Key Dates

Related Announcements

NOT-HL-22-028 - Notice of Additional FOAs for NHLBI participation in NOT-OD-21-100 "Notice of Special Interest (NOSI): Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health"

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-184- NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-183- NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)

PA-20-195- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-196- NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-20-261 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

PA-20-260 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA-20-262 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

PAR-18-069 - Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)

PAR-19-309 - Stimulating Innovations in Behavioral Intervention Research for Cancer Prevention and Control (R21 Clinical Trial Optional)

PAR-21-035 - Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)

PAR-21-038 - Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed)

PAR-20-052 - NCI Small Grants Program for Cancer Research

PAR-20-077 - NCI Program Project Applications (P01 Clinical Trial Optional)

PAR-19-274 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)

PAR-19-275 - Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)

PAR-19-276 - Dissemination and Implementation Research in Health (R03 Clinical Trial Optional)

PAR-20-309 - Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required)

PAR-21-069 - Multidisciplinary Studies of HIV/AIDS and Aging (R21 Clinical Trial Optional)

PAR-21-068 - Multidisciplinary Studies of HIV/AIDS and Aging (R01 Clinical Trial Optional)

PAR-20-070 - Research Infrastructure Development for Interdisciplinary Aging Studies (R21/R33 - Clinical Trial Optional

PAR-20-071 - Advanced-Stage Development and Utilization of Research Infrastructure for Interdisciplinary Aging Studies (R33 Clinical Trial Optional)

PAR-19-302 - NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required)

PAS-19-317 - Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)

PAS-19-316 - Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)

PAR-19-070 - Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)

PAR-19-071 - Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R21 Clinical Trial Not Allowed)

PAR-18-878 - Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Required)

PAR-18-878 - Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Required)

PAR-18-877 - Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional)

PAR-18-324 - Testing Interventions for Health-Enhancing Physical Activity (R01 Clinical Trial Optional)

PAR-20-180 - Identifying Innovative Mechanisms or Interventions that Target Multimorbidity and Its Consequences (R01- Clinical Trial Optional)

PA-18-159 - Mechanisms, Models, Measurement, & Management in Pain Research (R21 Clinical Trial Optional)

PA-18-141 - Mechanisms, Models, Measurement, & Management in Pain Research (R01 Clinical Trial Optional)

PA-18-790 - Patient Safety in the Context of Perinatal, Neonatal, and Pediatric Care (R01 - Clinical Trial Optional)

PA-18-791 - Patient Safety in the Context of Perinatal, Neonatal, and Pediatric Care (R03 - Clinical Trial Optional)

PAR-21-063 - NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required)

PAR-21-107 - NIDCD Early Career Research (ECR) Award (R21 Clinical Trial Optional)

PAR-20-279- Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)

PAR-19-212- Behavioral & Integrative Treatment Development Program (R01 Clinical Trial Optional)

PAR-19-213- Behavioral & Integrative Treatment Development Program (R34 Clinical Trial Optional)

PA-20-146 - NIDA Small Research Grant Program (Parent R03 Clinical Trial Required)

PAR-19-189 - Pilot Services Research Grants Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)

PA-18-350 - NIMH Exploratory/Developmental Research Grant (R21 Clinical Trial Not Allowed)

PAR-21-129 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01 Clinical Trial Required)

PAR-21-130 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)

PAR-21-131 - Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trial Required)

PAR-21-132 - Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

PA-20-141- Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)

PA-20-144 - Innovations in HIV Prevention, Testing, Adherence, and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R01 Clinical Trial Optional)

PA-20-145 - Innovations in HIV Prevention, Testing, Adherence, and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional)

PA-18-945 - Applying a Biopsychosocial Perspective to Self-Management of Chronic Pain (R01 Clinical Trial Optional)

PA-18-946 - Applying a Biopsychosocial Perspective to Self-Management of Chronic Pain (R21 Clinical Trial Optional)

PAR-19-057 - Strategies to Provide Culturally Tailored Palliative and End-of-Life Care for Seriously Ill American Indian and Alaska Native Individuals (R01 Clinical Trial Optional)

PAR-19-058 - Strategies to Provide Culturally Tailored Palliative and End-of-Life Care for Seriously Ill American Indian and Alaska Native Individuals (R21 Clinical Trial Optional)

