Opportunity Information: Apply for PA 14 335
Apply for PA 14 335
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Advancing Interventions to Improve Medication Adherence (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.242 Mental Health Research Grants 93.273 Alcohol Research Programs 93.361 Nursing Research 93.393 Cancer Cause and Prevention Research 93.395 Cancer Treatment Research 93.399 Cancer Control 93.867 Vision Research.
- This funding opportunity was created on Sep 5, 2014 and posted on Sep 5, 2014.
- Applicants must submit their applications by Jan 7, 2018. (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 $275,000.00 in funding.
- Eligible applicants include: State governments Special district governments City or township governments Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Native American tribal governments (Federally recognized) County governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education 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 Public and State controlled institutions of higher education.
- 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.
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Opportunity Summary:
Advancing Interventions to Improve Medication Adherence (R21) is an NIH funding opportunity (PA 14-335) issued through the NIH Adherence Network led by the Office of Behavioral and Social Sciences Research (OBSSR), with multiple NIH Institutes participating. The overall goal is to support early stage, exploratory projects that develop and test new or adapted interventions that can meaningfully improve how well people take prescribed medications. The emphasis is on interventions that can move the needle on adherence in real-world health contexts where missed doses, inconsistent refills, or early discontinuation undermine treatment effectiveness and drive preventable complications and costs.
The FOA is specifically designed for the Exploratory/Developmental Research Project Grant mechanism (R21), which means NIH is looking for novel, high-potential ideas that are not yet ready for a full-scale effectiveness trial. Applicants are expected to propose projects that are clearly distinct from traditional R01 work. Long-term, incremental studies in well established areas, or projects primarily aimed at accumulating confirmatory knowledge over extended periods, are not a good fit here. Instead, the announcement encourages studies that break new ground, test innovative approaches, pilot new technologies or strategies, or extend prior discoveries into new directions, populations, care settings, or delivery models.
A key feature of this opportunity is the breadth of clinical and public health situations it is willing to support. Proposed interventions can focus on medication adherence for a single disease or chronic condition (for example, hypertension), on preventing recurrence (for example, adherence to therapies intended to reduce cancer recurrence risk), or on the more complicated reality of multiple comorbid conditions (for example, combinations like hypertension, diabetes, alcohol use disorders, and HIV/AIDS). That flexibility allows applicants to tailor interventions to populations where adherence challenges may stem from different drivers such as symptom burden, side effects, regimen complexity, mental health needs, substance use, social determinants, or competing life demands.
NIH also signals what it expects for scientific rigor and interpretability in these exploratory projects. A well articulated theoretical or conceptual framework is considered essential. In practice, that means applicants should clearly explain why their intervention should work, what mechanisms it targets (such as motivation, habit formation, health beliefs, self regulation, social support, provider-patient communication, structural barriers, or cognitive/affective factors), and how those mechanisms connect to measurable changes in adherence and health outcomes. The FOA is not just about building a program and hoping it helps; it is about designing an intervention grounded in a coherent model that can be tested and refined.
Another central requirement is demonstrating feasibility for collecting multi-modal adherence data. NIH expects applicants to measure adherence using more than self-report alone. Projects should include (1) a patient self-report measure of adherence, (2) at least one non-self-report adherence measure, and (3) a relevant health outcome or biomarker that should plausibly change if adherence improves. Non-self-report adherence measures can include sources like pharmacy refill records, electronic medication monitoring, or similar objective/administrative data streams. For outcomes and biomarkers, the FOA gives examples such as blood pressure, HIV viral load, cholesterol levels, or HbA1c, depending on the condition being treated. If a disease area does not have a clearly established biomarker, the announcement allows for clinical assessments that can serve a similar validation function, such as medication blood levels, diagnostic interviews, or independent clinician ratings of symptoms and behaviors. The underlying idea is that adherence improvements should be linked to something clinically meaningful and measurable, even in an early stage study.
