An observational study in Vertical Human Immunodeficiency Virus Transmission, HIV Infection Pediatric and Infant Death, sponsored by Michael Hoelscher. Recruiting at 2 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Michael Hoelscher · Observational
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.
The UN Sustainable Development Goals set the ambitious goal to eliminate new paediatric HIV infections by 2030. Between 2010 and 2020, new HIV infections among children declined by more than 50%. This decline demonstrates the goal is achievable, but the loss of momentum in recent years indicates a need for further improvements. Results from the previous LIFE study conducted in Mozambique and Tanzania demonstrated that identifying HIV-infection in neonates and starting HIV treatment as early as birth is feasible and may reduce infant death and severe disease. However, this study also demonstrated that it is difficult to administer infant HIV treatments due to poor palatability of the infant drug formulation, socio-behavioural constraints for mothers, and care linkage challenges. This resulted in poor treatment adherence and efficacy (as measured by HIV suppression rates in the blood).
The investigators propose to expand and optimize treatment and prevention interventions for mothers living with HIV and their newborns and translate previous research findings into policy and practice, with a focus on primary healthcare to reduce access inequities in rural areas. The study aims to scale-up of tools used for vertical HIV transmission risk screening affiliated with immediate, risk-based HIV test \& treat procedures. Testing for high-risk case detection will be implemented in a hub-and-spoke model, where smaller, less well-equipped health facilities refer samples to nearby larger health facilities for diagnostic testing, ensuring rural communities have access to the interventions. The investigators will also provide personnel support for scale-up of high-risk case detection and high-risk infant care management. Furthermore, all high-risk mother-baby pairs will receive enhanced counselling services. eHealth tools for electronic result sharing across health facilities will be part of our package of interventions.
The investigators will evaluate the impact of the intervention package described above on key prevention of vertical HIV transmission (PVHT) program indicators (e.g., percentage of high-risk newborns immediately tested for HIV, percentage of newborns with HIV immediately started on treatment) in a stepped-wedge, cluster-randomized study. The investigators will also conduct a cost-effectiveness analysis of the intervention package. Furthermore, the investigators will conduct interviews and use self-reported questionnaires by the participants and site staff to better understand the socio-economic and behavioural factors contributing to high-risk classification.
For HIV-positive babies, the investigators will assess the impact of a novel HIV drug used for newborns, i.e. Dolutegravir (DTG), on health outcomes. The investigators will also characterize the impact of transmitted and acquired genotypic drug resistance, as well as transmitted viral strains, towards neutralization against established and novel broadly neutralizing antibodies. This information will be used to inform future prevention and treatment strategies for HIV-exposed newborns.
All mothers of HIV-positive babies taking part in this study will continue to have access to enhanced counselling and care support throughout the study, and the investigators will collect information on socio-behavioural factors influencing treatment outcomes to understand challenges related to infant HIV treatment.
This study will be performed by an established consortium of interdisciplinary African and European experts, closely collaborating with health authorities and policy makers, thus ensuring effective and sustainable implementation, programmatic stewardship, and global access to the proposed complex intervention.
51 studies on the registry are indexed under Infant Death; 15 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 368 across 11 observational studies indexed under Infant Death.
Browse Infant Death studies →Michael Hoelscher is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV-exposed infants and their mothers enrolled in the study
Procedure: Maternal HIV viral load testing at delivery for VHT risk assessment
HIV-positive infants, identified in the first 12 weeks, and their mothers will be rolled over from Cohort A to Cohort B for long-term follow-up for up to 12 months.
Maternal HIV viral load testing will be performed for all mothers enrolled in the study at delivery. Results will be used along with WHO-defined clinical criteria to determine risk status for VHT. The intervention also includes personnel to support the additional testing volume and management of high-risk cases and eHealth solutions for communication of test results between health facilities.
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
All infants enrolled in the study: 1) assessed for high-risk criteria for VHT at birth, 2) if high-risk, receiving enhanced post-natal prophylaxis (ePNP) and PoC birth EID testing, AND 3) if HIV-positive, initiated on ART
Time frame: 7 days
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
Time frame: 14 weeks
Proportion and rate of VHT at birth, week 4-8, and week 14
Time frame: 14 weeks
Risk-factors associated with VHT
Demographic, socio-economic, and behavioral data collected from mothers
Time frame: 14 weeks
Adherence to PNP and ePNP
Time frame: 14 weeks
Proportion and rate of clinical endpoints (mortality, morbidity) among HIV-positive infants at week 14, month 6, and month 12
Time frame: 12 months
Age at ART initiation among HIV-positive infants
Time frame: 12 months
Risk factors for poor ART adherence among high-risk mothers and infants
Time frame: 12 months
Proportion of HIV-positive infants virally suppressed at week 14, month 6, and month 12
Time frame: 12 months
Risk factors for poor viral suppression among HIV-positive infants
Time frame: 12 months
Proportion of HIV-positive infants on ART that experience grade III or greater laboratory ART toxicity
Time frame: 12 months
Retention to HIV EID and infant health care services
Time frame: 14 weeks (Cohort A), 1 year (Cohort B)
Proportion of pregnant women presenting with criteria considered high-risk for VHT at delivery
Time frame: 7 days
Proportion of mothers virally suppressed at week 14 post-partum
Time frame: 14 weeks
Proportion and rate of post-partum mothers newly fulfilling high-risk criteria based on socio-behavioural criteria (i.e., adherence issues)
Time frame: 14 weeks
Characteristics of transmitted viral strains (lineages, subtypes, resistance mutations) among HIV-positive infants and in comparison to their mothers viral sequences
Mother-child comparative genomic analysis and virus quasi-species diversity (major/minor and transmitted strains)
Time frame: 12 months
Proportion of HIV-positive infants who develop acquired drug resistance mutations during the study
Time frame: 12 months
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
Time frame: 12 months
Average public healthcare and healthcare-related expenditures
Time frame: 12 months
Average health worker time needed to care for mothers and infants per clinic visit, including for enhanced counselling sessions
Time frame: 12 months
Cost per HIV-exposed infant fulfilling the primary outcome
Time frame: 12 months
Empirical cost-effectiveness (incremental cost-effectiveness ratio) relating intervention costs to life-years saved among HIV-positive infants
Time frame: 12 months
Average global and dimensional patient satisfaction
Time frame: 14 weeks
Hub-and-spoke model and provider satisfaction (health care personnel, focal point persons, counsellor)
Time frame: 12 months
Socio-behavioural and personal aspects related to high-risk criteria for mother-child pairs (adherence, retention, disclosure, emotional well-being and health care satisfaction)
Time frame: 14 weeks
Descriptions of tasks, functions, acceptability, challenge and workloads related to PVHT and neonatal HIV focal persons
Time frame: 12 months
Descriptions of tasks, functions, acceptability, challenge and workloads related to counsellors (enhanced high-risk counselling)
Time frame: 12 months
Description on eHealth functionality, satisfaction, acceptance of linkage procedures
Time frame: 12 months
Plan to share: No
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Started Apr 2024 (actual). Primary completion is estimated for Dec 2025, 20 months after the start.
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Michael Hoelscher