HIV Point-of-Care Test Evaluation in Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Other: In-vitro Diagnostics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary and informed consent of the mother for her own study participation (if applicable). Voluntary and informed consent of the legal guardian of the child for participation of the child in the study. Mothers/legal guardians ≥18 years of age. Documented maternal HIV infection. Willingness to consent to HIV testing for the child and herself (if applicable). Willing to consent to active tracing including home tracing. Exclusion Criteria: Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability. Having delivered more than 48h ago Prisoners Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion. Stillbirths Infant requiring emergency care or born with severe malformation. If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g) Unlikely to comply with protocol as judged by the principal investigator or his designate

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: In-vitro Diagnostics<br>All infants are recruited into the same arm. | Other: In-vitro Diagnostics<br>* Ex-vivo performed diagnostic blood based test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of PoC HIV test | Specificity of the PoC HIV test | 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 PoC HIV test | Sensitivity of the PoC HIV test | Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-vitro Diagnostics, paediatrics