Tobacco Use and HIV in Low and Middle-Income Countries (U01 Clinical Trial Optional) | RFA CA 20 037

Opportunity Information: Apply for RFA CA 20 037

The Tobacco Use and HIV in Low and Middle-Income Countries (U01 Clinical Trial Optional) funding opportunity (RFA-CA-20-037) is a National Institutes of Health (NIH) cooperative agreement designed to support research at the intersection of tobacco use and HIV infection in low and middle-income countries (LMICs). The central aim is to build practical, evidence-based approaches that reduce tobacco use among people living with HIV in settings where health systems may be under-resourced and where the combined effects of smoking and HIV can substantially worsen health outcomes.

A major emphasis of the announcement is the development and evaluation of tobacco cessation interventions that are specifically tailored to HIV-positive populations in LMICs. This includes interventions that account for the realities of HIV care delivery in low-resource environments, such as limited clinical staffing, constrained budgets, variable access to cessation medications, and competing priorities within HIV clinics. The FOA also highlights the importance of addressing co-morbidities, particularly tuberculosis (TB), recognizing that tobacco use can increase TB risk and severity while HIV already elevates TB vulnerability. In practice, applicants are encouraged to design cessation approaches that can be integrated into HIV and TB services, adapted culturally and linguistically, and realistically implemented and maintained in LMIC health settings.

Because this is a U01 cooperative agreement, funded projects are typically expected to involve substantial programmatic involvement from NIH staff compared with a standard research grant. The “Clinical Trial Optional” designation indicates that applicants may propose studies that include clinical trials if appropriate, but a trial is not strictly required. The FOA explicitly supports the full arc of the work needed to test cessation strategies in these contexts, including research planning, intervention delivery, and follow-up activities, which signals interest not only in intervention design but also in implementation, retention over time, and measurement of outcomes after the active intervention period.

The opportunity is categorized under discretionary funding and falls within the education and health activity area, with CFDA number 93.393. A wide range of organizations are eligible to apply, reflecting an intent to attract cross-sector partnerships that can operate effectively in LMIC contexts. Eligible applicants include many levels of government (state, county, city/township, special districts), 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, nonprofits with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations (other than small businesses), and small businesses. The FOA also calls out additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, and non-U.S. entities (foreign organizations). This broad eligibility is consistent with the global focus and the need for strong in-country or regional capacity to recruit participants, deliver services, and sustain interventions.

Key dates included in the source information indicate the opportunity was created on July 7, 2020, with an original closing date of September 24, 2020. The source data does not specify an award ceiling or the expected number of awards, which suggests applicants would have needed to consult the full FOA text and related NIH budget guidance to understand typical funding ranges, project periods, and any constraints on direct costs or allowable expenses.

Overall, this FOA is aimed at generating actionable research that helps HIV programs in LMICs reduce the burden of tobacco-related disease, improve overall health outcomes for people living with HIV, and address compounding risks from conditions like TB. It is structured to fund not just theoretical work, but the real-world planning, implementation, and follow-up needed to demonstrate whether tailored cessation interventions can work effectively and sustainably in low-resource settings.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Tobacco Use and HIV in Low and Middle-Income Countries (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393.
• This funding opportunity was created on 2020-07-07.
• Applicants must submit their applications by 2020-09-24. (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 RFA CA 20 037

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