Limited Interaction Targeted Epidemiology: Epidemiology of Transmission and Treatment of HIV Among People Who Are at Increased Risk for HIV Infection in Latin America (LITE-LA) (UG3/UH3 Clinical Trial Optional) | RFA AI 24 009

Frequently Asked Questions (FAQs)

What is the LITE-LA funding opportunity?

Limited Interaction Targeted Epidemiology: Epidemiology of Transmission and Treatment of HIV Among People Who Are at Increased Risk for HIV Infection in Latin America (LITE-LA) is an NIH funding opportunity focused on building large, digitally constructed cohorts in Latin America to better understand HIV transmission (where and why new infections occur) and what happens after infection (linkage to care and viral suppression).

What is the main purpose of LITE-LA?

The program aims to produce high-resolution, actionable epidemiology by enrolling and following HIV-negative individuals from disproportionately affected populations, estimating HIV incidence over time, identifying patterns of risk connected to places and networks, and continuing follow-up after seroconversion to evaluate real-world treatment pathways and outcomes.

Which populations are specifically highlighted for enrollment?

The opportunity specifically emphasizes enrolling HIV-negative individuals from populations with disproportionately high HIV risk in Latin America, including men who have sex with men (MSM), transgender women (TGW), people who inject drugs (PWID), and/or female sex workers.

What does "limited interaction" mean in this opportunity?

"Limited interaction" signals a strong emphasis on digital-first research operations, with recruitment, enrollment, follow-up, and data capture relying heavily on online, mobile, and other electronic strategies rather than frequent in-person visits.

What is an "electronically-generated cohort" in the context of LITE-LA?

It refers to cohorts that are created and followed primarily through electronically enabled methods (for example, online and mobile approaches) to enable large-scale longitudinal follow-up and timely data capture, including among people who may be mobile or affected by stigma.

What kinds of outcomes or measures are these studies intended to generate?

Based on the description, the studies are intended to estimate HIV incidence and identify patterns of risk that can be linked to particular places, networks, and social conditions, not only individual behaviors. They also examine outcomes after infection such as engagement in care and achieving viral suppression (undetectable viral load).

Does follow-up stop if a participant becomes HIV-positive during the study?

No. A key feature is that participants who seroconvert are expected to continue in the study so investigators can examine treatment-related outcomes, including the pathway from diagnosis to care engagement and ultimately to viral suppression.

What comparisons does the program emphasize, and why?

The program emphasizes two major comparisons: (1) comparing those who do and do not seroconvert to help identify geographic hotspots and socially defined settings where incidence is high and to clarify personal and structural vulnerabilities; and (2) among those who seroconvert, comparing people who rapidly link to care and achieve suppression versus those who remain viremic to identify where treatment systems succeed or break down and why.

What types of vulnerabilities or drivers of risk are explicitly mentioned?

The opportunity highlights both personal vulnerabilities (examples provided include access to prevention, substance use, and sexual network dynamics) and structural vulnerabilities (examples include stigma, criminalization, barriers to healthcare, housing instability, discrimination, and economic exclusion).

Are digital trials allowed under this program?

Yes. Within the digital cohort framework, the NOFO allows for digital trials. This can include testing and refining digital study methods (such as approaches that improve retention, accurate reporting, or remote testing) and piloting evidence-based digital interventions (including mHealth and online prevention or treatment supports).

Is a clinical trial required?

No. The opportunity is listed as "clinical trial optional," meaning applications may include a clinical trial component but are not required to do so.

What is the funding mechanism for LITE-LA?

The funding uses a UG3/UH3 cooperative agreement structure, which commonly implies a phased approach: an initial UG3 stage for planning, feasibility work, and early operational milestones, followed by a UH3 stage for expanded implementation once predefined milestones are met.

What does it mean that this is a cooperative agreement?

As a cooperative agreement, NIH typically expects substantial programmatic involvement. Awardees should anticipate coordination with NIH staff on goals, progress, and major scientific or operational decisions.

Where is the research expected to take place?

The opportunity is focused on Latin America, with an emphasis on creating and following digitally constructed cohorts in the region to study HIV transmission and treatment outcomes in Latin American contexts.

What types of organizations are eligible to apply?

Eligibility is broad and includes many U.S.-based and international organization types. Examples listed include various levels of government (state, county, city/township, special districts), public and private higher education institutions, independent school districts, tribal governments and tribal organizations, public housing authorities, nonprofits (with and without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses.

Are non-U.S. (foreign) organizations eligible?

Yes. The eligibility language explicitly includes non-U.S. entities (foreign organizations) and regional organizations, reflecting the cross-border nature of the work and the importance of local partnerships in Latin America.

Are U.S. territories or possessions eligible applicants?

Yes. The eligibility categories explicitly include U.S. territories or possessions.

Does the eligibility language name specific institution types NIH wants to include?

Yes. The NOFO explicitly calls out categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, and tribally controlled colleges and universities, among others.

What kind of organizational capabilities does the opportunity appear to value?

Based on the description, the opportunity signals interest in applications that combine technical epidemiologic capacity with deep community reach, particularly organizations able to recruit and retain MSM, TGW, PWID, and sex worker populations while protecting privacy and minimizing harm.

What is the opportunity number and key dates provided?

The opportunity number is RFA AI 24 009. The creation date shown is 2024-03-28, and the closing date shown is 2024-07-30.

What is the CFDA listing provided for this opportunity?

The CFDA listing provided is 93.855.

What is the activity category for this opportunity?

The activity category is listed as health.

How does LITE-LA aim to improve understanding beyond individual behavior?

The cohort design and analyses are intended to link risk patterns to places, networks, and social conditions, not solely individual-level behavior, and to identify how structural conditions (like stigma or barriers to healthcare) shape both transmission and treatment outcomes.

How does the program connect transmission research with treatment research?

It is designed to follow participants longitudinally through seroconversion, allowing investigators to study both where infections happen (incidence and hotspots) and what happens after infection (diagnosis, engagement in care, and viral suppression), including comparisons that reveal where care systems perform well or fail.