NCT06267508Recruiting
Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
Source: ClinicalTrials.gov · Last updated 18 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 6000 (estimated)
- First submitted
- 24 Jan 2024
- Start date
- 30 Apr 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Michael Hoelscher
- Diseases
- HIV
- NCT number
- NCT06267508
What you commit to
- Study type: Observational
- Planned participants: 6000
- From 30 Apr 2024 to the primary completion date, Dec 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- 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;
- Stillbirths;
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde, Coordinator of this site? Confirm its status | Beira | Mozambique | Recruiting |
| National Institute for Medical Research (NIMR) Coordinator of this site? Confirm its status | Mbeya | Tanzania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.