HIV Point-of-Care Test Evaluation in Infants

NCT02545296 | Completed DMC

• 1 other identifier: LMU-IMPH-BABY-01
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

In-vitro Diagnostics; paediatrics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

In-vitro Diagnostics

OTHER

All infants are recruited into the same arm.

Other: In-vitro Diagnostics

Interventions

In-vitro Diagnostics OTHER

Ex-vivo performed diagnostic blood based test.

In-vitro Diagnostics

Eligibility Criteria

• Age: 1 Minute - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Michael Hoelscher: lead
• German Center for Infection Research: collaborator

Study Sites (1)

NIMR - Mbeya Medical Research Centre

Mbeya, Tanzania

Location

Related Publications (1)

• Sabi I, Mahiga H, Mgaya J, Geisenberger O, Kastner S, Olomi W, Saathoff E, Njovu L, Lueer C, France J, Maboko L, Ntinginya NE, Hoelscher M, Kroidl A. Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus-exposed Neonates in Tanzania. Clin Infect Dis. 2019 Feb 1;68(4):615-622. doi: 10.1093/cid/ciy538.

  PMID: 29961841 DERIVED

Study Officials

• Michael Hoelscher, Prof Dr

  Medical Centre of the University of Munich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: September 9, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: August 1, 2017
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

TA (1)