Surviving the Storm: The Impact of COVID-19 on Cervical Cancer Screening in Low- and Middle-Income Countries.

According to the Center for Disease Control and Prevention's National Breast and Cervical Cancer Early Detection Program, the cervical cancer screening rate dropped by 84% soon after the declaration of the COVID-19 pandemic. The challenges facing cervical cancer screening were largely attributed to the required in-person nature of the screening process and the measures implemented to control the spread of the virus. While the impact of the COVID-19 pandemic on cancer screening is well-documented in high-income countries, less is known about the low- and middle-income countries that bear 90% of the global burden of cervical cancer deaths. In this paper, we aim to offer a comprehensive view of the impact of COVID-19 on cervical cancer screening in LMICs. Using our study, "Prevention of Cervical Cancer in India through Self-Sampling" (PCCIS), as a case example, we present the challenges COVID-19 has exerted on patients, healthcare practitioners, and health systems, as well as potential opportunities to mitigate these challenges.

Impact of age at vaccination and cervical HPV infection status on binding and neutralizing antibody titers at 10 years after receiving single or higher doses of quadrivalent HPV vaccine.

Long-term follow-up of a cohort of unmarried girls who received one, two, or three doses of quadrivalent HPV vaccine, between 10 and 18 years of age, in an Indian multi-centric study allowed us to compare antibody responses between the younger and older age cohorts at 10-years post-vaccination, and study the impact of initiation of sexual activity and cervical HPV infections on antibody levels. Among the younger (10-14 years) recipients of a single dose, 97.7% and 98.2% had detectable binding antibody titers against HPV 16 and HPV 18 respectively at ten years post-vaccination. The proportions among those receiving a single dose at age 15-18 years were 92.3% and 94.2% against HPV 16 and HPV 18 respectively. Mean HPV 16 binding antibody titers were 2.1 folds (95%CI 1.4 to 3.3) higher in those vaccinated at ages 10-14 years, and 1.9 folds (95%CI 1.2 to 3.0) higher in those vaccinated at 15-18 years compared to mean titers seen in the unvaccinated women. Compared to previous timepoints of 36 or 48 months, binding antibodies against HPV 16 and neutralizing antibodies against both HPV 16 and HPV 18 were significantly higher at 10 years. This rise was more pronounced in participants vaccinated at 15-18 years. No association of marital status or cervical HPV infections was observed with the rise in titer. Durability of antibody response in single dose recipients correlated well with the high efficacy of a single dose against persistent HPV 16/18 infections irrespective of age at vaccination, as we reported earlier.

Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 9-14 years versus an established quadrivalent HPV vaccine in women aged 15-26 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial.

