Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
Recruiting · NCT06267508 · Observational (researchers observe without assigning treatment) · Lead sponsor: Michael Hoelscher
View the official record on ClinicalTrials.gov →Interventions studied
Maternal HIV viral load testing at delivery for VHT risk assessment
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Stillbirths;
- Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related intensive care, severe jaundice) or born with severe malformation;
- If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g); or
- Unlikely to comply with protocol as judged by the principal investigator or his designate
Where it is running
2 locations listed.
- Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde, - Beira, Mozambique
- National Institute for Medical Research (NIMR) - Mbeya, Mbeya, Tanzania