Universal Newborn Screening For Sickle Cell Disease In Mozambique

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSt. Jude Children's Research Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

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.

Disqualifiers

Stillbirths.

Children who received an erythrocyte (blood) transfusion within 3 months of testing. Exogenous (transfused) HbA could artificially lower the sickle hemoglobin concentration, thus causing false-negative results.

Patient participants: none

Stillbirths.

Trial design

Treatments tested in this trial

  • Point-of-care testing (POCT) -Patient participants
  • Point-of-care testing (POCT) - Healthy control participants
  • Context Assessment for Community Health (COACH) survey
  • Semi-structured interview

Treatment groups

6,750 Participants
are divided into 5 treatment groups

Locations

This trial has no locations