NIH – Digital, Limited Interaction Trials and Epidemiology (D-LITE): Targeting HIV Incidence in the United States (U01 Clinical Trial Required)

January 13, 2020 by


The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to conduct large-scale digital clinical trials to test whether digitally-delivered HIV prevention interventions can reduce HIV incidence among U.S. men who have sex with men (MSM) and/or transgender women and men. The major goal is to support investigators who will use innovative electronic methods to recruit and retain large samples of persons at high risk of HIV infections, conduct digitally-delivered interventions that promote HIV risk reduction and pre-exposure prophylaxis (PrEP) use, and assess the resulting impact on HIV incidence through mailed HIV test kits or other remote means.


There is a critical need to strengthen HIV prevention in the United States. While HIV incidence in the U.S. has declined modestly overall, progress has been uneven, and rates have risen among some subgroups. Recent epidemiologic data indicate that HIV cases among MSM in the U.S. increased from 2010 to 2016, with MSM accounting for 82% of new cases among males in 2017. Racial and geographic disparities are marked in the U.S. Compared to the incident rate of new HIV diagnoses per 100,000 white males in 2017, the rate was 7.6-fold higher for black males and 3.6-fold higher for Latinos. High HIV incidence rates have also been reported for transgender populations. Nearly twenty percent of HIV cases in the U.S. in 2016 were from rural areas or metropolitan statistical areas (MSA) with less than 500,000 residents; furthermore, the South accounted for 20,218 (52%) of all new HIV diagnoses in 2017. The Ending the HIV Epidemic: A Plan for America focuses mainly on the 50 primarily urban jurisdictions (48 counties and San Juan, P.R. and Washington, D.C) that account for about half the annual HIV incident cases in the U.S. Although the plan also targets the seven states with large numbers of rural cases, additional efforts are needed to reach the approximately 41% of annual HIV infections occurring in other, less densely populated areas of the country.

Potent tools to reduce HIV incidence are available and advancing. Widespread access to HIV treatment and improving rates of viral suppression bring concomitant benefits for HIV prevention. Expanded use of HIV pre-exposure prophylaxis (PrEP) stands to make a population-level impact on HIV incidence. The preventive impact of these biomedical prevention approaches, however, are impeded by substantial structural challenges that impede access to and use of biomedical HIV prevention. This is reflected in sharp racial/ethnic disparities in PrEP uptake and the late presentation of HIV-infected minorities to care. Effective engagement of hard-to-reach populations and impactful support for behavioral HIV risk reduction and biomedical prevention strategies will require novel approaches.

Smart phones, the internet, and other wireless technologies have dramatically changed the ways that people meet and interact. They also offer new approaches to track and gather information from diverse populations, as well as ways to deliver and test HIV prevention interventions. The LITE initiative (RFA-AI-16-031) has demonstrated the effectiveness of digital approaches for screening, recruiting, and retaining very large (i.e. more than 5,000 participants) observational cohorts of individuals at-risk for HIV infection, with enough HIV seroconversions occurring on study to provide adequate statistical power for digital clinical trials. LITE investigators have used postal mail and in-home HIV test kits to assess HIV-infection status, and various digital-based interventions have been used to reduce risks of HIV-infections.

Key Dates

Posted Date – January 8, 2020
Open Date (Earliest Submission Date) – February 20, 2020
Letter of Intent Due Date(s) – February 20, 2020
URL for more information

Filed Under: Funding Opportunities