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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out