Every seven years, NIH competitively renews its funding of the HIV/AIDS clinical trials networks operating in the United States and internationally. For the funding cycle starting in fiscal year 2021, NIAID solicited applications for the following four HIV/AIDS Clinical Trials Networks: HIV Prevention Clinical Trials Network, HIV Vaccines Clinical Trials Network, HIV/AIDS Adult Therapeutics Clinical Trials Network, and the HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network. This page provides links and resources related to the Notices of Funding Opportunities (NOFOs) for the networks. The NOFOs were issued in 2019, and awards were announced in November 2020.
Table of Contents
- HIV/AIDS Clinical Trials Networks NOFOs
- Core and Protocol Funds
- Coordinating Groups
- Additional Resources Provided by NIAID
In January 2019, NIAID released six Notices of Funding Opportunities (NOFOs) related to the NIH HIV/AIDS Clinical Trials Networks. This included four NOFOs for leadership and operations centers (LOCs) for the networks. Each of the following NOFOs includes a description of network research priority areas:
- HIV Prevention Clinical Trials Network: See RFA AI-19-005 in the NIH Guide.
- HIV Vaccines Clinical Trials Network: See RFA AI-19-006 in the NIH Guide.
- HIV/AIDS Adult Therapeutics Clinical Trials Network: See RFA AI-19-003 in the NIH Guide.
- HIV/AIDS Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network: See RFA AI-19-004 in the NIH Guide.
NIAID also issued NOFOs for Laboratory Centers (LCs) and Statistical and Data Management Centers (SDMCs):
NIAID published a NOFO for HIV/AIDS Clinical Trials Units (CTUs), RFA AI-19-045, on May 1, 2019.
Core Funds. NIAID will provide core funds directly to the Leadership and Operations Center (LOC), Laboratory Center (LC), Statistical and Data Management Center (SDMC) and network-affiliated Clinical Trials Units (CTUs) on an annual basis. Core funding is the initial fixed-base funding and provides infrastructure and salary support that is not protocol-specific. Examples include, but are not limited to
- Administrative and management support
- Community education and engagement structures and activities
- Clinical quality management activities
- Maintenance and replacement of equipment
- Travel to attend clinical trials network meetings
- Mentoring and training of staff
- Record retention to meet regulatory requirements
Protocol Funds (PF). NIAID will provide PF to the LOC, LC and SDMC on an annual basis. In addition, NIAID anticipates providing PF directly to network-affiliated CTUs on an annual basis. PF provides support to conduct protocols, including protocol-specific infrastructure or other requirements needed to conduct protocols at a site. PF varies annually, depending on costs of ongoing protocols and will be awarded to cover expenses attributable to protocol development, implementation or close-out of a clinical trial. Protocol funds include, but are not limited to, the following protocol-specific expenses
- Personnel salary (protocol-specific)
- Good and Services Tax (GST) where required
- Participant recruitment and retention
- Protocol-required tests and evaluations
- Participant reimbursement
- Travel for protocol-specific personnel, as required by network, to attend clinical trials network meetings
- Travel to attend protocol-specific trainings
- Equipment and supplies
- Community education and engagement structures and activities
- Protocol specimen shipment and storage
- Protocol-specific data management
- Protocol specific data analysis
- Travel to attend or conduct protocol-specific trainings or to evaluate site data management readiness for individual protocols
NIAID expects that equipment and services funded via core funds or PF will be made available, as appropriate, for other NIAID-funded network activities regardless of how funds were initially provided to purchase those items.
Based on communications with the LC, SDMC and CTUs/clinical research sites (CRSs), the LOC will estimate protocol funding needs for the network (salary and non-salary PF) annually and submit a budget request to NIAID. NIAID will then determine the amount of PF to be provided in the coming grant year. Adjustments in PF allocation will be made at regular intervals during each budget period, based on both performance and availability of funds.
