In 2013, WHO estimated that 3.3 million cases of TB had been missed (undiagnosed or with a significant delay in diagnosis or treatment). ?Missed? TB cases are a key driver of TB transmission, with approximately 9 million individuals developing TB globally each year, equivalent to 126 cases per 100,000 population. The overall goal of this proposal is to evaluate the utility of home-based point-of-care TB testing for early diagnosis and linkage to care of household contacts of TB patients, addressing the need for intensive case finding and early detection of infectious TB. Although well-accepted as an effective strategy for boosting HIV diagnosis and treatment rates, until recently home-based testing for TB has been impossible, as there has never existed an effective, mobile PoC technology for rapid diagnosis of TB. With the development of the new GeneXpert Omni diagnostic platform from Cepheid, home-based TB testing is now possible. Now is the time to study whether home-based testing for TB is feasible, and will contribute to early case detection or improve time-to-treatment rates. Our project has two Specific Aims: 1) To determine the acceptability and feasibility of using point-of-care technology to perform home-based TB testing of household contacts of TB patients, with subaim 1(a): To assess the intent-to-seek care of household contacts symptomatic for TB, and subaim 1(b): To determine the proportion of household contacts symptomatic for TB consenting to be tested (acceptability) and uptake of treatment referrals by those individuals infected with TB within two weeks of testing (feasibility); and 2) To describe the outcomes of household contacts screened and tested for TB in their home compared to those screened and referred for testing in a health facility, with subaim 2(a): To describe the barriers and facilitators to clinic follow-up by household contacts symptomatic for TB and provided with referral for TB testing or treatment initiation, and subaim 2(b): To determine whether point-of-care home-based TB testing reduces time-to-treatment initiation. This study will recruit TB index patients from the 5 health facilities that serve the Duncan Village Informal Settlement Area in Buffalo City Metro Health District, Eastern Cape Province, South Africa, a very high TB prevalence area. Findings from this project may represent a new strategy for increasing TB case finding and improving linkage to care for the 3 million missed cases of TB annually. Furthermore, early detection of TB disease, with improved linkage to care rates, may reduce TB transmission and prevalence in high-burden settings.
This exploratory study will evaluate the utility of home-based point-of-care TB testing for early diagnosis and linkage to care of household contacts of TB patients. If shown to be acceptable, and feasible, this intervention may represent a new strategy for increasing TB case finding and improving linkage-to-care for the 3 million missed cases of TB annually throughout the world. Furthermore, early detection of TB disease, with improved linkage-to-care rates, may reduce TB transmission and prevalence in high-burden settings.
