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

ConditionSickle Cell Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMakerere University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Decline of inability to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

Sickle Cell Disease screening information management and communication system
Other intervention
Mobile Health information managment system

Treatment groups

24,000 Participants

are divided into 2 treatment groups

Group A: Traditional centralised testing to point of care testingPlacebo comparator 1 intervention

Group B: Information management and communication systemActive comparator 1 intervention

Trial outcomes

Primary outcomes

Improved number and timeliness of refferal of infants with sickle cell disease for care

proportion with positive sickle cell disease screen recievign conformatory SCD test,penicillin , hydroxyurea

Time frame

12 months

Ajusted Mortality Rate of children with sickle cell disease

Evaluate the impact of the SCD SIMCS on access to screening.

Time frame

18 months

Sponsors and contacts

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Makerere University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

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