protocolSection identificationModule nctId: NCT06267508, orgStudyIdInfo 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Michael Hoelscher, class: OTHER, collaborators name: National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC), collaborators name: Instituto Nacional de Saúde (INS), Ministério da Saúde, collaborators name: University of Liverpool, descriptionModule 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., conditionsModule conditions: Vertical Human Immunodeficiency Virus Transmission, conditions: HIV Infection Pediatric, conditions: Infant Death, conditions: Infant Morbidity, conditions: Infant, Newborn, Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 6000, type: ESTIMATED, armsInterventionsModule interventions name: Maternal HIV viral load testing at delivery for VHT risk assessment, outcomesModule primaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes measure: Proportion and rate of VHT at birth, week 4-8, and week 14, secondaryOutcomes measure: Risk-factors associated with VHT, secondaryOutcomes measure: Adherence to PNP and ePNP, secondaryOutcomes measure: Proportion and rate of clinical endpoints (mortality, morbidity) among HIV-positive infants at week 14, month 6, and month 12, secondaryOutcomes measure: Age at ART initiation among HIV-positive infants, secondaryOutcomes measure: Risk factors for poor ART adherence among high-risk mothers and infants, secondaryOutcomes measure: Proportion of HIV-positive infants virally suppressed at week 14, month 6, and month 12, secondaryOutcomes measure: Risk factors for poor viral suppression among HIV-positive infants, secondaryOutcomes measure: Proportion of HIV-positive infants on ART that experience grade III or greater laboratory ART toxicity, secondaryOutcomes measure: Retention to HIV EID and infant health care services, secondaryOutcomes measure: Proportion of pregnant women presenting with criteria considered high-risk for VHT at delivery, secondaryOutcomes measure: Proportion of mothers virally suppressed at week 14 post-partum, secondaryOutcomes measure: Proportion and rate of post-partum mothers newly fulfilling high-risk criteria based on socio-behavioural criteria (i.e., adherence issues), secondaryOutcomes measure: Characteristics of transmitted viral strains (lineages, subtypes, resistance mutations) among HIV-positive infants and in comparison to their mothers viral sequences, secondaryOutcomes measure: Proportion of HIV-positive infants who develop acquired drug resistance mutations during the study, secondaryOutcomes 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, secondaryOutcomes measure: Average public healthcare and healthcare-related expenditures, secondaryOutcomes measure: Average health worker time needed to care for mothers and infants per clinic visit, including for enhanced counselling sessions, secondaryOutcomes measure: Cost per HIV-exposed infant fulfilling the primary outcome, secondaryOutcomes measure: Empirical cost-effectiveness (incremental cost-effectiveness ratio) relating intervention costs to life-years saved among HIV-positive infants, secondaryOutcomes measure: Average global and dimensional patient satisfaction, otherOutcomes measure: Hub-and-spoke model and provider satisfaction (health care personnel, focal point persons, counsellor), otherOutcomes 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), otherOutcomes measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to PVHT and neonatal HIV focal persons, otherOutcomes measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to counsellors (enhanced high-risk counselling), otherOutcomes measure: Description on eHealth functionality, satisfaction, acceptance of linkage procedures, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde,, city: Beira, country: Mozambique, contacts name: Joaquim Lequechane, role: CONTACT, contacts name: Ilesh Jani, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -19.84361, lon: 34.83889, locations facility: National Institute for Medical Research (NIMR), city: Mbeya, country: Tanzania, contacts name: Issa Sabi, MD, PhD, role: CONTACT, contacts name: Issa Sabi, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -8.9, lon: 33.45, hasResults: False