PROJECT SUMMARY / ABSTRACT
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.
