Predicting tuberculosis progression in young children with and without HIV

PROgression of Tuberculosis infECTion in young children living with and without HIV: the PROTECT study

['FUNDING_R01'] · UNIVERSITY OF CALIFORNIA-IRVINE · NIH-11488586

This project will look for blood markers that show which young children with or without HIV are most likely to develop active tuberculosis so they can get earlier prevention or treatment.

Quick facts

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorUNIVERSITY OF CALIFORNIA-IRVINE (nih funded)
Locations1 site (IRVINE, UNITED STATES)
Trial IDNIH-11488586 on ClinicalTrials.gov

What this research studies

Researchers will analyze stored blood and other samples from children in Uganda, South Africa, the Gambia, and Vietnam, including samples collected over time from children who later developed TB. They will compare children who stayed healthy to those who progressed to TB to find host immune markers that appear before disease. The team aims to identify a small set of markers that meet WHO accuracy goals and could be turned into a simple point-of-care test. The work includes children with and without HIV to make sure findings apply to those at highest risk.

Who could benefit from this research

Good fit: Ideal candidates are young children—particularly under age 5—who have recent TB exposure or known M. tuberculosis infection, including those living with HIV.

Not a fit: Children without any history of TB exposure or infection and most adults are unlikely to benefit directly from this specific pediatric-focused project.

Why it matters

Potential benefit: If successful, this could help identify high-risk children earlier so they can receive preventive treatment and avoid severe TB or death.

How similar studies have performed: Some adult and older-child biomarker studies have shown promising signals but few have met WHO targets, so a pediatric-focused biomarker approach is relatively novel and needed.

Where this research is happening

IRVINE, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.

View on NIH RePORTER →

Conditions: Acquired Immune Deficiency Syndrome Virus, Acquired Immunodeficiency Syndrome Virus

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.