The proposal is in response to NOT-OD-20-087 Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19, and applied for using PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional), through parent award R01AA023754 Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth, funded through PAR-14-620: Interventions for Health Promotion and Disease Prevention in Native American Populations. Due to the hardship created by the novel SARS-CoV-2 (COVID-19) public health emergency our clinical trial, taking place in remote and isolated Alaska Native communities, is currently shutdown. This administrative supplement would allow to continue data collection, re-startup intervention implementation in the final Community 5, and provide ongoing supervision and fidelity assessment in the 4 currently active SAMHSA funded intervention trial communities. While intervention in four active intervention communities is now funded by 4 SAMSHA Native Connections grants, the final Community 5 intervention is original to the parent grant and not the previous administrative supplement, and is funded by NIAAA. Further, we are not currently able to suspend research staff who are essential. These staff are engaged in active supervision of the 4 currently active during COVID suicide/alcohol risk preventative interventions to research standards with fidelity assessment. These staff are engaged in the continuing research process with 4 years of data collected prior to data collection shut down. Supplemental funding will allow us to accomplish the following objectives: 1) fully implement the intervention in the final NIAAA R01 trial community, with funding coming from the original parent grant, where startup was interrupted by the public health emergency; 2) complete data collection across all trial communities interrupted by the pandemic and; 3) analyze the completed prevention trial outcomes.
In response to the SARS-CoV-2 (COVID-19) public health emergency our clinical trial, taking place in remote and isolated Alaska Native communities, is currently shutdown and we anticipate prolonged delays in research progress to support participant health and safety, and increased costs when communities reopen. This administrative supplement will fund staff and resources, including funds for increased transportation costs to restart our work as soon authorities allow us and it is safe to do so, for two years beyond the end date of the parent project.
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