Point of Care Early Infant Diagnosis Patient Impact Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1752 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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POC EID

Point of Care Early Infant Diagnosis qualitative technologies (Alere q) will be implemented. Sample collection and testing will happen in the same location within the health care facility.

POC EID

Intervention Type DEVICE

Laboratory-based testing

Conventional laboratory-based testing using the Abbott m2000 technology will continue to be used per standard of care in Malawi. Dried blood spot samples will be collected at health care facilities and transported within the national network to centralized laboratories for testing.

No interventions assigned to this group

Interventions

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POC EID

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Younger than 12 months of age
* Clinical or other indication for an EID test (screen or confirmation), such as birth to an HIV-positive mother

Exclusion Criteria

* Older than 12 months of age
* Serious medical conditions which would make testing dangerous for the infant, or disrupt the accuracy of normal laboratory analysis and its interpretation
* Already initiated ART

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes