Notice of Intent to Publish a Funding Opportunity Announcement - Alcohol-HIV/AIDS Program Project Comorbidities, Coinfections, and Complications Research: Intervention and Cross-Cutting Foundational Research (P01 Clinical Trial Optional)

Key Dates

• June 3, 2020 - Alcohol-HIV/AIDS Program Project Comorbidities, Coinfections, and Complications Research: Intervention and Cross-Cutting Foundational Research (P01 Clinical Trial Optional). See NOFO RFA-AA-20-009.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to promote a new initiative by publishing a Notice of Funding Opportunity (NOFO) to solicit applications for research on the intersection of alcohol and HIV/AIDS.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The new Funding Opportunity Announcement (NOFO) will use the NIH Program Project (P01) mechanism to support cross-cutting research on alcohol and HIV/AIDS. NIAAA seeks to encourage research that can be translated into interventions in order to reduce infection and transmission of HIV. The goals of the proposed center must be consistent with the priorities as described in the NIH Office of AIDS Research (OAR), NIH Strategic Plan for HIV and HIV-Related Research. The NOFO will solicit applications for human studies that will advance operations or implementation research in the context of alcohol and HIV/AIDS by facilitating the development of: (1) broader systems approaches for monitoring complex HIV and alcohol-related patient outcomes including frailty, morbidity and mortality, and (2) interventions to reduce the impact of alcohol and alcohol-related comorbidities on HIV disease progression and transmission in the context of aging. Research funded under the NOFO should serve to advance the next generation of intervention studies to address alcohol use from prevention to treatment of HIV. Intervention studies should inform implementation efforts to improve provision of alcohol-related interventions and treatments for people living with HIV (PWH) in healthcare and community settings. This proposed research initiative is aligned with the research priorities set forth in the NIAAA Strategic Plan for Research and the NIH Strategic Plan for HIV and HIV-Related Research.  OAR is currently developing the FY 2026-2030: NIH Strategic Plan for HIV and HIV-Related Research. Learn more about this effort here for the development of the FY2026 - 2030 plan. These research areas include, but are not limited to, alcohol use and alcohol use disorders as risk factors for HIV and associated noncommunicable diseases.

Elucidate pathogenesis of HIV-associated comorbidities, coinfections, and complications: Study etiology, cofactors, pathogenesis, disease progression, and consequences of coinfections including those that contribute significantly to HIV acquisition, transmission, and viral persistence after therapy such as opportunistic infections, treatment-related, concomitant disease or substance use disorder, and other major causes of comorbidities.

? Investigate the pathogenesis of HIV-associated non-communicable diseases (NCDs) across the life-span and in diverse populations, including but not limited to malignancies, cardiovascular disease, diabetes, substance use disorder, and neurocognitive disorders, and their interactions with HIV.

Elucidate behavioral and social factors and processes: Expand the identification and analysis of behavioral, interpersonal, social, and structural factors, processes, dynamics, and contexts that influence and are influenced by HIV. Elucidate causal chains between HIV-associated factors, processes, dynamics, and contexts and their differential outcomes in prevention, treatment, co-occurring conditions, and cure in diverse populations and settings.

? Investigate the associations among and impacts of co-occurring behavioral and social factors, such as mental health, substance use, social support, and resilience, with respect to HIV risk, acquisition, transmission, disease progression, care, and cure.

Promote community-engaged and community-led HIV research: Enhance models of effective academic and community research partnerships, community-based participatory research, and community-initiated research in diverse settings. Support studies that identify factors that facilitate or impede effective community engagement in HIV research at all stages. Evaluate the impact of community engagement in HIV testing, prevention, treatment, care, and cure-directed concept/studies. Use established guidance, frameworks, and principles to inform meaningful and intentional community-engaged and community-led research.

? Develop and evaluate community-led interventions that address communities’ specific biomedical, behavioral, and social needs and priorities, including those focused on HIV-associated intersectional stigma and discrimination, as well as mental health and substance use.

The NOFO is expected to be published in Summer 2025 with an expected application due date in Fall 2025.

