Opportunity Information: Apply for RFA AI 11 031
Apply for RFA AI 11 031
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19)" 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 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jun 9, 2011 and posted on Jun 9, 2011.
- Applicants must submit their applications by Nov 8, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $6,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities County governments State governments Public and State controlled institutions of higher education For profit organizations other than small businesses City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal governments (Federally recognized) Independent school districts Small businesses Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:
The Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19) is a National Institutes of Health cooperative agreement funding opportunity (RFA-AI-11-031) led by the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with the National Institute of Mental Health (NIMH). It was posted on June 9, 2011, with an application deadline of November 8, 2011, and it supported research that connects laboratory and early human work in a single coordinated program. The core idea is to accelerate the development of topical microbicides intended to prevent sexual transmission of HIV by funding teams that can move candidates forward through an integrated set of preclinical and exploratory clinical studies, using an iterative process where results from one stage inform the next.
The scientific goal of the program is to advance a topical microbicide that is safe, effective, and acceptable for real-world use. The FOA explicitly allows either single agents or combination approaches, recognizing that multiple active ingredients or multi-mechanism products may be needed to improve protection or reduce the risk of resistance. The emphasis on both “preclinical” and “exploratory clinical” work signals that projects are expected to span disciplines and methods, such as formulation and product development, microbiology and immunology, safety and toxicology testing, pharmacokinetics and pharmacodynamics, and early phase clinical evaluation. The “integrated and iterative” language is important because it encourages programs to treat product development as a feedback loop rather than a linear pipeline, adjusting formulations, dosing strategies, delivery methods, or target populations based on accumulating evidence.
Structurally, applicants were required to propose a multi-project, multidisciplinary program rather than a single stand-alone study. At minimum, an application had to include at least two distinct research projects plus an Administrative Core to coordinate the overall effort. This structure is typical of U19 mechanisms, where the intent is to support a collaborative, programmatic set of activities with shared leadership, common goals, and strong coordination across components. The Administrative Core requirement highlights that NIH expected active project management, communication across teams, harmonized protocols where appropriate, and efficient decision-making to keep the preclinical and clinical elements aligned.
A notable eligibility and partnership requirement is that at least one component of the overall program (either a research project or a scientific core) had to come from a private-sector company, whether for-profit or non-profit. This reflects an explicit push toward product-focused development and translation, since companies often bring expertise in manufacturing, formulation optimization, regulatory strategy, quality systems, and scale-up planning. In practice, that requirement also encourages applicants to build a development pathway that can realistically move a promising microbicide toward later-stage trials and, eventually, implementation, rather than stopping at proof-of-concept science.
The FOA falls under multiple CFDA numbers spanning infectious diseases and mental health research, underscoring that microbicide success is not just a biomedical problem. Alongside virology and immunology, microbicide effectiveness in the real world depends heavily on human factors such as acceptability, adherence, sexual behavior contexts, and user preferences, which align with NIMH’s interests. That linkage supports research programs that consider how product characteristics (for example, formulation type, dosing frequency, sensory attributes, and ease of use) affect consistent use, and therefore ultimate prevention impact.
Funding for the opportunity was estimated at $6,000,000 in total, and it did not require cost sharing or matching funds. The instrument type was a cooperative agreement, which typically means NIH anticipated substantial involvement beyond standard grant oversight, such as scientific coordination, milestone-driven management, or collaborative planning between awardees and NIH program staff. This is consistent with a product-development-oriented program where alignment, timelines, and go/no-go decisions may be important.
Eligibility was broad and included many types of U.S. organizations and governments, including public and private higher education institutions, nonprofits with or without 501(c)(3) status, for-profit organizations (including small businesses), and various governmental entities. The FOA also allowed non-U.S. entities (foreign organizations), U.S. territories or possessions, and foreign components of U.S. organizations, which is particularly relevant in HIV prevention research where clinical studies, target populations, and collaborating sites may be international. The announcement also explicitly included a wide range of institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations, reflecting an intent to welcome diverse applicants and partnerships.
Overall, this opportunity was designed to fund coordinated teams capable of taking a topical microbicide concept and pushing it forward through the kinds of preclinical and early clinical steps that de-risk a candidate and position it for larger trials. The required multi-project structure, the built-in administrative coordination, the mandated private-sector participation, and the cooperative agreement format all point to a translational, milestone-aware approach aimed at moving promising HIV prevention products toward practical, user-acceptable interventions.
FAQs: Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19)
What is the IPCP HTM (U19) funding opportunity?
The Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (RFA-AI-11-031). It is led by the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with the National Institute of Mental Health (NIMH) and is designed to support coordinated research programs that link laboratory and early human research to accelerate topical microbicide development for HIV prevention.
Which NIH institutes are involved?
The opportunity is led by NIAID, with partnership from NIMH. This reflects both the biomedical and behavioral/acceptability aspects of developing an HIV prevention product intended for real-world use.
What is the purpose of the program?
