This FOA uses the bi-phasic, milestone-driven UG3/UH3 cooperative agreement mechanism (UG3/UH3), and runs in parallel with a companion FOA (RFA-HL-22-008), which seeks applications for a Data Coordinating Center (DCC).
Awards made under this FOA will support a milestone-driven planning phase,
including feasibility studies and pilot trials for up to 2 years, with possible transition to an implementation phase (UH3) for up to five additional years.
Only UG3 trials that meet the scientific milestones and award requirements of the UG3 phase may transition to the UH3 phase.
Applications submitted in response to this FOA must address both the UG3 and UH3 phases.
Applications must include plans for project management, subject recruitment and retention, scientific conduct of the trial including its design, randomization and power analysis; intervention, measurement, and statistical analysis of study results.
Performance-based milestones must be included in each phase.