HIV Point-of-Care Test Evaluation in Infants (BABY)

March 6, 2018 updated by: Michael Hoelscher

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

604

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Mbeya, Tanzania
        • NIMR - Mbeya Medical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 2 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Hoelscher

Collaborators

German Center for Infection Research

Investigators

  • Study Director: Michael Hoelscher, Prof Dr, Medical Centre of the University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LMU-IMPH-BABY-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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