HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Scientific and Data Research Center (U01 Clinical Trial Required) | RFA DK 18 031

Opportunity Information: Apply for RFA DK 18 031

This funding opportunity (RFA DK 18 031) is a National Institutes of Health cooperative agreement (U01; clinical trial required) under the Department of Health and Human Services, designed to tackle two tightly linked problems in the U.S. hemodialysis population: high levels of pain and unusually frequent, often high-dose opioid prescribing. The program is part of the NIH HEAL Initiative and is built around the idea that end-stage renal disease (ESRD) patients receiving in-center hemodialysis (HD) represent a unique, high-risk group where pain management, mental health, and opioid exposure intersect. The opportunity highlights that pain is common among Medicare ESRD HD patients, yet its reported prevalence varies markedly across regions, dialysis facilities, and potentially by ethnicity. It also notes that pain perception is associated with poorer quality of life and psychosocial factors such as limited social support, depressed mood, and other mental health disorders, making the problem broader than physical symptoms alone.

A central justification for the program is the unusually high rate of chronic opioid prescribing in this population. The announcement cites that roughly 20 percent of U.S. ESRD HD patients receive chronic opioid prescriptions, substantially higher than comparable Medicare populations. It further emphasizes that doses prescribed to HD patients can exceed CDC recommendations and that both opioid prescribing and higher dose levels are associated with worse clinical outcomes, including increased hospitalizations and mortality. In other words, the opportunity frames opioid exposure in dialysis patients not simply as a marker of severe illness, but as a potentially modifiable risk factor that may be contributing to preventable harm.

The HOPE Consortium structure is intended to support a coordinated, multi-site effort that can design, test, and monitor interventions at scale. The consortium is planned to include a single Scientific and Data Research Center (SDRC) and approximately five to six Clinical Centers (CCs). This specific opportunity is for the SDRC, which is expected to function as the organizing, analytic, and data-driven backbone of the consortium. While the full operational details are not provided in the excerpt, the SDRC role in a U01 consortium typically includes responsibilities such as harmonizing protocols across sites, developing and maintaining data systems, coordinating study operations and reporting, supporting statistical design and analysis, and enabling consistent implementation and evaluation of the intervention(s) across all participating clinical centers.

Programmatically, the consortium is expected to develop an integrated intervention that addresses pain and opioid use simultaneously in U.S. hemodialysis populations through two complementary strategies. First, it seeks to initiate multipronged, individualized, non-opioid pain treatment tailored to each patient. This reflects an emphasis on improving pain care while reducing reliance on opioids rather than focusing only on tapering or restriction. Second, for patients already affected by opioid dependence or problematic opioid use, the consortium aims to evaluate approaches that reduce dependence on full opioid agonists, including buprenorphine and other novel agents. The announcement specifically underscores that medical interventions such as naloxone and buprenorphine have not been adequately evaluated through randomized controlled trials in HD patients who use opioids, signaling a research gap the program intends to fill.

The opportunity also calls attention to underused non-pharmacologic and supportive approaches. It notes that behavioral modification strategies like cognitive behavioral therapy and group therapy, as well as social media or platform-based tools intended to share information and strengthen social support, have not been broadly employed in this population to reduce opioid prescribing and use while also addressing related comorbidities such as depression, anxiety, and pain. By naming these approaches explicitly, the announcement frames the desired intervention as potentially multidimensional, combining medical management with behavioral health and social support components, rather than treating pain and opioid exposure as isolated issues.

A key reason the ESRD hemodialysis setting is seen as ideal for this work is its built-in longitudinal structure. Patients receive ongoing, frequent, and closely monitored treatment in dialysis units, and the care environment produces rich clinical and administrative data streams. This continuous engagement and data availability can make it easier to launch interventions, track adherence and outcomes, and conduct rigorous evaluations, including randomized controlled trials. The U01 cooperative agreement mechanism further implies substantial NIH scientific and programmatic involvement, meaning the awardee is expected to collaborate closely with NIH and other consortium members to shape study design, data standards, and execution.

From an applicant and administrative perspective, the opportunity was released by NIH on December 10, 2018, with an original closing date of March 27, 2019. It anticipated a single award for the SDRC, with an award ceiling of $750,000. Eligibility was broad and included various government entities, public and private institutions of higher education, tribal governments and organizations, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and other applicants as allowed by the announcement. The listed CFDA numbers were 93.847 and 93.866, and the activity area was categorized under health (with additional categorization fields referencing food and nutrition/health).

Overall, this grant opportunity is aimed at building the centralized scientific, operational, and analytic hub for a national consortium that will develop and rigorously test integrated strategies to improve pain management and reduce harmful opioid exposure among hemodialysis patients. The emphasis is on interventions that are patient-tailored and non-opioid for pain whenever possible, coupled with evidence-based medication approaches like buprenorphine for individuals with opioid dependence, all evaluated in a structured, multi-site clinical trial environment supported by robust longitudinal dialysis data.

• The Department of Health and Human Services, 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 - Scientific and Data Research Center (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 Dec 10, 2018.
• Applicants must submit their applications by Mar 27, 2019. (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 $750,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

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