Administratively, this is a discretionary NIH grant opportunity with an award ceiling listed at $275,000. It was posted September 5, 2014, and the final due date window in the archived listing closes January 7, 2018 (with an archive date of February 7, 2018). The catalog references multiple CFDA program areas spanning behavioral health and chronic disease research domains, including mental health, alcohol research, nursing research, cancer prevention and control, vision research, and communication disorders, reflecting the multi-Institute nature of adherence as a cross-cutting problem.
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include public and state controlled institutions of higher education, private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses and other for-profit organizations (other than small businesses are also listed as eligible), and a wide range of government entities such as state governments, county governments, city or township governments, special district governments, and certain housing authorities. The eligibility language also highlights inclusion of organizations such as HBCUs, Hispanic-serving institutions, tribal colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, and faith-based or community-based organizations, among others. At the same time, the FOA is explicit that non-U.S. (foreign) organizations and foreign institutions are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components are not allowed as defined in NIH policy.
In practical terms, a competitive application under this FOA would propose an innovative adherence intervention with a clear rationale and mechanism, show that the team can recruit and implement the approach in the intended population, and present a measurement plan that triangulates adherence (self-report plus at least one objective measure) while also tracking a health indicator that should respond to better medication taking. The project should be framed as an early step that reduces uncertainty, generates preliminary effect estimates, refines methods, and positions the work for a later, larger trial, rather than attempting to function as a full definitive test of long-term clinical outcomes.
FAQs: Advancing Interventions to Improve Medication Adherence (R21) (PA 14-335)
What is this funding opportunity?
Advancing Interventions to Improve Medication Adherence (R21) (PA 14-335) is an NIH funding opportunity issued through the NIH Adherence Network led by the Office of Behavioral and Social Sciences Research (OBSSR), with multiple NIH Institutes participating. It supports early stage, exploratory projects focused on improving how well people take prescribed medications.
What is the main goal of the FOA?
The goal is to support projects that develop and test new or adapted interventions that can meaningfully improve medication adherence in real-world health contexts, where missed doses, inconsistent refills, or early discontinuation reduce treatment effectiveness and contribute to preventable complications and costs.
What grant mechanism does this FOA use?
This FOA is designed for the Exploratory/Developmental Research Project Grant mechanism (R21). It is intended for novel, high-potential ideas that are not yet ready for a full-scale effectiveness trial.
How is an R21 project expected to differ from an R01-style project under this announcement?
The FOA emphasizes that proposed projects should be clearly distinct from traditional R01 work. Long-term, incremental studies in well established areas, or projects mainly designed to accumulate confirmatory knowledge over extended periods, are described as a poor fit. Instead, the focus is on breaking new ground, testing innovative approaches, piloting technologies or strategies, or extending prior discoveries into new directions, populations, care settings, or delivery models.
What kinds of intervention ideas are encouraged?
Interventions that are innovative and have the potential to move the needle on adherence are encouraged, including new interventions, adapted interventions, pilots of new technologies, or strategies that shift delivery models or settings. The announcement supports exploratory testing and refinement rather than definitive long-term outcome trials.
Does the FOA limit projects to a single disease area?
No. The FOA supports a broad range of clinical and public health situations, including adherence for a single disease or chronic condition (for example, hypertension), adherence for preventing recurrence (for example, therapies intended to reduce cancer recurrence risk), and adherence in the context of multiple comorbid conditions (for example, combinations such as hypertension, diabetes, alcohol use disorders, and HIV/AIDS).
Can projects address adherence challenges related to comorbidities and complex patient needs?
Yes. The FOA explicitly acknowledges that adherence challenges can arise from many drivers, such as symptom burden, side effects, regimen complexity, mental health needs, substance use, social determinants, and competing life demands. This flexibility allows interventions to be tailored to populations facing different barriers.
Is a theoretical or conceptual framework required?
Yes. A well articulated theoretical or conceptual framework is described as essential. Applicants are expected to explain why the intervention should work, what mechanisms it targets, and how those mechanisms connect to measurable changes in adherence and health outcomes.