PAR-19-136 - End-of-Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R01 Clinical Trial Optional)

PAR-19-153 - End-of-Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R21 Clinical Trial Optional)

PAR-19-256 - Limited Competition: Modular Budget Research Project Grant for NIH Nurse Scientist Scholars (R01 Clinical Trial Optional)

PAR-19-381 - Patient Activation for Self-Management of Chronic Conditions (R01 Clinical Trial Optional)

PAR-19-382 - Patient Activation for Self-Management of Chronic Conditions (R21 Clinical Trial Optional)

Issued by

Office of Behavioral and Social Sciences Research (OBSSR)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Sexual and Gender Minority Research Office (SGMRO)

Office of Research on Women's Health (ORWH)

Purpose

This Notice of Special Interest (NOSI) is being issued by the NIH Adherence Network through the Office of Behavioral and Social Sciences Research (OBSSR) with participation from multiple NIH Institutes, Centers, and Offices. This NOSI calls for research grant applications that address patient adherence to treatment and prevention regimens to promote health outcomes. Applications may address healthcare regimen initiation, implementation, and/or persistence by patients. Descriptive and intervention research may address adherence determinants at one or more levels of ecologic influence, including the patient, caregiver/family, provider, healthcare system, and community levels. The specific research interests of participating NIH Institutes and Centers are detailed within.

Background

Increased adherence to recommended treatment and prevention regimens is an area of the behavioral and social sciences that promises substantial improvements in public health as well as savings in healthcare costs. Poor adherence to healthcare regimens is common across many chronic illnesses and patient populations. This includes use of prescribed medications and many other recommended prevention, screening, treatment, monitoring, and health behavior regimens.

Current concepts of adherence are multidimensional. Adherence to a specific health care behavior (e.g., taking a medicine, deciding to follow a diet, or making dietary changes) involves three dimensions: initiation (i.e., starting the recommended regimen), implementation (i.e., executing the schedule), and persistence (i.e., length of time on regimen before any discontinuation). Each dimension of adherence may have unique determinants, and each may require distinct behavioral and social interventions.

Adherence behavior is dynamic with the potential to change over time. The dynamic nature of adherence underscores the need to improve routine monitoring of adherence to recommended healthcare regimens, to prompt the delivery of support interventions when needed.

The determinants of adherence and non-adherence span a broad ecologic spectrum. These range across characteristics of the illness, the health care regimen, individual and social influences, and successively larger structural influences related to health care provision and health economics. Multilevel adherence determinants invite a range of possible interventions that target individuals, families, caregivers, health-care providers, communities, and/or healthcare system factors. They also invite careful specification and assessment of the mechanisms of action when developing and testing adherence interventions.

The next generation of research to address these adherence challenges will benefit from close attention to scientific rigor. Studies should clearly define adherence, compliment self-reported measures with objective assessment of behavior, and address intervention mechanisms of action. Applications are encouraged to apply approaches and tools for assessment of behavioral mechanisms developed under the NIH Common Fund’s Science of Behavior Change (SOBC) Program (see https://osf.io/zp7b4).

Research Objectives

The objective of this NOSI is to encourage research grant applications that address patient adherence to treatment and prevention regimens to promote health outcomes. Applications may address healthcare regimen initiation, implementation, and/or persistence by patients. Descriptive and intervention research may address adherence determinants at one or more levels of ecologic influence, including the patient, caregiver/family, provider, healthcare system, and community levels.

Research projects that could be addressed in response to this NOSI include, but are not limited to, the following topics. Further Institute- and Center-specific topics subsequently follow.

