Clinical trial NCT04032522: Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID- Long Term Impact on inFant hEalth (LIFE)
Official title: Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID - Long Term Impact on inFant hEalth: a Feasibility Study of point-of Care Testing at Birth Versus at 6 Weeks of Age, on the Uptake of ART and Infant Prophylaxis, and on Rates of Infant Survival, Morbidity and Retention in Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC)
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Saúde, Mozambique
name: NIMR- Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania
name: University of Lisbon Instituto Universitário Egas Moniz (IUEM) Lisbon, Portugal
name: Clinton Health Access Initiative Inc.
First posted: 2019-07-25
Enrollment: 6602
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: HIV infected pregnant women and their exposed infants will be recruited at maternity clinics in Mozambique and Tanzania. Assuming a 4% MTCT rate by week 6 and a difference of combined HIV-infected infant endpoints of 14% (Arm A) versus 30% (Arm B) the study target is to enrol at least 224 HIV infected infants (112 per arm) from both countries into the follow-up phase resulting in an overall recruitment number of 6000 mother-child pairs (3000 per arm), including an assumed 5% loss to follow-up. Furthermore, we will enrol 400 HIV-exposed infants from both countries after week 12 into a long-term follow-up phase to investigate MTCT rates and associated MTCT risks until the end of the study period after cessation of breastfeeding.

Brief summary: This study we will evaluate the benefit of HIV testing in neonates born from HIV-infected mothers in Tanzania and Mozambique. The study will use and evaluate novel point-of-care diagnostic systems, that can provide neonatal HIV test results within 2 hours. We will evaluate if HIV testing at birth followed by immediate neonatal HIV treatment initiation will lead to lesser infant's sickness, HIV progression or even death as compared to the current standard procedure which is infant HIV testing at week 6 after delivery. This will be associated with a cost-effectiveness analysis in order to guide national HIV programs for their guidelines. The study will further evaluate if point-of care viral load testing in mothers at birth will identify high-risk scenarios for HIV transmission from the mother to her child. This should lead to enhanced prophylactic treatments in HIV-exposed infants and we hypothesize that PoC VL monitoring at birth leads to lower transmission rates. The study will be performed at 28 maternity health facilities in Tanzania and Mozambique, half of them will be randomized to provide birth HIV PoC infant and maternal viral load testing, the other half will provide the current standard of care (infant HIV testing at week 6, no PoC VL monitoring at birth for the mother). The study is conducted in public health settings, and some study objectives also focus on how successful modern HIV treatments can be provided to infants, if HIV testing and treatment procedures are feasible for nurses and midwives, and if these procedures can be carried out in a timely manner. This study also includes a basic research component that will investigate how HIV spreads in the body of HIV-infected infants, and if early infant HIV diagnosis and treatment can reduce the spread in cells of HIV-infected individuals.


Eligibility criteria: Inclusion Criteria:

1. Voluntary and informed consent of the mother for her own study participation
2. Voluntary and informed consent of the legal guardian of the child for participation of the child in the study.
3. Mothers/legal guardians ≥18 years of age.
4. Documented maternal HIV infection.
5. Willingness to consent to HIV testing for the child and herself.
6. Willingness to consent to active tracing including home tracing.

Exclusion Criteria:

1. 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. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
2. Having delivered more than 72h (3 days) ago
3. Prisoners
4. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion
5. Stillbirths
6. 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.
7. 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)
8. Unlikely to comply with protocol as judged by the principal investigator or his designate

Primary outcomes:
measure: clinical impact of a PoC-EID
timeFrame: Proportion of combined clinical endpoints in HIV-infected infants at months 18 between arms
Secondary outcomes:
Other outcomes:
Locations:
city: Beira
country: Mozambique
facility: Centro de Investigacao Operacional da Beira (CIOB)
state: Sofala
city: Mbeya
country: Tanzania
facility: Mbeya Medical Research Centre
Study officials:
affiliation: Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich
name: Arne Kroidl, Dr. med
role: STUDY_CHAIR
affiliation: Instituto Nacional de Saúde, Mozambique
name: Ilesh Jani, Dr., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NIMR- Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania
name: Issa Sabi, Dr.
role: PRINCIPAL_INVESTIGATOR
References: