June 2018 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Genetic Engineering Technologies for HIV Cure Research

For the published request for applications, see the November 29, 2018 Guide announcement, Genetic Engineering Technologies for HIV Cure Research (U19 Clinical Trial Optional).

Single-Cell Multi-Omics of HIV Persistence

For the published request for applications, see the November 13, 2018 Guide announcement, Single-Cell Multi-Omics of HIV Persistence (R01 Clinical Trial Not Allowed).

Simian Vaccine Evaluation Units

For the published request for proposals, see the December 4, 2018 solicitation, Simian Vaccine Evaluation Units (SVEUs).

Clinical Research Products Management Center (CRPMC)

For the published request for proposals, see the February 15, 2019 solicitation, NIAID Clinical Research Products Management Center.

Data Management and Data Warehousing

Request for Proposals—proposed FY 2019 initiative

Contact: Kate Stotish

Objective: This contract will provide and support Clinical Data Management System (CDMS) and Data Warehousing and Reporting Tools (DWRT) for clinical studies implemented by the Vaccine Research Center’s (VRC) Clinical Trials Program (CTP) and collaborators.

Description: This initiative will support a CDMS and DWRT for clinical research to provide comprehensive and consistent data management support for the VRC’s CTP. The CTP implements natural history, therapeutic, and preventative clinical trials to test candidate products such as vaccines and immunomodulators for a range of infectious diseases. These services may be provided for trials activated at single or multiple sites that are domestic and/or international.

Specifically, the contract will provide a comprehensive array of data management support services, including protocol-specific web-based data collection plans/programming, management, and quality control; statistical consultation and reporting, design, and analysis; assistance in study materials development with related web-based reports and training; creating Data Collection Forms, electronic specimen tracking; adverse events dictionary and reconciliation, providing Regulatory Tracking System, and data reports to support safety/regulatory/security requirements and report on study progress. The contract will also create, manage, and maintain a secure, compliant repository for current and historical clinical trials outcomes data and analyses, while allowing instant accessibility of integrated and standardized data via advanced analytics and visualization reporting tools with web-based access.

Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis

For the published program announcement with special receipt, referral, and/or review considerations, see the June 7, 2018 Guide announcement, Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis (TBM) (R01, Clinical Trial Not Allowed).

Characterization of Mycobacterial Induced Immunity in HIV‐Infected and Uninfected Individuals

For the published program announcement with special receipt, referral, and/or review considerations, see the September 17, 2018 Guide announcement, Characterization of Mycobacterial Induced Immunity in HIV-infected and Uninfected Individuals (R21, Clinical Trial Not Allowed).

CNS‐Targeted Drug Delivery Strategies for HIV

For the published request for applications, see the August 8, 2018 Guide announcement, CNS-Targeted Drug Delivery Strategies for HIV (R01 Clinical Trial Not Allowed).

Engaging Men in HIV Testing, Prevention, and Care

For the published program announcements, see the November 1, 2018 Guide announcements, Engaging Men in HIV Testing, Prevention, and Care (R01 Clinical Trial Optional) and Engaging Men in HIV Testing, Prevention, and Care (R21 Clinical Trial Optional).

Next Generation Multipurpose (NGM) Prevention Technologies

For the published program announcement with special receipt, referral, and/or review considerations, see the March 4, 2019 Guide announcement, Next Generation Multipurpose Prevention Technologies (NGM) (R01, Clinical Trial Optional).

Sustained Release of Antivirals for Treatment or Prevention of HIV (SRATP)

Program Announcement With Special Receipt, Referral, and/or Review Considerations—proposed FY 2020 initiative

Contact: Jim Turpin

Objective: The objectives of this initiative are consistent with the Division’s priorities:

  • Halt the spread of HIV infection by defining highly effective prevention strategies, including a preventive vaccine
  • Cure HIV infection
  • Improve outcomes of treated HIV disease

Description: This initiative will support developing sustained release strategies for HIV prevention and treatment. Applicants may propose any combination of prevention and treatment products and sustained release platforms that will provide minimal windows of efficacy/protection identified below. The overarching objective will be to establish a pipeline of sustained release prevention and treatment candidates.

To meet the sustained release needs of the treatment and prevention fields the following definition and types of sustained release will be solicited:

1. Treatment sustained release: Oral therapy sustained release strategies must have a window of effectiveness of at least seven days from a single dose. Other sustained release approaches for therapy must have a minimal window of protection of 30 days from either a single dose regimen (injection) or continuous dosing regimen (implant, transdermal patch).
2. Prevention sustained release: All sustained release strategies designed to prevent HIV infection must have a minimum window of protection of 30 days from either a single dose regimen (injection) or continuous dosing regimen (implant, transdermal patch).

For all forms of sustained release development, applicants are encouraged to develop sustained release strategies that provide longer windows of therapy or protection than the minimal windows identified above.

Content last reviewed on March 13, 2019