Tobacco Cessation Program among Cab Drivers in Mumbai, India: An Interventional Study.

Background: Tobacco epidemic is one of the biggest public health threats, killing nearly seven million people annually. With implementation of smoke-free public places legislation, cabs in India are smoke free. However, large majority of cab drivers are addicted to tobacco. Aims: The objectives were to measure cab drivers' knowledge, attitude, and practices about tobacco pre and post intervention, educate them regarding hazards of tobacco and need for smoke-free cabs, perform oral cancer screening, and provide assistance to quit tobacco. Subjects and Methods: This interventional study among cab drivers was conducted in Mumbai during 2015-2018. Different cab unions in Mumbai were contacted and 400 cab drivers were enrolled and interviewed. They were offered health education, oral cancer screening, and tobacco cessation assistance at regular intervals for 1 year. Results: About 63.8% of cab drivers used tobacco, mainly in smokeless forms. Almost 94.1% intended to quit, 66.3% had made previous quit attempts, and 69.8% expressed the need of assistance for quitting. One hundred and twelve cab drivers were diagnosed with oral precancers and one with oral carcinoma. About 49.4% of cab drivers quit tobacco and 46.7% reduced tobacco consumption at the end of 1 year. According to multivariate logistic regression analysis, Muslim cab drivers were less likely to quit tobacco as compared to Hindus. Conclusion: Adherence to smoke-free laws plays a significant role in reducing exposure of cab drivers to secondhand smoke. This program demonstrates the successful implementation of tobacco cessation program that could be replicated among other workforces.

Effect of screening by clinical breast examination on breast cancer incidence and mortality after 20 years: prospective, cluster randomised controlled trial in Mumbai.

OBJECTIVE: To test the efficacy of screening by clinical breast examination in downstaging breast cancer at diagnosis and in reducing mortality from the disease, when compared with no screening. DESIGN: Prospective, cluster randomised controlled trial. SETTING: 20 geographically distinct clusters located in Mumbai, India, randomly allocated to 10 screening and 10 control clusters; total trial duration was 20 years (recruitment began in May 1998; database locked in March 2019 for analysis). PARTICIPANTS: 151 538 women aged 35-64 with no history of breast cancer. INTERVENTIONS: Women in the screening arm (n=75 360) received four screening rounds of clinical breast examination (conducted by trained female primary health workers) and cancer awareness every two years, followed by five rounds of active surveillance every two years. Women in the control arm (n=76 178) received one round of cancer awareness followed by eight rounds of active surveillance every two years. MAIN OUTCOME MEASURES: Downstaging of breast cancer at diagnosis and reduction in mortality from breast cancer. RESULTS: Breast cancer was detected at an earlier age in the screening group than in the control group (age 55.18 (standard deviation 9.10) v 56.50 (9.10); P=0.01), with a significant reduction in the proportion of women with stage III or IV disease (37% (n=220) v 47% (n=271), P=0.001). A non-significant 15% reduction in breast cancer mortality was observed in the screening arm versus control arm in the overall study population (age 35-64; 20.82 deaths per 100 000 person years (95% confidence interval 18.25 to 23.97) v 24.62 (21.71 to 28.04); rate ratio 0.85 (95% confidence interval 0.71 to 1.01); P=0.07). However, a post hoc subset analysis showed nearly 30% relative reduction in breast cancer mortality in women aged 50 and older (24.62 (20.62 to 29.76) v 34.68 (27.54 to 44.37); 0.71 (0.54 to 0.94); P=0.02), but no significant reduction in women younger than 50 (19.53 (17.24 to 22.29) v 21.03 (18.97 to 23.44); 0.93 (0.79 to 1.09); P=0.37). A 5% reduction in all cause mortality was seen in the screening arm versus the control arm, but it was not statistically significant (rate ratio 0.95 (95% confidence interval 0.81 to 1.10); P=0.49). CONCLUSIONS: These results indicate that clinical breast examination conducted every two years by primary health workers significantly downstaged breast cancer at diagnosis and led to a non-significant 15% reduction in breast cancer mortality overall (but a significant reduction of nearly 30%in mortality in women aged ≥50). No significant reduction in mortality was seen in women younger than 50 years. Clinical breast examination should be considered for breast cancer screening in low and middle income countries. TRIAL REGISTRATION: Clinical Trials Registry of India CTRI/2010/091/001205; ClinicalTrials.gov NCT00632047.