• Research to advance novel tools or improve existing approaches to monitor adherence and facilitate delivery of targeted interventions to improve adherence
• Studies that identify competing behaviors, psychosocial concerns, and/or social issues that contribute to non-adherence and associated changes in health outcomes, to inform future interventions and science
• Research to understand and address individual, social, and structural determinants of health contributing to inequities in adherence and associated health outcomes among NIH-designated health disparity populations, including those related to race, ethnicity, sexual and gender minority (SGM) status, rural residency, and socioeconomic status.
• Research that prioritizes adherence intervention development and delivery for individuals who have demonstrated non-adherence or who may be at-risk for non-adherence
• Research examining interventions designed to optimize adherence through caregivers, peers, or social support networks
• Studies of adherence-promoting interventions that are delivered through technological tools, such as mobile health technologies and electronic health records
• Research testing the efficacy of interventions at the health care provider or system level that may facilitate patient adherence
• Interventions that test multi-level and multi-component interventions (e.g., at the individual, health care provider, and community level) to improve adherence behavior

IC Specific Application and Submission Information:

Applicants must select the IC and associated FOA to use for submission of an application in response to this NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative. In addition, applicants using NIH Parent Announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-184 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-20-195- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• PA-20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-20-261 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
• PA-20-260 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-20-262 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
  
  All instructions in theSF424 (R&R) Application Guide and the listed funding opportunity announcements must be followed, with the following additions:

• For funding consideration, applicants must include NOT-OD-21-100in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
  
  Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

National Cancer Institute (NCI)

NCI seeks research that will improve adherence to recommended cancer prevention and treatment regimens in order to reduce cancer risk, improve treatment outcomes, and lower cancer-related morbidity, mortality, and disability. Multi-level studies and research aimed at high-risk, vulnerable, or underserved populations are encouraged. Topics of interest include but are not limited to:

• Improving adherence to lifestyle recommendations related to cancer incidence and outcomes, including diet, physical activity/sedentary behaviors, energy balance and obesity, UV protection, alcohol and tobacco use, and sleep.
• Improving adherence to recommended cancer prevention regimens, cancer screening tests, treatment regimens, maintenance therapy, and follow-up care.
• Understanding and addressing the effects of polypharmacy on symptoms and treatment adherence.
• Testing personalized approaches to improve adherence, including targeted and tailored adherence interventions and messages.
• Innovative, theory-driven applications of mobile health, health IT, and social media platforms to monitor and improve adherence.
• Developing novel interventions to improve adherence based on basic behavioral and social science findings (see ORBIT model for behavioral treatment development).
• Identifying optimal approaches for disseminating and implementing evidence-based adherence interventions within systems of care and home, school, workplace and community settings.

NCI FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Eye Institute (NEI)

NEI seeks research on adherence to interventions/treatments in the context of vision health and impairment. Areas of interest include but are not limited to adherence to low vision rehabilitation training, myopia prevention/treatment, pediatric amblyopia therapies, and glaucoma treatment regimens. In addition, improving adherence to prevention efforts (eye care screening) and development of novel personalized approaches and/or technological tools (mobile health) to enhance adherence are welcome. In the context of this NOSI, clinical trial studies that are greater than minimal risk will not be supported. (Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.) Investigators are strongly encouraged to discuss their plans with NEI program staff prior to submitting their application.

NEI FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Heart, Lung, and Blood Institute (NHLBI)

NHLBI is interested in supporting research across the translational spectrum for the development and evaluation of interventions targeting adherence to behavioral or pharmacologic regimens for the prevention and management of heart, lung, blood, and sleep conditions in order reduce risk of disease or reduce morbidity and mortality. NHLBI is particularly interested in applications that a) focus on adherence as a strategy for reducing health disparities, b) integrate an understanding of the multi-level determinants of adherence across social and economic contextual factors, c) incorporate advances in behavioral science, mobile and connected health technology, and healthcare informatics, and/or d) focus on identifying and overcoming the barriers and facilitators of adherence to evidence-based guidelines by patients and practitioners.

Additional examples of interest to NHLBI include:

