Key Dates

Related Announcements

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

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 percent in five years and by 90 percent 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 pre-exposure prophylaxis (PrEP) by high risk HIV negative individuals and achieving an undetectable viral load through antiretroviral therapy (ART) among people living with HIV (PLWH)--in geographic hotspots with disproportionate numbers of new HIV infections. PLWH who are virally suppressed cannot transmit HIV, but according to the CDC, PLWH engaged in HIV care but not virally suppressed account for 20% of new HIV transmissions.

To meet the Plan for America objectives, the target level for viral suppression among PLWH is 95%. According to the CDC, about two-thirds (63%) of PLWH currently demonstrate 12-month viral suppression, with significant disparities evident. Among PLWH in HIV care, racial/ethnic minorities, less educated and lower SES individuals, and adolescents and young adults are less likely to be prescribed ART, achieve viral suppression on ART, and maintain sustained viral suppression than their more advantaged or older counterparts. Lack of suppression, coupled with unprotected sexual contact or injection drug use, contributes to an elevated risk of HIV transmission within these groups. Better strategies are needed to promote ART initiation and adherence in PLWH from health disparity populations engaged in HIV care and to reduce HIV risk behaviors during periods of non-suppression. Although a variety of interventions exist to improve adherence to ART and other medications, many focus on health education and text message reminders and do not address social determinants associated with poorer ART adherence and viral suppression. Such factors include poverty, unemployment, limited health literacy, limited English proficiency, housing instability, food insecurity, criminal justice involvement, lack of social support, intimate partner violence, community violence, stigma and discrimination, and lack of access to culturally competent HIV care or pharmacy services. As a result, many adherence interventions are less effective with PLWH from health disparity populations or show initial effects that dissipate over time. In addition, many existing ART adherence interventions do not address HIV risk behaviors during periods of non-suppression. Therefore, multi-domain, multi-level interventions that address social determinants of health are needed to help PLWH from health disparity populations initiate and sustain ART adherence and reduce HIV risk behaviors.

Research Objectives

The purpose of this NOSI is to encourage research projects that test interventions to promote ART initiation, ART adherence, and suppressed viral load for PLWH engaged in HIV care 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 for this initiative is expected to be primarily Black and Latino men who have sex with men (MSM) and transgender women, as these populations have elevated rates of new HIV infection as well as risk of HIV transmission. Other health disparity populations with low levels of viral suppression within the proposed hotspots may also be included as appropriate, including non-Hispanic white MSM, cisgender African American or Latina women, or rural residents who inject drugs.

Interventions are expected to have the following features:

• Based in one or more HIV care settings, rather than interventions that are delivered independently from ongoing HIV care.
• Are delivered by personnel from the HIV care setting or collaborating service providers rather than research personnel.
• Simultaneously promote ART initiation/adherence and reduce high risk sexual and/or drug use behaviors during periods of non-suppression to prevent HIV transmission to sexual partners.
• Address relevant multi-domain, multi-level determinants of poor ART adherence, viral non-suppression, and high risk HIV behaviors (see the NIMHD Research Framework: https://www.nimhd.nih.gov/about/overview/research-framework.html).
• Use direct assessment of viral load (not only self-report) as the primary outcome in addition to relevant behavioral outcomes (e.g., ART adherence, condom use, PrEP use by sexual partners).
• Emphasize intervention effectiveness, comparative effectiveness, implementation strategies, or optimization of multi-component interventions.

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

• Testing of interventions in HIV care settings in multiple geographic hotspots.
• Use of cluster randomized trials rather than individual-level clinical trials.
• Interventions that directly engage sexual partners in ART adherence and HIV risk behavior reduction intervention components.
• Interventions that include clinician- or clinic-level intervention components to enhance cultural competency and reduce health-care related stigma and discrimination towards HIV positive individuals, racial/ethnic minorities, and/or sexual and gender minorities.
• Engagement of 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 care providers, including other types of healthcare providers, school systems, school-based student or parent associations, community-based organizations, consumer organizations, patient advocacy 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 the following areas of research involving people who use drugs (PWUD) including key populations e.g., Black/African American gay, bisexual, and men who have sex with men (MSM), Hispanics/Latinos MSM, Transgender Women, Female Sex Workers (FSW), High Risk Heterosexuals of racial ethnic minority groups (HRH) where drug use is a common contributing HIV risk:

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

• Testing of interventions that integrate HIV care with substance use disorder (SUD) treatment and/or harm reduction settings in multiple geographic hotspots.
• Interventions that directly engage sexual and/or injecting partners in ART adherence and HIV transmission prevention intervention components.
• Interventions that include clinician- or clinic-level intervention components to enhance cultural competency and reduce health-care related stigma and discrimination toward people living with HIV who are PWUD racial/ethnic minorities, and/or sexual and gender minorities.
• Engagement of members of the target high-risk health disparity PWUD populations or subgroups including as investigators, advisors, or peer interventionists.
• Collaboration with diverse local stakeholders in addition to HIV care providers, including other types of healthcare providers including care providers engaged in SUD prevention and care, school systems, justice settings, school-based student or parent associations, community-based organizations, consumer organizations, patient advocacy organizations, and faith-based organizations to enhance intervention relevance, feasibility, and sustainability.
• Projects that develop and test interventions to minimize delays in initiating or re-initiating PWUD in ART services that achieve and sustain viral suppression.
• Projects that incorporate cost-effectiveness analysis of intervention implementation and delivery.

Applications Not Responsive to the NOSI:

• Projects without a focus on 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 not testing interventions within existing HIV care settings.
• 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 do not simultaneously promote ART initiation/adherence and reduce high risk sexual and drug use behaviors during periods of non-suppression.
• Projects that do not directly assess viral load.

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)
   

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-21-015” (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
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