Feasibility and impact of rapid newborn screening for sickle cell disease in Tanzania: Results from the tabora region pilot program (SickleCare)

Abstract Background: Tanzania bears a substantial burden of sickle cell disease (SCD), with an estimated 11,000 affected newborns annually (Smart et al., 2019), ranking it among the top five countries globally for SCD births (Ambrose et al., 2018). Despite this high burden, routine newborn screening has yet to be implemented nationwide. In response, a regional pilot program was launched in Tabora Region of Tanzania in February 2025 to evaluate the feasibility and impact of early SCD detection among newborns and symptomatic children under five years of age. Methods: Screening was conducted at 19 health facilities participating in the SickleCare project using the HemoTypeSC™ rapid test. Newborns delivered at these facilities, as well as children under five presenting with symptoms suggestive of SCD, were screened. From February to July 2025, a total of 11,305 children were tested. Those identified as having sickle cell disease (HbSS) or carriers (Hb AS) were referred for confirmatory testing using the Gazelle Hb Variant™ rapid capillary electrophoresis platform. Key indicators included screening coverage, prevalence rates, and linkage to care. Results: Among the 11,305 children screened, 2.5% were identified with HbSS and 15.5% with HbAS trait. These findings exceed previous regional estimates in Tanzania, where SCD prevalence ranged from 1.2% to 2.0% and AS trait from 8.6% to 20.3%. Globally, SCD affects approximately 0.27% of newborns and AS trait occurs in about 7.7%, highlighting the elevated burden in Tabora. All children who screened positive for Hb SS were referred for confirmatory testing and successfully enrolled into care per Ministry of Health guidelines. Additionally, increased clinic attendance and community requests for screening indicate growing awareness and demand for SCD services in the Tabora region. Conclusion: The SickleCare pilot demonstrates that integrating rapid point-of-care screening for SCD into routine newborn and pediatric services is both feasible and effective in a resource-limited setting. The higher-than-expected prevalence rates reinforce the urgency of early detection and intervention, particularly in high-burden regions. These results support expansion to additional regions and eventual nationwide implementation. Achieving this goal will require additional investment in laboratory infrastructure, healthcare worker training, and community education. A national screening program could significantly reduce SCD-related morbidity and mortality and improve child health outcomes across Tanzania.