Long-term resistance to latent Mycobacterium tuberculosis infection (RV-19)
Information:
Sponsor - U. S. National Institutes of Health
Principal Investigators – W. Henry Boom, MD and Catherine Stein, PhD, CWRU; Harriet Mayanja-Kizza, MBChB, MMed, PhD, Uganda-CWRU Research Collaboration
Type of Study |
Prospective Observational Cohort Study |
Design |
Observational Cohort Study |
Project Site |
Kampala, Uganda |
Population |
Ugandan participants 15 years of age or greater Participants with MTB resistant or stable latent TB infection phenotype HIV-infected and HIV-uninfected participants |
Sample Size |
300 expected to be enrolled |
Study Period |
2019 - Current Participants will “roll-over” to this study, as TB resistant participants and stable LTBI controls are identified Participants will remain on study for approximately 6 years |
Goals:
To enroll and follow healthy participants/household contracts of TB patients identified from our prior and current research studies in Kampala, Uganda. Resister participants are those who have consistently tested negative for Mycobacterium tuberculosis (MTB) infection for more than 24 months. Participants with stable latent MTB infection (LTBI) will serve as controls. Continued follow-up of these cohorts will strengthen the evidence of a “resister” (RSTR) phenotype and a true biological resistance to infection that provides a unique cohort for further studies of Mycobacterium tuberculosis (MTB).
Objectives of Study:
- To maintain contact with, and assess MTB infection status over time in MTB resistant and MTB latently infected participants
- To assess the effects of HIV-infection on the stability of MTB infection status over time
- To explore associations between general health/demographic metrics and long-term stability of MTB resistance in a Ugandan population