Project title: “Long Term Follow Up of Multi-drug and Extensively Drug Resistant Tuberculosis Patients who Initiated Treatment in 2011-2013 and were Lost-to-follow-up”. International Science and Technology Center (ISTC), 01.03. 2016 – 28.02.2017.

Project Summary

a).Project Objectives:

The overall goal of this project is to evaluate long-term outcomes, including smear and culture results, of the M/XDR patients who LFU in Georgia.

The study objectives are:

1. To evaluate the bacteriological status (i.e. AFB smear/culture results/GeneXpert) of M/XDR-TB patients who started the treatment in 2011-2013 and were lost-to-follow-up;

2. To evaluate patients who remain sputum culture positive for development of increasing acquired drug resistance;

3. To identify the risk factors for development of increasing acquired drug resistance;

4. To define the minimum effective duration of M/XDR TB treatment.

b).Project Implementation:

After developing the study protocol and instrument, data collection

teams and supervisors will be trained. Seven teams, each including a nurse and a driver will be responsible for data and sample (sputum) collection and transportation. Clinical coordinators will be responsible for issuing a laboratory investigation request form for each patient.

Nurses will collect sputum samples that will be sent to the Laboratory for sputum smear microscopy and GeneXpert testing. Samples collected in western Georgia will be sent to the Kutaisi ZDL Laboratory (NCDC) and samples from eastern Georgia – to Tbilisi Laboratory (NCTLD). Culture testing and Drug Susceptibility Test (DST) on first and second line drugs will be performed at National Reference Laboratory (NRL-NCTLD).

c).Expected Results:

This project will define the long-term outcomes of patients with M/XDR-TB

who were lost-to-follow-up during treatment including survival, persistence of TB, and development of acquired drug resistance. Study implications include defined risk factors for the resistance amplification after LFU from treatment. Additionally, by comparing the length of treatment received before LFU among patients found to be culture negative/clinically confirmed as Cured and culture positive we will indirectly evaluate the minimum duration of treatment that might lead to the cure.