Cervical Cancer Screening in Low Resource Settings: Cytology versus HPV Triage for VIA Positive Women.

BACKGROUND: The objective of the study is to comparatively evaluate performance of human papillomavirus (HPV) hybrid capture 2 (HC2) and cytology as triage tests among visual inspection after application of 3-5% acetic acid (VIA) screen positive women, thus aiming to reduce the referral burden. METHODS: The community-based cross sectional cervical cancer screening with VIA was conducted among women aged between 30 and 65, residing in selected low socio-economic areas of Mumbai, India, during October 2010-March 2017. After obtaining informed consent, delivering health education and collecting socio-demographic data, participants were offered VIA screening by trained primary health workers. The VIA screen positive women underwent cytology, HPV HC2 and diagnostic colposcopy at nodal hospital. Women with positive colposcopy underwent cervical biopsies. RESULTS: 231 VIA positive women underwent cytology and HPV HC2 test, followed by colposcopy. Cervical biopsies were obtained in 83 cases. The sensitivity and specificity in detecting ≥ CIN 2 were 77.8 and 92.3 for HC2 and 66.7 and 98.2 for cytology. The false positivity and negativity rates were 7.7 and 22.2 for HC2 and 1.8 and 33.3 for cytology. CONCLUSIONS: HPV HC2 reduces referrals to larger extent and misses fewer cases compared to cytology, thus appearing a better triage test among VIA positive women.

Smokeless tobacco use and oral neoplasia among urban Indian women.

OBJECTIVES: Oral cavity cancers are fourth most common cancers among Indian women. The objectives were to create cancer awareness (CA) and screen tobacco-using women for oral cavity cancers. MATERIALS AND METHODS: A community-based CA and screening programme was conducted among women in Mumbai, India. The tobacco-using women participated in CA and oral cavity screening by oral visual inspection (OVI). All screen-positive women were referred to nodal hospital and assisted for diagnostic confirmation and treatment completion. RESULTS: Twelve slum clusters comprising of 138,383 population and 13,492 tobacco-using women have been covered. Among them, 11,895 (88.2%) participated in CA and 11,768 (87.2%) in OVI. A total of 377 (3.2%) women were screened positive, 275 (72.9%) complied with referral and 207 oral precancers [173 leukoplakia, 9 erythroplakia, 3 erythroleukoplakia and 41 sub-mucus fibrosis (SMF) including 35 women with multiple precancers] and 7 oral cancers were diagnosed. The detection rate of oral precancerous lesions and oral cancers was 17.6 and 0.6 per 1,000 screened women. Thirty-five women had multiple oral precancerous lesions. The results of multivariate analysis indicate dose-response relationship between tobacco use and risk of oral precancers. CONCLUSION: Good participation rates (>85%) for cancer awareness and OVI were seen among urban slum women in India. Many oral precancer and cancer cases were detected and were managed at the nodal hospital.

Evaluation of cytology as secondary triage in visual inspection after application of 4% acetic acid-based cervical cancer screening program.

CONTEXT BACKGROUND: Visual-based screening techniques are low cost and have good sensitivity. Hence, they appear promising for primary screening in low-resource settings. However, to reduce referrals for diagnostic colposcopy, there is need to triage these screen-positive women with test with good specificity. AIMS: The study aims to evaluate the performance of cytology as triage for visual inspection after application of 4% acetic acid (VIA) screen-positive women. SETTINGS AND DESIGN: Community-based cervical cancer screening using VIA was implemented among socioeconomically disadvantaged women in Mumbai, India. METHODS: Cytology was performed on screen-positive women. All primarily screen-positive women underwent colposcopy. Directed biopsies were obtained among women with positive findings on colposcopy. The gold standard used for final disease status was histopathology or negative colposcopy. STATISTICAL ANALYSIS USED: Test characteristics of cytology as triage test. RESULTS: Among the 138,383 population, 16,424 eligible women were screened with VIA. 785 (4.78%) women were VIA positive and 580 women participated in triage with cytology. The sensitivity and specificity of cytology at threshold of atypical squamous cells of undetermined significance in detecting ≥cervical intraepithelial neoplasia (CIN) 2 were 75.0 and 94.7, respectively. The positive and negative predictive values of cytology as triage test were 23.1 and 99.4, respectively, and the false positivity and false negativity rates were 5.34 and 25.0, respectively. CONCLUSION: Cytology triage with VIA can reduce referrals for colposcopy to 4.97% of original referrals but may miss around 25%, of high-grade CIN. The substantial reduction in referrals has special implication for low-resource settings, wherein compliance to referral and availability of diagnostic facilities are poor.

