A Vision of TB-Free India by 2025 with Preventive, and Curative Approach
Strengthening TB Action and Response (STAR) is supported by the US Centers for Disease Control and Prevention (CDC), Atlanta, under the Global Health Security Agenda (GHSA) to provide technical assistance to the National TB Control Program under the Ministry of Health and Family Welfare (MoHFW), Government of India (GOI). SHARE INDIA supports projects in Maharashtra in Mumbai, Nagpur, and other states to support the elimination of TB in India by the year 2025.
The STAR project has supported and transitioned three projects to the Revised National Tuberculosis Control Program (RNTCP), Mumbai. These projects are as follows. (1) In partnership with Tata Institute of Social Sciences (TISS), STAR Project extended support to TISS counsellors to improve the treatment adherence of patients undergoing treatment for Multi Drug-Resistant tuberculosis (MDR-TB). This intervention has contributed to the increase in MDR-TB treatment success by reducing the instances of loss to follow-up. (2) In partnership with Foundation for New and Improved Diagnostics (FIND), SHARE INDIA extended support to Cartridge Based Nucleic Acid Amplification Test (CBNAAT) laboratory quality improvement project. (3) In partnership with Hinduja hospital, the STAR Project supported in implementing the new MDR TB treatment guidelines with drug susceptibility based individualized treatment for MDR TB patients for the Mumbai District TB control program.
Project STAR currently encompasses four major components, namely Airborne Infection Control (AIC) in Mumbai, the End MDR-TB (EMTBD) project in Dharavi, Household contacts Active and Latent Tuberculosis intervention (HAaLT) project in Nagpur, and Engaging Local Experts in Validating and Analysing TB-data to End TB (ELEVATE) in Mumbai. Each of these four interventions retains specific program objectives and dedicated workforce.
Airborne transmission of tuberculosis in healthcare settings is a major public health concern. In overcrowded outpatient departments (OPD), vulnerable populations waiting for medical care, exposed to those with undiagnosed TB, can become infected and ill, as can healthcare workers. The AIC project works on making the secondary- and primary-level healthcare institutions AIC-compliant through a technical unit set up in the Municipal Corporation of Greater Mumbai (MCGM). A team of seven heterogeneous groups of professionals from microbiology, architecture, nursing, monitoring and evaluation and public health are recruited and trained on airborne infection control by CDC. The unit is operational since October 2016 and covers 13 wards/TB districts of Mumbai.
To build the capacity of the health system for airborne infection control compliance and health care worker surveillance in Mumbai and hand over the AIC unit and the healthcare worker surveillance activity to MCGM.
To expand the team and provide technical assistance to other states for establishing AIC interventions and compliance.
Assessments and training
A standardized tool of 41 indicators was developed from national AIC guidelines to capture the administrative, environmental and personal protective equipment compliance in MCGM health institutes. This tool is taken to the field and duly filled on site. The data collected from the tool is analysed and, based on the results, specific recommendations are made to the institution. This data is used to monitor the compliance level of the institution at an interval of every four months.
The AIC team conducted a webinar session on the e-NISCHIT platform across India on Airborne Infection Control in ART settings at the HIV-TB ECHO clinic for the ARTCs of Andhra Pradesh, Tamil Nadu, Delhi and Uttar Pradesh on 4 April and 16 May 2019.
The figure above depicts the result of AIC intervention in the health care institutions functioning in seven wards of Mumbai. The ‘Y' axis represents the government health care facilities covered by the AIC project. Each row consists of the observations from one health care facility on 41 indicators for AIC compliance that is being assessed by the project.
The ‘X' axis records the responses of health care facility against each of the 41 indicators being tracked by the project. The responses are colour coded. Red colour represents the state of indicator not found implemented, blue colour represents the indicators that are not applicable for the institution, yellow colour represents the indicators that are in-progress towards implementation and finally green colour represents successful implementation of the indicators. During the baseline assessment, it was found that the level of AIC compliance were low among many health care facilities. This is the reason for many red colour cells in the figure representing the observations from baseline assessment. The AIC team made recommendations to enhance the level of compliance based on the assessment. Implementation of these recommendations resulted in the improvement in compliance level. These changes in the status of the indicators is tracked and recorded in the subsequent follow up visits.
