Newborn Sickle Cell Screening in Mozambique

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This mixed-methods study in rural Mozambique evaluates whether integrating a national supply chain, newborn point-of-care screening, and linked pediatric clinics can improve early diagnosis and ongoing care for infants with sickle cell disease. The approach tracks how well the strategies are adopted over time and whether health outcomes for children under 2 years improve. Data will come from patient participants, healthy controls, and health system staff to understand feasibility, acceptability, and potential impact. The study uses real-world clinical settings to test a practical implementation package rather than a traditional diagnostic or treatment trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Hospital Rural de Nhamatanda
  Nhamatanda, Sofala, Mozambique Recruiting

Study contacts

• Principal investigator: Jane Hankins, MD — St. Jude Children's Research Hospital
• Study coordinator: Jane Hankins, MD
• Email: referralinfo@stjude.org
• Phone: 888-226-4343

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Optimizing Hydroxyurea in Children with Sickle Cell in Africa

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• Hematopoietic stem cell editing to treat sickle cell disease

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• Virtual reality options to help with VOC pain in adults with SCD

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• Mitapivat for reducing transfusion needs in sickle cell disease

  This study tests whether mitapivat, compared with placebo, can lower the number of blood transfusions needed by people with sickle cell disease.

  Recruiting at 5 sites Phase 3 Agios Pharmaceuticals, Inc. · Indianapolis, Indiana and 4 other locations · NCT07656415

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.