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

Part of paid clinical trials in Houston, Texas.

Sponsor
Makerere University
Study ID
NCT06563440
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 5 Years
Healthy Volunteers
Accepted

Interventions

  • Digital app and information system — OTHER
    A custom digital app and information system that consists of four modules: (1) ID module - captures child's demographic and biometric data and builds a printable QR-code; (2) Assay module - captures point of care test image, interprets, and transmits results to the central ministry of health data center; (3) Education module - stores and plays back short educational videos for pre- and post-screening counseling; (4) SCD e-Passport module - entry and display of child's salient clinical information.

Study Details

Although over 75% of children with sickle cell disease (SCD) are born in sub-Sahara where the disease highly contributes to under-5 mortality and causes life-long debilitation, evidence-based strategies to control SCD are not widely implemented in this region. Early detection of SCD by universal infant screening is a pillar of SCD control. Despite the affordability and move to adopt point-of-care (POC) SCD screening assays in sub-Sahara Africa, the absence of screening information management and communication systems (SIMCS) impedes standardized, systematic, coordinated, nationwide SCD screening programs. The long-term goal of the proposed research is to develop a SCD SIMCS that will enable universal SCD screening in the sub-Sahara African setting. The objective is to test and optimize a custom SCD SIMCS app and digital network to facilitate SCD screening and then evaluate its impact on access to SCD screening and care and on clinical outcomes of children with SCD in Uganda. The central hypothesis is that the SCD SIMCS will facilitate accurate and coordinated POC SCD screening that is accessible at health centers in urban and rural Uganda. The rationale is to build a custom SCD SIMCS on existing nationwide digital and health infrastructure in Uganda to standardize use of affordable POC assays at health centers nationwide. The central hypothesis will be tested by pursuing two specific aims: 1) Develop and evaluate a four-module ≥3G cell phone app for a novel SCD SIMCS (R21 Phase); 2) Evaluate the impact of the SCD SIMCS on access to screening and care and outcomes of children with SCD (R33 Phase). The investigators will pursue these aims using an innovative combination of software design and re-organization of SCD screening workflows. These include assembly of off-the-shelf software that is compatible with iOS and Android operating systems to reliably, accurately, and handily capture, interpret, transmit, and retrieve/playback information for patient's IDs, test results, salient clinical events, and education. The novel screening workflows are expected to dramatically reduce the cost and increase access to SCD screening and care. The proposed research is significant, because it will determine how to use POC SCD screening assays on a large nationwide scale. It will also enable coordination of evidence-based care and continuity of care between primary and specialist providers and longitudinally over the patient's lifetime - a critical aspect in controlling this life-long disease. The SCD SIMCS will also facilitate real time data management for research and policy for SCD control. The expected immediate outcome of this research is a SCD SIMCS that optimally functions on the digital and health infrastructure in Uganda and demonstration of its impact on access to SCD screening and care and on clinical outcomes of children with SCD. The expected long-term outcome is that the SCD SIMCS will be adopted, integrated, and scaled-up in the health systems of Uganda and other sub-Sahara Africa countries, particularly those where the POC assays have already been adopted as the national standard of SCD screening. If effective, the SCD SIMCS will have an important positive impact because it will reduce the cost of SCD screening, take screening services and evidence-based care closer to rural communities where the majority of children in sub-Sahara Africa live, and, ultimately, save millions of children from preventable and disability death.

Key Dates

Start date
Aug 21, 2024
Status verified
Aug 2024
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

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

Arms

  • Experimental: App/digital system
    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.
  • Active Comparator: No App/digital system
    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.

Primary Outcome Measure

Access to sickle cell disease screening and care [ Time Frame: One month from screening for sickle cell disease ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Sickle cell disease
By research site
Baylor College of Medicine· Houston, TX

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