This Notice calls for research on understanding and addressing gaps in the HIV care continuum.

In the United States and globally, ambitious goals have been targeted for HIV testing, adherence, and retention in care, and viral suppression to optimize HIV clinical outcomes and preventive benefit. In each step of the HIV care continuum, there have been significant advances to optimize the likelihood of viral suppression for men, women, and children living with HIV. For example, innovative approaches have been developed to increase rates of HIV testing, such as the use of social networks, technology-based approaches, HIV self-test distribution, community mobilization, and the implementation of HIV testing access in non-medical settings. For adherence to HIV medication regimens, significant investment and advances have been made to develop and implement objective measures of HIV medication use and a range of efficacious treatment adherence interventions. These interventions to increase adherence to regimens have been successfully implemented in the US and international settings. However, more work is needed, as indicated below. Progress has also been made in the development and testing of interventions designed to sustain retention in HIV care and treatment over longer periods of time. This target in the HIV care continuum has gained increased attention and import in recent years, due to the advances in HIV treatment and care that have made HIV a disease that can now be considered a chronic disease that requires lifelong treatment. Relative to the range of efficacious approaches to optimally target and intervene to increase rates of HIV testing and adherence to HIV treatments, the evidence base is much smaller for efficacious interventions to prevent patients dropping from HIV treatment and promoting sustained retention in HIV care. Similarly, there is a dearth of proven interventions available to locate and re-engage persons who dropped from HIV care and treatment and who are not currently receiving HIV treatment, as well as those without durable viral suppression.

Current evidence indicates that if 95% of all persons living with HIV know their status, 95% of those diagnosed receive antiretroviral treatment (ART), and 95% of those on treatment achieve sustained viral suppression, then incident HIV infections will decline, and an end to the HIV/AIDS pandemic is achievable. In some settings, there is evidence that with necessary resources, a comprehensive strategy, and effective approaches for HIV testing, linkage to care, adherence support, and retention in care, these “95-95-95” targets are feasible. e U.S. Ending the HIV Epidemic and PEPFAR 3.0 Strategy underscores the importance of doing the “Right things, in the Right Places” to curb the epidemic.

Substantial challenges remain, however. Additional tools are needed to inform the gaps and strategies that are unique to specific populations, cities, regions, and countries to enable the scale-up of services that will achieve epidemic control. Studies are encouraged that examine multi-level factors that can optimize care continuum success, including individual, contextual, and structural. Applications appropriate for this Notice could include formative basic behavioral and social science to better understand a step in the care continuum and/or multiple steps in the HIV care continuum, initial development and pilot tests of innovative approaches for intervention, and intervention efficacy trials and implementation science.

An important aspect of this will be collaborations between the scientific and service entities in communities. Research teams are strongly encouraged to have academic and Department of Health (DOH) or Ministry of Health (MOH) partnerships for the research applications, in order to optimize the match of the research directions with local needs, and to optimize the public health impact of the research implementation and findings. This Notice also encourages researchers to utilize a developmental perspective that addresses the substantial changes that occur across the lifespan (from infancy through older adulthood) that are associated with HIV treatment challenges. Additionally, given the complexity of advancing HIV care research, multidisciplinary and modeling approaches are encouraged that draw appropriately from multiple disciplines to reach solutions based on novel understandings of these complex problems.

Areas of Research Interest

Areas of programmatic interest include, but are not limited to:

