Funding Opportunity Number: PAR-25-378
Purpose
The purpose of this notice of funding opportunity (NOFO) is to support planning and development, including pilot or feasibility research, in advance of a clinical trial testing interventions to improve health in Native American populations. Proposed research may address health promotion, disease prevention, treatment, recovery, or services research to inform intervention implementation and dissemination. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, recruitment challenges, intervention feasibility and acceptability, outcome measures, data and statistical challenges or operational risks necessary to finalize the trial protocol completely. Native American populations experience unique sociopolitical, historical, and environmental stressors and risks that may exacerbate health conditions and/or impact the effectiveness of existing solutions to address the conditions. They also possess unique strengths and resiliencies that can mitigate stressors and inform intervention strategies. Research with Native American populations requires engagement with tribal partners and communities to develop or adapt interventions and evaluate them with clinical trial protocols that are rigorous and culturally appropriate. Preparatory studies may fill information gaps, address unknowns, allow for strengthening of tribal partnerships, and pilot test the feasibility of the intervention and clinical trial design, thereby improving scientific rigor and cultural appropriateness of the future clinical trial. Research projects may address topics within the identified interests of any of the participating Institutes or Centers. The inclusion of Native American investigators serving on the study team or as the PD(s)/PI(s) is strongly encouraged.
Scope
The activities proposed will depend on the stage of intervention development, the delivery setting, and the type of future trial proposed (e.g., efficacy, effectiveness, or implementation). Pilot tests of feasibility and acceptability of the intervention and/or future trial protocol are within scope of this NOFO.
Research should be designed in such a way that there is a high probability that interventions delivered can be scaled and sustained if the future trial finds the intervention to be effective. To ensure sustainability of intervention designs and service delivery strategies tested, applicants should, whenever possible, partner with tribes/communities and localities that use existing programming funds (e.g., funding from CDC, SAMHSA, Indian Health Services, Medicaid, Medicare and other insurance providers, and other program funding as appropriate) to support evidence-based programs and leverage those resources as the foundation for building infrastructure.
Examples of appropriate research activities include the following, but this list is not intended to be exhaustive:
- Activities to further develop and establish meaningful and trusted partnerships with Native communities.
- Develop culturally grounded study designs in collaboration with Native American community partners to ensure acceptability and feasibility in Native communities, including developing and/or selecting an intervention, defining the appropriate study population, outcome, study endpoint, and control or comparison group to use in the subsequent efficacy, effectiveness, or implementation trial.
- Determine the acceptability and feasibility of the intervention for study participants, Native American communities, and tribal partners, including standardization across sites and measures of intervention fidelity when appropriate.
- Adapt, standardize, and/or validate an intervention or assessment originally designed for non-Native populations for Native populations.
- Develop a novel intervention grounded in Indigenous Knowledge (see: https://www.whitehouse.gov/ostp/ostps-teams/climate-and-environment/indigenous-knowledge, empirical and/or theoretical evidence, and/or adapt or standardize an intervention currently used in Native American communities to plan for a future efficacy or effectiveness trial.
- Develop inclusive and culturally appropriate recruitment and retention strategies that engage Native communities.
- Develop culturally informed study protocols, data and safety monitoring plans, analytical plans, and data management and sharing plans.
- Standardize and test the effectiveness of training tools for implementation of the intervention or clinical trial protocol.
- Employ qualitative methods, including talking circles, interviews, or focus groups as needed to address study aims and the development, testing and validation of quantitative survey tools. Qualitative or mixed methods research may also be helpful to assess community or tribal approval and commitment and to contextualize quantitative research findings as appropriate.
- Planning activities to assess the potential feasibility and acceptability of implementation strategies to be utilized in a future implementation research trial in Native American communities, including planning for hybrid effectiveness implementation studies.
For more information, please see the opportunity webpage.