Smokeless tobacco use in Urban Indian women: Prevalence and predictors.

CONTEXT: India is the second largest consumer of tobacco. Tobacco consumption in nonsmoking forms is culturally accepted even among women. AIMS: This study aimed at understanding the patterns and predictors of smokeless tobacco (SLT) use among the urban low-socioeconomic women in Mumbai, India. MATERIALS AND METHODS: This is a cross-sectional community-based survey of tobacco usage among women residing in seven low-socioeconomic communities in suburbs of Mumbai, India. Staff for the study was recruited, trained, clusters selected, accurately mapped, households identified, meetings held with community leaders, and household surveys conducted. Women using tobacco were invited to participate in the detailed survey and interviewed to document the various sociodemographic factors and in depth information on tobacco use. The data were computerized and analyzed. RESULTS: About 22.30% of the total female population consumed tobacco, mainly in the smokeless forms, with only 0.50% of the tobacco users using smoked tobacco. Masheri was the most common form of tobacco used, followed by chewing tobacco. The median frequency of use of different tobacco products varied from 2 to 4 per day. The mean age at initiation of tobacco was 26.23 years. According to the results of univariate and multivariate logistic regression analysis, illiterate women, with advancing age, belonging to Hindu, Muslim, or Buddhist communities, who were either manual laborers or housewives, divorced or separated, and speaking Marathi were at higher risk of being tobacco user. CONCLUSION: Patterns and predictors of SLT use among women have been identified in the present study. This will guide in planning prevention and control strategies.

Effect of VIA screening by primary health workers: randomized controlled study in Mumbai, India.

BACKGROUND: Cervical cancer is the leading cause of cancer mortality among women in India. Because Pap smear screening is not feasible in India, we need to develop effective alternatives. METHODS: A cluster-randomized controlled study was initiated in 1998 in Mumbai, India, to investigate the efficacy of visual inspection with acetic acid (VIA) performed by primary health workers in reducing cervical cancer mortality. Four rounds of cancer education and VIA screening were conducted at 24-month intervals in the screening group, whereas cancer education was offered once at entry to the control group. The study was planned for 16 years to include four screening rounds followed by four monitoring rounds. We present results after 12 years of follow-up. Poisson regression method was used to calculate the rate ratios (RRs); two-sided χ(2) was used to calculate the probability. RESULTS: We recruited 75360 women from 10 clusters in the screening group and 76178 women from 10 comparable clusters in the control group. In the screening group, we achieved 89% participation for screening and 79.4% compliance for diagnosis confirmation. The incidence of invasive cervical cancer was 26.74 per 100000 (95% confidence interval [CI] = 23.41 to 30.74) in the screening group and 27.49 per 100000 (95% CI = 23.66 to 32.09) in the control group. Compliance to treatment for invasive cancer was 86.3% in the screening group and 72.3% in the control group. The screening group showed a statistically significant 31% reduction in cervical cancer mortality (RR = 0.69; 95% CI = 0.54 to 0.88; P = .003). CONCLUSIONS: VIA screening by primary health workers statistically significantly reduced cervical cancer mortality. Our study demonstrates the efficacy of an easily implementable strategy that could prevent 22000 cervical cancer deaths in India and 72600 deaths in resource-poor countries annually.

Cancer screening for women living in urban slums--acceptance and satisfaction.