Dharavi is the third-largest slum in the world, with an estimated population of 700,000 people. It spans 535 acres. Dharavi is defined by low-rise, closely packed houses, with a high density of population. This slum is occupied by people who migrate to the city to find jobs in the informal economy. It is also the most literate slum in the world, with a literacy rate of 69 percent. Prevalence of multi-drug-resistant TB in a densely populated area such as Dharavi is very high. Treatment completion for MDR-TB is low because patients commonly experience intolerance to drug toxicities, and also because they may be part of a highly mobile population. Many of those who work in Dharavi are economic migrants and leave Mumbai, presumably for home, soon after treatment initiation. The TB program reported that only 39 percent of people with MDR-TB in Dharavi complete treatment. Patients who do not complete treatment for MDR-TB may transmit the strain to household members, die from the disease, or feeling temporarily better, may return to work in Dharavi and transmit MDR-TB to their fellow workers. Given the enhanced transmission factors mentioned above, including crowded work and home conditions, as well as malnutrition, MDR-TB poses significant threats to the population of Dharavi specifically, to Mumbai generally, and to the communities to which, patients return in other parts of India. To address the increasing threat of TB and MDR-TB in the Dharavi slum, the CDC, SHARE INDIA in collaboration with MCGM, has planned to enhance community outreach and diagnosis, improve MDR-TB treatment adherence and treatment outcomes, and prevent further transmission of TB and MDR-TB. The End MDR-TB Dharavi Project is a comprehensive TB control program for Dharavi. The project aims to work on active case-finding among household contacts of MDR-TB patients and support early detection of MDR-TB cases in Dharavi. The project then strives to improve MDR-TB treatment outcomes by addressing migration, prevent lost to follow-up by addressing overall Adverse Drug Reactions (ADR) with focus on detecting early hearing loss by way of use of point-of-care audiometry. The project is also working on the prevention of TB transmission by conducting sensitizations as a part of workplace interventions in small-scale industrial outlets for early referral, treatment and promoting cough hygiene. This STAR project proposes to work with the MCGM program staff at eight public health institutions (PHI) that are located throughout Dharavi. Under the RNTCP program, Dharavi falls under Dadar district, which is divided into three tuberculosis units (TUs). TU1 is located in the Urban Health Centre (UHC) and TU2 is located at Pila Bungalow, serves the patients from the slums of Dharavi. These two TUs record higher load of TB cases from the district. TU3 is located at Shree Cinema, which is predominantly utilized by the non-slum population.
Intensive planning activities
Regular meetings are held with District TB Officers (DTO), Medical Officers (MO), Senior DOTS Plus Supervisors (SDPS) and TISS Counsellors to explore and understand crucial gaps related to (1) pattern of migration in Dharavi, (2) the volume of the lost to follow-up due to ADR, (3) referrals for ADR, including audiometry as part of monitoring hearing loss among patients on Second Line Injectable (SLI) and ECG for Bedaquiline patients, and (4) patient flow, the mechanism for contact tracing and active case finding.
Adverse drug reaction monitoring
The project will work to improve MDR-TB treatment outcomes by preventing lost to follow-up by addressing overall adverse drug reactions. The team has successfully field tested tools to monitor and track adverse drug reactions, subsequently reducing lost to follow-up due to ADR.
The project aims to work on early detection of MDR-TB cases among household contacts of MDR patients through regular home visits and provides appropriate referrals to care and treatment. The household contact tracing tool has been field tested at Dharavi and improved in content.
Sensitization workshops on health and hygiene are planned at workplaces as a part of workplace interventions in small-scale industrial outlets in Dharavi to improve health awareness. A pilot testing of content for workplace sensitization was conducted by the project team with 10 workers in the industries in Dharavi.
Audiometery and ECG
SHARE INDIA procured an audiometer from Shoebox, USA. This apparatus helps the project staffs to monitor the hearing capacity of MDTR patient who are currently being administered with second line injectable drugs. The team has undergone an online training session from the Shoebox online training center. Demonstration of the Audiometry was given to CTO (City Tuberculosis Officer), the District Tuberculosis Officer and the DTC staffs of Dadar district. A microplan is prepared and more equipment will be procured to routinely monitor the hearing loss. This activity will prevent sensorineural deafness.
To encourage the use of newer drugs such as Bedaquiline, the project will use the Smartheart Pro ECG device (electro cardiogram), which will be easy to use compared to the traditional ECG to monitor QTC prolongation on ECG of patients that are put on Bedaquiline.
The project will improve MDR-TB treatment outcomes, prevent sensorineural hearing loss, upscale strategies to pre-empt and prevent migration and bring out learnings to improve newer drug uptake and enhance treatment success.
HAaLT intervention in Nagpur provides technical assistance to the RNTCP in two districts, Nagpur Urban and Nagpur Rural of Maharashtra, to facilitate linkage for treatment for 2000 to 5000 household contacts among slum and non-slum dwellers to initiate active contact detection, and diagnosis of latent TB infection (LTBI). The results from this pilot project will establish best practices for contact investigation, LTBI testing and treatment for contacts. The project is likely to provide inputs for policy formulation on LTBI Management in India.
