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

NCT07610239 | Recruiting DMC

• 1 other identifier: Mak-SOMREC-2025-2124
• Study Type: interventional
• Target: 24,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (2)

• 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

  12 months

• Ajusted Mortality Rate of children with sickle cell disease

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

  18 months

Study Arms (2)

Traditional centralised testing to point of care testing

PLACEBO COMPARATOR

Routine new born screening strategy in health care centres in Uganda

Other: Sickle Cell Disease screening information management and communication system

Information management and communication system

ACTIVE COMPARATOR

Mobile Information Managment system

Other: Sickle Cell Disease screening information management and communication system

Interventions

Sickle Cell Disease screening information management and communication system OTHER

Mobile Health information managment system

Information management and communication system; Traditional centralised testing to point of care testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Providers of child health and maternity services at selected hospitals Infants born or attending child health and maternity services at selected hospitals . Infants are the targeted age-group in this study because this is the ideal age to screen for SCD and prevent complications and mortality that generally occurs early, by 5 years old. The infants will be recruited at birth or at vaccination visits

You may not qualify if:

• Decline of inability to provide informed consent

Sponsors & Collaborators

• Makerere University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Nalufenya Childrens

Jinja, Uganda

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mwanje Kavuma Mwanje

CONTACT

+256783132151; mwanjemobo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

UG (1)