National Heart, Lung, and Blood Institute (NHLBI)
The Division of Blood Diseases and Resources within the National Heart, Lung, and Blood Institute (NHLBI) intends to continue and expand a research program on sickle cell disease in sub-Saharan Africa by publishing a U01 Funding Opportunity Announcement (FOA) to solicit applications from existing sites of the Sickle Pan-African Research Consortium (SPARCO), and up to three new sites in non-currently represented Sub-Saharan African nations. The renewed and expanded SPARCO (including 3 existing sites and up to 3 new sites to be funded through this U01 FOA) as well as a Clinical Coordinating Center (to be funded through a U24 companion FOA) and the associated Sickle Africa Data Coordinating Center, SADaCC (to be funded through another U24 companion FOA) will together constitute the Sickle Cell Disease in Sub-Saharan Africa Network (SCD in SSA Network). This Network aims to develop a sustainable resource that will advance sickle cell disease related epidemiologic, translational, and clinical studies.
The Sickle Pan-African Research Consortium (SPARCO) (U24) and the Sickle Africa Data Coordinating Center (SADaCC) (U24) were awarded initial grants in 2017. SPARCO’s Clinical Coordinating Center (CCC) is located in Dar es Salaam, Tanzania and collaborative sites (funded currently through sub-awards from the CCC) are situated in Abuja, Nigeria; Kumasi, Ghana; and Dar es Salaam, Tanzania. The Data Coordinating Center (DCC), SADaCC, is located in Cape Town, South Africa. The goals of the current phase of the Network were to develop: 1) A REDCap SCD registry/database system to include 13,000 subjects of all ages; 2) Shared database elements and harmonized phenotype definitions/ontologies; 3) Regionally appropriate clinical SCD management guidelines; and 4) Associated skills development programs. Additionally, the Network was also charged within its final (4th) year of funding for this first phase with planning for the conduct of: a) Cohort studies; b) Programs for newborn screening, infection prevention, and wider hydroxyurea use; and c) Database expansion to include additional sub-Saharan African nations.
The next phase of the Network as invited by this FOA and its companion FOAs is intended to sustain, enhance and expand the SCD in SSA Network and to promote and expand capacity building activities relevant to SCD in sub-Saharan Africa. Enhancement of network infrastructure and the addition of new collaborative sites will advance SCD-related epidemiologic, translational, and clinical research in the region while concurrently improving SCD care.
The expanded program will make it possible to describe (for newly participating countries) or more accurately describe (for already participating countries) the current status of SCD as well as risk modifiers including access to care and clinical management in SSA countries, and provide comparative data to what is observed in the US and other countries. Follow-up of an expanded cohort will permit the evaluation in SSA and each of the participating countries of: 1) the incidence of clinical events, such as pain crisis and acute chest syndrome (ACS); 2) the possible association with various factors including care and management, such as infection prophylaxis and hydroxyurea use as well as socio-economic and environmental factors; 3) and the impact on health outcomes of improving the identification and care of patients with SCD. The expanded SCD in SSA Network will also implement and evaluate programs for newborn screening, infection prevention, and wider hydroxyurea use, which were planned by the Network in its first phase.
This Notice of Intent to Publish (NOITP) is being provided to allow potential eligible applicants sufficient time to develop competitive and responsive milestone-driven scientific projects and thus prepare the applicant for the timely submission of an application.
The intended FOA will utilize the U01 Cooperative Agreement mechanism (Clinical Trial Not Allowed) with a maximum project period of 5 years. Companion FOAs will utilize the U24 mechanism to support the CCC and SADaCC (the DCC). In the next phase of the Network, the CCC is expected to oversee and coordinate the Network Consortium site activities but is not expected to manage the budgets for the collaborative Consortium sites which will be supported by separate U01 awards through this FOA.
NHLBI intends to commit total costs of up to $1,053,000 in FY2021, $1,296,000 in FY2022, $1,296,000 in FY2023, $1,782,000 in FY2024, and $1,782,000 in FY2025 to fund up to 6 awards, including 3 awards to the three existing sites and up to 3 awards to new sites.
Application budgets for each application may not exceed direct costs of $100,000 in FY2021, $150,000 in FY2022, $150,000 in FY2023, $225,000 in FY2024, and $225,000 in FY2025.
An application that includes maintenance of an existing registry or database of SCD cases may request additional direct costs up to $125,000 in FY2021, and additional direct costs up to $100,000 per year in FY2022 through FY2025.
Shimian Zou, PhD
National Heart, Lung, and Blood Institute (NHLBI)