• Studies to identify the interaction of biological, behavioral, interpersonal, societal, and environmental factors associated with the risk of transmitting HIV, vulnerability, disease progression and resilience
• Studies to identify gaps and targets in the HIV care continuum and associated determinants to inform intervention development
• Studies to understand and decrease the differential effects of biomedical HIV care strategies in different populations; disparities could include gender, age-related, racial/ethnic, or sexual minority.
• Studies to further elucidate individual-level risk by using geospatial, neighborhood mapping or other techniques to determine and target community-level risk.
• Studies to develop, test, and implement innovations in HIV testing and linkage to care, that could include advancements in approaches and technologies
• Studies to develop, implement, and evaluate approaches to expedite earlier ART initiation for persons diagnosed with HIV
• Studies of strategies to promote ART engagement and uptake among individuals at substantial risk of transmitting HIV
• Studies of decision support tools that help individuals, couples, and clinicians make informed choices about HIV care options
• Studies to develop and test interventions to improve linkage to HIV care
• Studies to develop and test novel adherence interventions that impact on both behavioral adherence and persistence, and biological outcomes such as viral suppression
• Studies to understand and address provider, clinic, and systems-level factors that may impact antiretroviral initiation, antiretroviral adherence, or patient retention, for the purpose of informing provider training, clinic practice, and healthcare policy
• Studies that advance innovative approaches for ART delivery
• Studies to develop and test interventions to improve retention in HIV care as indicated
• Studies to develop and test interventions to improve viral suppression (including durable suppression) as indicated
• Studies of the impact of varying models of differentiated HIV care on retention in care
• Studies of interventions to prevent discontinuation of HIV care, and/or to address significant barriers to retention in care
• Studies to develop and test alternative strategies to re-engage former patients into HIV care
• Studies to develop and test targeted interventions designed to reduce documented gender, age-related, racial/ethnic, or sexual minority disparities in HIV care continuum outcomes.
• Studies to better understand and overcome the challenges faced by mobile populations, such as migrants, displaced people, and individuals who are homeless or marginally housed, in accessing and benefitting from HIV care services
• Studies to develop and test behavioral, provider, and healthcare systems interventions to facilitate uptake and use ART regimens
• Studies that utilize modeling and simulation techniques and systems science approaches (e.g., network analyses and systems dynamics approaches) to identify the most effective core elements of interventions and estimate and test when and where and under which conditions they should be targeted to an individual, social group, family, community, health care or other system to achieve maximum benefit
• Studies to develop and use adaptive designs and decision rules that are based on participant characteristics and responses to intervention in order to customize and tailor intervention strategies

It is strongly recommended that applicants review the NIMH Division of AIDS Research current Funding Opportunity Announcements (available on our website at https://www.nimh.nih.gov/about/organization/dar/aids-related-funding-opportunity-announcements-foas.shtml), and consult with a Program Officer before application submission.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

Application and Submission Information

This notice applies to due dates on or after May 7, 2020 and subsequent receipt dates through May 7, 2023.

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-20-144, 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-20-141, Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)

PA-19-126, Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Not Allowed)

PA-19-127, Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Required)

PA-19-116, Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required)

PA-19-117, Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed)

PA-19-118, Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required)

PA-19-119, Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Not Allowed)

PA-19-052, NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)

PA-19-129, NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Required)

PA-19-130, NIH Pathway to Independence Award (Parent K99/R00 - Independent Clinical Trial Not Allowed)

PA-19-121, Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)

PA-19-122, Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Not Allowed)

PA-19-272, PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA-19-273, PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

PA-19-270, PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed

PA-19-271, PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required

PAR-19-051, Emerging Global Leader Award (K43 Independent Clinical Trial Required)

PAR-19-098, Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed)

PAR-17-485, NIMH Research Education Mentoring Program for HIV/AIDS Researchers (R25)

PAR-18-714, Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 - Clinical Trial Not Allowed)

PAR-19-133, Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Required)

PAR-19-134, Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Not Allowed)

PAR-19-135, Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Required)

PAR-19-283, Fogarty HIV Research Training Program for Low-and Middle-Income Country Institutions (D43 Clinical Trial Optional)

PA-19-192, Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30)

PA-19-195, Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)

PA-19-196, Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31 -Diversity)

PA-19-188, Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32)

PA-18-403, Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32)

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-MH-20-023” (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 be not be considered for the NOSI initiative.

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Gregory Greenwood, PhD, MPH
National Institute of Mental Health (NIMH)
Telephone: 240-669-5532
Email: [email protected]

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)
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]