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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 ≥18 years of age;

• Documented maternal HIV infection;

• Willingness to consent to HIV testing for the child and herself (or just her child); and

• Willingness to consent to active tracing including home tracing.

Locations
Other Locations
Mozambique
Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde,
RECRUITING
Beira
United Republic of Tanzania
National Institute for Medical Research (NIMR)
RECRUITING
Mbeya
Contact Information
Primary
Arne Kroidl, MD
Arne.Kroidl@med.uni-muenchen.de
+49-89-4400
Backup
Amy Heilman
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2025-12
Participants
Target number of participants: 6000
Treatments
Cohort A
HIV-exposed infants and their mothers enrolled in the study
Cohort B
HIV-positive infants, identified in the first 12 weeks, and their mothers will be rolled over from Cohort A to Cohort B for long-term follow-up for up to 12 months.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC), University of Liverpool, Instituto Nacional de Saúde (INS), Ministério da Saúde
Leads: Michael Hoelscher

This content was sourced from clinicaltrials.gov

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