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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

Trial Parameters

Condition Vertical Human Immunodeficiency Virus Transmission
Sponsor Michael Hoelscher
Study Type OBSERVATIONAL
Phase N/A
Enrollment 6,000
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-04-30
Completion 2025-12
Interventions
Maternal HIV viral load testing at delivery for VHT risk assessment

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.

Eligibility Criteria

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 (or just her child); and 6. Willingness to consent to active tracing including home tracing. Exclusion Criteria: 7. 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. 8. Having delivered more than 72h (3 days) ago; 9. Prisoners; 10. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion; 11. Stillbirths; 12. Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related int

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