Limited Interaction Targeted Epidemiology: Viral Suppression (LITE-VS) (UG3/UH3 Clinical Trial Optional) | RFA AI 22 024

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The Limited Interaction Targeted Epidemiology: Viral Suppression (LITE-VS) funding opportunity (RFA-AI-22-024) is a National Institutes of Health (NIH) cooperative agreement that supports the creation and follow-up of large cohorts of people with HIV-1 in the United States using primarily digital, low-burden methods. The central idea is to build "digitally maintained" research cohorts that can be enrolled and tracked efficiently over time, with an emphasis on understanding real-world patterns of HIV care engagement and viral suppression rather than relying only on traditional clinic-based recruitment and follow-up. While the announcement allows clinical trials as an option, the core expectation is rigorous cohort-based epidemiologic research that can produce actionable insights into why some people remain consistently engaged in care and virally suppressed while others cycle in and out of care or experience ongoing challenges with sustained suppression.

A defining feature of LITE-VS is its focus on deliberately enrolling participants who have historically been harder to keep engaged in HIV care, especially people who report previous gaps in care and/or a lack of sustained viral suppression. Applicants are expected to use sampling strategies that do not merely capture the easiest-to-reach populations, but instead ensure meaningful representation of people at higher risk for poor outcomes across the HIV care continuum. In practical terms, that means designing recruitment pipelines, outreach approaches, and enrollment criteria that bring in participants who may have experienced interruptions in appointments, medication access problems, unstable housing, stigma, mental health or substance use challenges, or other barriers that can disrupt adherence and consistent care.

Once enrolled, projects are meant to follow participants longitudinally to map trajectories of care engagement, antiretroviral therapy (ART) adherence, and viral suppression over time. The research emphasis is prospective: investigators should collect data in ways that allow them to identify temporal antecedents (what happens before a change) and multilevel drivers (factors at the individual, interpersonal, clinic/health-system, and community or structural levels) that predict improvements or setbacks. The program is geared toward understanding change over time, such as what precedes a return to care after a gap, what factors predict a drop-off in adherence, or which conditions tend to accompany a shift from suppression to non-suppression (or vice versa). Because the cohorts are digitally maintained, applicants typically need to think carefully about how they will capture reliable outcome measures and time-stamped exposure data, potentially combining self-report, electronic health information, pharmacy or laboratory data linkages where feasible, and other digital signals in ways that respect privacy and participant burden.

The FOA also encourages methodological innovation around how cohorts like this are built and sustained. Applicants may propose and evaluate improved strategies for screening, enrollment, and retention, which is especially important when the target population includes people who may be intermittently reachable, distrustful of institutions, or facing competing life priorities. In other words, part of the work can be about figuring out how to run this kind of cohort effectively at scale, including which digital approaches actually keep participants connected and contributing data over time. In addition, the opportunity explicitly notes that projects should inform future interventions to promote sustained HIV care engagement and durable viral suppression, and teams have the option to test digitally delivered interventions aimed at improving these outcomes. That makes LITE-VS both observational and potentially intervention-oriented: even when an applicant is not running a clinical trial, the expectation is that results will be intervention-relevant and directly useful for designing or improving programs that increase suppression and consistent care.

Structurally, this is a cooperative agreement, which usually signals substantial NIH program involvement in shaping, monitoring, or coordinating aspects of the funded work compared with standard research grants. The mechanism is UG3/UH3, which is commonly used for phased awards where an initial planning or start-up period (UG3) transitions to an implementation phase (UH3) if predefined milestones are met. That format matches the needs of large digital cohorts, where early milestones might include building recruitment pipelines, finalizing digital platforms and data systems, demonstrating feasible enrollment rates, and showing the ability to retain participants and capture key outcomes before scaling to full cohort operations.

Eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses, among others. The announcement also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, non-U.S. (foreign) institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible; however, foreign components (as NIH defines them in its Grants Policy Statement) are allowed, which can matter for specific collaborations or specialized analytic or laboratory contributions that occur outside the U.S. within an otherwise U.S.-led project.

In summary, LITE-VS funds U.S.-based teams to build and follow large, digitally managed cohorts of people with HIV, with intentional recruitment of individuals who have experienced care gaps and/or challenges achieving sustained viral suppression. The program is designed to generate prospective, time-sensitive evidence about the drivers of engagement, adherence, and suppression, while also pushing the field toward practical improvements in digital recruitment and retention. The ultimate aim is to produce findings that can directly shape future interventions and, where appropriate, to allow testing of digital interventions that help people stay in care and maintain viral suppression over the long term.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Limited Interaction Targeted Epidemiology: Viral Suppression (LITE-VS) (UG3/UH3 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, 93.279, 93.855.
• This funding opportunity was created on 2022-04-13.
• Applicants must submit their applications by 2022-08-03. (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.

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