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.
Voluntary and informed consent of the mother for her own study participation (if applicable);
Voluntary and informed consent of the legal guardian of the child for participation of the child in the study;
Mothers/legal guardians ≥18 years of age;
Documented maternal HIV infection;
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.
Having delivered more than 72h (3 days) ago;
Prisoners;
Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion;
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.
Cohort
Prospective
Maternal HIV viral load testing at delivery for VHT risk assessment
Procedure/SurgeryMaternal 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
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
Proportion and rate of VHT at birth, week 4-8, and week 14
Risk-factors associated with VHT
Demographic, socio-economic, and behavioral data collected from mothers
Adherence to PNP and ePNP
Hub-and-spoke model and provider satisfaction (health care personnel, focal point persons, counsellor)
Socio-behavioural and personal aspects related to high-risk criteria for mother-child pairs (adherence, retention, disclosure, emotional well-being and health care satisfaction)
Descriptions of tasks, functions, acceptability, challenge and workloads related to PVHT and neonatal HIV focal persons
Descriptions of tasks, functions, acceptability, challenge and workloads related to counsellors (enhanced high-risk counselling)
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Michael Hoelscher
Lead sponsor
Ludwig-Maximilians - University of Munich
Sponsor institution
National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC)
Collaborator
Instituto Nacional de Saúde (INS), Ministério da Saúde
Collaborator
University of Liverpool
Collaborator