Capturing Spatial Patterns of New M. tuberculosis Infection (CP21)
Sponsor - U. S. National Institutes of Health
Principal Investigators – Charles Bark, MD, MS, CWRU; Noah Kiwanuka, MBChB, MPH, PhD, Uganda-CWRU Research Collaboration; Christopher Whalen, MD, MS, University of Georgia
|Type of Study||Prospective Cohort Study|
|Project Site||Kampala, Uganda|
|Sample Size||1260 total participants 15 years of age to 65 years of age, free of Mtb infection, followed quarterly for up to 2 years for incident tuberculosis infection and/or disease|
2021 - Present
Observational period is 2 years with an overall study duration of 5 years to enroll and follow all participants
Goal of Study:
To identify incident Mtb infections in a prospective community cohort study of HIV+ and HIV- adults in Kampala, Uganda. GPS tracking technology will be used to trace and longitudinally map subjects to locate areas of high Mtb transmission.
We will perform a prospective cohort study of 1260 adults from the Kawempe and Rubaga divisions of Kampala, Uganda, without evidence for previous infection with Mtb, to estimate the incidence of Mtb infection. Eligible residents who are between the ages of 15 and 65 years will be enrolled following informed consent. Study participants will be evaluated at baseline then followed quarterly for up to 2 years. During the quarterly visits, participants will complete questionnaires regarding exposure to TB, mobility and mixing patterns, and will give a blood sample to test for HIV infection and for immunologic analysis. To elucidate the mobility and mixing patterns of participants and exposure in high-risk settings, we will use Global Positioning Systems (GPS) to continually collect geographical positions via a wearable watch device.
The primary outcome will be incident Mtb infection. Incident infection will be defined as the conversion of either the IGRA or TST (or both) from negative to positive OR the development of TB disease (indicating recent infection with progression to disease). To assess incident infection, each participant will be tested with IGRA at quarterly intervals, and with TST at baseline, 12 months and at the end of study. To assess the concordance between IGRA and TST conversion, TST will be performed among all participants who convert the IGRA from negative to positive. Follow-up of the cohort will continue at quarterly intervals for 24 months
Immunology and Epidemiology