Proposal building with the involvement of all stakeholders
The proposal was developed by Indira Gandhi Government Medical College & Hospital (IGGMC), Nagpur, CDC Atlanta and SHARE INDIA. The Central TB Division (National Operational Research Committee), New Delhi reviewed and approved the proposal. A detailed protocol was developed by CDC, IGGMC, SHARE INDIA and was reviewed by all the stakeholders in a meeting that was called by IGGMC at Nagpur. The ethics protocol for the latent-TB intervention was reviewed by the experts at Ethics Committee, IGGMC, Nagpur. The protocol formally received approval in July 2019.The CDC is in the process of getting the protocol approved from the Human subjects non-research determination from the Human subjects protection committee.
Sensitization and building linkages
The RNTCP was approached and sensitized on the details of the project, the State TB Officer, (STO) and DTOs formally agreed to extend support and cooperation for the implementation of the project. The government departments will assist with staffing, training programs, X-ray facilities, and Rifapentine drug supply through DTO and CTO for the operational research project. A series of planning meetings are underway with all stakeholders in Nagpur along with CDC, State TB Training and Demonstration Centre (STDC), Qiagen; the partner for diagnostics interferon-gamma release assay (IGRA) testing kit, SHARE INDIA and the IGGMC. Several meetings and field visits were conducted with RNTCP officials working in all the TUs in the districts and all officials are now familiar with the objectives of the project and the role of each government health care worker in the project.
Development of project documents
The expert team has developed standard operating protocols (SOP) for household visit, contact screening for TB, paediatric diagnosis, blood collection, storage and transportation, LTBI treatment, follow-up, data flow, etc.. The SHARE INDIA team has also developed Information Education Communication (IEC) material in the local language (Marathi) and English to spread awareness about latent TB infection in the community and has designed a training curriculum for training of Medical officers of TB, RNTCP and project staff.
Upon receipt of all approvals and resources, the implementation will be planned from the last quarter of 2019.
The project is likely to provide valuable lessons on best practices on LTBI implementation, prevent active TB and give insights for policy formulation on LTBI management and TB prevention in India.
This project component focuses on improving data quality to help the tuberculosis program make better decisions based on reliable and accurate data. A series of workshops are planned on data analysis to capacitate the local district TB office staff to analyze and utilize TB programmatic data for program implementation and management. Based on the response from the participants, SHARE INDIA plans to advocate implementing the workshop at pan-India level.
Relevant details of the patients under RNTCP are entered in the NIKSHAY website (the web-enabled patient management system for TB control under RNTCP). But data always has some challenges, such as missing or duplicate data, where the same case is reported multiple times, demographics or test results are missing, or information on the cases is not updated, or a treatment outcome is not documented. The primary issue is the data management capacity of the RNTCP local staff. Cleaning data during collection, at entry and after entry can ensure better data quality. Our mission is to ensure that we have the best quality data possible so that it reflects the true situation of TB.
In response to this situation, the ELEVATE project was implemented by SHARE INDIA with the help of technical support from CDC. The project addresses some of the major issues concerning data and it use.
A total of 113 people were trained to enable the use of TB programmatic data at local level and hands-on analysis of NIKSHAY data in the Epi Profile (Excel-based) dashboard. The training was provided on data analysis to capacitate the local District TB office staff to analyze and utilize TB programmatic data for program implementation and management. The first phase of the workshop on data analysis was organized on 11–12 December 2018 in Mumbai. This workshop was attended by DTOs, SDPS, statistical assistants (SAs) and data entry operators (DEOs) from eight wards in Mumbai. The participants found the training helpful to plan their activities and make informed decisions. The second phase of the training was done on 11–12 April 2019, where the representatives from the remaining 16 wards in Mumbai participated. Based on the response from the participants, SHARE INDIA plans to advocate implementing and upscale the workshop at pan-India level.
An Excel dashboard was prepared with technical inputs from CDC to analyse and present the data available to each tuberculosis unit (TU). This dashboard was handed over to the officials in RNTCP. They were trained to export data from NIKSHAY, clean and validate the data in Excel and then import data into the dashboard. With the help of the ELEVATE dashboard participants could understand and visualize the status of their unit effortlessly, which enabled them to make informed decisions.
Post-workshop mentoring visit
The SHARE INDIA team visited 24 districts of Mumbai to understand the workshop feedback and provide support to the district teams on data analysis.
MS Office 2016 installation
The ELEVATE dashboard was only compatible with MS Excel 2016 and majority of the offices in Mumbai were using MS Excel 2010 or below. It was necessary to upgrade the software to make the ELEVATE dashboard functional. Therefore, information pertaining to software upgrades was gathered from each health facility. Then a vendor was identified for the installation of MS Office 2016. Now facilities have their computers upgraded and are able to use the ELEVATE dashboard.