Strengthening the HIV Pre-Exposure Prophylaxis (PrEP) Care Continuum through Behavioral, Social, and Implementation Science (R01 Clinical Trial Optional) | PA 18 281

Opportunity Information: Apply for PA 18 281

The National Institutes of Health (NIH) funding opportunity titled "Strengthening the HIV Pre-Exposure Prophylaxis (PrEP) Care Continuum through Behavioral, Social, and Implementation Science (R01 Clinical Trial Optional)" (Funding Opportunity Number PA-18-281; CFDA 93.242) supports research aimed at improving how PrEP is delivered, started, and maintained in real-world settings. The focus is not on developing new PrEP drugs, but on understanding and fixing the practical, social, and behavioral problems that keep people from benefiting from PrEP. The FOA is structured as an R01 grant mechanism and allows (but does not require) clinical trials, meaning applicants can propose studies that range from observational and mixed-methods work to intervention development and randomized or pragmatic trials, depending on what best fits the research question.

At its core, the announcement targets the full PrEP "care continuum," which generally includes awareness of PrEP, willingness to consider it, access to PrEP-competent services, initiation, adherence or correct use, ongoing retention in care (including follow-up visits and lab monitoring), and appropriate discontinuation and re-initiation when risk changes. NIH is seeking studies that first identify where the continuum is breaking down and why, then use that information to design and test solutions. In practice, this means projects may examine barriers and facilitators at multiple levels, such as individual factors (knowledge, risk perception, stigma, medical mistrust, mental health, substance use, competing life needs), interpersonal factors (partner dynamics, social support), clinical factors (provider bias, provider knowledge and comfort, workflow constraints, appointment availability), and structural factors (insurance coverage, cost-sharing, transportation, housing instability, criminalization, immigration concerns, clinic location, telehealth access, and local policy or program environments).

The FOA lays out three main objectives. First, it encourages research that pinpoints gaps in PrEP delivery and use and the determinants that produce those gaps. This could include studying why certain populations who could benefit from PrEP never reach a provider, why prescriptions are not written even when patients ask, why people stop PrEP soon after starting, or why follow-up monitoring is inconsistent. Second, it supports development and testing of interventions to strengthen PrEP delivery, uptake, adherence, persistence, and overall outcomes. Interventions can be behavioral (for example, counseling approaches, decision supports, adherence tools), social (peer navigation, community-based support, stigma reduction strategies), and implementation-focused (clinic workflow redesign, provider training, EHR prompts, pharmacy-based models, telePrEP models, integrated STI/PrEP services, task-shifting, and strategies to improve adoption and sustainment of evidence-based practices). Third, it explicitly prioritizes reducing disparities, particularly racial/ethnic and age-related disparities in PrEP use. This emphasis reflects persistent inequities where groups with high HIV incidence may have lower access to PrEP, lower uptake, or poorer persistence due to systemic barriers and differential treatment within healthcare and broader social systems.

Because the FOA is grounded in behavioral, social, and implementation science, strong applications typically connect intervention strategies to clearly defined mechanisms (why the intervention should work), specify measurable outcomes along the PrEP continuum, and account for context (the setting and constraints where PrEP is delivered). Projects may incorporate implementation frameworks and outcomes such as acceptability, feasibility, adoption, fidelity, penetration, sustainability, and cost, alongside clinical or public health outcomes like PrEP initiation rates, persistence over time, adherence measures, and downstream HIV prevention impacts. The "clinical trial optional" feature signals that NIH is open to rigorous testing of interventions, including randomized designs, stepped-wedge approaches, pragmatic trials embedded in health systems, and community-based evaluations, but also supports earlier-phase work that identifies determinants and refines interventions prior to large trials.

Eligibility is broad and includes a wide range of domestic and non-domestic entities. Eligible applicants listed include 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; other Native American tribal organizations; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other organizations. The opportunity also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, tribal governments that are not federally recognized, and foreign (non-U.S.) entities. This broad eligibility signals NIH interest in solutions that can be developed and tested in diverse communities and service systems, including settings that are often under-resourced or disproportionately affected by HIV.

In administrative terms, the FOA is a discretionary grant opportunity under NIH, using the grant funding instrument and categorized under health. The source data indicates an original closing date of January 7, 2020, and a creation date of November 29, 2017; applicants would typically need to verify current status and active submission dates through NIH and Grants.gov systems because NIH funding announcements often have multiple receipt dates over time or may be superseded by reissued opportunities. Overall, the opportunity is designed for research teams that can combine public health, behavioral science, community engagement, and implementation methods to produce practical, scalable strategies that measurably improve PrEP access and continuity, particularly for populations who have historically been left behind in HIV prevention services.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Strengthening the HIV Pre-Exposure Prophylaxis (PrEP) Care Continuum through Behavioral, Social, and Implementation Science (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 2017-11-29.
• Applicants must submit their applications by 2020-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

Apply for PA 18 281

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