• Research testing innovative approaches for monitoring and maintaining adherence in low resource settings.
• Research to target groups at high risk for non-adherence, such as adolescents/young adults and individuals with multiple comorbidities (including mental health and/or substance abuse), complex health regimens, and/or cognitive impairment.
• Research examining interventions designed to optimize adherence through caregivers, peers, or social support networks.
• Investigation of behavioral economic approaches to optimize adherence to lifestyle modifications (e.g., diet, physical activity) among patients with heart, lung, blood, and sleep diseases or risk factors.
• Studies of interventions that are delivered through technological tools, such as mobile health technologies and electronic health records, to target health care provider and/or patient behaviors and/or interactions for promoting adherence to evidence-based guidelines for heart, lung, blood, and sleep health.
• Research testing the efficacy of interventions at the health care system level that target, for example, health care provider practices (i.e., decision tools, access to resources such as medication plans, electronic medical record practices) as facilitators of patient adherence.
• Research to address social and structural determinants of health that contribute to disparities in adherence and health outcomes for heart, lung, blood, and sleep conditions.
• An investigation of factors that contribute to the persistence of adherence to lifestyle modification/preventive behaviors across the lifespan.
• Research to assess the contribution of nontraditional health care providers (e.g., clinical pharmacists, community health workers) who extend the point of contact beyond the medical care setting.

NHLBI FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Institute on Aging (NIA)

NIA seeks research on interventions to promote adherence to medical and behavioral regimens aimed at promoting healthy aging in Stages I through IV of the translational intervention development pipeline, as defined by the NIH Stage Model. NIA applications under this FOA are expected to articulate their research aims using the NIH Stage Model framework, identifying the Stage(s) of research proposed. In addition, applications are encouraged to apply the experimental medicine approach, i.e. articulate or test a hypothesis to identify an intervention’s principles/mechanism(s) of action, as described by the NIH Science of Behavior Change Common Fund Program. Areas of interest include those that leverage current understanding of psychology of aging or of behavioral and social contexts relevant to aging to promote adherence to exercise, healthful eating, prescribed medications, stress-reducing and/or positive affect inducing behaviors, and medical regimens. Of particular interest is the development of scalable principle-driven interventions that are highly relevant to the needs and capacities of individuals as they age and interventions that incorporate behavioral economic principles and/or technological innovations; a geriatric focus on multiple chronic conditions which can be accompanied by polypharmacy; and adherence to screening, vaccination, and other preventive measures in older adults.

NIA FOAs for this NOSI include the following or their subsequent reissued equivalents:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NICHD seeks research on adherence to interventions/treatment for NICHD populations of interest (including pediatric, pregnant women, lactating women and women of childbearing age, persons with intellectual and/or physical disabilities), including shared decision making and informed consent, healthcare provider adherence to clinical practice and/or preventive care guidelines, improving our understanding of reasons for nonadherence, social determinants of health and health disparities impact on adherence, and impact of adherence interventions on health outcomes and/or disease prevention.Special topics of interest include understanding and improving (a) adherence, health literacy, self-management, and medical decision making within the context of transition from adolescent to adult healthcare, especially for those with chronic conditions/illnesses or disabilities; (b) adherence to COVID-19 preventive measures and/or behaviors; (c) personalized devices or tools for improving medication adherence. For NICHD and Extramural Research Branch priorities, please refer to websites for the NICHD Strategic Plan and the Extramural Research Branch For the National Center for Medical Rehabilitation Research (NCMRR), please refer to the NCMRR website. The current NIH parent announcements in which NICHD participates are listed at https://www.nichd.nih.gov/grants-contracts/FOAs-notices/active-FOAs/parent.

NICHD FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIDCD conducts and supports research and research training on normal and disordered conditions of hearing, balance, taste, smell, voice, speech and language. Areas of interest include but are not limited to behavioral adherence to treatment in voice, speech, fluency, language, hearing, and vestibular-related balance disorders. Factors that potentiate use of hearing aids when accessible is also of interest. Studies emphasizing recruitment of underrepresented minorities are highly encouraged.

NIDCD FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Institute on Drug Abuse (NIDA)

NIDA is interested in research on the development of optimal behavioral strategies to promote adherence to medications and substance use disorder (SUD) treatment. Applications are encouraged for studies that include, but are not limited to: improvements in drug abuse treatment adherence interventions for use in primary care; technologies to boost effects and increase efficiency of adherence interventions, and; interventions to promote adherence to HIV medications.

NIDA FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Institute of Mental Health (NIMH)

NIMH has interest in adherence research in the context of mental health as well as HIV. Applicants are strongly encouraged to consult NIMH staff when developing plans for an application. All applications that propose clinical trials to test adherence strategies are required to follow the NIMH’s experimental therapeutics approach to intervention development and testing (see Support for Clinical Trials at NIMH) and must be submitted through one of several NIMH-specific clinical trials FOAs (below). NIMH is particularly interested in research on adherence interventions that support the NIMH Strategic Plan for Research.

