Improving HIV testing and treatment for mothers and newborns in Tanzania and Mozambique
Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
This study is trying to improve HIV testing and treatment for mothers and their newborns in Tanzania and Mozambique to help prevent the virus from passing from mother to child.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ludwig-Maximilians - University of Munich Academic / other |
| Locations | 2 sites (Beira and 1 other locations) |
| Trial ID | NCT06267508 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. It focuses on improving screening through maternal HIV viral load monitoring at delivery to identify high-risk mother-child pairs for vertical transmission. The study will implement a hub-and-spoke referral system to expand access to HIV testing services in rural areas. By optimizing treatment and prevention interventions, the study seeks to translate previous research findings into effective policy and practice.
Who should consider this trial
Good fit: Ideal candidates include mothers living with HIV who are willing to consent to HIV testing for themselves and their newborns.
Not a fit: Patients who have delivered more than 72 hours ago or those with emergency medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce new pediatric HIV infections and improve health outcomes for infants and mothers.
How similar studies have performed: Previous studies have shown success in identifying and treating HIV in neonates, indicating that this approach has potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntary and informed consent of the mother for her own study participation (if applicable); 2. Voluntary and informed consent of the legal guardian of the child for participation of the child in the study; 3. Mothers/legal guardians ≥18 years of age; 4. Documented maternal HIV infection; 5. Willingness to consent to HIV testing for the child and herself (or just her child); and 6. Willingness to consent to active tracing including home tracing. Exclusion Criteria: 7. 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. 8. Having delivered more than 72h (3 days) ago; 9. Prisoners; 10. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion; 11. Stillbirths; 12. 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; 13. 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 14. Unlikely to comply with protocol as judged by the principal investigator or his designate
Where this trial is running
Beira and 1 other locations
- 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)
Study contacts
- Study coordinator: Arne Kroidl, MD
- Email: Arne.Kroidl@med.uni-muenchen.de
- Phone: +49-89-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.