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.