BACKGROUND: To meet global cervical cancer elimination efforts, a wider range of affordable and accessible vaccines against human papillomavirus (HPV) are needed. We aimed to evaluate the immunogenicity and safety of a quadrivalent HPV vaccine (targeting HPV types 6, 11, 16, and 18), developed and manufactured by the Serum Institute of India (SIIPL). Here we report outcomes in the 9-14 years cohort. METHODS: This randomised, active-controlled, phase 2/3 trial was conducted at 12 tertiary care hospitals across India. Healthy participants aged 9-14 years or 15-26 years with no history of HPV vaccination were eligible for enrolment. Female participants were randomly assigned (1:1) with an interactive web response system, by use of a central computer-generated schedule and block randomisation (block sizes of 2, 4, 6, and 8), to receive the SIIPL quadrivalent HPV vaccine (Cervavac; SIIPL, Pune, India) or the comparator quadrivalent HPV vaccine (Gardasil; Merck Sharp & Dohme, Harleem, the Netherlands). Participants, investigators, laboratory technicians, and sponsors were masked to treatment allocation of female participants. Male participants were given the SIIPL quadrivalent HPV vaccine in an open-label manner. Study vaccines were administered intramuscularly with a two-dose schedule (at day 0 and 6 months) in the cohort aged 9-14 years, and with a three-dose schedule (at day 0, month 2, and month 6) in the cohort aged 15-26-years. Immunogenicity was assessed 30 days after the last dose by use of multiplexed ELISA. The primary outcome was the non-inferiority of immune response in terms of the geometric mean titre (GMT) of antibodies against HPV types 6, 11, 16, and 18 generated by the SIIPL quadrivalent HPV vaccine in girls and boys (aged 9-14 years) compared with the GMT generated by the comparator quadrivalent HPV vaccine in women aged 15-26 years at month 7 in the modified per-protocol population (ie, all participants who received all doses of study vaccines per assigned treatment group and had both day 0 and 1-month immunogenicity measurements after the last dose following protocol-defined window periods with no major protocol deviations). Non-inferiority was established if the lower bound of the 98·75% CI of the GMT ratio was 0·67 or higher. The co-primary outcome of occurrence of solicited adverse events (within 7 days of each dose) and unsolicited adverse events (up to 30 days after the last dose) was assessed in all participants who were enrolled and received at least one dose of study vaccine. The trial is registered with the Clinical Trials Registry - India (CTRI/2018/06/014601), and long-term follow-up is ongoing. FINDINGS: Between Sept 20, 2018, and Feb 9, 2021, 2341 individuals were screened, of whom 2307 eligible individuals were enrolled and vaccinated: 1107 (738 girls and 369 boys) in the cohort aged 9-14 years and 1200 (819 women and 381 men) in the cohort aged 15-26 years. No race or ethnicity data were collected. 350 girls and 349 boys in the SIIPL quadrivalent HPV vaccine group and 338 women in the comparator vaccine group were included in the modified per-protocol population for the primary endpoint analysis. The median follow-up for the analyses was 221 days (IQR 215-231) for girls and 222 days (217-230) for boys in the SIIPL quadrivalent HPV vaccine group, 223 days (216-232) for girls in the comparator vaccine group, and 222 days (216-230) for women in the comparator vaccine group. GMT ratios were non-inferior in girls and boys receiving the SIIPL quadrivalent HPV vaccine compared with women receiving the comparator vaccine: GMT ratios for girls were 1·97 (98·75% CI 1·67-2·32) for HPV type 6, 1·63 (1·38-1·91) for HPV type 11, 1·90 (1·60-2·25) for HPV type 16, and 2·16 (1·79-2·61) for HPV type 18. For boys the GMT ratios were 1·86 (1·57-2·21) for HPV type 6, 1·46 (1·23-1·73) for HPV type 11, 1·62 (1·36-1·94) for HPV type 16, and 1·80 (1·48-2·18) for HPV type 18. The safety population comprised all 1107 participants (369 girls and 369 boys in the SIIPL quadrivalent HPV vaccine group, and 369 girls in the comparator group). Solicited adverse events occurred in 176 (48%) of 369 girls and 124 (34%) of 369 boys in the SIIPL vaccine group and 179 (49%) of 369 girls in the comparator vaccine group. No grade 3-4 solicited adverse events occurred within 7 days of each dose. Unsolicited adverse events occurred in 143 (39%) girls and 147 (40%) boys in the SIIPL vaccine group, and 143 (39%) girls in the comparator vaccine group. The most common grade 3 unsolicited adverse event was dengue fever, in one (<1%) girl in the SIIPL vaccine group and three (1%) girls in the comparator group. There were no grade 4 or 5 adverse events. Serious adverse events occurred in three (1%) girls and three (1%) boys in the SIIPL vaccine group, and five (1%) girls in the comparator vaccine group. No vaccine-related serious adverse events were reported. There were no treatment-related deaths. INTERPRETATION: We observed a non-inferior immune response with the SIIPL quadrivalent HPV vaccine in girls and boys aged 9-14 years and an acceptable safety profile compared with the comparator vaccine. These findings support extrapolation of efficacy from the comparator vaccine to the SIIPL quadrivalent HPV vaccine in the younger population. The availability of the SIIPL quadrivalent HPV vaccine could help meet the global demand for HPV vaccines, and boost coverage for both girls and boys globally. FUNDING: Biotechnology Industry Research Assistance Council, Department of Biotechnology (DBT), Government of India, and Serum Institute of India.

Novel educational training of para medical professionals in cervical cancer screening.

Background: Cervical cancer is a public health problem in India due to weak national screening policy compounded by lack of resources including scarcity of trained personnel to carry out community-based screening program. Para medical professionals (PMPs) are closely related to women in local communities. Hence, training PMPs by incorporating novel technology and reduced time duration to achieve adequate competence in screening is an area underutilized and needs to be explored. Materials and methods: A pilot cross sectional analytical study was conducted at a tertiary referral cancer center using a shorter version of educational intervention of 2 weeks duration (EI2W) involving PMPs. Pre- and post-training assessment of knowledge, attitude, and practice (KAP) was done using questionnaires consisting of 5 domains viz. awareness of cervical cancer, awareness of cervical pre-cancer, practical screening methodology (practice oriented), data management and aspects of human papilloma virus (HPV). Wilcoxon signed-rank test was used for comparison and the degree of change was measured using analysis of covariance (ANCOVA). A p value of <0.05 was considered significant. Results: 118 PMPs were included. There was a significant improvement in scores of all domains (except cervical pre-cancer domain), following introduction of EI2W. Knowledge scores, post EI2W was better in Auxiliary Nurse Midwives (ANMs) than other participants. Awareness regarding cervical cancer was higher with more years of experience. The KAP analysis showed excellent interrater reliability in the practice 0.726 (0.649-0.792) followed by knowledge domain 0.711 (0.626-0.783). Conclusion: EI2W was effective in significantly improving the competence of PMPs, thus reducing human resource constraints in cervical cancer prevention and elimination.

