Not Yet RecruitingNot Applicable

Universal Newborn Screening For Sickle Cell Disease In Mozambique

6,750 participantsStarted 2026-08

Plain-language summary

The overarching goal of this study is to evaluate the feasibility of a new methodology that combines three multi-level implementation strategies to optimize the population-level uptake of essential evidence-based, standard of care treatments for infants with sickle cell disease (SCD) in low-resource settings. The study will be done in Mozambique.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children participants: All infants between birth and 6.0 months of age who are born or receive care at secondary-level facilities involved in the UNIQUE study. * Children participants will fall into one of two categories: * Patient participants: All infants between birth and 6.0 months of age who were screened through the UNIQUE study and tested positive for SCD (HbSS, HbSC, or other form of SCD) or had indeterminate results. * Healthy control participants: Infants between birth and 6.0 months of age who screen negative for SCD (HbAA) through the UNIQUE study or tested positive for sickle cell trait (HbAS). * Health facility staff participants: Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study. * Supply chain expert participants: Administrative professionals with experience working in or around the national supply chain systems in Mozambique to support procurement, importation, customs clearance, storage, and in-country distribution of medical products. * National public health system expert participants: Administrative professionals with experience working in the national public health system (e.g., Ministry of Health, MISAU) who oversee the delivery of health services to infants in-country, such as neonatal testing and vaccination programs. Exclusion Criteria: * Children participants: * Stillbirths. * Children who received an erythrocyte (blood) transfusion within 3 months of testing. Exogen…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is focused on newborn screening in Mozambique and isn't recruiting yet — is this study even relevant to my child's or family's situation, or are there other SCD screening or care programs that would be more appropriate for us right now?
2Since this is a screening and care-linkage study rather than a treatment trial, what would actually happen for a newborn identified with sickle cell disease through this program — what medical care or follow-up would be available in Mozambique once a diagnosis is made?
3The trial is measuring how many newly identified SCD cases get successfully connected to care — what does 'linked to care' actually mean in this context, and does it guarantee access to treatments like hydroxyurea or penicillin prophylaxis that are standard in other settings?
4Because this trial hasn't started recruiting yet, how long might it be before it's actually running, and in the meantime what are the best options available for screening or diagnosing sickle cell disease in a newborn?
5Given that this is a public health screening study rather than a clinical intervention trial, is there any direct medical benefit for the individual child enrolled, or is it primarily designed to improve population-level systems and data?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of eligible population screened for Sickle Cell Disease

Timeframe: 3 years

Percentage of new SCD cases linked to care

Timeframe: 3 years

Trial details

NCT IDNCT07719972

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-08

Contact for this trial

Jane Hankins, MD

888-226-4343 referralinfo@stjude.org

View on ClinicalTrials.gov More Sickle Cell Disease trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.