Sickle Cell DiseaseSMICSNCT07610239
Evaluation of an Information Management and Communication System for Population-wide Point-of-Care Infant Sickle Cell Disease Screening
A study testing Sickle Cell Disease screening information management and communication system in people with Sickle Cell Disease, run by Makerere University at 1 site in Uganda.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Sickle Cell Disease screening information management and communication system
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24,000 participants
- Where
- 1 siteUganda
- Study dates
- 25 Mar 2026to 30 Jun 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Decline of inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
Nalufenya Childrens
Jinja
Emmanuel Tenywa, 0703672573, etenywa81@gmail.com
Ruth Namazzi
About this study
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
Read the detailed description
We will conduct a cluster randomized trial (CRT) of the novel SCD SIMCS and utilize a logical framework of measurable indicators of barriers, utilization, mediating factors, and clinical outcomes of SCD screening and care to evaluate its impact. We will randomize health facilities rather than individual patients because it would be impossible to avoid contamination if we randomized individuals. This design is ideal for evaluating the effectiveness of systems level interventions.
Study procedures Trial Intervention. SCD SIMCS APP, which is an AI-enhanced mobile platform that captures, interprets and relays results of point of care tests for SCD to health care providers and to a centralised public data server at the Uganda Ministry of Health. The SCD SIMCS app prototype consists of four modules: (1) ID module - captures child's demographic and biometric data and builds a printable QR-code; (2) Assay module - captures HemoTypeSCTM and the Sickle Scan TM test image, interprets, and transmits results to the CPHL data centre; (3) Education module - stores and plays back short educational videos for pre- and post-screening counselling; (4) SCD e-Passport module - entry and display of child's longitudinal salient clinical information.
Baseline assessment; following stratified purposive sampling and consent from community leaders, Control and Experimental HCs will undergo baseline evaluation with regards to current resources and childcare visit workflows and the availability of the data sources and measurable indicators of interest. A baseline assessment of resources, workflows, and routine source data collection systems at the centres will facilitate implementation planning for the proposed SCD SIMCS and accurate measurement of its impact on the HCs.
- Conditions
- Sickle Cell Disease
- Being tested
- Sickle Cell Disease screening information management and communication system
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sickle Cell Disease screening information management and communication systemOther
Mobile Health information managment system
| Study group | Role | What they receive |
|---|---|---|
| Traditional centralised testing to point of care testing | Placebo comparator | Routine new born screening strategy in health care centres in Uganda Receives: Other: Sickle Cell Disease screening information management and communication system |
| Information management and communication system | Active comparator | Mobile Information Managment system Receives: Other: Sickle Cell Disease screening information management and communication system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Ajusted Mortality Rate of children with sickle cell disease
Evaluate the impact of the SCD SIMCS on access to screening.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start25 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610239
- Sponsor's protocol ID
- Mak-SOMREC-2025-2124
- Acronym
- SMICS
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Information Management and Communication System for Population-wide Point-of-Care Infant Sickle Cell Disease Screening
- ClinicalTrials.gov ID
- NCT07610239
- Acronym / sponsor ID
- SMICS / Mak-SOMREC-2025-2124
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24,000 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 May 2026 (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.
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
Detailed description
We will conduct a cluster randomized trial (CRT) of the novel SCD SIMCS and utilize a logical framework of measurable indicators of barriers, utilization, mediating factors, and clinical outcomes of SCD screening and care to evaluate its impact. We will randomize health facilities rather than individual patients because it would be impossible to avoid contamination if we randomized individuals. This design is ideal for evaluating the effectiveness of systems level interventions.
Study procedures Trial Intervention. SCD SIMCS APP, which is an AI-enhanced mobile platform that captures, interprets and relays results of point of care tests for SCD to health care providers and to a centralised public data server at the Uganda Ministry of Health. The SCD SIMCS app prototype consists of four modules: (1) ID module - captures child's demographic and biometric data and builds a printable QR-code; (2) Assay module - captures HemoTypeSCTM and the Sickle Scan TM test image, interprets, and transmits results to the CPHL data centre; (3) Education module - stores and plays back short educational videos for pre- and post-screening counselling; (4) SCD e-Passport module - entry and display of child's longitudinal salient clinical information.
Baseline assessment; following stratified purposive sampling and consent from community leaders, Control and Experimental HCs will undergo baseline evaluation with regards to current resources and childcare visit workflows and the availability of the data sources and measurable indicators of interest. A baseline assessment of resources, workflows, and routine source data collection systems at the centres will facilitate implementation planning for the proposed SCD SIMCS and accurate measurement of its impact on the HCs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional centralised testing to point of care testing | Placebo comparator | Other: Sickle Cell Disease screening information management and communication systemRoutine new born screening strategy in health care centres in Uganda |
| Information management and communication system | Active comparator | Other: Sickle Cell Disease screening information management and communication systemMobile Information Managment system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Decline of inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sickle Cell Disease screening information management and communication systemMobile Health information managment system | Other | Information management and communication system, Traditional centralised testing to point of care testing |
Primary outcome
Improved number and timeliness of refferal of infants with sickle cell disease for care
Time frame: 12 months
proportion with positive sickle cell disease screen recievign conformatory SCD test,penicillin , hydroxyurea
Ajusted Mortality Rate of children with sickle cell disease
Time frame: 18 months
Evaluate the impact of the SCD SIMCS on access to screening.
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 27 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sickle Cell Disease screening information management and communication system in people with Sickle Cell Disease, run by Makerere University at 1 site 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Mwanje Kavuma Mwanje (+256783132151, mwanjemobo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved number and timeliness of refferal of infants with sickle cell disease for care (time frame: 12 months). The study lists 2 primary outcomes in all. 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 27 May 2026.