Background: India has the largest number of Tuberculosis (TB) cases in the world with ~27% of the global TB and ~27% of the global multidrug-resistant (MDR) TB burden. The estimated annual TB incidence in India is 2.7 million with 92,000 HIV-TB coinfection and 130,000 MDR or Rifampicin Resistant TB cases. As per India’s national strategic plan 2017-2025, Ministry of Health (MOH) plans to eliminate TB by 2025. In 2018, National TB Elimination Program (NTEP) was able to achieve 2.15 million notifications (80% of the estimate), with treatment initiation for ~90% of the identified patients across both public and private sector. However only 58,347 DR TB cases (45% of the estimate) were detected in 2018, highlighting a significant gap in drug resistant TB detection.

“Making STRIDES against MDR-TB (Strengthening TB Resistance Testing & Diagnostic Systems)” is a multi-country partnership between Becton Dickinson & Co. (BD) and the The United States Agency for International Development (USAID). The partnership is aimed at improving access to and capacity for TB and drug resistant (DR) TB diagnosis in priority countries.

India is the first country to initiate activities under this partnership in collaboration with National Tuberculosis Elimination Program (NTEP) in 2018. Figure 1 highlights the key activities planned under the partnership.

Key Activities

A. Assessment of Liquid Culture and Drug Susceptibility Testing (LC & DST) laboratories

The purpose of lab assessments is to assess documentation, infrastructure, and processes (testing, sample management etc.) at identified C&DST labs. BD developed a standardized checklist, which was approved by Central TB Division (CTD) for use during lab assessments. Based on the assessment, a roadmap is developed to address the issues.

Dr. Richard Pfeltz, a senior scientist at BD Baltimore and an expert on Liquid Culture and Drug Susceptibility Testing (LC & DST), assessed ten public sector C&DST lab (four were assessed in Dec 2018 and six in Feb 2020). Gaps at various levels (record keeping, testing processes, basic infrastructure etc.) were observed and shared with National Tuberculosis Elimination program (NTEP) in de-briefing meetings. Action plans (containing short, medium and long term action items) are being developed for each lab.

B. Training & Capacity Building

The quality of testing is directly proportional to the skill level of the staff conducting the training. To improve the skill level of the staff managing TB specimens and conducting LC &DST training, STRIDES team conducted multiple training and capacity building activities.

• Training of trainers (ToT): In December 2018, 57 microbiologists from 31 National Reference Laboratories (NRLs) and Intermediate Reference Laboratories (IRLs) across the country were trained on best practices on LC & DST in Bangalore and Agra. The training was helpful in improving the knowledge of the participants. Impact:
  • ~25% to 40% increase in the knowledge level of master trainers after a two-day session.

• Follow-up skill assessment: Following the ToT, STRIDES team conducted skill assessment across ten out of the 31 C&DST labs which attended the training activity in Dec 2018. The purpose of the skill assessment was to evaluate the skill level of the laboratory staff pertaining to LC-DST testing at labs. STRIDES team developed a standardized interview guide (based on subjects taught during ToT) and a team of CTD nominated assessor and BD expert conducted interviews. Over 94 laboratory personnel were interviewed in Aug 2019 & Sep 2019. Impact:
  • Overall scores from ToT were maintained (follow-up assessment score of 71%)
  • Baseline score across all lab personal by each lab was established
  • Two categories, specimen processing and C&DST showed maximum improvement in knowledge since ToT

• Hands-on training: Based on the results of the skill assessment, a two-day hands-on training was organized to address the gaps in theoretical knowledge and current practices across ten C&DST labs (same labs as in skill assessment). The focus of the hands-on training was (a) reagent preparation, (b) specimen processing for isolation of M.TB and setting up DST, (c) interpretation of culture and DST results, (d) trouble-shooting procedures, (e) dealing with higher contamination rates and (f) quality assurance at labs. 63 participants attended these trainings. Impact:
  • Training score improved to 85% (post training) from 65% (pre-training)
  • Number of participants with scores >=80% increased significantly from 32% in the pre-training test group to 76% in the post-training test group

C. Demonstrating Utility of EpiCenter Software

Demonstration project at NTI Bangalore:
Under this demonstration project, a software system called EpiCenter/Tb-eXiST was set up in National TB Institute, Bangalore in Feb 2019. BD EpiCenter allows transfer of results from Liquid Culture equipment Bactec MGITTM to any information management (such as e-health) software digitally. A module in Epicentre, TB-eXiST (TB- eXtended individual drug Susceptibility Testing) helps in extending time to test (MGIT AST 4-13 days, TB eXiST up to 56 days); extending testing after Growth Control flagged positive and helps in selecting flexible 2nd line drug choice. Six key staff nominated by NTI, Bangalore was trained on the EpiCenter and TB-eXiST system. A feedback session was organized in Aug 2019 to understand the impact of use of software on data management. Impact:

• Improvement in result management including ability to extract individual patient reports
• Resolution of printer related issues, which reduced delays in sharing of results
• Significant reduction in errors, which has direct impact on costing
• Improvement in accuracy due to labelling of second line drugs, which was otherwise not possible

D. Strengthening specimen referral system (SRS)

• Assessment of the TB Diagnostic Network: STRIDES team conducted an assessment of TB specimen referral system in Mumbai and identified the following gaps in the process
  • Lack of visibility in sample and result movement
  • Absence of cool chain monitoring for sample movement
  • Team developed an action plan to address the issues identified in the assessment. The major activities are below:
    • Development of a framework to assess cost efficiency of different SRS models (status: completed)
    • Digital Health Intervention to track the specimen in a real time manner, and share results online by each specimen (status: on-going)
    • Design on field interventions to improve specimen management on the field (status: planned)

• Cost effectiveness framework for SRS: India has over 700 districts and specimen referral plans for transporting TB specimen, developed at district level, differ significantly. STRIDES team developed an excel model to quantify time, cost and quality associated with a given specimen referral model. This framework can help the national and state program managers in understanding which model would be most cost effective. Team plans to incorporate this framework in the Nikshay application.

• Digital Health Solution to improve specimen management:
  • STRIDES team collaborated with Tata Consultancy Services (TCS) in order to conduct an assessment on the field – Delhi, Bangalore and Bhubaneshwar – to understand the existing sample management processes and data collection protocols.
  • Based on the findings, team developed wireframe for an online solution. These wireframes were presented to MOH, WHO, USAID and other experts. MOH approved these wireframes and currently the team is engaged with Nikshay team to incorporate these functionalities in the Nikshay application. Once incorporated, these functionalities will help in tracking each specimen and ensuring accurate calculation for tracking turnaround times

E. Awareness campaign to share stories of TB champions

An awareness campaign “TB Talk Unmasked” has been launched which highlights the stories of TB survivors under the partnership. The video-based stories capture three perspectives—the survivor, the clinician and the policymaker. The videos are originally in English but have English and Hindi subtitles. The videos at available at https://tbtalkunmasked.com/