An interventional study of Point-of-care testing (POCT) -Patient participants and Point-of-care testing (POCT) - Healthy control participants in Sickle Cell Disease, sponsored by St. Jude Children's Research Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Other
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.
This prospective mixed-methods hybrid effectiveness-implementation feasibility study will evaluate the feasibility and effectiveness of an implementation strategy package designed to improve early diagnosis and care entry for children born with sickle cell disease (SCD) in rural, low-resource settings. The implementation strategy package includes three components: 1) integration of essential products into national supply chain systems, 2) integration of systematic newborn screening using point-of-care-testing into clinical site workflows and 3) linkage of children who screen positive to a PEN-Plus Non-Communicable Disease (NCD) clinic for longitudinal care. Participants will be tracked longitudinally to evaluate protocol adoption over time and clinical outcomes among participating children at 2 years of age.
Primary Objective
Secondary Objectives (Micro level):
Secondary Objectives (Meso level)
Secondary Objective (Macro level)
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's planned enrollment of 6,750 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children participants will fall into one of two categories:
Exclusion Criteria:
Children participants:
Healthy control 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: Point-of-care testing (POCT) -Patient 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: Point-of-care testing (POCT) - Healthy control participants
Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study.
Other: Context Assessment for Community Health (COACH) survey · Other: Semi-structured interview
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: Semi-structured interview
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: Semi-structured interview
Infants will be screened for Sickle Cell Disease using with point-of-care testing (POCT).
Infants will be screened for Sickle Cell Disease using with point-of-care testing (POCT) and prospectively monitored for survival.
The COACH survey will collect quantitative data on eight contextual factors that impact a site's ability to implement evidence-based interventions.
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.
Percentage of eligible population screened for Sickle Cell Disease
Time frame: 3 years
Percentage of new SCD cases linked to care
Time frame: 3 years
Comparison of under-2 mortality between participants with SCD whom received longitudinal care and participants who screened negative for SCD
The primary outcome measure will be 'Alive and in care: Yes or No'.
Time frame: 2 years post-screening and therapy
Percentage of SCD cases retained in care by 2 years of age
Time frame: 2 years post-screening and therapy
Percentage of eligible secondary-level clinical wards implementing systematic screening and linkage to longitudinal care for new SCD cases
Time frame: 3 years
Percentage of eligible health facility staff participants in secondary-level clinical wards implementing systematic screening and linkage to longitudinal care for new SCD cases
Time frame: 3 years
Comparison of SCD Screening Performance Results from Initial point-of-care (POCT), Gazelle, and Hemoglobin Fractionation
Investigators will estimate the sensitivity (proportion of diseased subjects that yield a positive test result) and specificity (the proportion of non-diseased subjects that yield a negative test result) of the POCT for detecting SCD compared to the gold standard with basic proportions.
Time frame: 3 years
Cost-Effectiveness of Integrating SCD Consumables into National Supply Chains
The standard formula known as incremental cost-effectiveness ratios (ICERs) will be used. ICER is a summary statistic used in economic evaluations to compare the relative value of different healthcare interventions. It is scored by comparing the resulting cost-per-QALY against a predefined threshold, where lower ICERs indicate better value.
Time frame: 2 to 5 years
Cost-Effectiveness of POCT for Early SCD Diagnosis
The standard formula known as incremental cost-effectiveness ratios (ICERs) will be used. ICER is a summary statistic used in economic evaluations to compare the relative value of different healthcare interventions. It is scored by comparing the resulting cost-per-QALY against a predefined threshold, where lower ICERs indicate better value.
Time frame: 2 to 5 years
Cost-Effectiveness of Decentralized PEN-Plus SCD Management
The standard formula known as incremental cost-effectiveness ratios (ICERs) will be used. ICER is a summary statistic used in economic evaluations to compare the relative value of different healthcare interventions. It is scored by comparing the resulting cost-per-QALY against a predefined threshold, where lower ICERs indicate better value.
Time frame: 2 to 5 years
Frequency of SCD Supply Stockouts at Study Sites
Time frame: 5 years
No study locations are listed for this record.
Plan to share: No
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St. Jude Children's Research Hospital