NCT02545296

HIV Point-of-Care Test Evaluation in Infants

HIV Point-of-Care Tests in Babies Study (BABY) - Operational Evaluation of HIV Point-of-Care Tests for Very Early Infant HIV Diagnostics in Infants Born to HIV Infected Mothers in Mbeya, Tanzania

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: Michael Hoelscher · Academic / Other
• Sex: All
• Age: 1 Minute – 48 Hours
• Healthy volunteers: Accepted

Summary

HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania.

Detailed description

This in-vitro diagnostic (IVD) study in infants born to HIV infected mothers evaluates the reliability and operational feasibility of an HIV Point-of-Care (PoC) test for HIV early infant diagnosis (EID) in a public health setting at obstetric clinics in Mbeya, Tanzania. Recruitment is planned to take place at 4 obstetric/maternity study sites in and around Mbeya over a time period of 12 months. The HIV PoC test will be validated against the Standard-of-Care diagnostic test, i.e. Dried Blood Spot (DBS) analyses. The PoC test under investigation is the Xpert HIV-1 Qual produced by Cepheid, Sunnyvale, USA.

Conditions

• HIV

Interventions

Type	Name	Description
OTHER	In-vitro Diagnostics	Ex-vivo performed diagnostic blood based test.

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-10-01
• Completion: 2017-08-01
• First posted: 2015-09-09
• Last updated: 2018-03-07

Locations

1 site across 1 country: Tanzania