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Universal Newborn Screening For Sickle Cell Disease In Mozambique
Sponsor: St. Jude Children's Research Hospital
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
6750
Start Date
2026-08
Completion Date
2031-08
Last Updated
2026-07-22
Healthy Volunteers
Yes
Conditions
Interventions
Point-of-care testing (POCT) -Patient participants
Infants will be screened for Sickle Cell Disease using with point-of-care testing (POCT).
Point-of-care testing (POCT) - Healthy control participants
Infants will be screened for Sickle Cell Disease using with point-of-care testing (POCT) and prospectively monitored for survival.
Context Assessment for Community Health (COACH) survey
The COACH survey will collect quantitative data on eight contextual factors that impact a site's ability to implement evidence-based interventions.
Semi-structured interview
Interview questions will revolve primarily around the current process for SCD screening and care referrals, factors impacting newborn care delivery and screening, and challenges to integrating SCD newborn screening and care referral into standard care delivery.