Clinical Trial Required)

Request for Applications—proposed FY 2021 initiative

Contact: Carl Dieffenbach

Objective: The focus of this funding opportunity announcement for Statistical and Data Management Centers (SDMC) is to provide statistical expertise and data management leadership for clinical trials in support of the NIH HIV/AIDS Clinical Trials Networks. Each SDMC will support coordination for design, conduct, and analysis of clinical trials to advance a chosen scientific agenda. The SDMC will provide the infrastructure and ongoing support critical to operational and regulatory aspects of data management necessary to ensure data quality and integrity while meeting all NIH, U.S. federal, and international standards for clinical research and clinical trials. The scope of data management responsibilities includes clinical and laboratory data, as well as immunologic, virologic, and both host and pathogen genomic data; management of data related to the inventory; and use of specimen repositories.

The SDMC is responsible for developing and maintaining validated and verifiable data collection systems, forms and formats, and generic and protocol-specific instruments, and determining how statistical methodologies and/or database systems and structures will be adapted to accommodate the Networks’ needs and others when required. The SDMC will work closely with the chosen Leadership and Operations Centers (LOC) to support continuing reporting of operational status by protocol across clinical trial sites, permit projections and reallocation of clinical trial resources, and use data tracking systems.

The SDMC will be expected to work closely with the LOC to contribute to the scientific agenda and develop and review the components of study protocols; develop composite protocol budgets and project plans for data management operations with Clinical Trials Units/Clinical Research Sites leaders; and coordinate with the LC(s) to achieve reliable laboratory data capture and export.

Description: The SDMC initiative will support:

  • Innovative research to foster novel statistical methodologies to address the research challenges of aligned LOC’s agenda
  • Alignment of statistical and data activities with the Network scientific agenda
  • Harmonization of processes/requirements both within the Network supported by a SDMC and across all funded SDMCs
  • Implementation and maintenance of validated and verified data capture, storage, retrieval, and tracking systems
  • Compliance with Clinical Data Interchange Standards Consortium (CDISC) requirements, including:
    • Clinical Data Acquisition Standards Harmonization (CDASH)
    • Analysis Data Model (ADaM)
    • Study Data Tabulation Model (SDTM)
  • Established processes for ensuring the validity of clinical data
  • Documentation of all research-related statistical and data activities, e.g., standard operating procedures according to regulatory standards

The SDMC will have primary responsibility for transmitting data for the LOC to NIH and NIAID data systems.

Each SDMC must comply with current applicable federal regulations.

Each SDMC must adhere to current globally-accepted standards, including the following:

  • International Conference on Harmonization (ICH) E2, Clinical Safety Data Management, ICH E3 Clinical Study Reports, ICH E6 Good Clinical Practice
  • Compliance with coding to M1 MedDRA Terminology and ICH M5, Data Elements and Standards for Drug Dictionaries
  • Compliance with coding to the World Health Organization Drug Dictionary, protocol-specific requirements, and all applicable NIH/NIAID/DAIDS policies and procedures
  • Compliance with current industry standards for clinical data management, current example–CDISC

Provisions to maintain compliance with changing industry standards must be in place at no additional cost to the government.

HIV/AIDS Clinical Trials Units (Clinical Trial Required)

Request for Applications—proposed FY 2021 initiative

Contact: Manizhe Payton

Objective: This initiative will provide the clinical research site infrastructure necessary to conduct clinical trials developed and implemented by the HIV/AIDS Clinical Trials Networks.

Description: The focus of this initiative is to support coordinated Clinical Trials Units (CTUs) for domestic and international HIV/AIDS clinical research. Each CTU will include an administrative hub and one or more domestic and/or international Clinical Research Sites (CRS). The CTUs will provide clinical and scientific expertise to conduct clinical research; laboratory, pharmacy, and local data management resources; and robust community engagement activities.

Each CTU will be responsible for overseeing and evaluating clinical trial conduct at the sites, ensuring compliance with policies and procedures, adhering to regulations, and developing standard operating procedures with Network leadership for selecting, implementing, and closing of clinical sites.

Each CTU will be linked to separately-funded network awards for leadership and operations, statistics and data management, and laboratory services.

  • Each CTU will be composed of one to eight experienced CRSs. A CRS is a discrete entity where clinical research protocols are implemented. The CRS must have demonstrated access to an appropriate clinical trial population based on demographics, incidence, and prevalence of HIV/AIDS, and other relevant population characteristics.
  • The CRS must:
    • Be staffed by trained, qualified professionals capable of conducting clinical research in accordance with Good Clinical Practice/International Conference on Harmonization (ICH) standards, local and/or national regulatory requirements, and other applicable NIH requirements.
    • Be directed by a CRS leader with the experience and qualifications to oversee all HIV/AIDS Network clinical activities at the CRS.
    • Have a main clinic location with appropriate infrastructure and equipment to conduct clinical research activities, although the CRS may include more than one location where clinical research activities are conducted.
    • Have a community advisory board and other community engagement strategies to meaningfully engage with the community in which the CRS works.
    • Be staffed by trained, qualified professionals with experience in good data management practices.
    • Perform quality management functions at all levels of the CRS to ensure research activities are conducted at the highest standards of quality and compliance.

All CTU activities will be compliant with current applicable Federal regulations.

