← Back to Search

Information Management System

Digital App for Sickle Cell Disease Screening (SIMCS SCD Trial)

N/A
Waitlist Available
Research Sponsored by Makerere University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years from diagnosis of sickle cell disease
Awards & highlights

Summary

"This trial aims to develop a system that will make it easier to screen children in Africa for sickle cell disease. The system will use a mobile app and digital network to improve access to screening and care

Who is the study for?
This trial is for infants in sub-Saharan Africa, specifically Uganda, to improve early detection and management of Sickle Cell Disease (SCD). It aims to integrate a digital app and information system into existing healthcare infrastructure.
What is being tested?
The trial is testing a custom mobile app designed for managing SCD screening data. The goal is to evaluate how this digital system affects access to screening services, continuity of care, and clinical outcomes for children with SCD.
What are the potential side effects?
Since the intervention involves a digital app rather than medication or medical procedures, traditional side effects are not applicable. However, there may be technical issues or challenges in integrating the technology into current health systems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Access to sickle cell disease screening and care
Secondary study objectives
Access to evidence-based care for sickle cell disease
Cost of sickle cell disease screening
Impact of a coordinated screening and treatment program

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: App/digital systemExperimental Treatment1 Intervention
Experimental Hospital/HCs will be provided with point of care test kits and smart phones loaded with airtime credit and the SCD SIMCS app. The health workers that normally provide pediatric care at the facilities will be trained in using the kits and SCD SIMCS app. Outcome measures to compare the effectiveness of SCD screening with and without the SIMCS will include proportions of accurately interpreted assay results, parents that receive counseling, infants seen for SCD care within 1 month of screening, and infants on penicillin. Variables to compute these outcome measures will be entered into cellphone eCRFs (Controls) or automatically transmitted from the SCD SIMCS App (Experimental) and retrieved from the SCD SIMCS database. Chi-squared test and contingent 95% confidence intervals and p-values will be computed to compare the proportions between SIMCS vs. non-SIMCS hospital/HCs.
Group II: No App/digital systemActive Control1 Intervention
Control Hospital/HCs will be provided with point of care test kits and smart phones loaded with airtime credit BUT no SCD SIMCS app. The health workers that normally provide pediatric care at the facilities will be trained in using the kits. To enable independent verification of the accuracy of interpretation of assay results, health workers will use the smart phones to take and send a photographic caption of every used point of care test strip to a designated central study phone from which they will be downloaded into a computer database. Control infants will be IDed by study number in the SCD SIMCS database.

Find a Location

Who is running the clinical trial?

Ministry of Health, UgandaOTHER_GOV
34 Previous Clinical Trials
1,337,831 Total Patients Enrolled
Makerere UniversityLead Sponsor
283 Previous Clinical Trials
1,879,817 Total Patients Enrolled
Baylor College of MedicineOTHER
1,018 Previous Clinical Trials
6,007,429 Total Patients Enrolled
~16000 spots leftby Jul 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top