Feasibility randomised controlled trial of face-to-face counselling and mobile phone messages compared to usual care for smokeless tobacco cessation in Indian primary care: Project CERTAIN.

INTRODUCTION: Smokeless tobacco (SLT) use in low- and middle-income countries (LMICs) has adverse health consequences. We hypothesize that it is feasible to test an intervention of mobile phone messages and face-to-face counselling session for SLT cessation in India. METHODS: We conducted an exploratory, individual parallel two group, randomised controlled trial (RCT), with baseline -and end-point (three months from randomisation) assessments in urban primary health centres in Odisha, India. A total of 250 current (i.e., users in the last three months) SLT users or dual users (i.e., smokers and SLT users) were recruited to the trial (125 in each group). Participants were randomised to either routine care, face-to-face counselling, and reminder mobile messages or routine care only. The primary outcomes were to assess the feasibility of running a full RCT including recruitment, compliance, and retention. RESULTS: A total seven (77.8%) out of nine primary care centres took part in the trial. Out of the 315 SLT users invited to participate, 250 provided consent and were randomised [79.4% (95% CI: 74.5, 83.7)]. Out of the 250 randomised SLT users, 238 [95% (95% CI: 91.8, 97.5)] were followed up at three months (117 in the intervention group and 121 in the control group). Of the participants in the intervention group, 74 (63.8%) reported that they received the mobile messages. CONCLUSIONS: This exploratory trial demonstrated the feasibility of delivering and evaluating an intervention of mobile phone messages and face-to-face counselling for SLT users in Indian primary care in a full randomised trial. IMPLICATIONS: This study found that combining mobile messages with face-to-face counselling for smokeless tobacco users visiting primary health care settings in India is feasible in terms of recruitment of users, compliance with the intervention, and retention of study participants within the trial.The biochemically verified smokeless tobacco abstinence rate was higher in the intervention group compared with the control groupThere was poor agreement between self-reported tobacco cessation and the measured salivary cotinine in smokeless tobacco users.The findings support the feasibility and acceptability of the intervention signalling the need for a larger clinical trial to test effectiveness of the intervention.

Serosurveys to detect SARS-CoV-2 antibodies among high-risk groups in six urban cities of Odisha, India.

INTRODUCTION: Personnel involved in essential services or residing in high-risk areas during the COVID-19 pandemic are at increased risk of getting infected. We evaluated the proportion of personnel infected in several high-risk groups in Odisha using seroprevalence studies. METHODOLOGY: During July to November, 2020, individuals from multiple high-risk groups in 6 urban cities (Bhubaneswar, Berhampur, Cuttack, Malkangiri, Paralakhemundi, and Rourkela) in Odisha, India, were recruited to the study after obtaining written informed consent. Blood samples collected from the study participants were tested for IgG antibodies against COVID-19 in Roche Cobas e441 (Roche Diagnostics, Rotkreuz, Switzerland). Information on socio-demographic variables, association with a confirmed or suspected case, and other details were collected using an electronic data capture tool and analysed with a statistical software. RESULTS: The overall COVID-19 seroprevalence was 34.9% (95%CI 33.6-36.2) among the 5434 individuals. The seroprevalence varied from 21.8% (95% CI, 19.6-24.1) in Rourkela to 54.9% (95% CI, 51.5-58.2) in Bhubaneswar. Seropositivity was maximum among prisoners (47.7%), followed by municipality/ sanitation staff (43.5%), and other office going staff (40.8%). Multivariate logistic regression indicated that participants aged 18-29 years, 30-44 years, residents of slums and vending zone, municipality staff, prisoners, residents of urban cities Malkangiri, Cuttack, Paralakhemundi, Bhubaneswar and those with previous history of COVID-19 were independent co-relates of seropositivity. CONCLUSIONS: The risk of COVID-19 varied among the high-risk groups of Odisha. Periodic seroprevalence studies in future are essential to protect the high-risk personnel involved in frontline activities during the pandemic.

Designing a mobile health smokeless tobacco cessation intervention in Odisha, India: User and provider perspectives.

Objective: There is limited evidence on the development of mobile health (mHealth) interventions for smokeless tobacco (SLT) cessation, despite its widespread use in South Asia. This formative qualitative study explored the perceptions of tobacco users and healthcare providers (HCPs) regarding developing a mHealth intervention for SLT cessation. Methods: This was a qualitative study using in-depth interviews (IDIs) with tobacco users (n = 26) and primary care physicians (PCPs) (n = 5) and focus group discussions (FGDs) with counsellors (n = 2) in four urban primary health centres (UPHCs) in Berhampur, Odisha from February to March 2020. The data were coded and analysed by two researchers using a framework analysis method. The discussion guides and initial codes were developed based on the Transtheoretical Model (TTM) of behaviour change. Results: The results were elaborated under four themes: (1) Current scenario of SLT use; (2) Barriers and facilitators for quitting SLT; (3) Barriers and facilitators for mHealth counselling; and (4) Design and delivery of the proposed intervention. SLT use was prevalent in the community regardless of sociodemographic factors. Peer factors accounted for both tobacco consumption as well as considering cessation. Participants considered mobile message counselling helpful and acceptable. Not having a mobile phone and illiteracy were identified as barriers while ease of access and rising popularity of social media applications were considered facilitators to the use of mHealth for quitting tobacco. Participants preferred messages that were pictorial, short and simple, in the local language, and tailored to individual's needs. Conclusions: This is the first study that provides evidence within the Indian context that the text messaging platform may be used for delivering an SLT cessation intervention. The integration of a theoretical basis and research findings from target users can guide future intervention development.

Effect of feeding practices on nutritional status of infant and young children residing in urban slums of berhampur: A decision tree approach.

