HIV Point-of-Care Test Evaluation in Infants (BABY)
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|ClinicalTrials.gov Identifier: NCT02545296|
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: In-vitro Diagnostics||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||604 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||August 2017|
All infants are recruited into the same arm.
Other: In-vitro Diagnostics
Ex-vivo performed diagnostic blood based test.
- Specificity of PoC HIV test [ Time Frame: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID ]Specificity of the PoC HIV test
- Sensitivity of PoC HIV test [ Time Frame: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID ]Sensitivity of the PoC HIV test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545296
|NIMR - Mbeya Medical Research Centre|
|Study Director:||Michael Hoelscher, Prof Dr||Medical Centre of the University of Munich|