Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID- Long Term Impact on inFant hEalth (LIFE) (LIFE)
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|ClinicalTrials.gov Identifier: NCT04032522|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2019
Last Update Posted : August 8, 2022
|Condition or disease||Intervention/treatment|
|HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC)||Other: point-of care (PoC) neonatal HIV early infant diagnosis (EID)|
|Study Type :||Observational|
|Estimated Enrollment :||6523 participants|
|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|
|Actual Study Start Date :||October 23, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||February 2023|
Intervention Arm (A)
Half of the health facilities will implement the intervention package. All mothers will be tested using PoC-VL at delivery and all HIV-exposed infants will be offered PoC-EID at birth and week 4-8. Newborns found to be HIV-positive will be offered immediate ART. Neonatal ART initiation will be supported at birth by trained nurses/midwives, and approved and supervised by local doctors from the affiliated HIV CTC. Following ART initiation infants will be referred for consolidated ART management to their paediatric HIV clinic following local procedures. Newborns testing HIV-negative will be offered postnatal prophylaxis (PNP) or enhanced postnatal prophylaxis (ePNP), depending on clinical risk factors, the maternal VL and country guidelines. Mothers with HIV-RNA >1000 copies/mL will receive immediate referral information for ART initiation if not on ART or enhanced ART counselling, with follow up virologic testing and switch of ART regimen as applicable at their local HIV clinic.
Other: point-of care (PoC) neonatal HIV early infant diagnosis (EID)
clinical impact of a PoC-EID for infants and neonates at birth and week 4-8 weeks, linked with nurse-supported immediate ART initiation in HIV-infected neonates, versus standard-of-care (SoC)
Control Arm (B)
The other half of the health facilities will implement the standard of care (SoC). Enrolled mothers will not receive immediate PoC VL at delivery, but infants deemed to be at high risk using clinical criteria (e.g. no or late initiation of maternal ART) will be offered ePNP. EID testing will follow the national algorithm with testing at 4-8 weeks, followed by referral for immediate ART initiation for all HIV-infected infants. As PoC EID testing is expected to be nationally implemented on a programme level we will facilitate the availability of PoC testing at these sites.
- clinical impact of a PoC-EID [ Time Frame: Proportion of combined clinical endpoints in HIV-infected infants at months 18 between arms ]The primary objective is to establish the clinical impact of a PoC-EID for infants and neonates at birth and week 4-8 weeks, linked with nurse-supported immediate ART initiation in HIV-infected neonates, versus standard-of-care (SoC) on the primary and secondary endpoints. Combined clinical outcomes will include mortality, morbidity (WHO Stage 2 or above disease, severe infant medical conditions), hospitalization, toxicity (Grade 3 or above laboratory abnormality), poor antiretroviral treatment response (confirmed virological failure, treatment termination or prolonged interruption), or loss to follow up of HIVinfected infants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032522
|Centro de Investigacao Operacional da Beira (CIOB)|
|Beira, Sofala, Mozambique|
|Mbeya Medical Research Centre|
|Study Chair:||Arne Kroidl, Dr. med||Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich|
|Principal Investigator:||Ilesh Jani, Dr., Ph.D.||Instituto Nacional de Saude (INS), Ministério da Saúde, Maputo, Mozambique|
|Principal Investigator:||Issa Sabi, Dr.||NIMR- Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania|