The NIH HEAL Initiative is offering cooperative agreement applications for multisite effectiveness clinical trials focusing on sickle cell disease (SCD) pain management. This grant aims to support studies on pharmacologic, nonpharmacologic, and multicomponent approaches for acute or chronic SCD pain. While allowing continued opioid use, it emphasizes that opioids should not be the sole intervention. Research should also explore the impact on psychological and functional outcomes, aiming to improve overall well-being. Studies addressing stigma, healthcare system barriers, and social factors hindering quality pain care for SCD patients are encouraged. Investigators should collect biological markers and phenotype participants by pain type, variability, co-occurring conditions, and social determinants of health.
Opportunity ID: 336351
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-AT-22-005 |
| Funding Opportunity Title: | HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Oct 29, 2021 |
| Last Updated Date: | Oct 29, 2021 |
| Original Closing Date for Applications: | Dec 15, 2021 |
| Current Closing Date for Applications: | Dec 15, 2021 |
| Archive Date: | Jan 20, 2022 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Special district governments Native American tribal governments (Federally recognized) Independent school districts City or township governments Public and State controlled institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to solicit cooperative agreement applications to support multisite 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 phenotype 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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-AT-22-005.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or after January 25, 2022 | PKG00270475 | Nov 18, 2021 | Dec 15, 2021 | View | |
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00269915 | Nov 15, 2021 | Dec 15, 2021 | View |
Package 1
Mandatory forms
336351 RR_SF424_5_0-5.0.pdf
336351 PHS398_CoverPageSupplement_5_0-5.0.pdf
336351 RR_OtherProjectInfo_1_4-1.4.pdf
336351 PerformanceSite_4_0-4.0.pdf
336351 RR_KeyPersonExpanded_4_0-4.0.pdf
336351 RR_Budget_3_0-3.0.pdf
336351 PHS398_ResearchPlan_4_0-4.0.pdf
336351 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
336351 RR_SubawardBudget30_3_0-3.0.pdf
336351 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
336351 RR_SF424_2_0-2.0.pdf
336351 PHS398_CoverPageSupplement_5_0-5.0.pdf
336351 RR_OtherProjectInfo_1_4-1.4.pdf
336351 PerformanceSite_2_0-2.0.pdf
336351 RR_KeyPersonExpanded_2_0-2.0.pdf
336351 RR_Budget_1_4-1.4.pdf
336351 PHS398_ResearchPlan_4_0-4.0.pdf
336351 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
336351 RR_SubawardBudget30_1_4-1.4.pdf
336351 PHS_AssignmentRequestForm_3_0-3.0.pdf