Pursue Strategies To Provide HIV PrEP and ART in STI Service Settings

NIAID will support research to design and evaluate strategies for reducing HIV incidence among people in the United States at greatest risk of infection by scaling up pre-exposure prophylaxis (PrEP) and antiretroviral treatment (ART) in sexually transmitted infections (STI) service settings.

Apply through the funding opportunity announcement (FOA) Innovative Models for Delivering PrEP and STI Services To Stop HIV in the United States (R33/R61, Clinical Trial Optional) to develop strategies for providing HIV testing, PrEP, and ART to people seeking STI services in the United States.

Research Priorities

Within this biphasic opportunity, the initial R61 phase will support investigators developing effective strategies and cost data for service provision, followed by an R33 phase in which investigators will design and implement studies to demonstrate the feasibility of rapidly scaling up these services with national, state, and local implementation partners.

NIAID’s research areas of interest include:

• Research examining multi-component strategies for scaling up HIV and STI testing, treatment, and prevention services in a cost-effective manner in conjunction with other diagnostic and treatment services that may be needed by the priority populations being served, including mental health care, harm reduction, substance use treatment, and family planning services
• Intervention strategies that incorporate stigma reduction and peer outreach and support programs to engage and retain populations at increased risk of HIV infection that are typically hard to reach
• Strategies that incorporate the use of digital health/mobile technologies to support STI and HIV testing, treatment, and prevention services and ongoing adherence and retention

Projects should focus on the populations most at-risk for HIV acquisition, based on available epidemiologic data. Such data should also be used to discern opportunities to address disparities in access to STI and HIV treatment and prevention services during the project.

Applications should include interventions to overcome stigma and discrimination; provide individualized services to optimize PrEP and ART uptake and retention; ensure ongoing access to ART, PrEP, and other prevention services; and provide quality STI services that meet current CDC recommendations.

For all services offered as part of a prevention strategy, researchers should seek consultation with appropriate community advisory groups.

If a clinical trial is proposed, all planning activities for the first trial must be completed by the time of application submission. The first trial must open to enrollment within 12 months of receiving the award. The FOA provides detailed information about which specific activities related to planning and completing a trial are allowed for the R61 phase and the R33 phase. If you have any questions, reach out to the scientific contact listed below to discuss your potential project.

Phased Award Process

The R61/R33 award requires milestones—defined as scheduled events in the project timeline that signify the completion of a major project stage or activity—for both the R61 and R33 phases. NIAID will review and may negotiate applicants’ proposed milestones before award.

The R61 phase provides investigators up to three years for hypothesis and milestone-driven research. NIAID requires clear and measurable criteria for a Go/No-Go decision by the end of year three that demonstrate readiness to implement the promising strategies on a wider scale during the R33 phase. Funding for the R33 phase will be contingent upon meeting the negotiated Go/No-Go criteria.

Before the R61 phase ends, awardees will submit an R33 transition package, which NIH program staff will review. Up to two years of support may follow for investigators ready to carry out studies to demonstrate the feasibility of rapidly scaling up these services with the national, state, and local implementation partners identified in their applications.

Learn more about the R61/R33 activity code and others like it by reading our Phased Award SOP.

Administrative Details

Application budgets are limited to $400,000 annual direct costs for both the R61 and R33 phases.

The total project period cannot exceed five years. Applicants may request up to three years of support for the R61 phase and up to two years of support for the R33 phase.

The sole application due date is October 13, 2021. Optional letters of intent are due one month earlier.

If you have questions, direct them to Dr. Dale Burwen, NIAID’s scientific/research contact, or Dr. John Pugh, the FOA's peer review contact.