LeverAging StraTegies to Maximize ImpLementation and Effectiveness for HIV (LAST MILE)

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission through the LeverAging StraTegies to Maximize ImpLementation and Effectiveness for HIV (LAST MILE) program. This program will encourage collaborations to perform effectiveness trials that incorporate implementation in real-world settings. Examples include combined efficacy-effectiveness trials, pragmatic trials, and hybrid effectiveness-implementation studies. The intent is to bridge findings from traditional clinical trials to real-world implementation. The work will focus on populations across various points of care for prevention or treatment of HIV and its associated coinfections and comorbidities occurring in any age group. The goal of this program is to advance cross-cutting areas of HIV research, including clinical, behavioral and social sciences, epidemiology, and implementation science. This program aligns with the NIH mission to implement advances in HIV/AIDS research. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...