Uganda Sickle Surveillance Study (US-3)

NCT06301893 | Recruiting

• 1 other identifier: US-3_Uganda (IRB#2013-4576)
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 4

Brief Summary

It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of HbSS and HbA

  Incidence of sickle cell disease (HbSS) and sickle cell trait (HbA)

  February 2014 to March 2015

Secondary Outcomes (1)

• Incidence of HbSS and HbA

  March 2015 - March 2030

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All Dried Blood Spot (DBS) samples collected from HIV exposed infants from all districts of Uganda from approximately February 2014 to March 2015 will be included in the primary analysis. Up to 1,000,000 additional samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings.

You may qualify if:

• Up to 1,000,000 samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings.

You may not qualify if:

• Repeat samples on the same individuals during the study period will be excluded.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Makerere University: collaborator
• Ministry of Health, Uganda: collaborator
• Mulago Hospital, Uganda: collaborator

Study Sites (4)

Makerere University

Kampala, Uganda

RECRUITING

Minister of Health

Kampala, Uganda

RECRUITING

National Coordinator EID Program

Kampala, Uganda

RECRUITING

Sickle Cell Clinic Department of Pediatrics & Child Health Mulago Hospital

Kampala, Uganda

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Perkin Elmer instrumentation is used for standardized isoelectric focusing tests using dried blood spots, followed by chemical elution of hemoglobin and electrophoresis using pre-cast gels. Newborn sickle genotype results with normal hemoglobin (HbA) and sickle hemoglobin (HbS) are typically FA, FAS, or FS although other variants including HbC may be detected. Calls will be made on each sample by trained technicians but also reviewed by supervisory personnel. Demographic information will be entered directly into a web-based electronic data capture system.

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

Study Officials

• Russell Ware, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Grace Ndeezi, MBChB, MMed, PhD

  Department of Pediatrics & Child Health College of Health Sciences Makerere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Latham, MA

CONTACT

5138037922; teresa.latham@cchmc.org

Wendi Long

CONTACT

wendi.long@cchmc.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: September 7, 2013
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

UG (4)