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RECRUITING
NCT06267508

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

Sponsor: Michael Hoelscher

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

6000

Start Date

2024-04-30

Completion Date

2025-12

Last Updated

2024-11-18

Healthy Volunteers

No

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.

Locations (2)

Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde,

Beira, Mozambique

National Institute for Medical Research (NIMR)

Mbeya, Mbeya, Tanzania