Sickle Cell DiseaseNCT06301893
Uganda Sickle Surveillance Study (US-3)
An observational study of Sickle Cell Disease, run by Children's Hospital Medical Center, Cincinnati at 4 sites in Uganda.
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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 1,000,000 participants
- Where
- 4 sitesUganda
- Study dates
- 7 Sep 2013to 31 Dec 2032
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Up to 1,000,000 samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings.
Who cannot join
- Repeat samples on the same individuals during the study period will be excluded.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wendi Long contact
Uganda4 sites, 4 recruiting
- Recruiting
Makerere University
Kampala
Grace Ndeezi, MBChB, MMed, PhD
- Recruiting
Minister of Health
Kampala
Jane R. Aceng, MD
- Recruiting
National Coordinator EID Program
Kampala
Charles Kiyaga, MBLSM
Charles Kiyaga, PhD
- Recruiting
Sickle Cell Clinic Department of Pediatrics & Child Health Mulago Hospital
Kampala
Deogratias Manube, MBChB, MMed
About this study
Official title: Prevalence and Mapping of Sickle Cell Trait and Disease in Uganda
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.
Read the 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
- Medical subject headings
- Anemia, Sickle Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HbSS and HbA
Incidence of sickle cell disease (HbSS) and sickle cell trait (HbA)
Measured: February 2014 to March 2015
Secondary outcomes (1)
Incidence of HbSS and HbA
Incidence of sickle cell disease (HbSS) and sickle cell trait (HbA)
Measured: March 2015 - March 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start7 Sep 2013
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000,000 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Ministry of Health, Uganda, Mulago Hospital, Uganda
- Responsible party
- Sponsor
- Investigators
- Russell Ware, MD, PhD, Principal investigator, Children's Hospital Medical Center, CincinnatiGrace Ndeezi, MBChB, MMed, PhD, Principal investigator, Department of Pediatrics & Child Health College of Health Sciences Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301893
- Sponsor's protocol ID
- US-3_Uganda (IRB#2013-4576)
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Mapping of Sickle Cell Trait and Disease in Uganda
- ClinicalTrials.gov ID
- NCT06301893
- Acronym / sponsor ID
- US-3_Uganda (IRB#2013-4576)
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Makerere University, Ministry of Health, Uganda, Mulago Hospital, Uganda
- Study start
- 7 Sep 2013 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Years
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Up to 1,000,000 samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings.
Key exclusion criteria (1 listed)
- Repeat samples on the same individuals during the study period will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of HbSS and HbA
Time frame: February 2014 to March 2015
Incidence of sickle cell disease (HbSS) and sickle cell trait (HbA)
1 secondary outcome
Incidence of HbSS and HbA
Time frame: March 2015 - March 2030
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendi Long contact
Russell Ware, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Grace Ndeezi, MBChB, MMed, PhD principal investigator
Department of Pediatrics & Child Health College of Health Sciences Makerere University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Children's Hospital Medical Center, Cincinnati at 4 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Latham, MA (5138037922, teresa.latham@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HbSS and HbA (time frame: February 2014 to March 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.