Effectiveness of family-centred sexual health education and HPV self-sampling in promoting cervical cancer screening among hard-to-reach indian women in rural and tribal areas: a community-based pilot study.

BACKGROUND: While cervical cancer deaths have declined steeply in high-income countries due to the widespread use of the Papanicolaou test (Pap test), the same trend has not emerged in low or middle-income countries (LMICs). Access to screening in LMICs like India is limited due to barriers such as limited healthcare infrastructures, lack of sexual health education, and stigma demarcating sexually transmitted infections (STIs). HPV self-sampling (HPV-SS), a woman-centered and at-home method for screening, can be utilized as a unique screening tool to overcome some of these barriers. Our study examined the effectiveness of HPV-SS, supported by family-centred arts-based sexual health literacy on the uptake of cervical cancer screening among hard-to-reach women in rural and remote areas in India. METHODS: Our community-based mixed methods pilot study recruited 240 participants (120 women and 120 male partners or family members) through female Accredited Social Health Activists (ASHA) across 3 Indian villages of Shirgoan, Khodala, and Jamsar in Palghar district. Inclusion criteria included women ages 30-69 who were under or never screened (UNS) and their male partners/family members aged 18 or over. Knowledge and attitudes about cervical cancer and screening and their perceived stigma surrounding STI were assessed using validated scales prior to and after attending a 2-hour arts-based sexual health education (SHE). In addition, participants' uptake of cervical cancer screening was assessed after attendance in SHE. FINDINGS: Results revealed significant improvement in knowledge and attitudes about cervical cancer and screening, and a reduction in the STI stigma after participation in SHE sessions (overall mean difference in Knowledge: z = 6.1 ± 2.4, P < 0.001; attitudes about Pap-test and VIA: z = 2.2 ± 8.4, P < 0.001 and z = 2.9 ± 8.2, P < 0.001; STI stigma: z = 2.8 ± 12.4, P < 0.001). 118 out of 120 female participants chose to be screened and 115 opted for HPV-SS. CONCLUSIONS: The implementation of HPV-SS coupled with family-centered arts-based and culturally appropriate SHE is highly promising in promoting cervical cancer screening among hard-to-reach women. Evidence from our study can be used to advance public health policies and inform the scale-up of similar initiatives in other villages and states across rural India and other LMICs.

Health-Related Quality of Life (HRQoL) Using EQ-5D-5L: Value Set Derived for Indian Breast Cancer Cohort.

OBJECTIVE: The purpose of this study was to report quality of life of newly diagnosed breast cancer patients from India in a large cohort using the EQ-5D-5L instrument. METHODS: The study used longitudinal data of 500 breast cancer and 200 non-cancer subjects registered at our centre, during June 2019 and March 2022. The EQ-5D-5L and EQ-VAS instruments were used to measure and compare utility scores among cancer and non-cancer subjects. Descriptive statistics were analyzed and Tobit regression model were used to confirm the predictors of the utility score. RESULTS: The cancer subjects had a mean EQ-ED-5L utility score of 0.8703 (SD=0.121), 0.8745 (SD=0.094) and 0.8902 (SD=0.107) at the time of baseline, completion and follow up surveys respectively.  EQ-5D-5L values had significantly worsened after diagnosis of cancer as compared to the non-cancer cohort (0.87 vs. 0.93, p value 0.000). EQ-5D-5L utility scores as per stage for the cancer cohort were 0.88, 0.86 and 0.83 respectively for stage I-II, III and IV. Similarly, the EQ-VAS scores for stage I-II, III and IV were 74.9, 72.6 and 73.2 respectively. Multivariate analysis confirmed strong association of age, religion and income with the utility-values. CONCLUSION: This is the first longitudinal study reporting the utility scores derived from a large cohort of breast cancer patients demonstrating lower utility scores compared to non-cancer cohort. The utility scores also improve post treatment completion for cancer patients and decrease with higher stage at diagnosis. This information will be useful for future health economic research in India pertaining to breast cancer.

