nctId: NCT06267508 id: LMU-IMPH-LIFE2Scale briefTitle: Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment acronym: LIFE2Scale overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-02-20 date: 2024-02-20 name: Michael Hoelscher class: OTHER name: National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC) name: Instituto Nacional de Saúde (INS), Ministério da Saúde name: University of Liverpool briefSummary: 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. conditions: Vertical Human Immunodeficiency Virus Transmission conditions: HIV Infection Pediatric conditions: Infant Death conditions: Infant Morbidity conditions: Infant, Newborn, Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED name: Maternal HIV viral load testing at delivery for VHT risk assessment measure: Proportion of HIV-exposed infants correctly identified as low- or high-risk and receiving birth EID testing and ePNP or ART as appropriate within 7 days of life measure: Turnaround times for EID testing at birth, 4-6 weeks, and 14 weeks (time from sample collection to receipt of results by the health facility and communication of results to the mother/caregiver) and maternal PoC VL testing at delivery and 14 weeks measure: Proportion and rate of VHT at birth, week 4-8, and week 14 measure: Risk-factors associated with VHT measure: Adherence to PNP and ePNP measure: Proportion and rate of clinical endpoints (mortality, morbidity) among HIV-positive infants at week 14, month 6, and month 12 measure: Age at ART initiation among HIV-positive infants measure: Risk factors for poor ART adherence among high-risk mothers and infants measure: Proportion of HIV-positive infants virally suppressed at week 14, month 6, and month 12 measure: Risk factors for poor viral suppression among HIV-positive infants measure: Proportion of HIV-positive infants on ART that experience grade III or greater laboratory ART toxicity measure: Retention to HIV EID and infant health care services measure: Proportion of pregnant women presenting with criteria considered high-risk for VHT at delivery measure: Proportion of mothers virally suppressed at week 14 post-partum measure: Proportion and rate of post-partum mothers newly fulfilling high-risk criteria based on socio-behavioural criteria (i.e., adherence issues) measure: Characteristics of transmitted viral strains (lineages, subtypes, resistance mutations) among HIV-positive infants and in comparison to their mothers viral sequences measure: Proportion of HIV-positive infants who develop acquired drug resistance mutations during the study measure: Characteristics of infant and maternal HIV strains to be neutralized against a panel of known broadly neutralizing antibody candidates (e.g., VRC07, 10-1074) and maternal autologous antibodies at time of transmission measure: Average public healthcare and healthcare-related expenditures measure: Average health worker time needed to care for mothers and infants per clinic visit, including for enhanced counselling sessions measure: Cost per HIV-exposed infant fulfilling the primary outcome measure: Empirical cost-effectiveness (incremental cost-effectiveness ratio) relating intervention costs to life-years saved among HIV-positive infants measure: Average global and dimensional patient satisfaction measure: Hub-and-spoke model and provider satisfaction (health care personnel, focal point persons, counsellor) measure: Socio-behavioural and personal aspects related to high-risk criteria for mother-child pairs (adherence, retention, disclosure, emotional well-being and health care satisfaction) measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to PVHT and neonatal HIV focal persons measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to counsellors (enhanced high-risk counselling) measure: Description on eHealth functionality, satisfaction, acceptance of linkage procedures sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde, city: Beira country: Mozambique name: Joaquim Lequechane role: CONTACT name: Ilesh Jani, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: -19.84361 lon: 34.83889 facility: National Institute for Medical Research (NIMR) city: Mbeya country: Tanzania name: Issa Sabi, MD, PhD role: CONTACT name: Issa Sabi, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: -8.9 lon: 33.45 hasResults: False