RESEARCH PROJECTS

1. Framework for TB Care in Prisons in New Delhi

The project titled “Framework for TB care in prisons in New Delhi” was successfully completed. Aim of this study was to screen all inmates of Tihar and Rohini Jail via ACF (Active Case Finding) survey for TB symptoms. TB symptomatic cases detected were tested to confirm TB as per the diagnostic algorithm under NTEP. Another objective was to develop a mechanism in consultation with jail authorities whereby the detected TB patients continue their treatment even after he/she is released from the jail. This project was undertaken in collaboration with State TB cell. Idea behind this project was to identify TB cases at Tihar Jail, confirm TB status with CBNAAT (Cartridge Based Nucleic Acid Amplification Technique) and initiate their treatment. This was a two year project whereby Active case finding was undertaken at Tihar and Rohini jail. The study came out with very prominent results. 17965 inmates were interviewed at Tihar and 914 patients reported as symptomatic. Out of these 106 turned out to be TB cases. Similar results were present at Rohini jail whereby 927 inmates were interviewed and 104 reported as symptomatic. This study showed that Active case finding has major benefits when targeted at the high risk group. Another major suggestion from this project was that a mechanism may be developed by the jail authorities whereby as soon as the tenure of inmate/convict is completed/he is released/referred as the case may be, the jail authorities should get in touch with the CMO of the district/Health authorities, where the inmate/convict is going to continue treatment.

2. Active Case Finding Campaign of Tuberculosis among People Who Use Intravenous Drugs in New Delhi.

Active case finding campaign was an activity propagated by the programme. This was a house to house survey for search of TB symptomatic. The objective of the OR is (a)Early identification of TB suspects (b) Early diagnosis (c) Treatment preparedness (d) Link to Treatment and Care. Targeted Population : Person who Inject drugs in the area of Delhi of Yamuna Bazaar and Hanuman Mandir in CP of New Delhi. After sensitization of field teams, active case find was started in both fields area with the help of New Delhi Municipal Corporation (NDMC) and Pilli Kothi Chest Clinic. A total of 1716 persons were sensitized. Based in 4 symptoms criteria, 256 identified symptomatic were investigated. 30 patients detected as TB and were put on treatment and 12 were under observation.

3. Effect of Counselling Intervention on Outcome Among MDR – TB Patients In Delhi.

It is an interventional study. MDR-TB has a high LTFU (Left to follow up) rate and counselling support could be an intervention to reverse it. A professional trained counsellor has been recruited for this purpose. The objectives are to assess to effect of the counselling intervention by :

(a) Treatment adherence among DR TB patients.

(b) Loss to follow up among DR TB patients.

(c) To provide psycho social support to DR TB patients and their family members.

(d) Early detection of TB among household of patients.

(e) Linkage the patient with existing social support services.

Till date, 106 MDR cases have been included in the study. The study is in process.

4. Mapping of Anti-Mycobacterial Drug Resistant Hotspots under National Tuberculosis Elimination Programme (NTEP) in Delhi State.

The study is being conducted by NDTB Centre and TB Association of India, funded by Delhi state OR Committee. Study was to map out hotspots of Drug Resistant TB cases in Delhi State so as to provide adequate diagnostic and Therapeutic services in the detected area. A trial run was done with help of GIS Agency among 20 MDR cases detected in Central Delhi area. Based on the results, the study will expand to entire Delhi.

5. BEAT (Building Evidence for Advance Treatment Against Tuberculosis) study:

Laboratory is actively taking part in BEAT (Building evidence for advance treatment against tuberculosis) research project entitled “To Evaluate the Efficacy and Safety of a Combination regimen of Bedaquiline, Delamanid, Linezolid and Clofazimine in Adults with Pre-extensive (Pre-XDR) and Extensively Drug-resistant Pulmonary Tuberculosis (XDR-TB). This is a prospective Cohort Study being conducted in collaboration with RBIPMT and NIRTD with following objectives:

a. To evaluate the safety and tolerability of a treatment regimen of 24 – 36 weeks (6-9 months) duration consisting of BDQ, DLM, LZD and CFZ in patients with pre-XDR or XDR-TB.

