Improving HIV testing and treatment for mothers and newborns in Tanzania and Mozambique

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.