Estimation of tuberculosis incidence at subnational level using three methods to monitor progress towards ending TB in India, 2015-2020.

OBJECTIVES: We verified subnational (state/union territory (UT)/district) claims of achievements in reducing tuberculosis (TB) incidence in 2020 compared with 2015, in India. DESIGN: A community-based survey, analysis of programme data and anti-TB drug sales and utilisation data. SETTING: National TB Elimination Program and private TB treatment settings in 73 districts that had filed a claim to the Central TB Division of India for progress towards TB-free status. PARTICIPANTS: Each district was divided into survey units (SU) and one village/ward was randomly selected from each SU. All household members in the selected village were interviewed. Sputum from participants with a history of anti-TB therapy (ATT), those currently experiencing chest symptoms or on ATT were tested using Xpert/Rif/TrueNat. The survey continued until 30 Mycobacterium tuberculosis cases were identified in a district. OUTCOME MEASURES: We calculated a direct estimate of TB incidence based on incident cases identified in the survey. We calculated an under-reporting factor by matching these cases within the TB notification system. The TB notification adjusted for this factor was the estimate by the indirect method. We also calculated TB incidence from drug sale data in the private sector and drug utilisation data in the public sector. We compared the three estimates of TB incidence in 2020 with TB incidence in 2015. RESULTS: The estimated direct incidence ranged from 19 (Purba Medinipur, West Bengal) to 1457 (Jaintia Hills, Meghalaya) per 100 000 population. Indirect estimates of incidence ranged between 19 (Diu, Dadra and Nagar Haveli) and 788 (Dumka, Jharkhand) per 100 000 population. The incidence using drug sale data ranged from 19 per 100 000 population in Diu, Dadra and Nagar Haveli to 651 per 100 000 population in Centenary, Maharashtra. CONCLUSION: TB incidence in 1 state, 2 UTs and 35 districts had declined by at least 20% since 2015. Two districts in India were declared TB free in 2020.

Does mobile phone instructional video demonstrating sputum expectoration improve the sputum sample quality and quantity in presumptive pulmonary TB cases? Protocol for a prospective pragmatic non-randomised controlled trial in Karnataka state, India.

INTRODUCTION: Sputum smear microscopy is the cornerstone of tuberculosis (TB) diagnosis under the Revised National Tuberculosis Control Programme (RNTCP) in India. Instructions on how to produce a good sputum sample are a part of RNTCP training manuals, but its assessment is not emphasised. Healthcare provider's instruction to expectorate a good sputum sample has limitations. Presumptive TB patients often submit inadequate (in quantity and/or quality) sputum samples, which may result in false-negative results. Objectives of the study are, among the selected RNTCP designated microscopy centres in Dakshina Kannada district, Karnataka, India, (a) to assess the effectiveness of mobile phone instructional video demonstrating sputum expectoration on sputum quality and quantity and (b) to explore the mobile phone video implementation challenges as perceived by the healthcare providers. METHODS AND ANALYSIS: This is a pragmatic, prospective, non-randomised controlled trial in two pairs of RNTCP Designated Microscopy Centres (located at secondary and primary healthcare facilities) of Dakshina Kannada district, India. Presumptive pulmonary TB patients aged ≥18 years will be included. We will exclude who are severely ill, blind, hearing impaired, patients who have already brought their sputum for examination, and transported sputum. In the intervention group, participants will watch a mobile phone instructional video demonstrating submission of an adequate sputum sample. The control group will follow the usual ongoing procedure for sputum submission. This study would require 406 participants for each group to achieve a power of 90% for detecting a difference of 15% between the two groups. The participant enrolment started in December 2019. ETHICS AND DISSEMINATION: Yenepoya University Ethics Committee, Mangaluru, India, has approved the study protocol (YEC-1/158/2019). It complies with the Declaration of Helsinki, local laws, and the International Council for Harmonization-good clinical practices. Investigators will present the results in scientific forums, publish in a scientific journal, and share with RNTCP officers. TRIAL REGISTRATION NUMBER: Clinical Trial Registry of India (CTRI/2019/06/019887).

Delivery of antiretroviral treatment services in India: estimated costs incurred under the National AIDS Control Programme

Competing domestic health priorities and shrinking financial support from external agencies necessitatesthat India’s National AIDS Control Programme (NACP) brings in cost efficiencies to sustain theprogramme. In addition, current plans to expand the criteria for eligibility for antiretroviral therapy(ART) in India will have significant financial implications in the near future. ART centres in India providecomprehensive services to people living with HIV (PLHIV): those fulfilling national eligibility criteriaand receiving ART and those on pre-ART care, i.e. not on ART. ART centres are financially supported(i) directly by the NACP; and (ii) indirectly by general health systems. This study was conducted todetermine (i) the cost incurred per patient per year of pre-ART and ART services at ART centres; and(ii) the proportion of this cost incurred by the NACP and by general health systems. The study usednational data from April 2013 to March 2014, on ART costs and non-ART costs (human resources,laboratory tests, training, prophylaxis and management of opportunistic infections, hospitalization,operational, and programme management). Data were extracted from procurement records andreports, statements of expenditure at national and state level, records and reports from ART centres,databases of the National AIDS Control Organisation, and reports on use of antiretroviral drugs. Theanalysis estimates the cost for ART services as US$ 133.89 (`8032) per patient per year, of which 66%(US$ 88.66, `5320) is for antiretroviral drugs and 34% (US$ 45.23, `2712) is for non-ART recurrentexpenditure, while the cost for pre-ART care is US$ 33.05 (`1983) per patient per year. The low costsincurred for patients in ART and pre-ART care services can be attributed mainly to the low costs ofgeneric drugs. However, further integration with general health systems may facilitate additional costsaving, such as in human resources.

Adoption of the 2015 World Health Organization guidelines on antiretroviral therapy: programmatic implications for India

The therapeutic and preventive benefits of early initiation of antiretroviral therapy (ART) for HIV arenow well established. Reflecting new research evidence, in 2015 the World Health Organization (WHO)recommended initiation of ART for all people living with HIV (PLHIV), irrespective of their clinical stagingand CD4 cell count. The National AIDS Control Programme (NACP) in India is currently following the 2010WHO ART guidelines for adults and the 2013 guidelines for pregnant women and children. This desk studyassessed the number of people living with HIV who will additionally be eligible for ART on adoption of the2015 WHO recommendations on ART. Data routinely recorded for all PLHIV registered under the NACP upto 31 December 2015 were analysed. Of the 250 865 individuals recorded in pre-ART care, an estimated135 593 would be eligible under the WHO 2013 guidelines. A further 100 221 would be eligible under theWHO 2015 guidelines. Initiating treatment for all PLHIV in pre-ART care would raise the number on ART from0.92 million to 1.17 million. In addition, nearly 0.07 million newly registered PLHIV will become eligible everyyear if the WHO 2015 guidelines are adopted, of which 0.028 million would be attributable to implementationof the WHO 2013 guidelines alone. In addition to drugs, there will be a need for additional CD4 tests andtests of viral load, as the numbers on ART will increase significantly. The outlay should be seen in the contextof potential health-care savings due to early initiation of ART, in terms of the effect on disease progression,complications, deaths and new infections. While desirable, adoption of the new guidance will have significantprogrammatic and resource implications for India. The programme needs to plan and strengthen the servicedelivery mechanism, with emphasis on newer and innovative approaches before implementation of theseguidelines.