Testing All Newborns for Sickle Cell Disease in Mozambique
Tests a way to screen newborns for sickle cell disease and link them to care.
Plain-language title generated from the registry record
Registry title: Universal Newborn Screening For Sickle Cell Disease In Mozambique
Key facts
- Where
- Nhamatanda, MozambiqueSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study looks at newborn screening for sickle cell disease in Mozambique. It includes infants up to 6.0 months old, plus health workers and health system experts.
- Age
- Infants from birth to 6.0 months. Health facility staff aged 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Infants who tested positive for sickle cell disease (HbSS, HbSC or another form) or had unclear results. Infants who tested negative (HbAA) or have sickle cell trait (HbAS) join as healthy controls.
- Earlier treatment
- Infants who had a blood transfusion within 3 months of testing cannot join.
- Biomarker or test result
- Sickle cell disease screening result from the UNIQUE study: positive, unclear, negative (HbAA) or sickle cell trait (HbAS).
Main reasons for not taking part
- Stillbirths
- Infants who had a blood transfusion within 3 months of testing
Read by machine on 11 November 2026.
Where in Mozambique
- Hospital Rural de NhamatandaNhamatanda, MozambiqueTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- St. Jude Children's Research Hospital
- Trial code
- NCT07719972
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
Universal Newborn Screening For Sickle Cell Disease In Mozambique
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.
Inclusion: 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.
Exclusion: 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; 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; Patient participants: none; Health facility staff participants: none; Supply chain expert participants: none; National public health system expert participants: none.