Innovative Multi-Level Approaches and Strategies to Prevent, Test and Treat HIV in Primary Care Settings in populations experiencing health disparities in Geographic Hot Spots in the U.S. (R01 Clinical Trial Required)

The objective of the Ending the HIV Epidemic: A Plan for America (EHE) is to reduce new Human Immunodeficiency Virus (HIV) infections in the United States by 75% in five years and by 90% by 2030.

A critical component of the EHE initiative involves early diagnosis of HIV infection, along with prevention of new transmissions (including use of pre-exposure prophylaxis preventive treatment [PrEP]); treatment of infections; and public health response to outbreaks in geographic hotspots with disproportionate numbers of new HIV infections.

NIMHD supports applications for research projects that examine innovative approaches to prevent, test, and treat HIV among populations or subgroups experiencing health disparities* and within primary care settings located in these hotspots.

Primary health care settings are important venues for HIV testing in the U.S. Patients seen in primary care settings could benefit from having established care with rapid transition into treatment for those who test HIV positive, or prevention services for those who test negative and are at risk.

In many cases, primary care clinicians effectively treat and manage persons living with HIV (PLWH) to initiate antiretroviral therapy (ART) and to promote ART adherence. Better strategies are needed to promote ART initiation and adherence in PLWH, and primary care clinicians are in a unique position to offer these innovative approaches.

NIMHD will support projects that evaluate comprehensive strategies addressing a range of prevention, care, and treatment barriers across one or more phases of the HIV treatment cascade (i.e., diagnosis, linkage to care, initiation of PrEP, adequate ART to achieve viral suppression, engagement in care, retention in care, and achievement of viral suppression).

Projects that test multi-level interventions that evaluate multi-level approaches at the patient, clinician, peer/family, setting, and community level to address social determinants of health are strongly encouraged (see NIMHD research framework for examples of determinants at different levels of influence).

It is strongly encouraged that leadership and/or clinicians and other personnel within the primary care setting(s) be involved as research partners. Study designs may involve intervention effectiveness, comparative effectiveness, success of intervention implementation strategies, or optimization of multi-component interventions. Trials that examine both clinical and behavioral outcomes as well as implementation processes and outcomes are strongly encouraged.

See the FOA for a complete list of research areas of interest.

*Applications must focus on one or more NIH-designated U.S. populations experiencing health disparities, which 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.

Priority populations for this research include men who have sex with men (MSM), transwomen of color, and youth and young adults ages 13-24—though ages 13-44 are targeted—who are African American or Latino, as these populations have the highest risk for acquiring new HIV infections.

In addition to Black and Latino MSM and transgender women, other populations experiencing health disparities of interest include non-Latino White MSM, cisgender Black or Latina women, and rural residents who inject drugs.

NIH Guide No.: RFA-MD-22-001

Page updated Jan. 12, 2024