Opportunity Information: Apply for RFA AI 13 012

  • The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Mucosal Environment and HIV Prevention (MEHP) (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research 93.865 Child Health and Human Development Extramural Research.
  • This funding opportunity was created on Mar 7, 2013 and posted on Mar 7, 2013.
  • Applicants must submit their applications by Jul 25, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $400,000.00 in funding.
  • Eligible applicants include: Private institutions of higher education Independent school districts Small businesses State 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 For profit organizations other than small businesses Special district governments Native American tribal governments (Federally recognized) City or township governments Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

The Mucosal Environment and HIV Prevention (MEHP) (R01) funding opportunity (RFA-AI-13-012) was a discretionary NIH grant program led by the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It was designed to push forward non-vaccine biomedical HIV prevention research by funding innovative, proof-of-concept and feasibility studies that could help make prevention products safer and more effective. The emphasis was on interventions such as microbicides, pre-exposure prophylaxis (PrEP), and multipurpose prevention technologies (MPTs), with the underlying idea that successful prevention depends not only on the drug or product itself, but also on how it behaves in real mucosal environments where HIV exposure and early infection occur.

A central purpose of the program was to improve understanding of how prevention candidates and strategies interact with both the micro- and macro-environments of mucosal tissues, specifically the genital mucosa (in both males and females) and the gastrointestinal (GI) mucosa. In practical terms, that means studying the local biological context that can influence whether a prevention method is protective, ineffective, or potentially harmful. This includes factors like microbial communities, immune activation and inflammation, epithelial barrier integrity, local tissue metabolism, and the composition of secretions that come into contact with prevention products. By supporting this kind of mucosal science, the FOA aimed to address gaps that can derail real-world effectiveness even when a product looks promising in more simplified laboratory settings.

The announcement highlighted three emerging and underserved program areas that applicants were expected to tackle. The first area focused on the role of the microbiome in HIV transmission and acquisition, and in determining prevention candidate safety and efficacy. This reflects growing evidence that vaginal, penile, and rectal microbial communities can shape inflammation, mucosal barrier function, and drug metabolism, and therefore can influence both susceptibility to HIV and the performance of topical or systemic prevention agents. The second area centered on tissue responses to prevention agents, encouraging studies that look closely at what products do to mucosal tissues at the cellular and immunological level. This could include examining epithelial disruption, cytokine and chemokine changes, recruitment or activation of HIV target cells, and other biological responses that might increase or decrease infection risk. The third area emphasized how genital secretions and hormones affect susceptibility to HIV infection, recognizing that hormonal status (including menstrual cycle effects, contraceptive hormones, pregnancy, or other endocrine influences) and the biochemical makeup of secretions can alter mucosal immunity, microbial composition, and product distribution or stability.

From an administrative and eligibility standpoint, this was an R01 mechanism with an award ceiling listed at $400,000, and it did not require cost sharing or matching. The opportunity was broadly open to many types of applicants, including public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), state and local governments, tribal governments and tribal organizations, school districts, public housing authorities, and a range of mission-focused institutions such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, AANAPISI institutions, and tribally controlled colleges and universities. Importantly, foreign organizations and foreign institutions were eligible to apply, and non-U.S. components of U.S. organizations were also allowed, consistent with NIH policy on foreign components.

Key dates show the FOA was posted March 7, 2013, with an original and current closing date of July 25, 2013, and it was archived August 25, 2013. The program was associated with CFDA numbers tied to allergy and infectious diseases research, microbiology and infectious diseases research, and child health and human development extramural research (93.855, 93.856, 93.865). The full announcement was hosted through the NIH grants guide, and administrative questions about accessing or linking to the FOA were routed to the NIH Office of Extramural Research (OER) webmaster contact.

Frequently Asked Questions (FAQs): Mucosal Environment and HIV Prevention (MEHP) (R01) - RFA-AI-13-012

What is the MEHP (R01) funding opportunity (RFA-AI-13-012)?

The Mucosal Environment and HIV Prevention (MEHP) (R01) opportunity (RFA-AI-13-012) was a discretionary NIH grant program intended to advance non-vaccine biomedical HIV prevention research. It supported innovative proof-of-concept and feasibility studies aimed at making HIV prevention products safer and more effective by focusing on how they perform in real mucosal environments where HIV exposure and early infection occur.

Which NIH institutes led and partnered on this program?

The program was led by the National Institute of Allergy and Infectious Diseases (NIAID), in partnership with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

What kind of HIV prevention research did the program prioritize?