What kinds of mechanisms can an intervention target?
The FOA provides examples of mechanisms such as motivation, habit formation, health beliefs, self regulation, social support, provider-patient communication, structural barriers, and cognitive or affective factors.
What does NIH expect for adherence measurement in these projects?
NIH expects feasibility for collecting multi-modal adherence data and specifically expects projects to measure adherence using more than self-report alone.
What adherence measures are required or expected?
The FOA expects a measurement approach that includes: (1) a patient self-report measure of adherence, (2) at least one non-self-report adherence measure, and (3) a relevant health outcome or biomarker that should plausibly change if adherence improves.
What counts as a non-self-report adherence measure?
Examples mentioned include pharmacy refill records, electronic medication monitoring, or similar objective or administrative data streams.
Do projects need to track clinical outcomes or biomarkers?
Yes. The FOA expects inclusion of a relevant health outcome or biomarker that should plausibly change if adherence improves, helping link adherence changes to clinically meaningful effects even in an early stage study.
What are examples of acceptable biomarkers or health outcomes?
The FOA gives examples such as blood pressure, HIV viral load, cholesterol levels, or HbA1c, depending on the condition being treated.
What if there is no clearly established biomarker for the disease area?
The FOA allows for clinical assessments that can serve a similar validation function. Examples include medication blood levels, diagnostic interviews, or independent clinician ratings of symptoms and behaviors.
Is self-report alone sufficient to meet the measurement expectations?
No. The FOA explicitly states that adherence should be measured using more than self-report alone, and it expects at least one non-self-report measure in addition to patient self-report.
What is the maximum award amount mentioned for this opportunity?
The archived listing includes an award ceiling of $275,000.
Who is leading this NIH effort and who is involved?
The opportunity is issued through the NIH Adherence Network led by OBSSR, with multiple NIH Institutes participating, reflecting adherence as a cross-cutting issue.
What research domains does this FOA touch based on the catalog references?
The catalog references multiple CFDA program areas spanning behavioral health and chronic disease research domains, including mental health, alcohol research, nursing research, cancer prevention and control, vision research, and communication disorders.
Which organizations are eligible to apply?
Eligibility is broad for U.S.-based applicants and includes public and state controlled institutions of higher education, private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses, and other for-profit organizations (including for-profits other than small businesses), as well as many types of governmental entities (state, county, city or township, special district governments, and certain housing authorities).
Are specific institution types explicitly highlighted as included?
Yes. The eligibility language highlights inclusion of organizations such as HBCUs, Hispanic-serving institutions, tribal colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, and faith-based or community-based organizations, among others.
Are non-U.S. (foreign) organizations eligible to apply?
No. The FOA is explicit that non-U.S. (foreign) organizations and foreign institutions are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. The FOA states that non-U.S. components of U.S. organizations are not eligible.
Are foreign components allowed in any form?
No. The FOA states that foreign components are not allowed as defined in NIH policy.
What does a competitive application generally need to demonstrate, based on the FOA description?
Based on the description provided, a competitive application would propose an innovative adherence intervention with a clear rationale and mechanism, demonstrate that the team can recruit and implement the approach in the intended population, and present a measurement plan that triangulates adherence (self-report plus at least one objective measure) while tracking a health indicator that should respond to improved medication taking.
What stage of evidence is this FOA trying to generate?
The FOA is positioned as an early step intended to reduce uncertainty, generate preliminary effect estimates, refine methods, and set the stage for a later, larger trial, rather than serving as a full definitive test of long-term clinical outcomes.
What are the posted and closing dates mentioned in the archived listing?
The opportunity was posted September 5, 2014. The final due date window in the archived listing closes January 7, 2018, with an archive date of February 7, 2018.
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| The Early Detection Research Network Data Management and Coordinating Center (U24) Apply for RFA CA 14 017 Funding Number: RFA CA 14 017 Agency: National Institutes of Health Category: Education Health Funding Amount: $4,500,000 |
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