BACKGROUND AND OBJECTIVES: Preventable cancers like cancers of cervix, breast and oral cavity claim more than 142,500 lives of Indian women annually. Mobile cancer screening may help in early detection and successful treatment in vulnerable populations. METHODS: This is a community based mobile cancer screening program in co-ordination with various non-governmental organizations. Participants included 182 women from low socio-economic background residing in Mumbai. Around twenty five consenting women were screened in each of the eight camps conducted. Health education programme (HEP) was given before screening. Tests included clinical breast examination (CBE) for breast , visual inspection with 5% acetic acid (VIA), visual inspection with lugols iodine (VILI) followed by colposcopic examination for cervix and oral visual examination (OVE) for oral cavity. Women requiring further diagnostic tests were referred to the nodal hospital. A satisfaction survey was carried out at the end of the examination. RESULTS: Out of 182 women screened, 179 received health education. More than 90% of the participants were satisfied with the various aspects of screening. Majority (90%) of them found the mobile screening facility more convenient and accessible than static site screening. The variables age and income were found to be significantly associated with the overall satisfaction of the participants. The satisfaction level regarding information given during HEP was moderate (74%) compared to other factors. INTERPRETATION AND CONCLUSION: The overall acceptance and satisfaction levels were encouraging with the mobile cancer screening programme. Such a facility can act as an important tool in cancer prevention and control in low socio-economic women.

Level of cancer awareness among women of low socioeconomic status in Mumbai slums.

BACKGROUND: Cancer, a major cause of morbidity and mortality in India can be prevented by early detection through screening, for which, awareness is essential. AIM: Determining cancer awareness among low socioeconomic women in Mumbai. SETTINGS AND DESIGN: Community based cancer screening study using a mobile van. MATERIALS AND METHODS: Data of consenting participants, collected using structured questionnaire, was differentiated into good and poor level of awareness using point based grading procedure. results: Mean age of 182 participants, majority (90.5%) belonging to lower socioeconomic strata, was 43.0∓8.8 years. Knowledge about cancer (84.6%) was good compared to knowledge of cancer screening (35.1%), awareness being higher among richer and more educated. Major sources of information were friends or relatives (46.1%) and media (35.2%). Only 6.6% had undergone prior screening. CONCLUSION: In spite of appreciable knowledge about cancer, creating awareness about screening, its availability, and motivating the general population for screening is necessary.

A cluster randomized, controlled trial of breast and cervix cancer screening in Mumbai, India: methodology and interim results after three rounds of screening.

Cervix and Breast cancers are the most common cancers among women worldwide and extract a large toll in developing countries. In May 1998, supported by a grant from the NCI (US), the Tata Memorial Hospital, Mumbai, India, started a cluster-randomized, controlled, screening-trial for cervix and breast cancer using trained primary health workers to provide health-education, visual-inspection of cervix (with 4% acetic acid-VIA) and clinical breast examination (CBE) in the screening arm, and only health education in the control arm. Four rounds of screening at 2-year intervals will be followed by 8 years of monitoring for incidence and mortality from cervix and breast cancers. The methodology and interim results after three rounds of screening are presented here. Good randomization was achieved between the screening (n = 75360) and control arms (n = 76178). In the screening arm we see: High screening participation rates; Low attrition; Good compliance to diagnostic confirmation; Significant downstaging; Excellent treatment completion rate; Improving case fatality ratios. The ever-screened and never-screened participants in the screening arm show significant differences with reference to the variables religion, language, age, education, occupation, income and health-seeking behavior for gynecological and breast-related complaints. During the same period, in the control arm we see excellent participation rate for health education; Low attrition and a good number of symptomatic referrals for both cervix and breast.

Workplace tobacco cessation program in India: A success story.

CONTEXT: This paper describes the follow-up interventions and results of the work place tobacco cessation study. AIMS: To assess the tobacco quit rates among employees, through self report history, and validate it with rapid urine cotinine test; compare post-intervention KAP regarding tobacco consumption with the pre-intervention responses and assess the tobacco consumption pattern among contract employees and provide assistance to encourage quitting. SETTINGS AND DESIGN: This is a cohort study implemented in a chemical industry in rural Maharashtra, India. MATERIALS AND METHODS: All employees (104) were interviewed and screened for oral neoplasia. Active intervention in the form of awareness lectures, focus group discussions and if needed, pharmacotherapy was offered. Medical staff from the industrial medical unit and from a local referral hospital was trained. Awareness programs were arranged for the family members and contract employees. STATISTICAL ANALYSIS USED: Non-parametric statistical techniques and kappa. RESULTS: Forty eight per cent employees consumed tobacco. The tobacco quit rates increased with each follow-up intervention session and reached 40% at the end of one year. There was 96% agreement between self report tobacco history and results of rapid urine cotinine test. The post-intervention KAP showed considerable improvement over the pre-intervention KAP. 56% of contract employees used tobacco and 55% among them had oral pre-cancerous lesions. CONCLUSIONS: A positive atmosphere towards tobacco quitting and positive peer pressure assisting each other in tobacco cessation was remarkably noted on the entire industrial campus. A comprehensive model workplace tobacco cessation program has been established, which can be replicated elsewhere.

