Point of Care Early Infant Diagnosis Patient Impact Study

Completed

• Conditions: HIV
• Interventions: Device: POC EID

• Registration Number: NCT02744404
• Lead Sponsor: Clinton Health Access Initiative Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1752

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POC EID	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.

Primary Outcome Measures

Name	Time	Method
ART initiation retention	6-9 months	Proportion of HIV-positive infants initiated on anti-retroviral therapy

Secondary Outcome Measures

Name	Time	Method
Test turnaround time	6-9 months	Number of days from testing to result being received by the health care facility
Tests received	6-9 months	Proportion of tests received by the health care facility

Trial Locations

Locations (7)

Nsanama Health Center; 🇲🇼 Nsanama, Malawi

Kamuzu Central Hospital; 🇲🇼 Lilongwe, Malawi

Mzuzu Central Hospital; 🇲🇼 Mzuzu, Malawi

Ntaja Health Center; 🇲🇼 Ntaja, Malawi

Ntcheu District Hospital; 🇲🇼 Ntcheu, Malawi

Migowi Health Center; 🇲🇼 Phalombe, Malawi

Machinga District Hospital; 🇲🇼 Liwonde, Malawi