Evaluation of immune response to single dose of quadrivalent HPV vaccine at 10-year post-vaccination.

BACKGROUND: The recent World Health Organization recommendation supporting single-dose of HPV vaccine will significantly reduce programmatic cost, mitigate the supply shortage, and simplify logistics, thus allowing more low- and middle-income countries to introduce the vaccine. From a programmatic perspective the durability of protection offered by a single-dose will be a key consideration. The primary objectives of the present study were to determine whether recipients of a single-dose of quadrivalent HPV vaccine had sustained immune response against targeted HPV types (HPV 6,11,16,18) at 10 years post-vaccination and whether this response was superior to the natural antibody titres observed in unvaccinated women. METHODS: Participants received at age 10-18 years either one, two or three doses of the quadrivalent HPV vaccine. Serology samples were obtained at different timepoints up to 10 years after vaccination from a convenience sample of vaccinated participants and from age-matched unvaccinated women at one timepoint. The evolution of the binding and neutralizing antibody response was presented by dose received. 10-year durability of immune responses induced by a single-dose was compared to that after three doses of the vaccine and in unvaccinated married women. RESULTS: The dynamics of antibody response among the single-dose recipients observed over 120 months show stabilized levels 18 months after vaccination for all four HPV types. Although the HPV type-specific (binding or neutralizing) antibody titres after a single-dose were significantly inferior to those after three doses of the vaccine (lower bounds of GMT ratios < 0.5), they were all significantly higher than those observed in unvaccinated women following natural infections (GMT ratios: 2.05 to 4.04-fold higher). The results correlate well with the high vaccine efficacy of single-dose against persistent HPV 16/18 infections reported by us earlier at 10-years post-vaccination. CONCLUSION: Our study demonstrates the high and durable immune response in single-dose recipients of HPV vaccine at 10-years post vaccination.

Behavioural interventions for tobacco cessation in India: A systematic review and meta-analysis.

Tobacco consumption is an area of public health concern in India. One of the unmet needs of many low-resource countries is to provide cost-effective tobacco cessation interventions for reducing tobacco-related mortality. This article reviews studies on non-pharmacological interventions for tobacco cessation in India. A systematic review by PICO (population, intervention, comparison, outcome) of behavioural intervention-based tobacco cessation studies that met the inclusion criteria, with a minimum 1-month follow-up, reporting outcomes in terms of frequencies or percentages published between 2010 and 2020 was performed. Following the review stages, 16 studies comprising 9,613 participants were included in the review. A pooled estimate was derived using both fixed-effects and random-effects models. The intervention showed good overall efficacy for any tobacco user (relative risk [RR] = 1.73 [95% confidence interval [CI]: 1.58-1.90) (fixed-effect model)] and (RR = 2.02 [95% CI: 1.64-2.48] [random-effects model]). Behavioural intervention studies targeted towards only smokers (RR of 1.81 [95% CI: 1.55-2.11] and 1.96 [95% CI: 1.52-2.53]) and combined smoking and smokeless tobacco users (RR of 1.69 [95% CI: 1.50-1.90] and 2.12 [95% CI: 1.49-3.01]) were equally efficacious. The review provides the effectiveness of behavioural interventions in quitting tobacco among users of both smoking and smokeless forms of tobacco. The review findings are of particular significance to inform health policy decisions on the integration of cost-effective brief behavioural intervention into existing health care services in resource-constrained countries.

Compliance for Community-Based Cervical Cancer Screening Program among Women of Age 30-65 Years Residing in Low Socioeconomic Settings of Mumbai, India.

Background: Low participation in screening and poor follow-up are major challenges in implementing population based screening in developing countries. Determinants of participation in a community-based organized cervical cancer screening program are discussed here. Objectives: The objectives were to study factors determining compliance of women for cervical cancer screening in an urban low socioeconomic setting. Methodology: Community-based service program was conducted for screening uterine cervix cancers with a visual inspection of the cervix on the application of 5% acetic acid by trained primary health workers. The process involved the selection of clusters, household surveys, health education, and screening of eligible women for uterine cervix cancer. Logistic regression analysis was conducted to identify determinants of participation in cervical cancer screening. Results: A total of 138,383 population were surveyed, of which 21,422 eligible women were contacted and 16,424 (82.50%) complied for screening. According to the results of univariate and multivariate analysis, women belonging to the age group of 30-39 (80.69%), literate women with school level or education up to Senior College (78.97% and 80.86%) (odds ratio [OR], 1.323; P ≤ 0.001) and (OR, 1.402; P ≤ 0.001), belonging to Hindu religion (77.20%), speaking Marathi (77.07%), and with a family history of cancer (81.93%) had higher participation for screening, while women belonging to the Muslim community (73.95%) (OR, 0.743; P ≤ 0.001), speaking other than Marathi and Hindi language (73%) (OR, 0.872; P = 0.017), illiterate women (70.71%), and graduate women (70.78%) had lower participation. Conclusion: High compliance can be achieved by providing good-quality health education and setting up of screening clinics in vicinity of participating women.

