Opportunity Information: Apply for RFA AI 13 011
Apply for RFA AI 13 011
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Limited Competition Multicenter AIDS Cohort Study (MACS) Clinical Research Sites (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants 93.279 Drug Abuse and Addiction Research Programs 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research 93.399 Cancer Control 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Mar 8, 2013 and posted on Mar 8, 2013.
- Applicants must submit their applications by Jul 11, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $17,900,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $4,200,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following 1. Eligible Applicants Eligible Organizations Only applications from the current MACS clinical research sites (CRSs) may be submitted in response to this limited competition U01 AI035039, Northwestern University (Chicago, IL) Chicago MACS U01 AI035040, University of California at Los Angeles (Los Angeles, CA) Natural History of HIV/AIDS in Homosexual Men Los Angeles MACS U01 AI035041, University of Pittsburgh (Pittsburgh, PA) The Pittsburgh Mens Study Pittsburgh MACS U01 AI035042, Johns Hopkins University (Baltimore, MD) The Study to Help the AIDS Research Effort (SHARE) Baltimore MACS Foreign Institutions Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. See announcement for more detailed information.
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Opportunity Summary:
This funding opportunity, RFA AI 13 011, is a National Institutes of Health (NIH) cooperative agreement (U01) aimed at renewing and continuing support for the clinical research sites (CRSs) that make up the Multicenter AIDS Cohort Study (MACS). The MACS is a long-running, multicenter effort focused on men who report sex with men (MSM), and the core objective of this renewal is to maintain and extend the clinical, epidemiologic, and basic research infrastructure that has been built over decades. In practical terms, NIH is supporting the continued follow-up of this well-characterized cohort to better understand the long-term course of HIV infection, both untreated and treated, and to keep generating insights into the clinical epidemiology of HIV and the factors that predict disease outcomes among HIV-positive MSM.
A major emphasis of the announcement is the value of continuity. The MACS has accumulated unusually deep longitudinal information, including clinical data and a rich repository of specimens collected across many years. That depth allows researchers to examine how HIV disease patterns shift over time, how treatment changes outcomes in the real world, and how aging and comorbid conditions intersect with HIV. The FOA reflects NIH interest in leveraging those long-term assets to answer questions that cannot be addressed easily with short-term studies, such as slow-developing complications, long-latency conditions, and the evolving effects of antiretroviral therapy across the lifespan.
The FOA also describes a structural shift in how the cohort will be maintained going forward: the MACS CRSs are expected to transition to a rolling cohort design. This means that as existing participants die or are permanently lost to follow-up, new participants can be recruited to sustain the cohort size and preserve the study's ability to produce statistically meaningful findings over time. Rolling enrollment is intended to keep the cohort current and robust, while still preserving the longitudinal strengths of the study. It also helps the MACS remain relevant as the HIV epidemic, prevention strategies, and treatment standards continue to evolve.
This is a limited competition. Eligibility is restricted to the four current MACS clinical awardee institutions because NIH is explicitly prioritizing demonstrated capacity to recruit and retain this specific population, and because the work depends heavily on the established infrastructure, relationships, protocols, and historical continuity at those sites. The eligible organizations are the current MACS CRSs funded under the earlier U01 awards: Northwestern University (Chicago, IL), University of California at Los Angeles (Los Angeles, CA), University of Pittsburgh (Pittsburgh, PA), and Johns Hopkins University (Baltimore, MD). Foreign institutions and non-U.S. entities are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible, although foreign components (as defined by NIH policy) are allowed.
From an administrative and funding perspective, the opportunity is categorized as discretionary and uses a cooperative agreement mechanism, which generally indicates substantial NIH scientific or programmatic involvement compared with a standard grant. NIH anticipated making four awards, aligning with the four existing sites. The estimated total funding level listed is $17.9 million, with an award ceiling of $4.2 million. There is no cost sharing or matching requirement. The opportunity was posted on March 8, 2013, with an application closing date of July 11, 2013, and an archive date of August 11, 2013.
The announcement is associated with multiple CFDA program areas, reflecting the cross-cutting nature of HIV research and its overlap with related health domains. These include mental health research, drug abuse and addiction programs, cancer detection/diagnosis and cancer treatment/control, and allergy/infectious diseases and microbiology/infectious diseases research. That breadth signals that the MACS is not only about virology or infectious disease outcomes in isolation, but also about the broader health consequences and co-occurring conditions that affect people living with HIV, including cancers and behavioral health factors.
Overall, the FOA is essentially a continuation and modernization effort for a landmark cohort study. NIH is investing in keeping the MACS clinical sites operating and productive, maintaining long-term follow-up, and updating the cohort structure through rolling enrollment so the study remains scientifically powerful and relevant. The limited-competition design underscores that the primary goal is not to establish new sites, but to preserve and extend the unique long-term dataset, specimen resources, and participant engagement that the existing MACS sites have built over time.
Funding Opportunity FAQs (RFA AI 13 011 - MACS Clinical Research Sites Renewal)
What is RFA AI 13 011?
RFA AI 13 011 is a National Institutes of Health (NIH) funding opportunity to renew and continue support for the clinical research sites (CRSs) that make up the Multicenter AIDS Cohort Study (MACS). The award mechanism is a cooperative agreement (U01), which generally means NIH will have substantial scientific or programmatic involvement compared with a standard research grant.
