Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment

NCT06267508 | Recruiting

• 1 other identifier: LMU-IMPH-LIFE2Scale
• Study Type: observational
• Target: 6,000
• Locations: 2 countries
• Sites: 2

Brief Summary

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; HIV Infection Pediatric; Infant Death; Infant Morbidity; Infant, Newborn, Diseases

Keywords

Prevention of Vertical HIV Transmission (PVHT); Infant HIV Prophylaxis; Early Infant HIV Diagnosis; Infant Antiretroviral Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  7 days

Secondary Outcomes (22)

• 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

  14 weeks

• Proportion and rate of VHT at birth, week 4-8, and week 14

  14 weeks

• Risk-factors associated with VHT

  14 weeks

• Adherence to PNP and ePNP

  14 weeks

• Proportion and rate of clinical endpoints (mortality, morbidity) among HIV-positive infants at week 14, month 6, and month 12

  12 months

Other Outcomes (5)

• Hub-and-spoke model and provider satisfaction (health care personnel, focal point persons, counsellor)

  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)

  14 weeks

• Descriptions of tasks, functions, acceptability, challenge and workloads related to PVHT and neonatal HIV focal persons

  12 months

Study Arms (2)

Cohort A

HIV-exposed infants and their mothers enrolled in the study

Procedure: Maternal HIV viral load testing at delivery for VHT risk assessment

Cohort B

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.

Interventions

Maternal HIV viral load testing at delivery for VHT risk assessment PROCEDURE

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.

Cohort A

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Mothers living with HIV presenting for delivery at included health facilities
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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;
• Willingness to consent to HIV testing for the child and herself (or just her child); and
• Willingness to consent to active tracing including home tracing.

You may not qualify if:

• 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;
• Stillbirths;
• Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related intensive care, severe jaundice) or born with severe malformation;
• If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g); or
• Unlikely to comply with protocol as judged by the principal investigator or his designate

Sponsors & Collaborators

• Michael Hoelscher: lead
• 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

Study Sites (2)

Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde,

Beira, Mozambique

RECRUITING

National Institute for Medical Research (NIMR)

Mbeya, Mbeya, Tanzania

RECRUITING

MeSH Terms

Conditions

Infant Death; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Arne Kroidl, MD

CONTACT

+49-89-4400; Arne.Kroidl@med.uni-muenchen.de

Amy Heilman

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich,

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 20, 2024
• Study Start: April 30, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1); MO (1)