Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
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.
- EligibilityCriteria: 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 - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Mothers living with HIV presenting for delivery at included health facilities - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Pregnant women living with HIV and their exposed infants recruited at maternity clinics in Mozambique and Tanzania. The investigators expect to recruit 4000-6000 mother-child pairs in 12 months, or 56-71 mother-child pairs per cluster-randomization period (7 weeks) into Cohort A.  Assuming 12-week VHT rates of 2.5% and 1% VHT rates in Mozambique and Tanzania respectively, the investigators expect to roll-over approximately 105 HIV positive infants (75 in Mozambique and 30 in Tanzania) from both countries into Cohort B. - SamplingMethod: Probability Sample