Examples of NIMH-relevant research projects include but are not limited to the following:

• Adherence interventions designed to improve mental health or HIV health outcomes, along with examination of change mechanisms.
• Adherence interventions capitalizing on innovations in technology which are consistent with NOT-MH-18-031 and the NIMH Advisory Council report, Opportunities and Challenges of Developing Information Technologies on Behavioral and Social Science Clinical Research.
• Applications that use existing patient-level data, such as electronic medical records and prescription refill or claim data, to support adherence.
• Development and testing of predictive algorithms to identify those at risk for future non-adherence.
• Pragmatic trials of adherence monitoring and support strategies that fit seamlessly into existing clinical practice.
• Adherence approaches to reduce empirically documented disparities in care and outcomes for racial and ethnic minorities and other underserved groups.
• Adherence interventions that support shared decision making and patient engagement.
• Stepped interventions or differentiated care approaches that use adaptive designs and decision rules based on participant responses to tailor and modulate intervention strategies.
• Approaches for effectively implementing and sustaining high-value adherence strategies.

Adherence strategies can target patients, providers, clinics, and healthcare and/or other service systems. NIMH encourages investigators to design their studies to maximize the likelihood that findings will meaningfully inform and be translated into practice, whether at the patient, clinic, system, and/or policy level. To the greatest extent possible, such research should be conducted in community practice and externally valid settings; involve research participants from highly generalizable target populations, including racially and ethnically diverse samples, individuals across the lifespan, and those with co-occurring conditions; and, utilize care providers and technologies that can be readily and widely implemented in routine care settings. NIMH encourages investigators to partner with public and private stakeholders. Such collaborations may help ensure findings are relevant, practical, and actionable.

NIMH FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Institute on Minority Health and Health Disparities (NIMHD) is interested in supporting research and interventions considering determinants from more than one domain or level of influence (see NIMHD Research Framework). Intervention design should be based on theories from minority health and health disparities science. Research must focus on one or more minority or health disparity population (African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations). Applications may include but are not limited to multi-disciplinary etiologic and intervention research projects in community settings that advance the understanding of the mechanisms, pathways, and processes related to adherence to health promotion behaviors (e.g., healthy eating, physical activity, safe infant sleep practices, etc.), preventive screening recommendations, medication or other medical treatment regimens, and/or chronic disease self-management strategies. Research may propose using available secondary data, health system data and/or collection of primary data. Projects focused on patient-clinician communications, shared decision making, or other interactions, processes or services that occur within healthcare settings are not a priority for this NOSI but should instead be submitted to PAR-20-310, Health Services Research on Minority Health and Health Disparities (R01 Clinical Trial Optional) or PAR-19-093, Leveraging Health Information Technology (Health IT) to Address Minority Health and Health Disparities (R01 Clinical Trial Optional).

NIMHD FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Institute of Nursing Research (NINR)

NINR supports research that can build the scientific foundation for clinical practice, prevent disease and disability, manage and eliminate symptoms caused by illness, and enhance end-of-life and palliative care. In the context of this NOSI, research areas of relevance include, but are not limited to: interventions that consider social ecological models that influence adherent behaviors; studies to understand gaps in adherence to national guidelines that promote healthy lifestyles and preventive behaviors; and secondary data analysis to identify moderators of evidence-based intervention strategies and that can inform new approaches to adherence research. Studies that focus on health disparity populations are of particular interest.

NINR FOAs for this NOSI include the following or their subsequent reissued equivalents:

National Center for Complementary and Integrative Health (NCCIH)

NCCIH is interested in research on the use of complementary and integrative health approaches to improve adherence to treatment and prevention regimens to promote health outcomes, as well as research to improve adherence to complementary and integrative treatment or health promotion approaches. For this NOSI, complementary approaches of interest include those with physical and/or psychological therapeutic inputs, often called mind and body approaches (e.g., acupuncture, yoga, tai chi, qi gong, meditation, hypnosis, music-based interventions, art therapy, spinal and/or joint manipulation, or massage therapy). NCCIH will support applications that have a primary outcome of improving adherence to a treatment or prevention regimen or adherence to a mind and body approach. NCCIH will not support applications with a primary outcome of assessing the efficacy or effectiveness of the treatment or intervention approach on a clinical outcome through this FOA (please see NCCIH Clinical Trial Funding Opportunities instead). Investigators are strongly encouraged to discuss their plans with NCCIH program staff prior to submitting their application.

