Through the new notice of funding opportunity (NOFO) Leadership and Coordination Center for the MACS/WIHS Combined Cohort Study (U01, Clinical Trials Not Allowed), you can apply to manage the MACS/WIHS Combined Cohort Study (MWCCS)—an epidemiological study of middle-aged and older people living with HIV (PLWH) and comparable individuals living without HIV (PLWOH), to enable follow-up of a deeply phenotyped cohort of approximately 5,700 participants from across the United States.
The MACS study was started in 1985 and WIHS in 1995 under NIAID leadership. In 2019, the two cohorts were combined as the MWCCS and transferred to National Heart, Lung, and Blood Institute leadership. This long-running epidemiological study is now supported by more than 10 NIH institutes and centers. The MWCCS combined cohort study takes a populomics approach, i.e., examination of health determinants across multiple scales of influence using multidisciplinary methods to investigate the web of influences impacting the health, quality of life, and survival of adults living with HIV.
Leadership and Coordination Center (LACC)
NIH intends to fund a single LACC to improve clinical guidance and oversight of the cohort and create an enhanced structure for scientific leadership, scientific work group support, participant outcomes ascertainment, internal training, operational accountability, community and participant engagement, and promotion of the cohort to external stakeholders.
The NOFO requires a multiple principal investigator (mPI) leadership structure, and the mPI team should include individuals with demonstrated deep knowledge and familiarity with MWCCS. Two companion NOFOs are also open, for MWCCS Clinical Research Sites and the MWCCS Data Analysis and Sharing Center. Both are limited competitions, meaning only previously funded MWCCS recipients may apply.
In your application to the LACC NOFO, do the following:
- Identify specific aims which are measurable, ambitious, yet achievable, and well-aligned with the scientific priorities of NIH.
- Carefully consider, explain, and justify your philosophy of leadership.
- Propose specific mechanisms and strategies for monitoring and ensuring that all MWCCS investigators and staff adhere to the highest standards of ethical conduct.
- Prioritize participants safety and well-being in all decision making, and adhere to all study protocols, procedures, and policies with high fidelity and required timeliness.
NIAID’s Research Priorities
NIAID is interested in continuing the MWCCS as a cohort study platform that will collect and make publicly available high-quality risk factor, viral suppression, and other outcome data on HIV and associated comorbidities in middle-aged and older adults in the United States, with particular interest in the following areas of research:
- HIV virology and immunology measures, seroconversion among PLWOH, HIV reservoir.
- Co-infections (e.g., HBV, HCV, CMV, SARS-CoV-2, HPV, emerging pathogens).
- Chronic immune activation, inflammatory pathogenesis.
NIAID’s priority topics for analysis, publication, and dissemination are:
- Predictors of emergent HIV drug resistance.
- Basic science of immune activation and inflammatory pathogenesis in PLWH.
Find a full list of all participating institutes’ platform and investigational priorities in the NOFO.
Award and Deadline Information
Application budgets may not exceed $2 million in annual direct costs.
Your proposed project period must be 6 years, spanning fiscal years 2026 through 2031.
Deadline
Applications are due on May 2, 2025, by 5:00 p.m. local time of applicant organization.
Direct your inquiries to NIAID’s scientific/research contact, Dr. Gerald B. Sharp, at GSharp@niaid.nih.gov or 240-627-3217.