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NCT07719972

Universal Newborn Screening For Sickle Cell Disease In Mozambique

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 5 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2026 to Sep 24, 2026
    • Secondary endpoints: details revised at 4 of 9 entries
    • Study description expanded, about 7 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Percentage of eligible population screened for Sickle Cell Disease
Timeframe: 3 years
Percentage of new SCD cases linked to care
Timeframe: 3 years

Secondary (9)

Comparison of under-2 mortality between participants with SCD whom received longitudinal care and participants who screened negative for SCD
Percentage of SCD cases retained in care by 2 years of age
Percentage of eligible secondary-level clinical wards implementing systematic screening and linkage to longitudinal care for new SCD cases
Percentage of eligible health facility staff participants in secondary-level clinical wards implementing systematic screening and linkage to longitudinal care for new SCD cases
Comparison of SCD Screening Performance Results from Initial point-of-care (POCT), Gazelle, and Hemoglobin Fractionation
Show 4 moreShow less
Cost-Effectiveness of Integrating SCD Consumables into National Supply Chains
Cost-Effectiveness of POCT for Early SCD Diagnosis
Cost-Effectiveness of Decentralized PEN-Plus SCD Management
Frequency of SCD Supply Stockouts at Study Sites

Arms and interventions

Patient participantsOther

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 participantsOther

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 participantsOther

Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study.

Supply chain expert participantsOther

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 participantsOther

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.

Other: Point-of-care testing (POCT) -Patient participants, Point-of-care testing (POCT) - Healthy control participants, Context Assessment for Community Health (COACH) survey, Semi-structured interview

Sites

1 site in 1 country

  • Hospital Rural de NhamatandaNhamatanda, Sofala, Mozambique