What is the purpose of this funding opportunity?
The purpose is to maintain and extend the clinical, epidemiologic, and basic research infrastructure built by the MACS over decades, and to support continued follow-up of a well-characterized cohort of men who report sex with men (MSM) to better understand the long-term course of HIV infection (both untreated and treated).
What is the MACS, and who does it study?
The Multicenter AIDS Cohort Study (MACS) is a long-running, multicenter cohort study focused on men who report sex with men (MSM). It has accumulated deep longitudinal clinical information and a rich repository of specimens collected over many years.
What kinds of research questions is NIH prioritizing through this renewal?
Based on the long-term nature of MACS data and specimens, the renewal emphasizes questions that are difficult to answer in short-term studies, including slow-developing complications, long-latency conditions, real-world effects of antiretroviral therapy over time, and how aging and comorbid conditions intersect with HIV.
Why does the announcement emphasize continuity?
Continuity is central because MACS has unusually deep longitudinal data and specimens collected across many years. Maintaining the same sites and infrastructure preserves the value of historical comparisons, long follow-up periods, established protocols, and participant engagement that enable rigorous long-term analyses.
What is meant by a "rolling cohort design" in this FOA?
A rolling cohort design means that as existing participants die or are permanently lost to follow-up, new participants can be recruited to sustain cohort size. The goal is to keep the cohort statistically robust and current while preserving the study's longitudinal strengths.
Why is rolling enrollment being introduced?
Rolling enrollment is intended to keep the MACS cohort size stable and the study scientifically powerful over time. It also helps the cohort remain relevant as the HIV epidemic, prevention strategies, and treatment standards continue to evolve.
What type of NIH award mechanism is used?
This opportunity uses a cooperative agreement mechanism (U01). In practical terms, this indicates substantial NIH scientific or programmatic involvement, rather than the more independent structure typical of some other grant mechanisms.
Is this an open competition?
No. This is a limited competition. Eligibility is restricted to the four current MACS clinical awardee institutions because NIH is prioritizing demonstrated capacity to recruit and retain the specific study population and to preserve established infrastructure and historical continuity at those sites.
Which organizations are eligible to apply?
Only the four current MACS clinical research sites funded under earlier U01 awards are eligible: Northwestern University (Chicago, IL), University of California at Los Angeles (Los Angeles, CA), University of Pittsburgh (Pittsburgh, PA), and Johns Hopkins University (Baltimore, MD).
Are foreign institutions eligible to apply?
No. Foreign institutions and non-U.S. entities are not eligible to apply. Non-U.S. components of U.S. organizations are also not eligible.
Are foreign components allowed under NIH policy?
Yes. While foreign institutions and non-U.S. entities are not eligible, foreign components (as defined by NIH policy) are allowed.
How many awards did NIH anticipate making?
NIH anticipated making four awards, aligning with the four existing MACS clinical research sites.
What is the estimated total funding level and the maximum award amount?
The estimated total funding level listed is $17.9 million. The award ceiling is $4.2 million.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement stated for this opportunity.
What are the key dates for this opportunity?
The opportunity was posted on March 8, 2013. The application closing date was July 11, 2013. The archive date was August 11, 2013.
What does the FOA say about the kinds of data and resources involved?
The FOA highlights that the MACS includes deep longitudinal clinical data and a rich repository of specimens collected over many years. These assets support analyses of disease patterns, treatment effects, aging, comorbidities, and predictors of outcomes among HIV-positive MSM.
What is the main scientific value of keeping the existing MACS sites rather than creating new ones?
The main value is preserving and extending a unique long-term dataset, specimen resources, and participant engagement. The FOA underscores that the goal is not to establish new sites, but to maintain the established infrastructure, relationships, protocols, and historical continuity already in place.
What NIH program areas (CFDA associations) are connected to this announcement?
The announcement is associated with multiple CFDA program areas, including mental health research, drug abuse and addiction programs, cancer detection/diagnosis and cancer treatment/control, and allergy/infectious diseases and microbiology/infectious diseases research.
Why are multiple CFDA program areas associated with this opportunity?
The breadth of CFDA associations reflects that MACS research is cross-cutting. It is not limited to virology or infectious disease outcomes alone, and it also addresses broader health consequences and co-occurring conditions affecting people living with HIV, including cancers and behavioral health factors.
What population and outcomes are specifically mentioned as central to the FOA?
The FOA centers on men who report sex with men (MSM), with a focus on understanding the long-term course of HIV infection, examining both untreated and treated disease trajectories, and identifying factors that predict disease outcomes among HIV-positive MSM.
How does this FOA describe the overall intent of the renewal?
It is described as a continuation and modernization effort for a landmark cohort study: keeping MACS clinical sites operating and productive, maintaining long-term follow-up, and updating cohort structure through rolling enrollment so the study remains relevant and scientifically powerful.
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Next opportunity: Crossroads of the American Revolution Association, Inc.
Previous opportunity: Limited Competition Multicenter AIDS Cohort Study Center for the Coordination, Analysis, and Management of the MACS (CAMACS)(UM1)
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