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NCT07719972Not yet recruiting

Universal Newborn Screening For Sickle Cell Disease In Mozambique

Source: ClinicalTrials.gov · Last updated 22 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
6750 (estimated)
First submitted
17 Jul 2026
Start date
1 Aug 2026
Primary completion date
31 Aug 2031
Lead sponsor
St. Jude Children's Research Hospital
NCT number
NCT07719972

What you commit to

  • Study type: Interventional
  • Planned participants: 6750
  • From 1 Aug 2026 to the primary completion date, 31 Aug 2031
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Other

  • Patient participants: none
  • Health facility staff participants: none.
  • Supply chain expert participants: none.
  • National public health system expert participants: none.

Who the study is looking for

  • 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.

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.