HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required) | RFA DK 18 030

Opportunity Information: Apply for RFA DK 18 030

This NIH HEAL Initiative funding opportunity (RFA-DK-18-030) supports the creation of a coordinated research consortium called the Hemodialysis Opioid Prescription Effort (HOPE). The focus is a high-need Medicare End-Stage Renal Disease (ESRD) population receiving in-center hemodialysis, where pain is common and unevenly distributed across regions, dialysis facilities, and potentially across ethnic groups. The opportunity is grounded in evidence that pain in hemodialysis patients is tied to worse quality of life and is often intertwined with limited social support, depressed mood, and other mental health conditions. At the same time, chronic opioid prescribing is unusually frequent in this group (around 20 percent), and prescribed doses often exceed CDC recommendations. In this population, opioid exposure and higher dose levels have been associated with increased hospitalization and mortality, making safer and more effective pain strategies an urgent clinical and public health priority.

The HOPE consortium is designed to test an integrated approach that addresses pain and opioid use at the same time, rather than treating them as separate problems. The program plans to do this in two complementary ways. First, it emphasizes multipronged, individualized, non-opioid pain management tailored to each patient, reflecting the idea that pain drivers and responses vary widely in ESRD. Second, it supports clinical evaluation of medication-based strategies to reduce opioid dependence among affected patients, specifically including buprenorphine and other novel agents. The description highlights major gaps in the evidence base: behavioral interventions such as cognitive behavioral therapy or group-based approaches, as well as technology-enabled support models (including social media style platforms for sharing information and strengthening social support), have not been widely used in this setting to reduce pain perception, opioid prescribing rates, opioid dose, or opioid use, nor have they been systematically leveraged to address related depression and anxiety. Likewise, medical interventions such as naloxone and buprenorphine have not been adequately tested in randomized controlled trials among hemodialysis patients who use opioids, leaving clinicians with limited dialysis-specific guidance despite substantial risk.

The award mechanism is a U01 cooperative agreement, which typically means NIH will have substantial scientific involvement and coordination roles rather than acting only as a funder. The consortium structure described includes 5 or 6 Clinical Centers (CCs) working alongside a centralized Scientific and Data Research Center (SDRC). Clinical Centers are expected to recruit and follow hemodialysis patients longitudinally and implement the intervention protocols, while the SDRC typically supports harmonized data collection, study coordination, and cross-site analytic work. The opportunity explicitly requires a clinical trial, signaling that applicants should be prepared to run rigorous prospective testing, commonly randomized designs, to produce actionable evidence for real-world dialysis care. A key rationale for choosing the ESRD hemodialysis setting is feasibility and scientific leverage: patients are seen frequently on a predictable schedule, treatment is continuously monitored, and dialysis organizations often have robust clinical and administrative data streams, all of which support careful implementation and evaluation of complex interventions over time.

Eligibility is broad across U.S.-based organizations, spanning state, county, local, and special district governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The announcement also calls out several institution types as eligible, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, and Tribally Controlled Colleges and Universities, as well as faith-based or community-based organizations and U.S. territories or possessions. Foreign institutions are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and NIH-defined foreign components are not allowed, keeping the work fully domestic.

Administratively, the funding instrument is categorized as discretionary and the activity areas include health (and related CFDA listings 93.847 and 93.866). The agency is the National Institutes of Health, and the original closing date listed for this specific opportunity was March 27, 2019. The award ceiling shown is $500,000, indicating the maximum federal amount expected per award under the listing provided. Overall, the intent is to generate practical, dialysis-specific evidence for combining individualized non-opioid pain care, psychosocial and support interventions, and carefully evaluated medication approaches like buprenorphine to reduce opioid reliance, improve mental health comorbidities, and ultimately lower hospitalization and mortality risks in the hemodialysis population.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847, 93.866.
• This funding opportunity was created on 2018-12-10.
• Applicants must submit their applications by 2019-03-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA DK 18 030

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: