NCT07719972

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,750

participants targeted

Target at P75+ for not_applicable

Timeline
61mo left

Started Aug 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

5 years

First QC Date

July 17, 2026

Last Update Submit

July 17, 2026

Conditions

Sickle Cell Disease

Keywords

MozambiquePatient participantsHealthy control participantsHealth facility staff participantsSupply chain expert participantsNational public health system expert participants

Outcome Measures

Primary Outcomes (2)

  • Percentage of eligible population screened for Sickle Cell Disease

    3 years

  • Percentage of new SCD cases linked to care

    3 years

Secondary Outcomes (9)

  • Comparison of under-2 mortality between participants with SCD whom received longitudinal care and participants who screened negative for SCD

    2 years post-screening and therapy

  • Percentage of SCD cases retained in care by 2 years of age

    2 years post-screening and therapy

  • Percentage of eligible secondary-level clinical wards implementing systematic screening and linkage to longitudinal care for new SCD cases

    3 years

  • Percentage of eligible health facility staff participants in secondary-level clinical wards implementing systematic screening and linkage to longitudinal care for new SCD cases

    3 years

  • Comparison of SCD Screening Performance Results from Initial point-of-care (POCT), Gazelle, and Hemoglobin Fractionation

    3 years

  • +4 more secondary outcomes

Study Arms (5)

Patient participants

OTHER

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.

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

Healthy control participants

OTHER

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).

Other: Point-of-care testing (POCT) - Healthy control participants

Health facility staff participants

OTHER

Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study.

Other: Context Assessment for Community Health (COACH) surveyOther: Semi-structured interview

Supply chain expert participants

OTHER

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.

Other: Semi-structured interview

National public health system expert participants

OTHER

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.

Other: Semi-structured interview

Interventions

Point-of-care testing (POCT) - Healthy control participantsOTHER

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

Healthy control participants
Semi-structured interviewOTHER

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.

Health facility staff participantsNational public health system expert participantsSupply chain expert participants
Point-of-care testing (POCT) -Patient participantsOTHER

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

Patient participants
Context Assessment for Community Health (COACH) surveyOTHER

The COACH survey will collect quantitative data on eight contextual factors that impact a site's ability to implement evidence-based interventions.

Health facility staff participants

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Children participants:
  • 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
  • Healthy control participants:
  • 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.
  • Health facility staff participants: none.
  • Supply chain expert participants: none.
  • National public health system expert participants: none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Point-of-Care TestingPublic HealthSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Point-of-Care SystemsPatient Care ManagementHealth Services AdministrationHealthPopulation CharacteristicsEnvironment and Public HealthData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Jane Hankins, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

  • Ana O. Mocumbi, MD PhD FESC

    Eduardo Mondlane University, National Institute of Health, Chronic Disease Determinants Program

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Hankins, MD

CONTACT

888-226-4343referralinfo@stjude.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 22, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2031

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share