Uganda Sickle Surveillance Study (US-3)

NCT ID: NCT06301893

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-07
• Study Completion Date: 2032-12-31

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.

Detailed Description

The investigators propose a cross-sectional study of sickle cell trait (SCT) and disease in all districts of Uganda using dried blood spots (DBS) collected from HIV exposed babies over a 12-month period. About 90,000 DBS samples collected from HIV exposed children from all districts of Uganda from February 2014 to March 2015 will be analyzed. Follow-up analysis will occur on up to 1,000,000 samples collected during 2015 - 2030 based on surveillance findings and secondary objectives. The study will be conducted at the Central Public Health (CPHL) in Kampala where the samples from across the country are collected for PCR testing. The investigators will perform hemoglobin analysis using isoelectric focusing (IEF). The overall prevalence and the prevalence by district of SCT and SCD will be determined. Geospatial mapping will be performed using a specialized software program to produce a map illustrating the prevalence of SCT and SCD throughout the country and allow associations between sickle cell trait/disease with either malaria prevalence or HIV co-morbidity. Further analysis of sickle cell disease or hemoglobin variants will be conducted using HPLC and DNA-based techniques.

Conditions

Sickle Cell Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makerere University

OTHER

Sponsor Role: collaborator

Ministry of Health, Uganda

OTHER_GOV

Sponsor Role: collaborator

Mulago Hospital, Uganda

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Ware, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Grace Ndeezi, MBChB, MMed, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Makerere University

Kampala, , Uganda

Site Status: RECRUITING

Minister of Health

Kampala, , Uganda

Site Status: RECRUITING

National Coordinator EID Program

Kampala, , Uganda

Site Status: RECRUITING

Sickle Cell Clinic Department of Pediatrics & Child Health Mulago Hospital

Kampala, , Uganda

Site Status: RECRUITING

Countries

Uganda

Central Contacts

Teresa Latham, MA

Role: CONTACT

teresa.latham@cchmc.org

5138037922

Wendi Long

Role: CONTACT

wendi.long@cchmc.org

Facility Contacts

Grace Ndeezi, MBChB, MMed, PhD

Role: primary

Jane R. Aceng, MD

Role: primary

Charles Kiyaga, MBLSM

Role: primary

Deogratias Manube, MBChB, MMed

Role: primary

Other Identifiers

US-3_Uganda (IRB#2013-4576)

Identifier Type: -

Identifier Source: org_study_id