NCCIH FOAs for this NOSI include the following or their subsequent reissued equivalents:

Office of Research on Women's Health (ORWH

The mission of the ORWH is to improve the quality of women’s lives, reduce their disease burden across the life course, and address health disparities among populations of women in the United States. In support of this initiative, ORWH is interested in applications that promote innovative and rigorous research on adherence and its impact on women’s health and/or sex and gender influences on health. There is a growing recognition that the quality and generalizability of biomedical research findings depend on the consideration of sex as a biological variable (SABV) to advance science for the health of women and men. The 2019-2023 Trans-NIH Strategic Plan for Women’s Health Research ( Advancing Science for the Health of Women ) identifies the guiding principles, research goals and objectives to advance the health of women.

Application and Submission Information

This notice applies to due dates on or after May 7, 2021 and subsequent receipt dates through June 8, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-20-183- NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-184- NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• PA-20-195- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-196- NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-20-261 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
• PA-20-262 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
• PA-20-260 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PAR-18-069 - Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)
• PAR-19-309 - Stimulating Innovations in Behavioral Intervention Research for Cancer Prevention and Control (R21 Clinical Trial Optional)
• PAR-21-035 - Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)
• PAR-21-038 - Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed)
• PAR-20-052 - NCI Small Grants Program for Cancer Research
• PAR-20-077 - NCI Program Project Applications (P01 Clinical Trial Optional)
• PAR-19-274 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)
• PAR-19-275 - Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)
• PAR-19-276 - Dissemination and Implementation Research in Health (R03 Clinical Trial Optional)
• PAR-20-309 - Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required)
• PAR-21-069 - Multidisciplinary Studies of HIV/AIDS and Aging (R21 Clinical Trial Optional)
• PAR-21-068 - Multidisciplinary Studies of HIV/AIDS and Aging (R01 Clinical Trial Optional)
• PAR-20-070 - Research Infrastructure Development for Interdisciplinary Aging Studies (R21/R33 - Clinical Trial Optional
• PAR-20-071 - Advanced-Stage Development and Utilization of Research Infrastructure for Interdisciplinary Aging Studies (R33 Clinical Trial Optional)
• PAR-19-302 - NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required)
• PAS-19-317 - Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)
• PAS-19-316 - Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)
• PAR-19-070 - Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional)
• PAR-19-071 - Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R21 Clinical Trial Not Allowed)
• PAR-18-878 - Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Required)
• PAR-18-878 - Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Required)
• PAR-18-877 - Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional)
• PAR-18-324 - Testing Interventions for Health-Enhancing Physical Activity (R01 Clinical Trial Optional)
• PAR-20-180 - Identifying Innovative Mechanisms or Interventions that Target Multimorbidity and Its Consequences (R01- Clinical Trial Optional)
• PA-18-159 - Mechanisms, Models, Measurement, & Management in Pain Research (R21 Clinical Trial Optional)
• PA-18-141 - Mechanisms, Models, Measurement, & Management in Pain Research (R01 Clinical Trial Optional)
• PA-18-790 - Patient Safety in the Context of Perinatal, Neonatal, and Pediatric Care (R01 - Clinical Trial Optional)
• PA-18-791 - Patient Safety in the Context of Perinatal, Neonatal, and Pediatric Care (R03 - Clinical Trial Optional)
• PAR-21-063 - NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required)
• PAR-21-107 - NIDCD Early Career Research (ECR) Award (R21 Clinical Trial Optional)
• PAR-20-279- Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)
• PAR-19-212- Behavioral & Integrative Treatment Development Program (R01 Clinical Trial Optional)
• PAR-19-213- Behavioral & Integrative Treatment Development Program (R34 Clinical Trial Optional)
• PA-20-146 - NIDA Small Research Grant Program (Parent R03 Clinical Trial Required)
• PAR-19-189 - Pilot Services Research Grants Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)
• PA-18-350 - NIMH Exploratory/Developmental Research Grant (R21 Clinical Trial Not Allowed)
• PAR-21-129 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01 Clinical Trial Required)
• PAR-21-130 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)
• PAR-21-131 - Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trial Required)
• PAR-21-132 - Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)
• PA-20-141- Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)
• PA-20-144 - Innovations in HIV Prevention, Testing, Adherence, and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R01 Clinical Trial Optional)
• PA-20-145 - Innovations in HIV Prevention, Testing, Adherence, and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional)
• PA-18-945 - Applying a Biopsychosocial Perspective to Self-Management of Chronic Pain (R01 Clinical Trial Optional)
• PA-18-946 - Applying a Biopsychosocial Perspective to Self-Management of Chronic Pain (R21 Clinical Trial Optional)
• PAR-19-057 - Strategies to Provide Culturally Tailored Palliative and End-of-Life Care for Seriously Ill American Indian and Alaska Native Individuals (R01 Clinical Trial Optional)
• PAR-19-058 - Strategies to Provide Culturally Tailored Palliative and End-of-Life Care for Seriously Ill American Indian and Alaska Native Individuals (R21 Clinical Trial Optional)
• PAR-19-136 - End-of-Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R01 Clinical Trial Optional)
• PAR-19-153 - End-of-Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R21 Clinical Trial Optional)
• PAR-19-256 - Limited Competition: Modular Budget Research Project Grant for NIH Nurse Scientist Scholars (R01 Clinical Trial Optional)
• PAR-19-381 - Patient Activation for Self-Management of Chronic Conditions (R01 Clinical Trial Optional)
• PAR-19-382 - Patient Activation for Self-Management of Chronic Conditions (R21 Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

