HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required)

The purpose of this Funding Opportunity Announcement (FOA) is to solicit cooperative agreement applications to support multisite efficacy or effectiveness clinical trials of pharmacologic, nonpharmacologic, and/or multicomponent approaches for acute and/or chronic sickle cell disease (SCD) pain management, allowing continued opioid pain management as needed. However, opioid medication use alone should not be the only intervention studied. Trials supported under this initiative may also address the impact of these approaches on related psychological and functional outcomes to support improved overall well-being and quality of life. In addition, studies that address stigma, structural health care system, and social factors that may hinder quality comprehensive pain care for patients with SCD are also of interest. Investigators are encouraged to include the collection of well-justified biological markers or psychological processes that have demonstrated that they may mediate pain outcomes. Trials should collect sufficient measures to phenotypeclinically characterize participants such as type of pain, variability of pain, co-occurring conditions, and social determinants of health. The studies must address questions within the mission and research interests of the NIH HEAL Initiative and evaluate preventive or treatment strategies or interventions including medications, biologics, procedures, medical and assistive devices and technologies, behavioral interventions, rehabilitation strategies, complementary interventions, integrated approaches, and delivery system strategies in well controlled trials in patients with SCD to manage acute and/or chronic pain.