Actively Recruiting
Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
Led by Michael Hoelscher · Updated on 2024-11-18
6000
Participants Needed
2
Research Sites
82 weeks
Total Duration
On this page
Sponsors
M
Michael Hoelscher
Lead Sponsor
N
National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary and informed consent of the mother for her own study participation (if applicable)
- Voluntary and informed consent of the legal guardian of the child for participation of the child in the study
- Mothers/legal guardians 8 years of age
- Documented maternal HIV infection
- Willingness to consent to HIV testing for the child and herself (or just her child)
- Willingness to consent to active tracing including home tracing
You will not qualify if you...
- Deficiency in the mother, making it difficult or impossible for her or her infant to participate or understand study information
- Delivered more than 72 hours (3 days) ago
- Prisoners
- Women with emergencies requiring immediate medical assistance that are unresolved at study inclusion
- Stillbirths
- Infant needing emergency care or born with severe malformation
- Investigator judgment that study participation adds unacceptable risk or burden (e.g. significant congenital malformation, very low birth weight under 1500g)
- Unlikely to comply with study protocol as judged by the principal investigator or designate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde,
Beira, Mozambique
Actively Recruiting
2
National Institute for Medical Research (NIMR)
Mbeya, Mbeya, Tanzania
Actively Recruiting
Research Team
A
Arne Kroidl, MD
CONTACT
A
Amy Heilman
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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