The FOA seeks to expand the HIV/AIDS prevention toolkit among alcohol impacted populations with a range of patterns of episodic and long-term use and associated behavioral and biological risks for HIV acquisition. This includes integration of effective prevention and treatment interventions with an understanding of the overarching framework for reducing the incidence of new infections by facilitating cross-cutting informative research.This R34 Funding Opportunity Announcement (FOA) supports studies that are both necessary and sufficient to inform the planning of a clinical trial within the scope of the companion announcement HIV Prevention and Alcohol (R01 Clinical Trials Optional). The NIAAA expects that applications to this FOA will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, this FOA will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention of HIV. In this NIAAA funding opportunity for pilot clinical trials the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a clinical trial and testing of intervention tools.
