Opportunity Information: Apply for RFA MH 19 425

This funding opportunity, titled "Revision Application for Implementation Research to Inform and Enhance PEPFAR HIV Pre-exposure Prophylaxis (PrEP) Delivery (R01 Clinical Trial Optional)" (RFA-MH-19-425), is a discretionary grant program offered by the U.S. Department of Health and Human Services through the National Institutes of Health, specifically the National Institute of Mental Health (NIMH), in collaboration with the Office of the Global AIDS Coordinator (OGAC). It invites revision applications, meaning it is designed for investigators who already hold certain NIH awards and are seeking additional support to expand, refine, or redirect an existing project in a way that directly strengthens the evidence base for PrEP delivery within PEPFAR-supported settings.

The core purpose is to support implementation science research that can directly inform how PrEP is delivered and scaled up at PEPFAR sites. In practical terms, the emphasis is not simply on whether PrEP works (its efficacy is already well established), but on how to implement PrEP programs effectively in real-world health systems: how services are organized, how clients are identified and engaged, how providers and clinics adopt and sustain PrEP workflows, and how barriers like stigma, adherence challenges, clinic capacity constraints, and drop-off along the service cascade can be addressed. Because this is framed as implementation research, proposed work is expected to generate actionable, generalizable lessons that can be used to improve program performance across multiple sites or contexts supported by PEPFAR.

The announcement uses the R01 mechanism and notes that clinical trials are optional, which signals flexibility in study design. Applicants may propose trials when appropriate (for example, testing different implementation strategies, service delivery models, or demand-generation approaches), but they are not required to run a clinical trial to be competitive. Implementation-focused designs could include pragmatic trials, cluster-randomized designs, stepped-wedge approaches, hybrid effectiveness-implementation models, mixed-methods evaluations, or other rigorous strategies suited to answering delivery and scale-up questions. The central expectation is that the research will produce clear implementation-relevant evidence that can improve PrEP rollout, quality, and reach within PEPFAR systems.

In terms of funding parameters, the opportunity lists an award ceiling of $150,000 and anticipates up to 10 awards. The funding activity category is Health, and the CFDA number is 93.242. The opportunity was created on December 18, 2018, with an original closing date of February 18, 2019. These details suggest a targeted, relatively modest expansion budget intended to add a focused implementation component to existing work, rather than to fund a large, standalone multi-year program from scratch.

Eligibility is broad and includes a wide range of domestic organizational types: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding institutions of higher education in those specific categories); for-profit organizations other than small businesses; small businesses; and other entities as described in the full eligibility text. This broad eligibility reflects the interdisciplinary and cross-sector nature of implementation research, where strong proposals often involve partnerships among academic researchers, implementing organizations, ministries of health, and service delivery sites.

Overall, this RFA is aimed at generating practical evidence that helps PEPFAR programs improve PrEP delivery at scale. The focus is on implementation science questions that matter for program impact, such as uptake, persistence, integration into existing HIV prevention and treatment platforms, and strategies that make PrEP delivery more feasible, acceptable, equitable, and sustainable in the real-world settings where PEPFAR operates.

  • The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Revision Application for Implementation Research to Inform and Enhance PEPFAR HIV Pre-exposure Prophylaxis (PrEP) Delivery (R01 Clinical Trial Optional)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
  • This funding opportunity was created on Dec 18, 2018.
  • Applicants must submit their applications by Feb 18, 2019. (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 $150,000.00 in funding.
  • The number of recipients for this funding is limited to 10 candidate(s).
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal 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, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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