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Studies

Observational Recruiting

NCT06267508 on ClinicalTrials.gov

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

  • Sponsor: Michael Hoelscher
  • Collaborators: National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC), Instituto Nacional de Saúde (INS), Ministério da Saúde, University of Liverpool
  • Enrollment: 6000 (Estimated)
  • Study start: 2024-04-30 (Actual)
  • Primary completion: 2025-12-01 (Estimated)
  • Study completion: 2025-12-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief 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

Intervention / Treatment

  • Procedure: Maternal HIV viral load testing at delivery for VHT risk assessment

Primary Outcome Measures

  • Proportion of HIV-exposed infants correctly identified as low- or high-risk and receiving birth EID testing and ePNP or ART as appropriate within 7 days of life (7 days)
    All infants enrolled in the study: 1) assessed for high-risk criteria for VHT at birth, 2) if high-risk, receiving enhanced post-natal prophylaxis (ePNP) and PoC birth EID testing, AND 3) if HIV-positive, initiated on ART

Countries

Mozambique, Tanzania

Locations and Investigators

  • Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde,, Beira, Mozambique (Recruiting)
  • National Institute for Medical Research (NIMR), Mbeya, Tanzania (Recruiting)
    • Issa Sabi, MD, PhD