European and Developing Countries Clinical Trials Partnership1 Jul 2018 - 30 Jun 2021
Mycobacterium tuberculosis Infection Rates Among Health Care WorkerThe dual epidemic of HIV and TB has heightened the risk of TB among health care workers (HCWs) especially in Sub Saharan Africa which bears the highest burden of both diseases. HCWs primarily working in HIV clinics are seemingly at greater risk of M.tb infection as an estimate of 25% of persons living with HIV (PLHIV) will have active TB at initial visit to HIV clinics [1]. This study aims to measure the additional risk of M.tb infection; identify the factors associated with the infection rates among HCWs in HIV care and treatment settings and incorporate the findings in a TB infection control training for the HCWs. Objective(s) 1. To estimate the burden of M.tb infection among HCWs in HIV care and treatment center as measured by QFT-Plus. Secondary Objective(s) 1. To assess if exposure to HIV care and treatment environment is associated with an increased risk of acquiring M.tb infection by comparing M.tb infection rates between HCWs mainly in HIV care and treatment centers and HCWs not working in the HIV care and treatment centers within the same hospital. 2. To identify predictors of M.tb infection among HCWs in HIV care and treatment centers 3. To explore immune correlates or risk/protection among HCWS with QFT conversion 4. To measure the level of TB infection control practices at baseline, month 12 and month 24 among HIV care and treatment centres using standard WHO TB infection control audit tool. 5. To implement TB infection control (TB IC) trainings and measure the outcome through pre and post-test scores and through monitoring of M.tb QFT-Plus conversion rates at month 6; month 12; and month 24. 6. To assess if the level of TB infection control practices is associated with M.tb infection rates by comparing to M.tb infections rates among HCWs stratified by the level of TB IC being implemented by HIV care and treatment centres at 2 years. Method: This will be a prospective cohort study with 4 study visits that will recruit HCWs in high HIV and TB burden hospitals from 2 states in the North central region of Nigeria having the highest HIV prevalence in the region (i.e. Abuja & Nasarawa). A non-probability sampling method will be used in selecting 13 hospitals with dedicated PEPFAR funded HIV care and treatment centers in Abuja & Nasarawa. We assume a 25% LTBI rate among that the unexposed group (general HCWs); a 35% LTBI rate (anecdotal evidence) among the exposed group (HCWs primarily working in the HIV clinics); a power of 80% and 5% significant level, which gives a total of 328 HCWs per group and a total of 656 HCWs as a minimum. Following informed consent, TB risk assessment questionnaire will be administered, 5 mls blood collected for QFT-Plus and 5mls blood for PBMC will collected from eligible study participants. Results: This will be based on objectives of the study and displayed in tables and figures. Thus prevalence M.tb infection among healthcare students, as measured by the QFT-Plus, will be calculated for all enrolled participants. Summaries of M.tb rates will be presented by age, gender, residential district; years of employment at the hospital etc. Multiple logistic regression performed and result presented. Additional analysis will be performed following exploration of immune correlates of protection or risk. Conclusion: This will be presented according to the objectives and findings of the study.
