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BJGMC Team Convenes PHOENIx Pre-study Event for Maharashtra Government TB Program Officials
With the highest burden of tuberculosis and drug-resistant TB globally, treatment success rate of less than 50%, and alarming rates of loss to follow-up and mortality, India faces serious challenges in the fight against TB. Preventing the spread of disease is critical. Proximity places household contacts of TB patients at particularly high risk of infection.
The Indo-JHU Clinical Research Team is invested in preventing household spread of TB. From 2015–2017, the site participated in a multinational, cross-sectional feasibility study to assess whether it was possible to reach adult and child household members of MDR-TB patients, evaluate their baseline health, determine HIV status (a known risk factor for TB), and assess their knowledge, attitudes, and perceptions about TB disease, preventive therapy, and participating in research. What the study team found was that household contacts of MDR-TB patients were eager for information about, and therapy for, preventing TB infection.
Following the feasibility study, the BJGMC-CRS now is poised to begin the PHOENIx Phase III clinical trial on protecting household contacts of newly diagnosed MDR-TB index cases. The trial is being conducted under two trial networks: the AIDS Clinical Trials Group (ACTG) and the International Maternal, Pediatric, Adolescent, AIDS Clinical Trials Network (IMPAACT), and is sponsored by the U.S. National Institutes of Health. The multicenter trial will be conducted in Haiti, South Africa, Uganda, and India and will assess efficacy and safety of two anti-TB medicines: isoniazid and delaminid.
Collaboration and coordination with local government TB program officials are critical for ensuring transparency and a shared understanding of the study’s purpose, methods, consent process, logistics, and potential implications for India’s national TB control efforts. To that end, the Research Team recently convened the first PHOENIx study community sensitization workshop for supervisors of Maharashtra’s state government TB control program. Fifty-four participants were in attendance, including Dr. Padmja Jogewar, the supervising TB officer for the state; Dr. Sanjay Darade, the supervising TB office for the district of Pune; the medical officer from the state TB demonstration and training centre as well as medical officers, MDR-TB supervisors, and state TB supervisors. Representation from BJGMC included Dean Dr. Sudhir Nanandkar, Deputy Dean Dr. Samir Joshi, PHOENIx study lead and Head of TB Department Dr. Sanjay Gaikwad, and the BJGMC outreach team.
Dr. Vidya Mave, Indo-JHU Clinical Research Site Director, welcomed the audience and introduced guest speakers. Dr. Jogewar spoke of the need for research on preventive therapy for MDR-TB, and she offered the full support from the Revised National Tuberculosis Control Program (RNTCP) in Marharashtra state. BJGMC Dean Dr. Nanandkar expressed the importance of the study and pledged institutional support. Dr. Nishi Suryavanshi, Deputy Director of the Indo-JHU Clinical Research Partnership presented an overview and background of the study, and Dr. Sandesh Patil explained the study schema, eligibility criteria for participant enrollment, and procedures. Community Outreach Coordinator Ms. Savita Kanade discussed logistics for participant involvement.
The team is eager to begin, and grateful for the support of local collaborators who are dedicated to control of TB in India.