BACKGROUND: Appropriate infant and young child feeding (IYCF) practices in the early years of life will ensure optimal growth and development of the child. However, many children are not fed in the recommended way. OBJECTIVES: To assess the risk of malnutrition as a result of various feeding practice patterns among the children with the application of the decision tree algorithm. METHODS: It was a community-based cross-sectional study conducted in the urban slums of Berhampur Municipal Corporation in Ganjam District, Odisha, India, from January to December 2019. Among a sample of 360 children of 6-23 months, nutritional status and feeding practices were determined. Data were analyzed using R version 3.6.1 developed by R Foundation for Statistical Computing, Vienna, Austria. The effect of IYCF practices on nutritional status was explained with the decision tree method with the use of a Chi-squared automatic interaction detection algorithm. RESULTS: The prevalence of children with early initiation of breastfeeding (EIBF), exclusive breastfeeding (EBF), minimum meal frequency (MMF), and minimum dietary diversity (MDD) was 62.2%, 59.7%, 41.9%, and 19.4%, respectively. The prevalence of wasting, stunting, and underweight among the participants was 36.4%, 31.1%, and 35.3%, respectively. The significant factors which classified and predicted wasting were EBF, EIBF, and MDD, for stunting factors were EBF, MMF, and MDD and for underweight, significant factors were EBF, EIBF, and MDD. CONCLUSION: With the decision tree approach, the probability of malnutrition in relation to various feeding practices patterns can be easily explained to the mothers and health workers as compared to interpreting odds ratio and strict adherence to IYCF guidelines can also be ensured.

Serological surveys to inform SARS-CoV-2 epidemic curve: a cross-sectional study from Odisha, India.

This was a population based cross-sectional study carried out to estimate and compare the seroprevalence, hidden prevalence and determine the demographic risk factors associated with SARS-CoV-2 infection among adults in the three largest cities of Odisha, India, and ascertain the association with the progression of the epidemic. The survey carried out in August 2020 in the three largest cities of the state of Odisha, India. Blood samples were collected from the residents using random sampling methods and tested for anti- SARS CoV-2 antibodies using an automated CLIA platform. A total of 4146 participants from the 3 cities of Bhubaneswar (BBS), Berhampur (BAM) and Rourkela (RKL) participated. The female to male participation ratio was 5.9:10 across the three cities. The gender weighted seroprevalence across the three cities was 20.78% (95% CI 19.56-22.05%). While females reported a higher seroprevalence (22.8%) as compared to males (18.8%), there was no significant difference in seroprevalence across age groups. A majority of the seropositive participants were asymptomatic (90.49%). The case to infection ratio on the date of serosurvey was 1:6.6 in BBS, 1:61 in BAM and 1:29.8 in RKL. The study found a high seroprevalence against COVID-19 in urban Odisha as well as high numbers of asymptomatic infections. The epidemic curves had a correlation with the seroprevalence.

A trend analysis of animal bite cases attending a Tertiary Care Hospital, Odisha during COVID lockdown.

A nationwide lockdown was imposed from March 25, 2020, to curb the spread of the COVID-19 pandemic. The study aimed to analyze the trend, pattern of animal bite cases and to quantify the reduction in the incidence of animal bite cases due to diminution of exposure time with animals as a result of lockdown. The interrupted time series method was used to evaluate the effect of lockdown on the incidence of animal bite cases. Right after the lockdown, the mean number of reported animal bite cases decreased significantly (P = 0.04) by 8.3%. Furthermore, the month-to-month change of cases for the postlockdown period was in decreasing trend (ß3 = 0.872) and was significant (P < 0.05). Reduction in the exposure time with street animal surely reduce the incidence in animal bite cases and hence, the Government should take appropriate actions to control the intermixing of street dogs with marginal populations at the village and urban slums level.

Safety and immunogenicity study of a new purified chick embryo cell rabies vaccine Vaxirab-N (Pitman-Moore strain) manufactured in India.

Zydus Cadila Health care, India developed a new purified chick embryo cell rabies vaccine (PCECV, Vaxirab-N; 1 mL) by adapting Pitman-Moore strain of virus on to the chick embryo fibroblast cell line in 2006. During 2007-10, a series of safety and immunogenicity studies were conducted as per ICH-GCP guidelines after obtaining permission from Drug Controller General of India. In the first study, Vaxirab-N was administered to 35 healthy adult volunteers by intramuscular (IM) route using pre exposure regimen. The geometric mean concentration (GMC) of rabies virus neutralizing antibody (RvnAb) of 7.5 IU/mL on day 35. In the second study, Vaxirab-N was administered to 35 healthy adult volunteers using simulated post- exposure prophylaxis regimen by IM route. A GMC of 6.3 IU/mL on day 14, 13.2 IU/mL on day 28 and 8.6 IU/mL on day 90 was obtained. In the third study, Vaxirab-N administered by intradermal (ID) route using Updated Thai Red Cross (TRC) regimen in 36 healthy adult volunteers showed GMC of 7.8 IU/mL on day 14, 11.5 IU/mL on day 28 and 6.0 IU/mL on day 90. The 4th study was multi centric and Vaxirab-N was administered to 129 animal bite cases by IM route using post-exposure Essen regimen. The GMC following this schedule was 8.2 IU/mL on day 14, 13.01 IU/mL on day 28, 7.92 IU/mL on day 90 and 3.72 IU/mL on day 180. Mild to moderate adverse events were reported to Vaxirab-N but no serious adverse events were reported in any of these studies. In conclusion, Vaxirab-N developed by Zydus Cadila was found to be safe and immunogenic by both intramuscular and intradermal route and is recommended for rabies prophylaxis (CTRI No. 2010/091/000055 and 2010/091/000509).