For funding consideration, applicants must include: "NOT-OD-21-100" (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative. Please see NOT-OD-20-106 for reference.

Investigators planning to apply in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with a relevant Scientific/Research Contact (below) well in advance of the planned submission date.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Scientific/Research Contact(s)

Wendy Nelson, PhD, MPH
National Cancer Institute (NCI)
Telephone:240-276-6971
Email:nelsonw@mail.nih.gov

Janet S. de Moor, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6806
Email:demoorjs@mail.nih.gov

Cheri Wiggs, PhD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: cheri.wiggs@nih.gov

Laurie Friedman Donze, PhD
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-827-1408
Email: laurie.donze@nih.gov

Luke Stoeckel, PhD
National Institute on Aging (NIA)
Telephone: 202-570-9388
Email: luke.stoeckel@nih.gov

Karen C. Lee, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-3973
Email: karen.lee2@nih.gov

Lana Shekim, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: shekiml@nidcd.nih.gov

Will M. Aklin, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5909
Email: aklinwm@nida.nih.gov

Susan T. Azrin, PhD (for NIMH non-HIV applications)
National Institute of Mental Health (NIMH)
Telephone: 301-640-9642
Email: susan.azrin@nih.gov

Priscah Mujuru DrPH, MPH, RN
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-9765
E-mail: mujurup@mail.nih.gov

Michael J. Stirratt PhD (for NIMH HIV applications)
National Institute of Mental Health (NIMH)
Telephone: 240-627-3875
Email: stirrattm@nih.gov

Karen Huss, PhD, RN, ANP-BC, FAAN, FAAAAI, FAHA
National Institute of Nursing Research (NINR)
Telephone: 301-594-5970
Email: hussk@mail.nih.gov

Dave Clark, DrPH
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-827-1916
Email: dave.clark@nih.gov

OBSSR, ORWH, and SGMRO do not award grants. Please contact one of the IC program contacts listed above for questions regarding funding interest.

Deborah Young-Hyman, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Phone: 301-451-0724
Email: deborah.young-hyman@nih.gov

Rebecca DelCarmen Wiggins, PhD
Office of Research on Women’s Health (ORWH)
Phone: 301-451-8689
Email: rdelcarm@mail.nih.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Please direct all inquiries to the Grants Management Specialist or Officer listed on the relevant FOA.