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.

A Family-Centered Sexual Health Intervention to Promote Cervical Cancer Screening Uptake Among Low-Income Rural Women in India: Protocol for a Community-Based Mixed Methods Pilot Study.

BACKGROUND: Human papillomavirus (HPV) is the primary cause of cervical cancer, which is preventable through screening and early treatment. The Papanicolaou (Pap) test and visual inspection with acetic acid (VIA), which are traditionally performed in clinical settings, have been used effectively to screen for cervical cancer and precancerous changes and reduce cervical cancer mortality in high-income countries for many decades. However, these screening methods are not easily accessible to women living in low- and middle-income countries, especially women living in rural areas. OBJECTIVE: The project will use HPV self-sampling, which will be supported by a sexual health literacy intervention, to increase rural women's participation in cervical cancer screening. The objectives are to determine the effectiveness of this program in (1) increasing sexual health literacy, (2) reducing the gendered stigma of HPV and cervical cancer, and (3) promoting cervical cancer screening by using HPV self-sampling. METHODS: The pilot study will use a community-based, family-centered, mixed methods design. We will recruit 120 women aged 30 to 69 years who are underscreened or were never screened for cervical cancer, along with 120 supportive male relatives or friends from 3 low-income rural/tribal villages in Maharashtra, India. Participants will attend gender-specific sexual health education sessions, followed by a movie matinee. Data will be collected through an interviewer-administered questionnaire before and after sexual health education sessions. The questionnaire will include items on social demographics, medical histories, attitudes, sexual health stigma, cervical cancer knowledge, and screening practices. Women will self-select whether to use HPV self-sampling. Those who do not may undergo a Pap test or VIA. Participants' views regarding barriers and facilitators and their suggestions for improving access and uptake will also be elicited. This protocol was approved by the research ethics boards of Toronto Metropolitan University (formerly known as Ryerson University; reference number: REB 2020-104) and Tata Memorial Center (reference number: OIEC/3786/2021 /00003). RESULTS: The Preventing Cervical Cancer in India Through Self-Sampling study was funded in January 2020 for 15 months. Due to the COVID-19 pandemic, the project was extended by 1 year. The study outcome measures will include changes in knowledge and attitudes about cervical cancer screening, the proportion of participants who self-select into each cohort, the proportion of positive test results in each cohort, and the proportion of participants with confirmed cervical cancer. Women's experiences regarding barriers and facilitators of screening uptake will be captured. CONCLUSIONS: Our multifaceted work could lead to reduced cervical cancer mortality and morbidity and increased community capacity in sexual health promotion and cervical cancer prevention. The insights and lessons learned from our project can be used to inform the adaptation and scale-up of HPV self-sampling among women across India and in other countries; promote collective commitment to family-centered wellness; and support women to make healthful, personalized cervical screening decisions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/35093.

Cancer cervix: Epidemiology and disease burden.

Cervical cancer remains a major public health problem, ranking as the fourth most common cause of cancer incidence and mortality in women worldwide. Wide variations in cervical cancer incidence and mortality were observed with highest incidence rates in Sub Saharan Africa and with 85% of deaths occurring in developing regions of the world. Non-existent or inadequate screening in public health care settings and limited access to the standard treatment options explains the large geographic variation in cervical cancer rates. Persistent infection with high-risk Human papillomavirus (HPV) types is the major risk factor for cervical cancer. High parity, long-term use of oral contraceptive pills, tobacco consumption, co-infection with other sexually transmitted agents, lifestyle factors such as multiple sexual partners, younger age at first sexual intercourse, immunosuppression, and diet have been identified as the co-factors most likely to influence the risk of acquisition of HPV infection and its further progress to cervical carcinogenesis. Differential screening rates and changes in epidemiological patterns have contributed to decreasing trends in cervical cancer in some developed regions of the world. Lower rates were also observed in North Africa and the Middle East, which may be attributed to cultural norms and conservative sexual behaviors. Across world regions, HPV prevalence was highest in women younger than 35 years of age, declining to a plateau in middle age and showed significant association between national age standardized incidence rates and corresponding estimates of HPV prevalence. The five most common HPV types in HPV-positive women worldwide were HPV16, HPV18, HPV31, HPV58, and HPV52, representing 50% of all HPV infections with HPV-16 and HPV-18 infections accounting for about 70% of the total infection burden. Tracking changing trends in the cervical cancer epidemiological patterns including HPV genotypes will immensely contribute toward effective prevention and control measures for cervical cancer elimination.

