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Background: The World Health Organization recommends direct observation of treatment (DOT) to support patients with tuberculosis (TB) and to ensure treatment completion. As per national programme guidelines in India, a DOT provider can be anyone who is acceptable and accessible to the patient and accountable to the health system, except a family member. This poses challenges among children with TB who may be more comfortable receiving medicines from their parents or family members than from unfamiliar DOT providers. We conducted a non-inferiority trial to assess the effect of family DOT on treatment success rates among children with newly diagnosed TB registered for treatment during June–September 2012. Methods: We randomly assigned all districts (n = 30) in Gujarat to the intervention (n = 15) or usual-practice group (n = 15). Adult family members in the intervention districts were given the choice to become their child’s DOT provider. DOT was provided by a non-family member in the usual-practice districts. Using routinely collected clinic-based TB treatment cards, we compared treatment success rates (cured and treatment completed) between the two groups and the non-inferiority limit was kept at 5%. Results: Of 624 children with newly diagnosed TB, 359 (58%) were from intervention districts and 265 (42%) were from usual-practice districts. The two groups were similar with respect to baseline characteristics including age, sex, type of TB, and initial body weight. The treatment success rates were 344 (95.8%) and 247 (93.2%) (p = 0.11) among the intervention and usual-practice groups respectively. Conclusion: DOT provided by a family member is not inferior to DOT provided by a non-family member among new TB cases in children and can attain international targets for treatment success. Trial Registration: Clinical Trials Registry–India, National Institute of Medical Statistics (Indian Council of Medical Research) [ABSTRACT FROM AUTHOR]

Background: Reducing malnutrition through food supplementation is a critical component of the WHO End Tuberculosis (TB) strategy. A results-based financing (RBF) initiative in Madhya Pradesh, India—called Mukti—introduced an intensive nutrition intervention, including home visits, counseling, food basket distribution, and assistance in obtaining government benefits. Phase 1 of the program (Dhar District), implemented by ChildFund India (ChildFund) and funded by USAID, coincided with the COVID-19 lockdown in 2020. Under an RBF reimbursement scheme, ChildFund was paid based on treatment retention for 6 months and weight gain of 6 kg for adults. Methods: The evaluation used a mixed methods approach. Qualitative components included interviews with key informants and focus groups with program participants. Quantitative components included an analysis of program data (i.e., patient demographics, receipt of program services, and weight gain). An impact analysis of retention in treatment used data from a government database. A difference-in-differences model was used to compare results from baseline data and the program period for Dhar District to similar data for the adjacent Jhabua District. Results: The program was well implemented and appreciated by patients and providers. Patients received an average of 10.2 home visits and 6.2 food baskets. While all age and sex groups gained weight significantly over their 6-month treatment period, there was no program impact on treatment retention. Seventy-six percent of patients achieved both outcome goals. And though average program costs were under budget, ChildFund experienced a loss in the results-based financing scheme, which was covered by USAID to continue program expansion. Conclusions: Implementing a nutrition supplementation and education program for TB patients in India is feasible. The intervention improved weight gain despite COVID-19-related lockdowns. The Mukti program did not impact treatment retention, which was already high at baseline. Program costs were modest, but the results-based financing reimbursement scheme resulted in a loss for the implementer. Overall, the RBF model led to an increased focus on outcomes for program staff and other stakeholders, which led to more efficient service delivery. Future research should examine total costs (including donated staff time) more extensively to determine the cost-effectiveness of Mukti and similar interventions. [ABSTRACT FROM AUTHOR]

India has been implementing active case-finding (ACF) for TB among marginalised and vulnerable (high-risk) populations since 2017. The effectiveness of ACF cycle(s) is dependent on the use of appropriate screening and diagnostic tools and meeting quality indicators. To determine the number of ACF cycles implemented in 2021 at national, state (n = 36) and district (n = 768) level and quality indicators for the first ACF cycle. In this descriptive study, aggregate TB program data for each ACF activity that was extracted was further aggregated against each ACF cycle at the district level in 2021. One ACF cycle was the period identified to cover all the high-risk populations in the district. Three TB ACF quality indicators were calculated: percentage population screened (≥10%), percentage tested among screened (≥4.8%) and percentage diagnosed among tested (≥5%). We also calculated the number needed to screen (NNS) for diagnosing one person with TB (≤1538). Of 768 TB districts, ACF data for 111 were not available. Of the remaining 657 districts, 642 (98%) implemented one, and 15 implemented two to three ACF cycles. None of the districts or states met all three TB ACF quality indicators' cut-offs. At the national level, for the first ACF cycle, 9.3% of the population were screened, 1% of the screened were tested and 3.7% of the tested were diagnosed. The NNS was 2824: acceptable (≤1538) in institutional facilities and poor for population-based groups. Data were not consistently available to calculate the percentage of i) high-risk population covered, ii) presumptive TB among screened and iii) tested among presumptive. In 2021, India implemented one ACF cycle with sub-optimal ACF quality indicators. Reducing the losses between screening and testing, improving data quality and sensitising stakeholders regarding the importance of meeting all ACF quality indicators are recommended. [ABSTRACT FROM AUTHOR]

Background: TB is a preventable and treatable disease. Yet, successful treatment outcomes at desired levels are elusive in many national TB programs, including India. We aim to identify risk factors for unfavourable outcomes to TB treatment, in order to subsequently design a care model that would improve treatment outcomes among these at-risk patients.Methods: We conducted a cohort analysis among TB patients who had been recently initiated on treatment. The study was part of the internal program evaluation of a USAID-THALI project, implemented in select towns/cities of Karnataka and Telangana, south India. Community Health Workers (CHWs) under the project, used a pre-designed tool to assess TB patients for potential risks of an unfavourable outcome. CHWs followed up this cohort of patients until treatment outcomes were declared. We extracted treatment outcomes from patient's follow-up data and from the Nikshay portal. The specific cohort of patients included in our study were those whose risk was assessed during July and September, 2018, subsequent to conceptualisation, tool finalisation and CHW training. We used bivariate and multivariate logistic regression to assess each of the individual and combined risks against unfavourable outcomes; death alone, or death, lost to follow up and treatment failure, combined as 'unfavourable outcome'.Results: A significantly higher likelihood of death and experiencing unfavourable outcome was observed for individuals having more than one risk (AOR: 4.19; 95% CI: 2.47-7.11 for death; AOR 2.21; 95% CI: 1.56-3.12 for unfavourable outcome) or only one risk (AOR: 3.28; 95% CI: 2.11-5.10 for death; AOR 1.71; 95% CI: 1.29-2.26 for unfavourable outcome) as compared to TB patients with no identified risk. Male, a lower education status, an initial weight below the national median weight, co-existing HIV, previous history of treatment, drug-resistant TB, and regular alcohol use had significantly higher odds of death and unfavourable outcome, while age > 60 was only associated with higher odds of death.Conclusion: A rapid risk assessment at treatment initiation can identify factors that are associated with unfavourable outcomes. TB programs could intensify care and support to these patients, in order to optimise treatment outcomes among TB patients. [ABSTRACT FROM AUTHOR]