Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment

NCT06267508 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 6000

Last updated 2024-11-18

No results posted yet for this study

Summary

This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.

Conditions

  • Vertical Human Immunodeficiency Virus Transmission
  • HIV Infection Pediatric
  • Infant Death
  • Infant Morbidity
  • Infant, Newborn, Diseases

Interventions

PROCEDURE

Maternal HIV viral load testing at delivery for VHT risk assessment

Maternal HIV viral load testing will be performed for all mothers enrolled in the study at delivery. Results will be used along with WHO-defined clinical criteria to determine risk status for VHT. The intervention also includes personnel to support the additional testing volume and management of high-risk cases and eHealth solutions for communication of test results between health facilities.

Sponsors & Collaborators

  • National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC)

    collaborator UNKNOWN
  • Instituto Nacional de Saúde (INS), Ministério da Saúde

    collaborator UNKNOWN
  • University of Liverpool

    collaborator OTHER
  • Michael Hoelscher

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Mozambique
  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267508 on ClinicalTrials.gov