Key Dates

Related Announcements

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

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

Issued by

National Institute on Minority Health and Health Disparities (NIMHD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Purpose

Background

The objective of the Ending the HIV Epidemic: A Plan for America is to reduce new HIV infections in the United States by 75% in five years and by 90% by 2030 (https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview). This will be accomplished by implementing proven strategies to prevent new HIV infections – including use of PrEP by high-risk HIV-negative individuals and achieving an undetectable viral load through antiretroviral therapy (ART) among individuals living with HIV – in geographic hotspots with disproportionate numbers of new HIV infections. New infections disproportionately occur in young men who have sex with men (MSM) from racial/ethnic minority populations, particularly African Americans and Latinos. However, the subpopulations at the highest risk of acquiring HIV may vary across geographic hotspots, and the challenges in engaging these high-risk populations may also vary depending on local or state HIV-related resources, laws and policies, and social norms and cultural factors. If local prevention efforts do not successfully engage these highest risk populations, the plan to drastically reduce new HIV infections in the next two decades is not likely to succeed.

In addition to engagement of high-risk populations in HIV prevention programs through culturally relevant outreach, such programs, if they are to be effective, must also address the life circumstances and social and structural environments that may make reducing HIV risk challenging. Such factors may include poverty, unemployment, mental health and substance use problems, housing instability, food insecurity, criminal justice involvement, social isolation, intimate partner violence, community violence, stigma and discrimination, lack of access to healthcare, and lack of clinician awareness or willingness to prescribe PrEP. Successful implementation of HIV prevention programs is likely to require adaptation of intervention content, format, or mode of delivery, or additional intervention elements, to be acceptable and feasible to populations that may be experiencing competing priorities and life demands. In addition, interventions are not likely to produce sustained reductions in HIV risk if they are solely focused on individual-level knowledge, attitudes, and behavior. Therefore, multi-level intervention components, including those that involve peers, partners, family members, school systems, community members, community- or faith-based organizations, healthcare systems, community clinics and other service providers, are necessary.

Research Objectives

The purpose of this NOSI is to encourage research projects that test the effectiveness of multi-level interventions to prevent HIV infection in high-risk health disparity populations or subpopulations in one or more geographic hotspots (see https://files.hiv.gov/s3fs-public/Ending-the-HIV-Epidemic-Counties-and-Territories.pdf for a list of hotspots). The population focus is expected to include HIV-negative MSM and/or transgender women who are African American or Latino/a, as these populations have the highest risk for acquiring new HIV infections and account for over half of new infections. Projects may include these populations globally or specific subpopulations that are relevant to the selected hotspots. Examples of potential subgroups include, but are not limited to, MSM or transgender women who are African American or Latino; identify as bisexual; have mental health or substance use disorders; belong to house and ballroom communities; or who are under 18, homeless, recent immigrants, involved in the criminal justice system, or engaged in sex work or exchange sex. Other health disparity populations in addition to Black and Latino MSM and transgender women that could be considered for inclusion are non-Hispanic White MSM, cisgender Black or Latina women, or rural residents who inject drugs).

Projects are generally expected to be clinical trials in which participants or settings are prospectively assigned by study investigators to intervention conditions as part of the project. However, projects may also involve the evaluation of initiatives being implemented by county, state, or regional service providers (independent of NIH funding), where prospective assignment by study investigators does not occur. Rigorous quasi-experimental study designs with appropriate control or comparison conditions or populations are expected for projects that are not clinical trials.

Interventions are expected to have the following features:

• Promote PrEP use, condom use, and HIV testing in HIV-negative individuals, with intervention content that can be updated to reflect new prevention options that emerge during the project (e.g., long acting PrEP, HIV vaccine).
• Encompass multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, health-care system) and multiple levels (e.g., individual, interpersonal, community, societal; see the NIMHD Research Framework: https://www.nimhd.nih.gov/about/overview/research-framework.html).
• Use existing evidence-based HIV-prevention interventions or practices (including adaptations), either alone or in combination with new intervention elements. Entirely new interventions are not the focus of this NOSI.
• Use HIV serostatus and/or changes in HIV-related behaviors (e.g., condom/PrEP use, HIV testing) as primary outcomes.
• Are led by or conducted in partnership with clinicians and service providers responsible for delivering HIV prevention services or programs at the local, state, or regional level.
• Emphasize intervention effectiveness, comparative effectiveness, success of intervention implementation strategies, or optimization of multi-component interventions.
• Are tested with samples reflective of the diversity within the target population (e.g., with respect to sexual orientation, gender identity, race/ethnicity, SES, or rural urban status).

