Leadership and Coordination Center (LACC) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed)

The National Institutes of Health has released a funding opportunity to renew the MACS/WIHS Combined Cohort Study for the period of 2026 to 2032. This long-running study focuses on the health of adults living with HIV and comparable individuals without HIV, utilizing a multidimensional approach to assess health determinants across various biological, social, and environmental factors. The goal is to advance understanding of the factors influencing health outcomes and aging in this population, with an emphasis on addressing disparities and fostering community engagement. A single Leadership and Coordination Center will be funded to oversee the study, providing governance, operational accountability, and scientific leadership. The initiative will ensure consistent quality and ethical practices while enhancing communication and collaboration among stakeholders. The award budget will not exceed $2 million in direct costs annually, with a total of $3 million allocated for the first year. The Leadership and Coordination Center will centralize participant health outcomes monitoring, coordinate clinical event adjudications, and lead efforts to engage community advisory boards. Eligible applicants include institutions of higher education, nonprofit organizations, for-profit organizations, local governments, and tribal entities within the United States. Applicants must establish a leadership team with experience in HIV-related clinical care, cohort study management, and community engagement. Applications must feature a clear governance plan and demonstrate the team’s qualifications to guide the study’s scientific and operational components. Applications from foreign organizations are not eligible. Proposals must include detailed plans for the Joint Unified Modular Protocol, outlining the study’s data collection and participant engagement processes. Submissions must also address responsibilities for clinical oversight, scientific leadership, and community advisory board support. Additional required components include a governance plan, biographical sketches of principal investigators, and specific aims aligned with the study’s scientific priorities. Applicants are expected to comply with NIH policies on data management, sharing, and reporting. Applications will be evaluated based on the significance and innovation of the proposed work, the rigor and feasibility of the approach, and the expertise and resources of the applicant organization. Reviewers will assess the team’s ability to address the study’s scientific priorities, implement a centralized governance structure, and ensure ethical practices. Specific attention will be paid to the integration of participant safety, quality control, and stakeholder engagement into the project plan. The application deadline is May 2, 2025, with an optional letter of intent due 30 days prior. Funding decisions will be announced in January 2026, with projects expected to begin in April 2026. Applications must be submitted through Grants.gov, followed by completion of all requirements in eRA Commons. Failure to meet deadlines or comply with submission requirements may result in disqualification. Applicants are encouraged to ensure all organizational registrations and individual investigator profiles are active well in advance of the deadline.