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
N/A
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 research aims to improve HIV healthcare for mothers living with HIV and their newborns in Tanzania and Mozambique, focusing on preventing HIV transmission from mother to child. The study evaluates whether adding maternal HIV viral load testing at delivery better identifies mother-child pairs at high risk of transmission and whether high-risk infants receive appropriate prevention and care. It builds on previous findings about early infant HIV treatment challenges and seeks to reduce access inequities in rural areas by expanding HIV testing services through a hub-and-spoke referral system. The study involves maternal HIV viral load testing at delivery to assess vertical HIV transmission risk, combined with WHO clinical criteria for risk classification. The intervention includes personnel support for managing high-risk cases, eHealth tools for sharing test results between health facilities, and enhanced counseling for high-risk mother-baby pairs. High-risk infants and their mothers are followed long-term for up to 12 months to monitor health outcomes and treatment adherence. Participants will undergo HIV testing at birth and follow-up visits at 4-6 weeks, 14 weeks, 6 months, and 12 months, with assessments of viral suppression, drug resistance, and clinical outcomes. The study also collects socio-behavioral data through interviews and questionnaires to understand factors affecting treatment outcomes. Researchers will measure key program indicators such as the proportion of high-risk newborns tested and started on treatment within seven days, turnaround times for testing, and cost-effectiveness of the intervention package. Continuous support and counseling are provided throughout the study duration.
CONDITIONS
Brief 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 participation
- Voluntary and informed consent of the legal guardian for the child's participation
- Mothers or legal guardians aged 18 years or older
- Documented maternal HIV infection
- Willingness to consent to HIV testing for the mother and/or child
- Willingness to consent to active tracing including home tracing
You will not qualify if you...
- Mother has a condition that makes participation or understanding study information difficult
- Delivery occurred more than 72 hours (3 days) ago
- Prisoners
- Women with emergencies needing immediate medical care at inclusion
- Stillbirths
- Infant requiring emergency care or born with severe malformation
- Investigator judges participation may add unacceptable risk or burden (e.g., very low birth weight under 1500g)
- Unlikely to comply with study protocol as judged by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 weeks
Participants who undergo routine care are observed with maternal HIV viral load testing at delivery to assess risk of vertical HIV transmission. Results are used to guide risk-based infant HIV testing and care. Enhanced counselling services are provided to high-risk mother-baby pairs.
Visits at birth, 4-6 weeks, and 14 weeks for testing and follow-up
Duration - Up to 12 months
HIV-positive infants and their mothers receive long-term follow-up to observe health outcomes, treatment adherence, viral suppression, and socio-behavioural factors influencing infant HIV treatment.
Regular visits for up to 12 months depending on infant HIV status
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
A
Amy Heilman
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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