Universal Newborn Screening For Sickle Cell Disease In Mozambique
Starting soon · Not applicable
Conditions studied: Sickle Cell Disease
In brief
The overarching goal of this study is to evaluate the feasibility of a new methodology that combines three multi-level implementation strategies to optimize the population-level uptake of essential evidence-based, standard of care treatments for infants with sickle cell disease (SCD) in low-resource settings. The study will be done in Mozambique.
Key facts
- Study ID
- NCT07719972
- Run by
- St. Jude Children's Research Hospital
- People needed
- 6750
- Starts
- 2026-08-01
- Expected to finish
- 2031-08-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Children participants: All infants between birth and 6.0 months of age who are born or receive care at secondary-level facilities involved in the UNIQUE study.
- Children participants will fall into one of two categories:
- Patient participants: All infants between birth and 6.0 months of age who were screened through the UNIQUE study and tested positive for SCD (HbSS, HbSC, or other form of SCD) or had indeterminate results.
- Healthy control participants: Infants between birth and 6.0 months of age who screen negative for SCD (HbAA) through the UNIQUE study or tested positive for sickle cell trait (HbAS).
- Health facility staff participants: Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study.
- Supply chain expert participants: Administrative professionals with experience working in or around the national supply chain systems in Mozambique to support procurement, importation, customs clearance, storage, and in-country distribution of medical products.
- National public health system expert participants: Administrative professionals with experience working in the national public health system (e.g., Ministry of Health, MISAU) who oversee the delivery of health services to infants in-country, such as neonatal testing and vaccination programs.
You may not qualify if…
- Children participants:
- Stillbirths.
- Children who received an erythrocyte (blood) transfusion within 3 months of testing. Exogenous (transfused) HbA could artificially lower the sickle hemoglobin concentration, thus causing false-negative results.
- Patient participants: none
- Healthy control participants:
- Stillbirths.
- Children who received an erythrocyte (blood) transfusion within 3 months of testing. Exogenous (transfused) HbA could artificially lower the sickle hemoglobin concentration, thus causing false-negative results.
- Health facility staff participants: none.
- Supply chain expert participants: none.
- National public health system expert participants: none.
Full record on ClinicalTrials.gov
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