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Universal Newborn Screening For Sickle Cell Disease In Mozambique

NCT07719972 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6750

Last updated 2026-07-22

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Point-of-care testing (POCT) -Patient participants

Infants will be screened for Sickle Cell Disease using with point-of-care testing (POCT).

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Jane Hankins, MD · St. Jude Children's Research Hospital

  • Ana O. Mocumbi, MD PhD FESC · Eduardo Mondlane University, National Institute of Health, Chronic Disease Determinants Program

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2031-08-31
Completion
2031-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07719972 on ClinicalTrials.gov