Distribution of Protocol Funds to Network-Affiliated CTUs/CRSs
NIAID anticipates providing PF salary support directly to network-affiliated CTUs and adjusting PF allocation mid-budget period based on both performance and availability of funds. For protocol-specific CRSs, NIAID anticipates providing PF salary support to the network LOC, which will in turn provide it to protocol-specific CRSs only if they are not affiliated with a CTU. CTUs/CRSs will receive non-salary PF support through the associated network LOC.
Distribution of Protocol Funds to Network-Affiliated LCs and SDMCs
PF will be distributed to the LCs and SDMCs directly from NIAID prior to enrollment of study participants following the process described above.
PF may also be provided to the LOC for its use and distribution to the LC and SDMC to provide additional support for protocol-related expenses for activities that are not directly related to participant accrual.
NIAID Strategic Working Group (SWG)
- The Strategic Working Group (SWG) provides expert advice on the scientific priorities of the NIH HIV/AIDS Clinical Trials Networks.
- Manages a portfolio of cooperative agreements supporting domestic and international Clinical Trials Units and Clinical Research Sites associated with the HIV/AIDS Clinical Trials Networks
DAIDS Clinical Laboratory Oversight Team (DCLOT)
- DAIDS laboratory staff from the Vaccine, Prevention and Therapeutic programs who represent the points of contact for investigators performing clinical trials and applicable clinical research projects supported by DAIDS.
- HANC’s mission is to support the science and operations of the networks by increasing efficiency and resource-sharing through coordination of critical activities across networks and with other research and advocacy partners.
NIAID will provide additional support services for clinical trials that must be conducted under an Investigational New Drug (IND) or Investigational Device Exemption (IDE). These services may include the following:
- Clinical Site Monitoring (CSM)
- Site initiation visits before clinical trial implementation to ensure compliance with DAIDS, U.S., and, where appropriate, country-specific regulatory requirements and guidelines
- Site closeout visits to ensure clinical trials are completed, clinical records are stored, and investigational products are disposed of appropriately
- Reports on all site monitoring visits, including problems and deficiencies, and recommendations for remedial or corrective actions
- Clinical Research Products Management Center (CRPMC)
- Acquisition, storage and distribution of clinical research products in support of NIAID DAIDS clinical trials.
- Regulatory Support Center (RSC)
- Day-to-day support for regulatory activities for domestic and international NIAID DAIDS-supported and/or sponsored network clinical trials.
- Patient Safety Monitoring in International Laboratories (SMILE)
- Evaluation and capability development of international laboratories to ensure the integrity and reliability of tests for monitoring safety and efficacy of experimental products investigated in DAIDS - supported clinical trials.
- Virology Quality Assurance (VQA) Program
- Quality assurance support to domestic and international laboratories performing virology assays for DAIDS clinical trials
- Immunology Quality Assurance (IQA) Program
- National/international standardization and overall performance of immunology laboratories participating in NIAID DAIDS-sponsored clinical trials and research programs
- Assistance in the development of new technology and laboratory assays that may be useful in monitoring patients living with HIV and in the evaluation of potential HIV vaccines
- Clinical Pharmacology Quality Assurance Program
- Quality assurance activities of pharmacology assays and data, and activities to increase awareness of the importance of pharmacology at clinical sites
- Mycobacterium tuberculosis (Mtb) Quality Assessment Program (TBQA)
- Assessment of Mtb testing in direct support of clinical trials to diagnose active and latent Mtb infection, monitor disease progression, assess treatment response and vaccine efficacy in domestic and international laboratories.
- External Quality Assurance Program Oversight Laboratory (EQAPOL)
- Supports the development, implementation and oversight of external quality assurance programs that monitor national and international laboratories involved in HIV/AIDS research and clinical trials to support vaccine immunogen advancement
- Provides a resource for the development of new assays, and assistance in the standardization, optimization, validation, and implementation of assays required for candidate vaccine and antibody mediated prevention trials and associated proficiency testing programs