Digital, Limited Interaction Trials and Epidemiology (D-LITE): Targeting HIV Incidence in the United States (U01 Clinical Trial Required) | RFA AI 19 067

Opportunity Information: Apply for RFA AI 19 067

The Digital, Limited Interaction Trials and Epidemiology (D-LITE): Targeting HIV Incidence in the United States funding opportunity (RFA AI 19 067) is a National Institutes of Health (NIH) cooperative agreement (U01) that supports large-scale digital clinical trials focused on reducing new HIV infections in the United States. It is explicitly a clinical trial required announcement, meaning applicants are expected to propose and run a real-world trial that tests whether a digitally delivered HIV prevention intervention can measurably lower HIV incidence. The core populations of interest are U.S. men who have sex with men (MSM) and transgender women and men, particularly those at higher risk of acquiring HIV, reflecting the ongoing disproportionate burden of HIV in these communities.

The central idea behind D-LITE is to move beyond small pilot studies and instead fund trials big enough to detect changes in HIV incidence, while relying on limited in-person interaction. Applicants are expected to use modern electronic and mobile methods to recruit participants at scale, enroll them efficiently, and keep them engaged over time with minimal face-to-face contact. This typically implies recruitment through online platforms, social media, dating or networking apps, digital outreach through community partners, and remote eligibility screening and consent processes, all designed to reach people where they already are and to reduce the friction that often limits participation in prevention research.

Interventions under this program are meant to be delivered digitally and should directly support HIV risk reduction behaviors and greater uptake and appropriate use of pre-exposure prophylaxis (PrEP). In practice, this could include app-based or web-based counseling, tailored risk feedback, adherence and persistence supports for PrEP, reminders and check-ins, telehealth-style navigation to PrEP services, linkage to culturally competent providers, and other technology-enabled strategies that can be deployed broadly. The expectation is not simply to educate, but to change outcomes by improving prevention behaviors and service uptake in a way that is feasible, scalable, and sustainable outside of a traditional clinic-heavy research model.

A defining feature of this FOA is how outcomes are to be measured. Rather than relying primarily on clinic visits, the program emphasizes remote assessment of HIV incidence, including the use of mailed HIV test kits or other remote testing approaches. This reflects a broader push toward decentralized clinical trials, where key trial activities (recruitment, intervention delivery, follow-up, and outcome measurement) can happen outside standard research sites. Applicants should be prepared to design rigorous procedures for verifying outcomes, maintaining participant privacy, ensuring data quality, and handling follow-up steps such as confirmatory testing and linkage to care for participants with reactive results, consistent with ethical and clinical standards.

In terms of who can apply, eligibility is broad and includes many U.S.-based organization types: state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; 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. The FOA also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), as well as faith-based or community-based organizations and eligible federal agencies. U.S. territories or possessions are also included as eligible applicants, reinforcing the intent to reach diverse communities and settings.

There are important restrictions related to non-U.S. applicants. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, foreign components are allowed as defined by the NIH Grants Policy Statement, which generally means a U.S. applicant organization may include certain foreign elements in the project if justified and permitted under NIH policy, even though the primary applicant must be domestic and the work is fundamentally aimed at HIV incidence in the United States.

Administratively, this opportunity is categorized as discretionary funding and uses the cooperative agreement mechanism (U01). A cooperative agreement typically signals substantial programmatic involvement from NIH staff compared to a standard research project grant, often including collaboration on key scientific or operational aspects, milestone tracking, or coordination across funded projects. The FOA was created on January 8, 2020, with an original closing date of June 20, 2020. The CFDA numbers associated with the opportunity are 93.242, 93.855, and 93.865, and the sponsoring agency is the NIH.

Overall, D-LITE is aimed at accelerating the shift toward pragmatic, scalable HIV prevention trials that can reach large numbers of MSM and transgender people through digital channels, promote proven prevention tools like PrEP, and measure real reductions in HIV incidence using remote testing and follow-up systems. The program is essentially asking applicants to combine strong HIV prevention science with modern digital trial methods, robust recruitment and retention strategies, and credible remote outcome measurement to demonstrate population-level prevention impact.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Digital, Limited Interaction Trials and Epidemiology (D-LITE): Targeting HIV Incidence in the United States (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.855, 93.865.
• This funding opportunity was created on 2020-01-08.
• Applicants must submit their applications by 2020-06-20. (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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