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Trial record 41 of 633 for:    test AND point-of-care

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
Sponsor:
Collaborator:
German Center for Infection Research
Information provided by (Responsible Party):
Michael Hoelscher, Ludwig-Maximilians - University of Munich

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Other: In-vitro Diagnostics Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
In-vitro Diagnostics
All infants are recruited into the same arm.
Other: In-vitro Diagnostics
Ex-vivo performed diagnostic blood based test.




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Voluntary and informed consent of the mother for her own study participation (if applicable).
  2. Voluntary and informed consent of the legal guardian of the child for participation of the child in the study.
  3. Mothers/legal guardians ≥18 years of age.
  4. Documented maternal HIV infection.
  5. Willingness to consent to HIV testing for the child and herself (if applicable).
  6. Willing to consent to active tracing including home tracing.

Exclusion Criteria:

  1. 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.
  2. Having delivered more than 48h ago
  3. Prisoners
  4. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion.
  5. Stillbirths
  6. Infant requiring emergency care or born with severe malformation.
  7. 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)
  8. Unlikely to comply with protocol as judged by the principal investigator or his designate

Information from the National Library of Medicine

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


Locations
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Tanzania
NIMR - Mbeya Medical Research Centre
Mbeya, Tanzania
Sponsors and Collaborators
Michael Hoelscher
German Center for Infection Research
Investigators
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Study Director: Michael Hoelscher, Prof Dr Medical Centre of the University of Munich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Hoelscher, Prof Dr, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02545296     History of Changes
Other Study ID Numbers: LMU-IMPH-BABY-01
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Michael Hoelscher, Ludwig-Maximilians - University of Munich:
In-vitro Diagnostics
paediatrics