This NOFO will utilize the P01 Research Program Projects (Clinical Trial optional)

'ackground

Alcohol misuse is common among people living with HIV (PWH). Patterns of alcohol use impact transmission of HIV, engagement and retention in care, and susceptibility to coinfections (e.g., COVID-19, hepatitis C and tuberculosis). HIV can now be treated effectively with multiple antiretroviral medications, which suppress viral replication and result in a longer life. Even after establishing viral control, alcohol use remains a complicating factor with clinical manifestations such as continuing systemic inflammation and organ and tissue damage. Research on patterns of alcohol use is needed to understand how and at what levels alcohol consumption complicates HIV treatment and aging among PWH. In addition, more studies are necessary to: (1) elucidate the mechanisms by which alcohol use impacts comorbidities, including mental health and other substance use disorders, (2) determine whether decreasing alcohol use improves HIV-relevant individual and community outcomes, (3) examine whether state-of-the-art medications used to treat Alcohol Use Disorder (AUD) and common comorbidities or coinfections are safe and effective for PWH, and 4) implement interventions in vulnerable populations that are racially, ethnically and gender minority diverse and geographically distributed. Support for studies using both validated biological measurements and self-reports of alcohol use would promote the identification of subgroup variation and ensure better understanding of the risks to particularly vulnerable populations.

Objectives

The NOFO will solicit applications that address HIV and alcohol-related frailty, morbidity and mortality, and interventions that reduce the impact of alcohol on HIV disease progression and transmission.

Examples include studies that seek, but are not limited to:

• Developing interventions that combine behavioral and biological strategies leading to significant and sustainable reductions in the impact of alcohol on viral load and the spread of HIV, and other effective strategies that focus on addressing long-term underlying pathophysiology.
• Discovering innovative approaches to measure and treat HIV and alcohol misuse in diverse populations who continue high-risk patterns of harmful or hazardous drinking across the lifespan.
• Developing strategies to prevent HIV and common alcohol-associated coinfections (e.g., COVID-19, hepatitis C, tuberculosis) and reduce comorbidities, co-infections, and complications (CCC) that are also common (e.g. tobacco and depression) among PWH.
• Supporting and advancing novel research to address and mitigate underlying alcohol and HIV-associated medical and social inequalities that diminish the health and well-being of PWH in underserved and marginalized communities in domestic and international settings.
• Pursuing innovative research methods and the use of new and improved technologies to facilitate advances across the research agenda and to improve the translation of basic behavioral and biological research findings into clinical and community practice.
• Using emerging new methodologies focused on analysis and representation of large/complex datasets could also be explored, particularly in relationship to the use of electronic medical records and/or other sources of reliable information related to engagement in care.
• Advancing the understanding of how the severity of alcohol use (including AUD) impacts clinical outcomes for PWH and identifying new ways of engaging and retaining this target population in effective treatment.
• Examining the additive or synergistic impact for specific comorbidities in determining clinical outcomes for PWH who have sustained organ and tissue damage due to past alcohol use (e.g., sick quitters), relapse, and understanding the optimal recovery process.

Outcomes include, but are not limited to health outcomes for PWH who continue to drink or have problems associated with past drinking:

• Improving linkage to care and retention in HIV and alcohol care.
• Accelerating reductions in alcohol use resulting in increased viral suppression and reduce harmful viral expression.
• Identifying mitigating social determinants of poor outcomes (such as homelessness).
• Reducing frailty and subsequent mortality.
• Reducing the incidence of new infections through Treatment as Prevention (TasP).
• Reducing HIV and alcohol disparities in key populations of men and women and in the Southern US and other high-incidence locations particularly those related to Ending the HIV Epidemic (EHE).

P01 Program Project

The P01 Program Project is designed to foster teams capable of using coordinated, focused approaches to address high priority topics in alcohol research and to develop a sustained thematic approach required for resolution of complex issues in alcohol research. Thus, grant applications are expected to identify a relevant and important issue, propose innovative research that will address the related questions, provide a rationale for the proposed team approach, and establish an appropriate timeline. The central theme of the proposed Program Project should reflect the expertise of the participating investigators, should take advantage of the institution's strengths and/or unique facilities including access to relevant clinical populations, and should be directed toward a high priority topic of significant importance in alcohol research. All activities will be under the general direction and supervision of the Project Director(s)/Principal Investigators(s) (PD(s)/PI(s)), who will function as Director(s) of the Program Project. The PD(s)/PI(s) should be established, independent scientist(s) in the field of alcohol research and in the chosen scientific area of the proposed program project. Strong research capability together with a well-developed research plan is fundamental to the establishment of coordinated, collaborative research across departmental structures of an institution. A Program Project should be an identifiable organizational unit within an institutional structure. Collaborations that take advantage of unique scientific opportunities, complimentary expertise and resources across different institutions are encouraged.

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Kendall J. Bryant, Ph.D.
Director, HIV/AIDS Research, NIAAA
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
6700B Rockledge Drive
Bethesda MD 20892-6902
[email protected]