Universal Newborn Screening For Sickle Cell Disease In Mozambique

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07719972
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Point-of-care testing (POCT) -Patient participants — OTHER
    Infants will be screened for Sickle Cell Disease using with point-of-care testing (POCT).
  • Point-of-care testing (POCT) - Healthy control participants — OTHER
    Infants will be screened for Sickle Cell Disease using with point-of-care testing (POCT) and prospectively monitored for survival.
  • Context Assessment for Community Health (COACH) survey — OTHER
    The COACH survey will collect quantitative data on eight contextual factors that impact a site's ability to implement evidence-based interventions.
  • Semi-structured interview — OTHER
    Interview questions will revolve primarily around the current process for SCD screening and care referrals, factors impacting newborn care delivery and screening, and challenges to integrating SCD newborn screening and care referral into standard care delivery.

Study Details

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 Dates

First listed
Jul 22, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
6,750 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: 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.
  • Other: 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).
  • Other: Health facility staff participants
    Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study.
  • Other: 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.
  • Other: 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.

Primary Outcome Measure

Percentage of eligible population screened for Sickle Cell Disease [ Time Frame: 3 years ]

Central Contacts

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