Tobacco and cancer awareness program among school children in rural areas of Ratnagiri district of Maharashtra state in India.

Background: Promoting awareness of tobacco and cancer in the community needs multipronged efforts. We performed a study to evaluate whether we could raise awareness about the harmful effects of tobacco, oral and esophageal cancer among school students by providing them health education. Moreover, we also compared the awareness level in students of age group 12 to ≤14 years with the age group >14 to 18 years. Methods: We conducted an awareness program in the schools of Ratnagiri district of Maharashtra state. Students aged 12-18 years participated in this study. We provided health education to school students using a standard presentation; the presentation was rich in illustrations depicting the harmful effects of tobacco as well as oral and esophageal cancer's signs, symptoms, diagnosis, treatment, and preventive measures. After the health talk, a questionnaire was circulated. The questions were focused on tobacco, signs, and symptoms of the diseases along with early detection, prevention, and treatment of cancer. Results: A total of 1354 students participated in the program. Totally, 567 (41.9%) students were from 6th to 8th grade (Group A, age group 12 to ≤14) and 787 (58.1%) students were from 9th to 12th standards (Group B, age group >14 to 18). Overall scores were high, ranging from 69% to 98%. Group A scored in the range of 69% to 95%, and Group B scored in the range 72%-98% The difference between the two groups was found to be statistically significant (P-value ≤0.05). Conclusion: A standardized health education program helped to raise awareness about the harmful effects of tobacco and cancer amongst school children. Further studies are needed to evaluate whether educating school children has an impact on community understanding of the disease.

Screening for breast cancer: Cost-effective solutions for low- & middle-income countries.

Low- and middle-income countries (LMICs) have limited financial resources and proportionately smaller portions allocated for health budget. With competing health priorities, treatment of the diagnosed cases and establishment of treatment facilities are the main concerns in LMICs. Infectious diseases, reducing infant, child and maternal mortality may seem crucial as compared to early cancer detection. LMICs that are committed to providing comprehensive cancer care, will need to judiciously choose the screening tool depending on specifics of how the tool is expected to perform in the population and the cost-effectiveness with respect to the number of lives expected to be saved. Increasing awareness about breast health in general and common cancers and non communicable diseases (NCDs), in particular, may lead to symptomatic women approaching the healthcare facilities at an earlier stage. When the limited available resources are mobilized towards cancer screening, increasing awareness would lead to greater acceptability of the programme. The reach of the programme to achieve good population coverage, the establishment of the diagnostic referral linkages and the availability and accessibility of treatment facilities, will all decide the outcome of the screening programme.

Vaccine efficacy against persistent human papillomavirus (HPV) 16/18 infection at 10 years after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre, prospective, cohort study.

BACKGROUND: A randomised trial designed to compare three and two doses of quadrivalent human papillomavirus (HPV) vaccine in adolescent girls in India was converted to a cohort study after suspension of HPV vaccination in trials by the Indian Government. In this Article, the revised aim of the cohort study was to compare vaccine efficacy of single dose to that of three and two doses in protecting against persistent HPV 16 and 18 infection at 10 years post vaccination. METHODS: In the randomised trial, unmarried girls aged 10-18 years were recruited from nine centres across India and randomly assigned to either two doses or three doses of the quadrivalent HPV vaccine (Gardasil [Merck Sharp & Dohme, Whitehouse Station, NJ, USA]; 0·5 mL administered intramuscularly). After suspension of recruitment and vaccination, the study became a longitudinal, prospective cohort study by default, and participants were allocated to four cohorts on the basis of the number vaccine doses received per protocol: the two-dose cohort (received vaccine on days 1 and 180 or later), three-dose cohort (days 1, 60, and 180 or later), two-dose default cohort (days 1 and 60 or later), and the single-dose default cohort. Participants were followed up yearly. Cervical specimens were collected from participants 18 months after marriage or 6 months after first childbirth, whichever was earlier, to assess incident and persistent HPV infections. Married participants were screened for cervical cancer as they reached 25 years of age. Unvaccinated women age-matched to the married vaccinated participants were recruited to serve as controls. Vaccine efficacy against persistent HPV 16 and 18 infections (the primary endpoint) was analysed for single-dose recipients and compared with that in two-dose and three-dose recipients after adjusting for imbalance in the distribution of potential confounders between the unvaccinated and vaccinated cohorts. This trial is registered with ISRCTN, ISRCTN98283094, and ClinicalTrials.gov, NCT00923702. FINDINGS: Vaccinated participants were recruited between Sept 1, 2009, and April 8, 2010 (date of vaccination suspension), and followed up over a median duration of 9·0 years (IQR 8·2-9·6). 4348 participants had three doses, 4980 had two doses (0 and 6 months), and 4949 had a single dose. Vaccine efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95·4% (95% CI 85·0-99·9) in the single-dose default cohort (2135 women assessed), 93·1% (77·3-99·8) in the two-dose cohort (1452 women assessed), and 93·3% (77·5-99·7) in three-dose recipients (1460 women assessed). INTERPRETATION: A single dose of HPV vaccine provides similar protection against persistent infection from HPV 16 and 18, the genotypes responsible for nearly 70% of cervical cancers, to that provided by two or three doses. FUNDING: Bill & Melinda Gates Foundation.

