RecruitingNCT06267508

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

Sponsor

Michael Hoelscher

Enrollment

6,000 participants

Start Date

Apr 30, 2024

Study Type

OBSERVATIONAL

Conditions

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

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is working to improve HIV testing and treatment for newborns of HIV-positive mothers, to make sure babies who are HIV-positive are found quickly and started on treatment as early as possible. **You may be eligible if...** - You are a mother or legal guardian aged 18 or older - The mother has documented HIV infection - The baby was delivered within the past 72 hours - You are willing to consent to HIV testing for yourself (if applicable) and your child - You are willing to allow the study team to follow up, including home visits if needed **You may NOT be eligible if...** - The mother has a condition making it difficult to participate or understand study information - The baby was delivered more than 72 hours ago - You are currently incarcerated - You are dealing with a medical emergency requiring immediate care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMaternal 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.