b. To determine the time to sputum culture conversion with this combination treatment regimen.

c. To determine the steady state Cmin levels of DLM, BDQ and their metabolites at weeks 2, 8 and 16

d. To explore the steady state pharmacokinetics (PK) of BDQ and DLM in a subgroup of pre-XDR and XDR-TB patients on the combination treatment regimen (intense PK)

6. STREAM (Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients with MDR- TB) study:

STREAM (Standard Treatment Regimen of Anti-tuberculosis drugs for patients with MDR- TB) trial is being conducted in Delhi state in collaboration with Union and Institute of Tropical medicine (ITM), Belgium and for this purpose RBIPMT has been selected as study site along with our laboratory. Our laboratory is providing diagnostic facilities to conduct the trial. This trial is in progress and has following objectives:

To assess whether the proportion of participants with a favourable efficacy outcome at week 76 on regimen consisting of Bedaquiline, clofazimine, Ethambutol, Levofloxacin and Pyrazinamide given for 40 weeks supplemented by isoniazid and prothionamide for the first 16 weeks (intensive phase).

7. National TB Prevalence Survey:

The Central TB Division (CTD), Government of India in collaboration with Indian Council of Medical Research (ICMR), New Delhi, National Institute for Research in Tuberculosis, Chennai and World Health Organization (WHO), India is conducting a National TB Prevalence Survey in India. NIRT Chennai is has been identified as a Nodal and coordinating centre. This national level survey has objective of estimating the point prevalence of pulmonary tuberculosis in India. For this purpose CTD has selected many IRLs and NRLs including our laboratory to participate in the survey and to provide diagnostic facilities. Laboratory received samples from selected clusters and has been processed for culture and drug susceptibility testing.

8. Utility of Stool Cartridge Based Nucleic Acid Amplification Test in Diagnosis of Pulmonary Tuberculosis in Children

This study is being conducted at New Delhi TB Centre in collaboration with LN Hospital. All the patients attending Chest clinic, Lok Nayak hospital are being evaluated for pulmonary TB in Department of Paediatrics will be screened for enrolment. Written informed consent and/or assent will be obtained from those satisfying the study criteria. A detailed history and clinical examination will be done in enrolled cases and routine TB workup including CXR and Mantoux will be done. Gastric aspirate sample (5ml) as well as a Stool sample (5g) will be obtained from these cases. The sample will be processed at the NDTB Centre as per the current operational guidelines. Mycobacterial Growth Indicator tube cultures will be put up from both samples. After the testing process, the data collected will be entered in Microsoft Excel Sheet and analysed. The categorical variables such as Stool CBNAAT and Gastric Aspirate CBNAAT positives will be expressed as proportions.

9. Urogenital Tuberculosis in Married Females with Recurrent Urinary Tract Infection

This study will be conducted in collaboration with MAMC and LN Hospital. The patients will be counselled to collect three consecutive early morning samples in a wide mouthed sterile container under all aseptic conditions. The urine would be processed immediately. Endometrial biopsy will be taken in premenstrual phase from married female patients. The sample would be collected in two different sterile containers under all aseptic conditions, one containing formalin and the second containing normal saline and labelled with full patient details and transported to the laboratory within 4 hours. Urine will be centrifuged and the endometrial biopsy sample will be processed and subjected to the Acid Fast Staining, culture on Lowenstein-Jensen medium and culture on Mycobacterium Growth Indicator Tube (MGIT0 and drug sensitivity testing. After the testing process, the data will be entered into MS-EXCEL and data analysis shall be done using SPSS as per the objectives of the study.

10. Role of Cartridge Based Nucleic Acid Amplification Test (CBNAAT) in the Rapid Diagnosis of Cutaneous Tuberculosis and Detection of Rifampicin Resistance

This study is being conducted at NDTB Centre in collaboration with MAMC and LN Hospital. The biopsy sample from the lesion of selected patients will be tested by histopathology, CBNAAT and liquid culture. After the testing process, The obtained data will be analysed by SPSS for Windows version 25.0 (SPSS Inc., Chicago,IL, USA) statistical package program.