CTU activities must adhere to current globally-accepted standards, including the following:

  • International Conference on Harmonization (ICH) E2, Clinical Safety Data Management, ICH E3 Clinical Study Reports, ICH E6 Good Clinical Practice
  • Compliance with coding to M1 MedDRA Terminology and ICH M5, Data Elements and Standards for Drug Dictionaries
  • Compliance with coding to the World Health Organization Drug Dictionary, protocol-specific requirements, and all applicable NIH/NIAID/DAIDS policies and procedures
  • Compliance with current industry standards for clinical data management, current example–Clinical Data Interchange Standards Consortium (CDISC). Provisions to maintain compliance with changing industry standards must be in place at no additional cost to the government.

NIAID is seeking “research ready” CRSs that have demonstrated experience conducting investigational new drug-level clinical research and have demonstrated access to the appropriate clinical trial participant populations for studies. There are no changes to the overall goals of this initiative to provide appropriate scientific and technical expertise as well as clinical research infrastructure to support the NIAID research priorities. Significant effort during the current grant project period is focused on streamlining and harmonizing administrative, regulatory and protocol operations, and funding across all Networks, and it is expected that CTUs will be integrated into this harmonized approach.

HIV/AIDS Maternal, Adolescent, and Pediatric Health Therapeutics Clinical Trials Leadership and Operations Center (Clinical Trial Required)

Request for Applications—proposed FY 2021 initiative

Contact: Sheryl Zwerski

Objective: The focus of the HIV/AIDS maternal, adolescent, and pediatric health therapeutics research agenda will be to address the scientific gaps for infants, children, adolescents, and pregnant/postpartum women. This initiative will provide scientific leadership and operational management to support a coordinated, multidisciplinary effort to advance the field of maternal, adolescent, and pediatric HIV/AIDS research primarily, but not exclusively, by conducting domestic and international, multisite Phase I, II, and III clinical trials.

Description: The focus of this funding opportunity announcement is the Leadership and Operations Center for the HIV/AIDS Maternal, Adolescent, and Pediatric Health Therapeutics Clinical Trials Network.

The Maternal, Adolescent, and Pediatric Health Therapeutics scientific agenda includes:

  • Using innovative approaches for rational product selection and prioritization, design and conduct trials to evaluate [pharmacokinetics (PK), safety, antiviral efficacy] and bring to licensure promising antiviral drugs and regimens, including long-acting delivery systems in
    • Pediatric HIV-infected populations from newborns to adolescent/young adults
    • Maternal populations including HIV-infected pregnant postpartum and lactating women for optimization of antiretroviral therapy (ART) for maternal and newborn health and around the critical period of vertical transmission risk
  • Evaluating novel therapeutic interventions to enhance the host immune response to HIV and to promote ART-free remission in pediatric populations from newborn to adolescence
  • Within the context of clinical trials, evaluating and characterizing host and viral processes involved in reservoir establishment and maintenance, and evaluating tools and approaches to identify, characterize, and measure HIV reservoirs
  • Evaluating (PK, safety, efficacy) new anti-tuberculous drugs and regimens, for treatment and prevention of drug-sensitive and drug-resistant tuberculosis (TB) disease in
    • Pediatric and adolescent populations with and without HIV infection
    • Maternal populations including HIV-infected and uninfected pregnant, postpartum, and lactating women
  • Within the context of clinical trials or other appropriate settings, evaluate diagnostic, prognostic, or treatment response biomarkers for TB disease with a particular focus on young children, non-sputum samples, and suitability for point-of-care platforms
  • Design and conduct trials to investigate neuroprotective ART and other neuroprotective strategies for infants and children
    • In the context of clinical trials, refine and optimize tools for evaluation of neurobehavioral function
  • Working with Division of Microbiology and Infectious Diseases and other partners, design and conduct trials to evaluate novel preventive and/or therapeutic approaches for high-priority diseases of importance to maternal and pediatric HIV infected/affected populations
  • With other partner institutes, evaluate other co-morbidities and complications of importance for pediatric, adolescent, and maternal populations
  • Collaborate with vaccine network to evaluate preventive HIV and TB vaccines

Operational principles for the NIH HIV/AIDS Clinical Trials Network include:

  • Implementing and maintaining standardized processes, forms, and project management functions across the network to allocate and track project resources and allow trans-network coordination and reporting. Protocol-based project plans including timelines and resources will allow better forecasting of network activities.
  • Incorporating new researchers, particularly from underrepresented populations and those in resource-limited countries, within the context of conducting the network's research agenda.
  • Integrating community participation in network activities, from scientific agenda to protocol development and community engagement, and providing support for network community advisory boards and community training and education as needed to ensure the success of the network’s research agenda.

Novel Biomarkers for the Development of HIV Incidence Assays With Improved Specificity

For the published requests for applications, see the April 11, 2018 Guide announcements, Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R01 Clinical Trial Optional) and Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R21 Clinical Trial Not Allowed).

In Vivo Targeted Degradation of HIV Proteins

For the published request for proposals, see the July 18, 2018 Solicitation of NIH and CDC for Small Business Innovation Research (SBIR) Contract Proposals (PHS 2019-1).

Particle-Based Delivery of HIV Env Immunogens

For the published request for proposals, see the July 18, 2018 Solicitation of NIH and CDC for Small Business Innovation Research (SBIR) Contract Proposals (PHS 2019-1).

Co-Delivery and Formulation of Adjuvants for HIV Vaccines

For the published request for proposals, see the July 18, 2018 Solicitation of NIH and CDC for Small Business Innovation Research (SBIR) Contract Proposals (PHS 2019-1).

Content last reviewed on July 24, 2018