Limited Interaction Targeted Epidemiology (LITE) to Advance HIV Prevention (UG3/UH3) | Apply Online

Frequently Asked Questions (FAQs)

What is the LITE to Advance HIV Prevention (UG3/UH3) opportunity?

LITE to Advance HIV Prevention (UG3/UH3) is an NIH cooperative agreement funding opportunity (RFA-AI-16-031) released by HHS/NIH (within NIAID's scope) to support large-scale epidemiologic studies focused on HIV prevention in the United States. The emphasis is on modernizing how HIV incidence and prevention-related data are collected by using innovative, technology-enabled approaches that limit the need for frequent in-person study visits.

What is the main purpose of this funding opportunity?

The main purpose is to build and follow large cohorts in populations disproportionately affected by HIV in the U.S., generating actionable epidemiologic evidence that can inform and accelerate HIV prevention strategies. A core goal is to enable reliable HIV incidence estimation and related prevention insights using "limited interaction" cohort methods.

Which populations are specifically prioritized for cohort enrollment and follow-up?

The FOA specifically highlights cohorts in: men who have sex with men (MSM), transgender women, and Black/African American women. These are identified as populations that remain disproportionately affected by HIV.

Is the geographic focus limited to the United States?

Yes. The FOA describes large-scale epidemiologic studies focused on HIV prevention in the United States.

What does "Limited Interaction Targeted Epidemiology (LITE)" mean in practice?

In practice, LITE refers to cohort recruitment and follow-up models designed to reduce frequent in-person study visits by using technology-forward approaches. Examples described include mobile or web-based engagement, remote data capture, digital communications, and home-based or community-based specimen collection.

What kind of study design is the FOA aiming to support?

The FOA aims to support large-scale longitudinal cohort studies (large cohorts followed over time) that can measure HIV incidence (including observing new HIV infections/seroconversions) and generate prevention-relevant epidemiologic data.

What is the UG3/UH3 structure and why does it matter?

This opportunity uses the NIH "Phased Innovation Awards" structure, meaning the project is intentionally split into two sequential stages (UG3 followed by UH3) with clear performance expectations. Applicants are expected to propose and justify plans for both phases up front, since transitioning from UG3 to UH3 is central to the program design.

What is the purpose of the UG3 phase?

The UG3 phase functions as a start-up and feasibility period. It focuses on demonstrating that the study can enroll and retain enough HIV-negative individuals at high risk so the cohort can observe a targeted number of new HIV infections (seroconversions) over time. It is essentially the phase where the cohort platform and methods are proven to work.

What is expected during UG3 in terms of recruitment and baseline status?

Applicants are expected to design methods that can efficiently reach high-risk individuals, confirm HIV-negative status at baseline, and maintain reliable longitudinal follow-up using limited-interaction models (such as mobile/web engagement and remote data collection).

What is the purpose of the UH3 phase?

The UH3 phase is the implementation and scale period. If UG3 milestones are met, the cohort and data collection platform established during UG3 are used to conduct the full epidemiologic study, producing larger and more definitive datasets relevant to HIV prevention.

Is transition from UG3 to UH3 automatic?

No. The FOA states that progression to the UH3 phase is not automatic. Continuation is contingent on meeting pre-specified UG3 milestones, with a strong emphasis on enrollment performance, cohort follow-up, and achieving seroconversion milestone targets.

What kinds of milestones influence whether a project can transition to UH3?

The FOA emphasizes milestones related to enrollment performance, cohort follow-up/retention, and achieving seroconversion milestone targets. These milestones are used to demonstrate that the cohort is appropriately risk-enriched and that the approach can support meaningful HIV incidence estimation.

Who reviews the decision to transition to UH3?

The FOA states that, upon meeting the UG3 milestones, the project is administratively reviewed by NIAID and may be prioritized for transition to the UH3 award.

What does "risk-enriched cohort" mean in the context of this FOA?

Based on the FOA description, a risk-enriched cohort is one in which enrolled HIV-negative participants are at sufficiently high risk such that a targeted number of new HIV infections (seroconversions) can be observed over time. This is important for robust HIV incidence estimation.

What outcomes or data is the UH3 phase expected to produce?

The FOA describes producing larger and more definitive datasets on HIV incidence, correlates of risk, prevention uptake, and other outcomes relevant to improving HIV prevention programs and interventions.

What is meant by "technology-enabled approaches" in this opportunity?

The FOA describes approaches such as mobile or web-based engagement, remote data capture, digital communications, and home-based or community-based specimen collection, as well as other technology-forward strategies suitable for large cohorts.

Does this FOA require frequent in-person study visits?

The FOA is designed to reduce the need for frequent in-person study visits. It prioritizes limited-interaction approaches that rely on technology-enabled engagement and remote or distributed data/specimen collection models.

What makes this award a cooperative agreement rather than a standard grant?

The FOA is a cooperative agreement, which means recipients should expect substantial programmatic involvement from NIH staff. The description indicates active collaboration, shared stewardship of research goals, and ongoing oversight of milestones and deliverables.

What should applicants expect from NIH involvement during the project?

Applicants should plan for a more interactive relationship than typical investigator-initiated mechanisms, including structured reporting, milestone tracking, and potential adjustments guided by NIH program leadership to keep the project aligned with the FOA's objectives.

Who is the sponsoring agency and which NIH institute is notably involved?

The sponsoring agency is HHS/NIH. The FOA is described as notably within NIAID's scope, and NIAID is identified as performing the administrative review for potential transition to UH3 after UG3 milestones are met.

What is the FOA number for this opportunity?

The FOA number listed is RFA-AI-16-031.

What is the funding activity category?

The funding activity is categorized under Health.

What CFDA numbers are associated with this opportunity?

The associated CFDA numbers listed are 93.242, 93.855, and 93.856.

When was this FOA posted and when did it close?

The FOA was posted on May 26, 2016 (and created the same day). The original/current closing date listed is December 5, 2016.

What types of organizations are eligible to apply?

Eligibility is described as broad and includes: state, county, city/township, and special district governments; public and state-controlled and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those specific categories); for-profit organizations (other than small businesses) and small businesses; and other organizations as described in the FOA's eligibility clarification language.

Are for-profit entities eligible?

Yes. The FOA includes for-profit organizations (other than small businesses) and also explicitly includes small businesses as eligible applicants.

Are tribal governments and tribal organizations eligible?

Yes. The FOA includes federally recognized tribal governments and other tribal organizations among eligible applicants.

Are public housing authorities eligible?

Yes. Public housing authorities/Indian housing authorities are included in the eligibility list.

What must applicants describe regarding the two phases?

Applicants are required to describe and justify plans for both the UG3 and UH3 phases up front. The FOA emphasizes that the funding pathway and scientific payoff depend on the ability to transition from feasibility/demonstration (UG3) to sustained cohort-based epidemiologic research (UH3).

What is the core evidence the UG3 phase is meant to demonstrate?

The UG3 phase is meant to demonstrate that the proposed approach can successfully recruit and retain an appropriate cohort, maintain longitudinal follow-up using limited-interaction methods, and observe sufficient seroconversions to support meaningful incidence estimation.

How does this FOA aim to improve HIV prevention efforts?

By producing actionable epidemiologic evidence (including HIV incidence and prevention uptake data) from large, technology-enabled cohorts in disproportionately affected populations, the FOA aims to inform and accelerate HIV prevention strategies, programs, and interventions.