Evaluating the Performance of Hybrid Capture 2 Test as a Primary Screening Test from Studies Conducted in Low and Middle-Income Country Settings- Special Focus India.

Among the screening tests for cervical cancer, advantages of screening with second generation molecular Hybrid Capture 2 (HC2) test is the high sensitivity and negative predictive value that makes it easy to implement as a cervical cancer screening policy necessitating less screening rounds. High income countries are now implementing HC2 test in their national cervical cancer screening program. Since the acceptance of any screening test depends on the sensitivity of the test, the current study was carried out to evaluate the sensitivity of HC2 test reported from Low- and Middle-income countries (LMIC) which share major burden of cervical cancer globally and to establish if HC2 test could be used as a primary screening test in India. MATERIALS AND METHODS: The population based cross sectional studies from LMICs which evaluated HC2 test as a primary screening modality to diagnose Cervical intraepithelial neoplasm grade 2 and above (CIN2+) lesions were included. RESULTS: A total of 18 studies from LMIC involving 1,13,086 women were reviewed for sensitivity of HC2 as a primary screening test. The overall average sensitivity and specificity to diagnose CIN2+ lesions were 79.84% (95% CI-71.01,86.73) and 85.63% (95% CI- 84.37,86.92) respectively. India demonstrated an average sensitivity and specificity of 65% (95% CI 57,77) and 93% (95% CI- 92,94) respectively. CONCLUSION: Results from LMIC demonstrate a comparably low sensitivity of HC2 test to diagnose CIN2+ lesions as compared to that reported from High income countries. Sensitivity of HC2 was substantially low for India. The current study discusses issues of HC2 assay and the role of untreated Reproductive tract infections as probable causes for low sensitivity of the test. This needs further research in an attempt to improve the sensitivity of the test in an era of self-sampling and low-cost HPV test on horizon to improve the coverage for cervical cancer.
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Determinants of Compliance to Population-Based Oral Cancer Screening Program among low Socioeconomic Women in Mumbai, India.

BACKGROUND: The use of tobacco, especially smokeless variety, is common and culturally accepted among Indian women. Hence, oral cavity cancers rank as the fourth most common cancers among Indian women. OBJECTIVES: The objectives of this study were to study factors determining compliance of women for oral cancer screening in a population-based program in Mumbai and to create awareness among women regarding ill effects of tobacco and importance of oral cancer screening. MATERIALS AND METHODS: This is a community-based organized service program for awareness and screening of oral cavity cancers among women residing in low socioeconomic areas of Mumbai, India. Screening was conducted by oral visual inspection by trained primary health workers (PHWs). Univariate and multivariate logistic regression analyses were conducted to identify predictors of participation in oral cancer screening. RESULTS: 138,383 population was surveyed, out of which 13,492 eligible women were enlisted for oral cancer screening. Among these, 12,495 were contacted and 11,895 (95.12%) women participated in a cancer awareness program and 11,768 (94.18%) participated in oral cancer screening. According to results of multivariate logistic regression analysis, women belonging to Hindu religion 94.57%, with mother tongue Marathi 94.76%, and with family history of cancer 95.84% complied significantly higher to oral cancer screening as compared to other women. CONCLUSION: This program has assisted in identifying predictors of compliance to oral cavity screening. Furthermore, it demonstrates that good compliance can be achieved through multiple household visits, personal invitation during camps, organizing well-planned Health Education Program, and the use of simple, low-cost visual inspection test performed by trained PHWs.