The central purpose is to accelerate development of topical microbicides intended to prevent sexual transmission of HIV by funding teams that can advance candidates through an integrated set of preclinical studies and exploratory (early phase) clinical studies. The design encourages an iterative development cycle where results from one stage inform decisions and refinements in the next.
What kinds of products does the FOA support?
The FOA supports topical microbicides for prevention of sexual transmission of HIV. It explicitly allows both single-agent products and combination approaches, recognizing that multiple active ingredients or multi-mechanism strategies may be needed to improve protection or reduce the risk of resistance.
Does the FOA require both preclinical and clinical work?
Yes. The program emphasizes spanning both preclinical and exploratory clinical work within one coordinated program. The intent is to connect laboratory-based development and early human evaluation rather than funding isolated projects that stop at only one stage.
What does "integrated and iterative" mean in this context?
"Integrated and iterative" means the program is expected to function as a feedback loop rather than a one-way pipeline. Findings from formulation, microbiology, immunology, safety/toxicology, pharmacokinetics/pharmacodynamics, or early clinical evaluation can lead to adjustments in the candidate product, dosing strategy, delivery approach, or other design choices as evidence accumulates.
What types of research activities are expected to be included?
Based on the program description, expected activities can include cross-disciplinary elements such as formulation and product development, microbiology and immunology studies, safety and toxicology testing, pharmacokinetics and pharmacodynamics, and early phase clinical evaluation. The defining feature is that these elements are coordinated within a single program aimed at advancing a microbicide candidate.
Is this a single-project grant or a multi-project program?
It is a multi-project, multidisciplinary program, not a single stand-alone study. Applications were required to propose multiple coordinated components under a U19 structure.
What is the minimum required structure of an application?
At minimum, an application had to include at least two distinct research projects plus an Administrative Core. The Administrative Core is intended to coordinate the overall effort across projects and any shared activities.
Why is an Administrative Core required?
The Administrative Core requirement signals that NIH expected active program management and coordination. This includes organizing communication across teams, aligning and harmonizing protocols where appropriate, and supporting efficient decision-making so that preclinical and clinical elements remain coordinated and responsive to new findings.
Is private-sector participation required?
Yes. At least one component of the overall program (either a research project or a scientific core) had to come from a private-sector company, whether for-profit or non-profit.
What is the rationale for requiring a private-sector company component?
The requirement reflects a push toward product-focused translation. Private-sector partners often contribute practical development capabilities such as manufacturing and formulation optimization, regulatory strategy, quality systems, and scale-up planning, which helps build a realistic pathway from early research toward later-stage trials and eventual implementation.
What is the funding instrument and what does it imply?
The funding instrument is a cooperative agreement (U19). A cooperative agreement typically indicates substantial NIH involvement beyond standard grant oversight, which can include scientific coordination, milestone-driven management, and collaborative planning between awardees and NIH program staff. This aligns with a product-development-oriented program where timelines, coordination, and go/no-go decision points may matter.
How much funding was available and is cost sharing required?
Total estimated funding for the opportunity was $6,000,000. The FOA did not require cost sharing or matching funds.
When was the opportunity posted and what was the application deadline?
The FOA was posted on June 9, 2011, and the application deadline was November 8, 2011.
Who was eligible to apply?
Eligibility was broad and included many types of U.S. organizations and governments. Examples listed include public and private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit organizations (including small businesses), and a range of governmental entities.
Are non-U.S. (foreign) organizations eligible?
Yes. The FOA allowed non-U.S. entities (foreign organizations), as well as U.S. territories or possessions and foreign components of U.S. organizations. This is particularly relevant for HIV prevention research that may involve international collaborations or study sites.
Does the FOA encourage participation by diverse institution types?
Yes. The announcement explicitly included a wide range of institution types, such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations, indicating an intent to welcome diverse applicants and partnerships.
Why is NIMH involved in a microbicide development program?
The FOA spans CFDA numbers covering infectious diseases and mental health research, reflecting that microbicide success depends on more than biomedical efficacy. Human factors like acceptability, adherence, sexual behavior contexts, and user preferences can strongly influence real-world effectiveness, aligning with NIMH interests.
What kinds of real-world use factors does the FOA highlight?
The description emphasizes that product characteristics can influence consistent use, including aspects such as formulation type, dosing frequency, sensory attributes, and ease of use. These factors can affect acceptability and adherence and therefore the ultimate prevention impact.
What is the overarching scientific goal?
The overarching goal is to advance a topical microbicide that is safe, effective, and acceptable for real-world use by supporting coordinated programs that can de-risk and mature candidates through preclinical and exploratory clinical steps.
How does this FOA aim to move candidates toward later-stage trials?
The required multi-project structure, dedicated administrative coordination, mandated private-sector participation, and cooperative agreement format together indicate a translational, milestone-aware approach. The intent is to position promising candidates for larger trials by integrating development activities and using iterative decision-making informed by accumulating evidence.
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