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Point of Care Early Infant Diagnosis Patient Impact Study

NCT02744404 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1752

Last updated 2018-07-27

No results posted yet for this study

Summary

In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories. However, test volumes are growing and many parts of the country do not have close or easy access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are growing numbers of high quality Point-Of-Care (POC) diagnostic technologies available and there is increasing interest in using these technologies to alleviate critical testing needs. This protocol describes an observational study looking at the patient impact of implementing POC EID technologies within the routine standard of care at seven facilities.

Conditions

Interventions

DEVICE

POC EID

Sponsors & Collaborators

  • Ministry of Health, Malawi

    collaborator OTHER_GOV

  • UNICEF

    collaborator OTHER

  • Clinton Health Access Initiative Inc.

    lead OTHER

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

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 NCT02744404 on ClinicalTrials.gov