Establishing a model workplace tobacco cessation program in India.

BACKGROUND: Tobacco use is highly prevalent and culturally accepted in rural Maharashtra, India. AIMS: To study the knowledge, attitude, and practices (KAP) regarding tobacco consumption, identify reasons for initiation and continuation of tobacco use, identify prevalence of tobacco consumption and its relation with different precancerous lesions, provide professional help for quitting tobacco, and develop local manpower for tobacco cessation activities. SETTINGS, DESIGN, METHODS AND MATERIAL: The present study was conducted for one year in a chemical industrial unit in Ratnagiri district. All employees (104) were interviewed and screened for oral neoplasia. Their socio-demographic features, habits, awareness levels etc. were recorded. Active intervention in the form of awareness lectures, focus group discussions, one-to-one counseling and, if needed, pharmacotherapy was offered to the tobacco users. RESULTS: All employees actively participated in the program. Overall, 48.08% of the employees were found to use tobacco, among which the smokeless forms were predominant. Peer pressure and pleasure were the main reasons for initiation of tobacco consumption, and the belief that, though injurious, it would not harm them, avoiding physical discomfort on quitting and relieving stress were important factors for continuation of the habit. Employees had poor knowledge regarding the ill-effects of tobacco. 40% of tobacco users had oral precancerous lesions, which were predominant in employees consuming smokeless forms of tobacco. CONCLUSIONS: Identifying reasons for initiation and continuation of tobacco consumption along with baseline assessment of knowledge, attitudes, and practices regarding tobacco use, are important in formulating strategies for a comprehensive workplace tobacco cessation program.

Determinants of compliance in a cluster randomised controlled trial on screening of breast and cervix cancer in Mumbai, India. 1. Compliance to screening.

OBJECTIVES: This study aims to investigate the efficacy of screening by low-cost technology in down-staging and reducing mortality due to breast and cervix cancer. METHODS: The present trial is a community-based, cluster randomised controlled cohort study on screening for breast and cervix cancers (clinical breast examination and visual inspection of the cervix after application of 4% acetic acid). Univariate and multivariate logistic regression analyses are conducted to identify the predictors of participation in screening. RESULTS: The average compliance is 71.43 and 64.93% for breast and cervix cancer screening, respectively, with the highest compliance in round 1. At the end of 3 screening rounds, 94 and 84% of the eligible women were screened at least once for breast and cervix cancer, respectively. Younger women, women from other than Hindu and Muslim communities, school level-educated women, women belonging to lower-income families, Marathi-speaking women, married women and women who had previously consulted for any breast or gynaecological complaints had higher compliance to participation in screening. CONCLUSIONS: Good compliance rates to screening have been demonstrated in the trial, reflecting acceptance of the study by the society, which has implications while translating the trial into a programme.

Determinants of compliance in a cluster randomised controlled trial on screening of breast and cervix cancer in mumbai, India. 2. Compliance to referral and treatment.

OBJECTIVES: The study aims to investigate the efficacy of screening by low-cost technology in down-staging and reduction of mortality due to breast and cervix cancer. METHODS: The present trial is a community-based, cluster randomised controlled cohort study on screening for breast and cervix cancers (clinical breast examination and visual inspection of the cervix after application of 4% acetic acid). Univariate and multivariate logistic regression analyses are conducted to identify the predictors of compliance to referral among screen-positive women and to treatment among cancer cases. RESULTS: The compliance to diagnostic investigations is 73% among screen-positive women referred for breast cancer and 79% among women referred for cervix cancer. Younger women, women working in service or being self-employed, school level-educated women, mother tongue Marathi, participation in screening in all 3 rounds and women referred as screen positive for cervix cancer had higher compliance to diagnostic investigations. The compliance to treatment completion is higher in women diagnosed with breast cancer, at 95%, compared to 86% for cervix cancers and 81% for cervix pre-cancers. CONCLUSIONS: Good compliance rates along with a proper system of referral, further investigations, confirmation of diagnosis and treatment as demonstrated in this trial are crucial for successful screening programmes.