1062-India-Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)

The PHOENIx MDR-TB study is a Phase 3 clinical trial designed to assess the efficacy and safety of Delamanid (DLM) compared to Isoniazid (INH) in preventing the development of active multidrug-resistant tuberculosis (MDR-TB) in high-risk household contacts (HHCs) of adults diagnosed with MDR-TB. This study is co-funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the NIH.
•        Objective: The main objective of the trial is to evaluate the effectiveness of a 26-week regimen of DLM versus INH for preventing confirmed or probable active TB in HHCs. High-risk HHCs include individuals with HIV, non-HIV immunosuppression, latent TB infection, and children under 5 years of age.
•        Study Design: Households with at least one eligible HHC will be randomized into one of two treatment arms:
Arm A: DLM daily for 26 weeks.
Arm B: INH daily for 26 weeks plus pyridoxine (vitamin B6) for the same duration.

All participants will undergo follow-up for 96 weeks, with study visits at various intervals to monitor safety, efficacy, and clinical outcomes.

1.   Participate in index and HHC follow-up in the field
2. Data Analysis:
•        Screening Data Analysis: Students will assist in analyzing the screening data collected from potential index cases and household contacts (HHCs). 
•        Evaluation of Baseline Data: Students will help evaluate the baseline data for enrolled index cases, including microbiological data, clinical assessments, physical examination results, chest X-rays, and any relevant biomarkers.  Assessment of TB program data as well as screening lab data for MDR TB diagnosis will be assessed to determine discordance in microbiological test results. Epidemiological profiles of MDR TB cases will also be summarized.
2.        Manuscript Completion:
•        Assist in finalizing research manuscripts, including data analysis, writing, editing, and preparing documents for publication.

Type of Setting: Indian Government/ Private Hospitals and Medical Schools
Primary Locations: BJGMC Sassoon General Hospitals, Pune.

This placement would be a good fit for someone passionate about public health and clinical research, especially in the context of infectious diseases like MDR-TB. The ideal candidate would have an interest in clinical research, data analysis, and working directly with diverse populations to identify barriers and facilitators to enrollment. Strong communication, attention to detail, and a collaborative approach to problem-solving are essential for contributing to the study’s data evaluation and manuscript development.

1.        Medical Knowledge about Infectious Diseases (TB):
•        Understanding of TB pathogenesis, transmission, and clinical manifestations, especially pulmonary TB, and familiarity with diagnostic methods.
2.        Qualitative Research:
•        Experience with qualitative research methods, including conducting interviews, focus groups, or surveys, and analyzing qualitative data to identify themes, barriers, and facilitators related to TB prevention and treatment
3.        Data Analysis:
•        Proficiency in quantitative software (e.g., R) for analyzing data.
4.        Manuscript Writing Skills:
•        Understanding of mixed-method research approaches and experience in manuscript writing, including literature reviews and contributing to scientific papers.

Name: Amita Gupta, lkodali3@jh.edu 

I would describe my communication and mentorship styles as... 

approachable, collaborative, and committed, with an open-door policy and regular engagement with students and the Indian team.

A complementary student would have a working style and mentorship expectations that are..

that align with open communication, proactive collaboration, and a willingness to engage regularly for mutual growth and success.

Estimated Costs:

Housing: $500/month
Food: $250/month 
Local Transportation: $100/month 
Internet: $20/month data sim card

Total: $870/month

Additional support from PI:

Site will provide an additional stipend to help offset costs