Specific Areas of Research Interest

Areas of special interest include, but are not limited, to the following:

• Testing of interventions in multiple geographic hotspots.
• Use of cluster randomized trials or multi-site quasi-experimental studies.
• Interventions that include clinician- or healthcare setting-level intervention components to enhance cultural competency, reduce health-care related stigma and discrimination, and increase clinician comfort and willingness to prescribe PrEP.
• Engagement of community members of the target high-risk health disparity populations or subgroups as investigators, advisors, or peer interventionists.
• Collaboration with diverse local stakeholders in addition to HIV-prevention service providers, including school systems, school-based student or parent associations, community-based organizations, consumer organizations, and faith-based organizations, to enhance intervention relevance, feasibility, and sustainability.

• Projects that examine cost-effectiveness of intervention implementation and delivery.

NIDA is interested in supporting research under this NOSI involving people who use drugs (PWUD) including members of key populations among whom drug use is a common HIV acquisition risk: gay, bisexual, and other men who have sex with men (MSM), Transgender Persons, Sex Workers, and High Risk Heterosexuals (HRH). Outside of drug use, populations should conform to the criteria for highest risk based on available evidence outlined elsewhere in this NOSI (including incorporation of jurisdictions included in the Ending the HIV Epidemic initiative) and efforts should be made to incorporate members of these populations as active contributors to intervention development and implementation.

Areas of special interest to NIDA include but are not limited to the following:

• Multi-level interventions that incorporate substance use treatment, harm reduction or other settings that commonly provide substance use services.
• Interventions that directly engage sexual and/or drug use (injecting and non-injecting) partners in HIV risk reduction.
• Structural interventions to reduce HIV acquisition that incorporate improved access to substance use prevention, treatment and harm reduction.
• Interventions that include provider or organization-level components to enhance cultural competency and reduce stigma and discrimination towards PWUD, particularly those who are members of racial/ethnic minorities, and/or sexual and gender minorities.
• Multi-level interventions that incorporate outreach to novel settings with the capacity to engage difficult-to-reach populations of PWUD or key populations among whom drug use is common.
• Interventions that address HIV prevention and drug use in the context of addressing comorbidities such as intimate partner violence, marginal housing or serious mental disorder.
• Collaboration with diverse local organizations and stakeholders such as drug use prevention programs, public health and social service outreach, substance use treatment settings, school systems, justice settings, community-based organizations, population advocacy organizations, and faith-based organizations.
• Projects that incorporate novel approaches to PrEP delivery such as injectable PrEP.
• Projects that incorporate cost-effectiveness analysis for intervention implementation and delivery.

Applications Not Responsive to the NOSI:

• Projects that do not test HIV prevention interventions in HIV-negative individuals from one or more NIH-designated health disparity populations (Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities).
• Projects that test interventions outside of the identified geographic hotspots (see https://files.hiv.gov/s3fs-public/Ending-the-HIV-Epidemic-Counties-and-Territories.pdf).
• Projects that test interventions that are not multi-level (see https://www.nimhd.nih.gov/about/overview/research-framework.html).
• Projects that do not include partnerships with service providers responsible for delivering HIV prevention services or programs at the local, state, or regional level.

Application and Submission Information

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

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-MD-21-014” (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.

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

Inquiries

Scientific/Research Contact(s)

Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email:jennifer.alvidrez@nih.gov

Richard A Jenkins, Ph.D
National Institute On Drug Abuse (NIDA)
Phone: 301-443-6504
E-mail: jenkinsri@nida.nih.gov

Susannah Allison, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: allisonsu@mail.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)

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@nida.nih.gov