Evaluation of an Information Management and Communication System for Population-wide Point-of-Care Infant Sickle Cell Disease Screening

Sponsor
Makerere University
Study ID
NCT07610239
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Sickle Cell Disease screening information management and communication system — OTHER
    Mobile Health information managment system

Study Details

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

Key Dates

First listed
May 27, 2026
Start date
Mar 25, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
24,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Placebo Comparator: Traditional centralised testing to point of care testing
    Routine new born screening strategy in health care centres in Uganda
  • Active Comparator: Information management and communication system
    Mobile Information Managment system

Primary Outcome Measure

Improved number and timeliness of refferal of infants with sickle cell disease for care [ Time Frame: 12 months ]

Central Contacts

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