Understanding Quality of Life during and Loss to Follow-up from Drug-Resistant Tuberculosis Treatment in Pune, India

Post Date: 
2017-05-15
Clinical Site(s): 
Country: 
Summary: 
This study will examine a) risk factors for loss to follow-up from DR-TB treatment, b) actively trace DR-TB patients lost to follow-up from treatment and c) establish a prospective observational cohort of MDR-TB, XDR-TB and DS-TB patients as well as healthy controls nested within ongoing RNTCP tuberculosis treatment programs in Pune, India. The overall aim of this research is to identify specific unmet DR-TB patient needs and inform the development and implementation of patient-centered treatment strategies and support efforts. We broadly hypothesize that the drivers of poor DR-TB treatment retention are factors not captured in routine patient care data registries – namely quality of life as well as social and structural factors.
 
Objectives
  1. Examine the timing and risk factors of DR-TB patient loss to follow-up in Western Maharashtra, India by integrating retrospective Revised National TB Control Program (RNTCP) patient, laboratory and programmatic registry data from 2011-2016
  2. Compare longitudinal quality of life during the first 6 months of treatment for newly diagnosed drug-sensitive (DS-TB) and DR-TB patients in public sector treatment to healthy neighborhood controls in Western Maharashtra, India 
  3. Actively ascertain true outcomes, self-reported barriers to treatment retention and support program preferences among DR-TB patients lost to follow-up during public sector treatment in Western Maharashtra, India through prospective phone follow-up and in-person interviews 
 
Secondary Objectives
  1. Characterize baseline health-related quality of life (WHOQOL-BREF) among patients undergoing public sector DS-TB and DR-TB treatment in Pune, India
  2. Identify risk factors for poor health-related quality of life (WHOQOL-BREF) at baseline among patients undergoing DS-TB and DR-TB treatment 
  3. Determine if lower baseline health-related quality of life (WHOQOL-BREF) is independently associated with a greater number of missed treatment doses during the first 6 months of DR-TB treatment 
  4. Characterize the prevalence of depressive symptoms (PHQ-9 score >10) and anxiety symptoms (GAD-2) among DS-TB and DR-TB patients as well as healthy controls at baseline as well as 2m and 6m after enrollment
  5. Identify risk factors for depressive symptoms (PHQ-9 score >10) among DS-TB and DR-TB patients at treatment initiation
 
Collaborators: 
  • Government of Maharashtra, Health Services, Pune, India
  • Aundh Chest and General Hospital, Pune, India
  • Johns Hopkins School of Public Health