Increasing breast cancer awareness and breast examination practices among women through health education and capacity building of primary healthcare providers: a pre-post intervention study in low socioeconomic area of Mumbai, India.

OBJECTIVES: The present study aimed to improve breast cancer (BC) awareness and practices using Information, Education and Communication (IEC) modules and health educational sessions for women and primary healthcare providers in low socioeconomic community of Mumbai. DESIGN: Pre-post quasi-experimental design. SETTING: The study was conducted in a lower socioeconomic area of G-South ward of Mumbai, Maharashtra. The baseline and endline survey was conducted using structured interview schedules. PARTICIPANTS: 410 women were selected, aged between 18 and 55 years who were not pregnant, lactating or diagnosed with BC. INTERVENTION: A health education-based intervention module was developed to educate women through group and individual sessions. OUTCOMES: Summative indices were constructed to understand the net mean difference in knowledge of signs, symptoms and risk factors. Analysis of variance (ANOVA) and paired t-test were used to check the significant improvement of intervention. RESULTS: Our results showed statistical significance in difference in mean knowledge scores for both signs and symptoms (mean difference (MD) 4.09, SD 4.05, p<0.00)) and risk factors of BC knowledge (MD 5.64, SD 4.00, p<0.00) among women after intervention. There was a marked improvement in the knowledge of BC among women with low education category. A significant improvement in knowledge of symptoms and risk factors among health workers was also observed. Our interventions resulted in positive change in breast examination practices. The breast self-examination (BSE) practices improved from around 3% to 65% and around 41% additional women went for clinical breast examination after intervention. CONCLUSIONS: This study found a significant improvement in knowledge of BC signs and symptoms, risk factors and BSE practices among study participants following our health education interventions among these subpopulations. This evidence calls for inclusion of similar interventions through health education and capacity building of primary healthcare providers in national programmes.

Narrow band imaging observed oral mucosa microvasculature as a tool to detect early oral cancer: an Indian experience.

BACKGROUND: Narrow band imaging (NBI) is a novel method with the potential to improve the diagnostic capability of white-light. METHODS: A prospective observational study of 50 consecutive patients, with suspicious malignant/premalignant lesions. White-light images were assessed as suspicious for malignancy/negative for malignancy, whereas NBI images were classified based on the IPCL patterns. All lesions underwent biopsy and accuracy was compared with the histopathology (Fig. 1). Fig. 1 Representative images of the IPCL patterns from Types I-IV RESULTS: 25 lesions (49%) were positive for malignancy, 2 (3.9%) lesions showed severe dysplasia, and 24(47%) were considered negative on histopathology. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of white light and NBI in detecting invasive carcinoma was 74.07%, 79.17%, 80.00%, 73.08% and 76.47%, and 92.67%, 90.16%, 92.56%, 91.67% and 92.16% respectively. The NBI group had a significantly better sensitivity and specificity to white light. The interobserver concordance was κ = 0.881. CONCLUSION: NBI is a highly effective tool to detect invasive carcinomas amongst suspicious lesions of the oral cavity.

Acquisition, prevalence and clearance of type-specific human papillomavirus infections in young sexually active Indian women: A community-based multicentric cohort study.

In context of the ongoing multi-centric HPV vaccine study in India, unvaccinated married women (N = 1484) aged 18-23 years were recruited in 2012-2015 as age-matched controls to the vaccinated women and followed up yearly. We assess type-specific prevalence, natural history and potential determinants of human papillomavirus (HPV) infection in these unvaccinated women. Cervical samples were collected yearly for at least four consecutive years. A Multiplex Type-Specific E7-Based polymerase chain reaction assay was used to detect 21 HPV types. HPV prevalence was 36.4% during 6 years. Most common HPV types were 16 (6.5%) and 31 (6.1%). Highest persistence were observed for HPV 35 (62.5%) and 52 (25%). New HPV acquisition rate was 5.6/1000 person-months of observation (PMO), highest for HPV 16 (1.1/1000 PMO). Type-specific clearance rates ranged between 2.9-5.5/100 PMO. HPV 16 and/or 18 infections were 41% (95% CI 4-63%) lower among women with 2-<3 years between marriage and first cervical sample collection compared to those with <2 years. HPV prevalence and acquisition rates in young Indian women were lower than their Western counterparts. HPV 16 infections being most common shows the importance and potential impact of HPV vaccination in India. Women with 2-3 years exposure had reduced risk possibly due to higher infections clearance.