Evaluation of an Information Management and Communication System for Population-wide Point-of-Care Infant Sickle Cell Disease Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sickle Cell Disease screening information management and communication system.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A cluster randomized trial (CRT) of the novel sickle cell disease (SCD), M-health based SCD Information Management and Communication system SIMCS vs routine new born screening strategy in health care centres in Uganda to evaluate impact on access screening, coordination of care and clinical outcomes
Detailed description
We will conduct a cluster randomized trial (CRT) of the novel SCD SIMCS and utilize a logical framework of measurable indicators of barriers, utilization, mediating factors, and clinical outcomes of SCD screening and care to evaluate its impact. We will randomize health facilities rather than individual patients because it would be impossible to avoid contamination if we randomized individuals. This design is ideal for evaluating the effectiveness of systems level interventions.
Study procedures Trial Intervention. SCD SIMCS APP, which is an AI-enhanced mobile platform that captures, interprets and relays results of point of care tests for SCD to health care providers and to a centralised public data server at the Uganda Ministry of Health. The SCD SIMCS app prototype consists of four modules: (1) ID module - captures child's demographic and biometric data and builds a printable QR-code; (2) Assay module - captures HemoTypeSCTM and the Sickle Scan TM test image, interprets, and transmits results to the CPHL data centre; (3) Education module - stores and plays back short educational videos for pre- and post-screening counselling; (4) SCD e-Passport module - entry and display of child's longitudinal salient clinical information.
Baseline assessment; following stratified purposive sampling and consent from community leaders, Control and Experimental HCs will undergo baseline evaluation with regards to current resources and childcare visit workflows and the availability of the data sources and measurable indicators of interest. A baseline assessment of resources, workflows, and routine source data collection systems at the centres will facilitate implementation planning for the proposed SCD SIMCS and accurate measurement of its impact on the HCs.
Interventions
- Other Sickle Cell Disease screening information management and communication system
Mobile Health information managment system
Primary outcome measures
- Improved number and timeliness of refferal of infants with sickle cell disease for care [Time frame: 12 months]
- Ajusted Mortality Rate of children with sickle cell disease [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
Providers of child health and maternity services at selected hospitals Infants born or attending child health and maternity services at selected hospitals . Infants are the targeted age-group in this study because this is the ideal age to screen for SCD and prevent complications and mortality that generally occurs early, by 5 years old. The infants will be recruited at birth or at vaccination visits
Exclusion criteria
- Decline of inability to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Uganda · 1 center
- Nalufenya Childrens — Jinja
Identifiers
NCT: NCT07610239 · Mak-SOMREC-2025-2124