Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

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

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

Sexual and Gender Minority Research Office (SGMRO)

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.

Office of Research on Women's Health (ORWH)

Purpose

The NIH Office of Disease Prevention (ODP) within the Office of the Director Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) announces the availability of administrative supplements to active grants and cooperative agreements to support research on preventive interventions with populations that experience health disparities.

The ODP is coordinating the new trans-NIH research effort, ADVANCE: Advancing Prevention Research for Health Equity, which grew out of the ODP’s portfolio analysis of NIH research. In an examination of NIH-funded grants and cooperative agreements between fiscal years 2012 and 2017, the ODP found that only 8.5% of all projects focused on preventing the leading risk factors or causes of death and disability (e.g., poor nutrition, low physical activity, smoking), falling well below their burden on the nation’s health. An additional analysis of the NIH research portfolio showed that between fiscal years 2016 and 2019, only 3.6% of NIH-funded prevention projects included a randomized intervention to address a leading risk factor in populations that experience health disparities. ODP is therefore soliciting supplements to facilitate a greater focus among current NIH grantees on preventive interventions in populations that experience health disparities.

Key Definitions

Populations that experience health disparities (HD Populations): Populations defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as health disparity populations based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. NIH-designated U.S. health disparity populations currently include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.

Preventive Intervention: For the purposes of this NOSI, preventive interventions include interventions for both primary and secondary prevention. As defined by the CDC (https://www.cdc.gov/pictureofamerica/pdfs/picture_of_america_prevention.pdf), primary prevention involves intervening before health conditions occur by altering risk factors through behavioral, social, environmental, or policy changes. Secondary prevention involves identification of health conditions before the onset of signs and symptoms through screening and intervening to reduce the risk of disease progression. Preventive interventions are inclusive of interventions to prevent or reduce risk factors, screen for risk factors or signs of early disease, or provide referrals or brief treatment to prevent disease onset or progression. Projects developing technologies, such as devices and algorithms, as part of risk factor screening or preventive interventions also fall within this definition.

Program Description and Requirements

This administrative supplement NOSI is designed to support NIH grantees who can add, enhance, or strengthen preventive intervention research with HD populations that is within scope of their existing projects. Parent awards that involve testing prospective interventions, including preventive, treatment, or disease self-management interventions, or the implementation or dissemination of such interventions, are the most appropriate for this NOSI. Parent awards that involve intervention development or pilot/feasibility testing are also appropriate.

Preventive interventions that move beyond individual-level factors to address social and structural determinants of health at interpersonal, organizational, community, and societal levels are strongly encouraged (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants at different levels of influence). Supplement activities conducted in collaboration with relevant community, service system, and/or healthcare partners are strongly encouraged in order to develop and evaluate preventive interventions that are relevant, acceptable, and sustainable in community and service settings.

All proposed supplement activities should have adequate statistical power to conduct valid analyses with HD populations. Projects that exclusively use qualitative data are not a priority for this NOSI. Supplements requesting funds solely to achieve original planned recruitment targets (e.g., current enrollment of racial/ethnic minorities is behind schedule) are not a priority for this NOSI. Administrative supplements must be within the scope of the parent award. Applications may not propose changes to the overall clinical trial or human subjects designation of the award.

Appropriate topics for supplements include, but are not limited to, those listed below. Applicability or feasibility of these topics may depend on the stage of the intervention in the parent award (e.g., intervention development or planning, active enrollment, post-intervention assessment, etc.).

For parent awards that are developing and/or testing preventive interventions:

• Expanding the study sample to include and/or add HD populations not currently included. Address statistical power to conduct valid analyses.
• Adding additional recruitment or intervention sites to test the intervention across a broader range of HD populations and/or community or service settings.
• Adding participants from HD populations to conduct valid analyses related to intersectionality (i.e., belonging to two or more HD populations, OR at least one HD population with one or more additional stigmatized or marginalized statuses related to age, gender, nationality, immigrant status, disability, religion, justice involvement, health conditions, occupational or educational status, or other factors).
• Adding measures or assessments to better understand the mechanisms of actions or intervention outcomes for HD populations (e.g., assessing additional social or structural determinants of health as moderators, adding follow-up assessments to determine maintenance of intervention effects).
• Adding intervention components to address additional risk factors for the target health outcome that were not originally included (e.g., adding smoking cessation components to a hypertension intervention to prevent stroke).
• Adding intervention components to prevent a health condition not originally included (e.g., adding diabetes prevention components to a depression prevention intervention).
• Adding measures or assessments to assess the impact of the intervention on additional health conditions that share risk factors (e.g., adding an assessment of cognitive functioning/impairment to a study examining the impact of a sleep intervention on cardiovascular health among older adults).
• Adding a dissemination or implementation component not originally included, including process evaluations to understand interventions effects for HD populations and assessment of barriers and facilitators to implementation and sustainability.
• Adding a cost/outcome analysis not originally included.

For parent awards that are developing and/or testing treatment or disease self-management interventions:

• Adding a prevention component of relevance for HD populations with the existing health condition (e.g., adding screening, brief intervention and referral to treatment for substance misuse and use disorders to a treatment intervention for periodontal disease or other chronic conditions; adding smoking cessation to an antiretroviral therapy (ART) adherence intervention for people living with HIV).

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) August 1, 2022, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-OD-22-159 (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.
• Project budgets are limited to $250,000 direct costs, not including Consortia F&A. Project budgets may not exceed the yearly budget of the parent award.
• Requests may be for up to one year of support only.
• The proposed project period must be within the budget period of the parent award.
• The Research Strategy section of the application is limited to 6 pages.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email:[email protected]

Elizabeth Ginexi, PhD.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-827-0160
Email:[email protected]

Susan Czajkowski, Ph.D.
National Cancer Institute (NCI)
Telephone: 240.660.0159
Email: [email protected]

Nicole Redmond, MD, PhD, MPH
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0379
E-mail:[email protected]

Lisa Postow, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0202
E-mail:[email protected]

Mary Y. Masterson, PhD, MS
National Heart, Lung, and Blood Institute (NHLBI)
Tel: 301-827-6113 E-mail:[email protected]

I-Jen Castle, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-827-4406
E-mail: [email protected]

Afrouz Azari Anderson, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-496-4558
E-mail: [email protected]

Barbara Ann Oudekerk, PhD
National Institute on Drug Abuse (NIDA)
Phone: (301) 827-0641
E-mail: [email protected]

Judith Cooper, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: (301) 496-5061
E-mail: [email protected]

Lorena Baccaglini, DDS, MS, PhD
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-435-7908
E-mail: [email protected]

Elise Rice, PhD
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-4814
E-mail: [email protected]

Robert J Kuczmarski, DrPH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 451-8354
E-mail:[email protected]

Barbara Linder, MD, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 594-0021
E-mail:[email protected]

Jenna Norton, PhD, MPH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
E-mail:[email protected]

Priscah Mujuru, DrPH, MPH, RN
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-9765
E-mail: [email protected]

Sundania J.W. Wonnum, PhD, LCSW
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: [email protected]

Amanda Alise Price, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-827-8391
Email: [email protected]

Elizabeth Anne Barr, PhD
Office of Research on Women's Health (ORWH)
Phone: 301-402-7895
E-mail:[email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email:[email protected]

Nancy Emenaker, PhD, RDN, FAND
National Cancer Institute (NCI DCP)
Telephone: 240.276.7125
Email: [email protected]