Vitalizing Community for Health Promotion Against Modifiable Risk Factors of Noncommunicable Diseases (V-CaN) in Rural Central India: Protocol for a Hybrid Type II Implementation Effectiveness Trial.

BACKGROUND: Low- and middle-income countries are facing the emerging burden of chronic noncommunicable diseases (NCDs). Apart from loss of human lives and premature deaths, NCDs result in huge costs for treatment to individuals and the health system. Although NCDs develop in later life, the risk factors begin at an early age. The key to the control of the global epidemic of NCDs is primary prevention based on comprehensive community-based programs. OBJECTIVE: This study aims to develop, implement, and evaluate the effect of a participatory health promotion initiative utilizing the existing mechanisms of Village Health Nutrition and Sanitation Committees (VHNSCs), women's self-help groups (SHGs), and schools on modifiable risk factors for NCDs among young people aged 10-30 years. METHODS: The proposed type II hybrid effectiveness implementation cluster randomized field trial will be conducted in the catchment area of 4 primary health centers (PHCs) in Wardha district, India, comprising 100 villages with a population of 144,000. Each PHC will be randomly allocated to one of the 3 intervention arms or the control arm. The 3-intervention arm PHCs will utilize a unique strategy with either VHNSC or SHG members or school students as change agents for health action against common modifiable NCD risk factors. This study will be implemented in 3 phases from January 2022 to December 2024. First, the preparatory phase for baseline assessments includes anthropometry, behavioral and biochemical risk factors for NCDs, and participatory development of the health promotion intervention modules. Second, the implementation phase will focus on capacity building of the change agents and implementation of the participatory health promotion initiative. The implementation will include organization of community-based events, 6-monthly participatory assessment of change, and preparation of a sustainability and exit plan toward the end of this phase. Third, the evaluation phase will consist of studying the effectiveness of each intervention strategy in the reduction of risk factor prevalence at the population level. RESULTS: We will assess 12,000 (3000 in each arm) randomly selected individuals for behavioral risk factors and 1600 (400 in each arm) individuals for biochemical risk factors during baseline as well as endline assessments. Difference in differences, ANOVA or multivariate analysis of covariance, and regression analysis will be performed to assess the effectiveness of the interventions. Qualitative methods such as focus group discussions and stories of change will be documented and analyzed using thematic framework analysis. The implementation outcomes will be reported using the PRISM (Practical Robust Implementation and Sustainability Model) RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. The results are expected to be published by mid-2025. CONCLUSIONS: This study will show the magnitude of risk factors for NCDs, its determinants, feasibility, effectiveness of community-based interventions, and health promotion models for NCD prevention. TRIAL REGISTRATION: Clinical Trials Registration India CTRI/2020/10/028700; https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47597&EncHid=&userName=V-CaN. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42450.

Determinants of adverse treatment outcomes among patients treated under Revised National Tuberculosis Control Program in Wardha, India: Case-control study.

BACKGROUND: Tuberculosis (TB) leads to a considerable loss of lung functions and Quality Adjusted Life Years. Several factors are associated with adverse treatment outcomes from TB which further increases this loss. We undertook the study to study the determinants of adverse treatment outcomes among tuberculosis patients treated under the Revised National Tuberculosis Control Program in a tuberculosis unit in India. METHODS: 88 cases and 187 controls from among patients registered in Wardha Tuberculosis Unit in the year 2014 were interviewed to study the determinants of adverse treatment outcomes of tuberculosis. All patients with adverse treatment outcomes were taken as cases. Controls were chosen from relapse free successfully treated patients using simple random sampling. RESULTS: On multivariate analysis indoor air pollution, pulmonary TB, discrimination due to TB and poor satisfaction with services significantly increased the odds of adverse treatment outcomes whereas the senior treatment supervisor visiting the patients during treatment was protective. CONCLUSION: Appropriate new interventions and strengthening of the existing mechanisms to reduce treatment interruptions along with proper implementation of the program will help in reducing the adverse treatment outcomes and improving program performance.

Recurrence of tuberculosis among newly diagnosed sputum positive pulmonary tuberculosis patients treated under the Revised National Tuberculosis Control Programme, India: A multi-centric prospective study.

INTRODUCTION: There is lack of information on the proportion of new smear-positive pulmonary tuberculosis (PTB) patients treated with a 6-month thrice-weekly regimen under Revised National Tuberculosis Control Programme (RNTCP) who develop recurrent TB after successful treatment outcome. OBJECTIVE: To estimate TB recurrence among newly diagnosed PTB patients who have successfully completed treatment and to document endogenous reactivation or re-infection. Risk factors for unfavourable outcomes to treatment and TB recurrence were determined. METHODOLOGY: Adult (aged ≥ 18 yrs) new smear positive PTB patients initiated on treatment under RNTCP were enrolled from sites in Tamil Nadu, Karnataka, Delhi, Maharashtra, Madhya Pradesh and Kerala. Those declared "treatment success" at the end of treatment were followed up with 2 sputum examinations each at 3, 6 and 12 months after treatment completion. MIRU-VNTR genotyping was done to identify endogenous re-activation or exogenous re-infection at TB recurrence. TB recurrence was expressed as rate per 100 person-years (with 95% confidence interval [95%CI]). Regression models were used to identify the risk factors for unfavourable response to treatment and TB recurrence. RESULTS: Of the1577 new smear positive PTB patients enrolled, 1565 were analysed. The overall cure rate was 77% (1207/1565) and treatment success was 77% (1210 /1565). The cure rate varied from 65% to 86%. There were 158 of 1210 patients who had TB recurrence after treatment success. The pooled TB recurrence estimate was 10.9% [95%CI: 0.2-21.6] and TB recurrence rate per 100 person-years was 12.7 [95% CI: 0.4-25]. TB recurrence per 100 person-years varied from 5.4 to 30.5. Endogenous reactivation was observed in 56 (93%) of 60 patients for whom genotyping was done. Male gender was associated with TB recurrence. CONCLUSION: A substantial proportion of new smear positive PTB patients successfully treated with 6 -month thrice-weekly regimen have TB recurrence under program settings.

Magnitude and determinants of adverse treatment outcomes among tuberculosis patients registered under Revised National Tuberculosis Control Program in a Tuberculosis Unit, Wardha, Central India: A record-based cohort study.

INTRODUCTION: Deaths, defaults, relapses, and treatment failures have made the control of TB difficult across the globe. METHODOLOGY: This study is a record-based follow-up of a cohort of patients registered under Revised National Tuberculosis Control Program in the year 2014 in Wardha Tuberculosis Unit, India. Data was collected from the records available at the District Tuberculosis Office. RESULTS: Data of 510 patients was analyzed. The sputum conversion rate was 88%. The overall treatment success rate was 81.9%, and rates of any adverse outcome, deaths, defaults, failure, and shift to Category IV regimen were 32.60/100 person years at risk (PYAR), 16.88/100 PYAR, 11.12/100 PYAR, 3.45/100 PYAR, and 1.15/100 PYAR, respectively. The median times for the above outcomes were 81days, 110days, 66days, 118days, and 237days, respectively. The cumulative probability of occurrence at 6months of any adverse outcome, deaths, default, failure, and shift to Category IV regimen was 0.145, 0.056, 0.088, 0.002, and 0.004, respectively. On multivariate analysis, the determinant of any adverse outcome was age >45years, whereas extrapulmonary disease was protective. The hazard of defaulting was also significantly higher in male patients and those aged >45years. CONCLUSION: Appropriate interventions and program implementation to reduce the adverse treatment outcomes and interruptions will help in improving program performance.