The emphasis was on non-vaccine biomedical HIV prevention interventions, including microbicides, pre-exposure prophylaxis (PrEP), and multipurpose prevention technologies (MPTs). The program focused on understanding not only the prevention agent itself, but also how the product interacts with mucosal biology that can affect safety and effectiveness.

What was the main scientific idea behind focusing on the mucosal environment?

The program was built around the idea that successful HIV prevention depends on how a drug or product behaves within mucosal tissues and secretions where HIV exposure occurs. Local mucosal conditions can influence whether an intervention is protective, ineffective, or potentially harmful, even if it appears promising in simplified laboratory settings.

Which mucosal tissues were specifically highlighted?

The FOA specifically highlighted the genital mucosa (in both males and females) and the gastrointestinal (GI) mucosa.

What types of mucosal factors did the FOA describe as important to study?

The announcement described several local factors that can influence prevention outcomes, including microbial communities, immune activation and inflammation, epithelial barrier integrity, local tissue metabolism, and the composition of secretions that come into contact with prevention products.

What were the three emerging and underserved program areas applicants were expected to address?

The FOA highlighted three areas: (1) the role of the microbiome in HIV transmission and acquisition and in determining prevention candidate safety and efficacy; (2) tissue responses to prevention agents; and (3) how genital secretions and hormones affect susceptibility to HIV infection.

What did the FOA mean by focusing on the microbiome?

The microbiome focus referred to studying how vaginal, penile, and rectal microbial communities can shape inflammation, mucosal barrier function, and drug metabolism, and in turn influence susceptibility to HIV and the performance of topical or systemic prevention agents.

What kinds of questions fit under "tissue responses to prevention agents"?

This area encouraged studies examining what prevention products do to mucosal tissues at cellular and immunological levels. Examples mentioned included epithelial disruption, cytokine and chemokine changes, recruitment or activation of HIV target cells, and other biological responses that could increase or decrease infection risk.

What did the FOA highlight about genital secretions and hormones?

The FOA emphasized that hormonal status and the biochemical makeup of genital secretions can alter mucosal immunity, microbial composition, and product distribution or stability, which can affect susceptibility to HIV infection.

Which hormonal factors were explicitly mentioned?

The announcement referenced menstrual cycle effects, contraceptive hormones, pregnancy, and other endocrine influences as examples of hormonal status that could affect susceptibility and product performance.

What grant mechanism was used for this opportunity?

This opportunity used the NIH R01 research project grant mechanism.

What was the award ceiling listed for this program?

The award ceiling listed in the FOA was $400,000.

Was cost sharing or matching required?

No. The FOA indicated that cost sharing or matching was not required.

Who was eligible to apply?

Eligibility was broad. The FOA was open to public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), state and local governments, tribal governments and tribal organizations, school districts, public housing authorities, and a range of mission-focused institutions (including HBCUs and other serving institutions described in the FOA).

Were minority-serving and mission-focused institutions explicitly included?

Yes. The FOA listed multiple categories, including historically black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, AANAPISI institutions, and tribally controlled colleges and universities.

Could for-profit organizations apply?

Yes. For-profit organizations, including small businesses and other for-profit entities, were included among eligible applicants.

Could government entities apply?

Yes. The FOA included state and local governments, tribal governments and tribal organizations, school districts, and public housing authorities among eligible applicants.

Were foreign organizations eligible to apply?

Yes. Foreign organizations and foreign institutions were eligible to apply. The FOA also allowed non-U.S. components of U.S. organizations, consistent with NIH policy on foreign components.

What were the key dates for this funding opportunity?

The FOA was posted on March 7, 2013. The original and current closing date was July 25, 2013. The announcement was archived on August 25, 2013.

Is this opportunity still open?

No. Based on the dates provided, the FOA closed on July 25, 2013 and was archived on August 25, 2013.

Which CFDA numbers were associated with the program?

The FOA listed CFDA numbers 93.855, 93.856, and 93.865, tied to allergy and infectious diseases research, microbiology and infectious diseases research, and child health and human development extramural research.

Where was the full announcement hosted?

The full announcement was hosted through the NIH grants guide.

Who was listed as the contact for administrative questions about accessing or linking to the FOA?

Administrative questions about accessing or linking to the FOA were routed to the NIH Office of Extramural Research (OER) webmaster contact.

What does it mean that this was a discretionary NIH grant program?

Based on the description provided, it indicates the program was a specific NIH funding initiative for targeted research priorities (here, mucosal environment considerations in non-vaccine HIV prevention), rather than a general open-ended funding announcement.

What types of studies did the FOA aim to fund (stage and scope)?

The FOA aimed to fund innovative proof-of-concept and feasibility studies intended to address gaps that can affect real-world safety and effectiveness of HIV prevention products in mucosal settings.

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