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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMichael Hoelscher

About this trial

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

Qualifiers

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;

Disqualifiers

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.

Having delivered more than 72h (3 days) ago;

Prisoners;

Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion;

Trial design

Treatments tested in this trial

  • Maternal HIV viral load testing at delivery for VHT risk assessment

Treatment groups

6,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Michael Hoelscher

Lead sponsor

Ludwig-Maximilians - University of Munich

Sponsor institution

National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC)

Collaborator

Instituto Nacional de Saúde (INS), Ministério da Saúde

Collaborator

University of Liverpool

Collaborator