January 28, 2020 - ATN Request for Proposals (RFP): Research Aimed at Ending the HIV Epidemic: A Plan for America
Letter of intent due date: March 1, 2020
Proposal due date: March 23, 2020
The US National Institutes of Health (NIH)-sponsored Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) aims to develop and conduct innovative behavioral, community-based, translational, therapeutic, microbicide and vaccine trials in HIV-at-risk and HIV-infected youth ages 12 to 24 years, with a focus on the inclusion of minors. The objectives and overarching goals of the ATN are to increase the numbers of at-risk youth who are aware of their serostatus, and for those who are diagnosed with HIV, to increase the numbers in each segment of the care continuum to 95% and to bend the infection rate curve downward toward zero. Currently, the ATN is comprised of three U19s, each supporting a research program with a well-defined research focus supported by core (e.g. program management, analysis) infrastructures and any needed subject recruitment and enrollment capacity. Each U19 Program conducts a number of scientifically meritorious research projects and has enrollment capacities to permit an effective collaborative effort among the participating investigators. The ATN is further comprised of a U24 Coordinating Center to provide support, coordination, and operational infrastructure to the Network. The ATN’s structure allows for the ability to perform high priority studies generated from the Network and/or in collaboration with other networks, agencies and other outside investigators.
The purpose of this RFP is to encourage collaboration among investigators and the ATN by providing funding support for scientifically meritorious research projects that address the scientific objectives of the ATN in support of the Ending the HIV Epidemic: A Plan for America. This funding opportunity is open to all investigators with the skills, knowledge, and resources necessary to carry out the proposed research. Projects must be led by an ATN investigator or an investigator in collaboration with an ATN investigator, AND must include documented collaboration with health departments or community-based organizations (e.g., funded by CDC/HRSA) within EHE geographic areas. Junior-level investigators paired with appropriate senior mentors are encouraged to apply to this RFP.
Early in 2019, the Department of Health and Human Services (DHHS) announced Ending the HIV Epidemic: A Plan for America (EHE), reinvigorating efforts at addressing HIV concentrated in heterogeneous “hot-spots” across the US through four fundamental strategies to be tailored by local communities’ needs and strengths. These strategies include diagnosing all individuals with HIV expeditiously, treating people with HIV promptly and effectively, preventing new HIV infections with proven interventions, and responding rapidly to potential HIV outbreaks with prevention and treatment services to meet the needs of communities. While efforts are already underway to rapidly implement this important initiative, the focus has been mostly among adult populations.
CDC estimates a disproportionately higher rate of undiagnosed HIV among adolescents (13-24 years) than all other age groups, which has a significant likelihood of contributing to onward transmission events, particularly when youth have the lowest uptake of effective prevention modalities like pre-exposure prophylaxis. Challenges in identifying, linking, engaging and retaining young people with HIV in care yet again lead to disproportionately low rates of viral suppression compared to all other age groups. While adolescent-specific evaluations of the HIV care continuum suggest that structural level interventions may improve time to linkage, and that shorter time achieving such successful referrals in turn improves likelihood of youth engaging with a second clinical care appointment, much work remains to understand how to best support an adolescent’s antiretroviral adherence to achieve durable viral suppression. Expanding EHE efforts to directly address such important implementation strategies among marginalized populations of adolescents in racial/ethnic, sexual and gender minority communities that bear a disproportionate burden of HIV is therefore a critical public health imperative.
IV. Funding Source and Mechanism
Application budgets are limited to $125,000 Total Costs per year and need to reflect the actual needs of the proposed project. The maximum project period is two years.
V. Scope of Work
The ATN is interested in receiving proposals that address the EHE goals within one or more of the following focused research areas:
• Implementation science research to address one or more of the four pillars of the EHE with projects already underway within the ATN, including but not limited to:
o Research studies that investigate and implement the uptake of interventions to increase HIV & STI testing, treatment and prevention in youth populations.
o Research studies that increase understanding of approaches to reach youth who are unaware they have HIV and link them to care.
• Expansion of ongoing ATN efforts into EHE geographic areas to reach underserved youth populations
• Build connections with health departments and other community-based partners in EHE geographic areas through research to better understand one or more of the following:
o the role of community health workers/outreach workers/liaisons to increase youth linkage to care and engagement in care, including services for co-occurring conditions such as substance use disorder, mental health disorder
o the role of clinical care providers to increase movement along the PrEP care cascade
o HIV prevention approaches within a sexual health wellness framework (i.e., sex education)
o The identification of HIV outbreaks among youth in EHE geographic areas to target appropriate prevention and treatment efforts that meet their needs through the utilization of data from the ATN and/or other sources
VI. Proposal Procedure and Requirements
Applicants are asked to submit the following by March 23, 2020:
• Proposal Title
• Proposed investigator(s) and the names and institutional affiliations of the PI and collaborating investigators, including local partners (i.e., health department, community based organization)
• Local partnership memoranda of understanding/agreements (include in appendix)
o The necessary agreements should be forged to indicate how information and resources have been or will be committed, invested, distributed and/or shared (e.g. local health department financial and human resources, data sharing, other efforts to link newly identified infected youth to clinical care; efforts to track HIV-negative youth for re-testing and linkage to prevention services).
o Preliminary agreements are acceptable but must be executed before an award can be made
• Brief proposal (not to exceed five pages) to include:
o Brief summary of significance, rationale and approach
o Background information, including previous studies and/or data pertinent to this application
o Description of integration with current ATN projects/infrastructure
• Human subjects considerations, if applicable (not to exceed one page), to describe how subjects will be protected from research risks, data and safety monitoring plans, potential benefits of research participation, etc.
• Estimated annual budget with justification, not to exceed $125,000 total costs per year
VII. Review Process
NIH ATN Program Officers, in addition to other scientific experts, will review each proposal. The following will be considered in accordance with standard NIH review procedures:
• Relevance to the EHE initiative;
• Relevance to and integration with the ATN;
• Scientific and technical merit of the proposed projects;
• Funding availability and;
• Program priorities.
Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
VIII. Key Dates/Timeline
RFP Release Date: January 28, 2020
Letter of Intent Due Date: March 1, 2020
Proposal Due Date: March 23, 2020
Review Timeframe: May 2020
Award Issued: August 2020
IX. Contact Information
Address to which proposals should be submitted: ATN U24 at ATNadmin@unc.edu.
Administrative questions may be submitted: ATN U24 at ATNadmin@unc.edu.
Scientific questions may be submitted to: Sonia Lee (Sonia.email@example.com)