Transgender People: Immunity, Prevention, and Treatment of HIV and STIs (R21 Clinical Trial Not Allowed) | PAR 20 054

Opportunity Information: Apply for PAR 20 054

The National Institutes of Health (NIH) funding opportunity titled "Transgender People: Immunity, Prevention, and Treatment of HIV and STIs (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-20-054) is a discretionary grant program designed to support early-stage, hypothesis-generating research focused on transgender people. The central goal is to better understand how gender-affirming interventions, including hormones, pharmaceuticals, and surgical procedures used in gender reassignment, may influence biology and immune function in ways that could affect a persons susceptibility to HIV and other sexually transmitted infections (STIs). By emphasizing exploratory research, this FOA aims to build foundational knowledge that can inform future, larger-scale studies and eventually improve HIV and STI prevention and treatment approaches tailored to transgender communities.

This opportunity uses the NIH R21 mechanism, which is typically intended for innovative, exploratory projects that may be higher risk but have the potential to open up important new lines of inquiry. A key restriction is that clinical trials are not allowed under this announcement, meaning applicants should propose studies that do not meet NIH definitions of a clinical trial, such as testing an intervention to evaluate health-related outcomes. Instead, the FOA is oriented toward mechanistic, biological, and immunological characterization work, for example studies examining how specific gender-affirming hormone regimens might affect mucosal immunity, systemic immune markers, inflammation, microbiome-related factors, or other biologic pathways relevant to HIV acquisition and STI vulnerability. The overall intent is to clarify interactions between gender-affirming care and immune or biological processes that could influence infection risk, disease progression, or responses to prevention tools.

The funding activity category is health, and the program is associated with CFDA number 93.855. The award ceiling listed is $200,000, reflecting the smaller, exploratory nature of R21 grants. The opportunity was created on 2019-11-12, with an original closing date of 2021-05-11, indicating it was time-bound to that submission window as posted in the source information.

Eligibility is broad and includes many types of applicants. In addition to standard eligible entities such as state, county, and city or township governments, special district governments, independent school districts, and public and state-controlled institutions of higher education, the FOA allows applications from private institutions of higher education, for-profit organizations (other than small businesses), and small businesses. It also includes nonprofit organizations both with and without 501(c)(3) IRS status (when not an institution of higher education). Tribal eligibility is extensive, covering federally recognized Native American tribal governments as well as tribal organizations and Indian/Native American tribal governments that are not federally recognized. Public housing authorities and Indian housing authorities are also eligible.

The FOA explicitly highlights additional eligible applicants that NIH wants to encourage, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal government agencies, and faith-based or community-based organizations. It also allows non-domestic (non-U.S.) entities (foreign organizations), regional organizations, and applicants located in a U.S. territory or possession. Taken together, this broad eligibility structure supports participation from academic researchers, community-rooted organizations, and institutions serving populations that are often underrepresented in biomedical research, which aligns with the FOAs focus on generating needed evidence in transgender health and infectious disease prevention.

In practical terms, applicants responding to this announcement would be expected to propose research that advances understanding of immune and biological mechanisms in transgender people in the context of gender-affirming medical or surgical care, with clear relevance to HIV and STI prevention or treatment science. The emphasis on characterizing impact and susceptibility signals an interest in studies that can explain why certain risks may change, how prevention tools might work differently, or what biologic factors should be monitored, without moving into interventional clinical trial testing under this specific R21 call.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Transgender People: Immunity, Prevention, and Treatment of HIV and STIs (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2019-11-12.
• Applicants must submit their applications by 2021-05-11. (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 $200,000.00 in funding.
• 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.

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