Uganda Sickle Surveillance Study (US-3)

Sickle Cell Disease Clinical Trial

Official title:

Prevalence and Mapping of Sickle Cell Trait and Disease in Uganda

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301893
• Other study ID #: US-3_Uganda (IRB#2013-4576)
• Status: Recruiting
• Start date: September 7, 2013
• Est. completion date: December 31, 2032

Study information

• Verified date: February 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Teresa Latham, MA
• Phone: 5138037922
• Email: teresa.latham[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000000
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
Uganda	Makerere University	Kampala
Uganda	Minister of Health	Kampala
Uganda	National Coordinator EID Program	Kampala
Uganda	Sickle Cell Clinic Department of Pediatrics & Child Health Mulago Hospital	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Makerere University, Ministry of Health, Uganda, Mulago Hospital, Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of HbSS and HbA	Incidence of sickle cell disease (HbSS) and sickle cell trait (HbA)	February 2014 to March 2015
Secondary	Incidence of HbSS and HbA	Incidence of sickle cell disease (HbSS) and sickle cell trait (HbA)	March 2015 - March 2030