Strategies for primary HPV test-based cervical cancer screening programme in resource-limited settings in India: Results from a quasi-experimental pragmatic implementation trial.

BACKGROUND: In order for low and middle income countries (LMIC) to transition to Human Papilloma Virus (HPV) test based cervical cancer screening, a greater understanding of how to implement these evidence based interventions (EBI) among vulnerable populations is needed. This paper documents outcomes of an implementation research on HPV screening among women from tribal, rural, urban slum settings in India. METHODS: A mixed-method, pragmatic, quasi-experimental trial design was used. HPV screening on self-collected cervical samples was offered to women aged 30-60 years. Implementation strategies were 1) Assessment of contextual factors using both qualitative and quantitative methods like key informant interviews (KII), focus group discussions (FGDs), pre-post population sample surveys, capacity assessment of participating departments 2) enhancing provider capacity through training workshops, access to HPV testing facility, colposcopy, thermal ablation/cryotherapy at the primary health care centers 3) community engagement, counselling for self-sampling and triage process by frontline health care workers (HCWs). Outcomes were assessed using the RE-AIM (Reach, Effectiveness, adoption, implementation, maintenance) framework. RESULTS: Screening rate in 8 months' of study was 31.0%, 26.7%, 32.9%, prevalence of oncogenic HPV was 12.1%, 3.1%, 5.5%, compliance to triage was 53.6%, 45.5%, 84.6% in tribal, urban slum, rural sites respectively. Pre-cancer among triage compliant HPV positive women was 13.6% in tribal, 4% in rural and 0% among urban slum women. Unique challenges faced in the tribal setting led to programme adaptations like increasing honoraria of community health workers for late-evening work and recalling HPV positive women for colposcopy by nurses, thermal ablation by gynaecologist at the outreach camp site. CONCLUSIONS: Self-collection of samples combined with HCW led community engagement activities, flexible triage processes and strengthening of health system showed an acceptable screening rate and better compliance to triage, highlighting the importance of identifying the barriers and developing strategies suitable for the setting. TRIAL REGISTRATION: CTRI/2021/09/036130.

Patient and caregiver perspectives of select non-communicable diseases in India: A scoping review.

BACKGROUND AND OBJECTIVES: Patient-reported measures of encounters in healthcare settings and consideration of their preferences could provide valuable inputs to improve healthcare quality. Although there are increasing reports of user experiences regarding health care in India in recent times, there is a lack of evidence from Indian healthcare settings on the care provided for patients with chronic diseases. METHODS: We selected diabetes mellitus and cancer as representatives of two common conditions requiring different care pathways. We conducted a scoping review of studies reporting experiences or preferences of patients/caregivers for these conditions, in PubMed, Global Index Medicus and grey literature, from the year 2000 onwards. Both published and emergent themes were derived from the data and summarised as a narrative synthesis. RESULTS: Of 95 included studies (49 diabetes, 46 cancer), 73% (65) were exclusively quantitative surveys, 79% included only patients (75), and 59.5% (44) were conducted in government centres. Studies were concentrated in a few states in India, with the underrepresentation of vulnerable population groups and representative studies. There was a lack of standardised tools and comprehensive approaches for assessing experiences and preferences of patients and caregivers, concerning diabetes and cancers in India. The commonest type of care assessed was therapeutic (74), with 14 cancer studies on diagnosis and nine on palliative care. Repeated visits to crowded centres, drug refill issues, unavailability of specific services in government facilities, and expensive private care characterised diabetes care, while cancer care involved delayed diagnosis and treatment, communication, and pain management issues. CONCLUSIONS: There is a need for robust approaches and standardised tools to measure responsiveness of the healthcare system to patient needs, across geographical and population subgroups in India. Health system reforms are needed to improve access to high-quality care for treatment and palliation of cancer and management of chronic diseases such as diabetes.

Protocol for the formative phase of a trial (SHE-CAN) to test co-designed implementation strategies for HPV-based cervical screening among vulnerable women in two diverse settings in India.

BACKGROUND: In view of the WHO's call for the elimination of cervical cancer as a public health problem, and current low screening coverage, Indian policy makers need evidence on how to effectively implement cervical screening programmes, ensuring equity in access. Our study will follow the INSPIRE implementation framework to co-design and test HPV-based screening approaches in two states of India with different health system organisation, based on understanding the status of screening as currently implemented, readiness and challenges to transition to HPV-based screening, and preferences of key stakeholders. Here, we describe our protocol for the formative phase of the study (SHE-CAN). METHODS: The study population includes women from vulnerable populations, defined as residents of tribal areas, rural villages, and urban slums, in the states of Mizoram and Tamil Nadu. The baseline assessment will use mixed methods research, with desktop reviews, qualitative studies, and surveys. A capacity assessment survey of screening and treatment facilities will be done, followed by interviews with healthcare providers, programme managers, and community health workers. Interviews will be conducted with previously screened women and focus group discussions with under and never-screened women and community members. Stakeholder workshops will be held in each state to co-design the approaches to delivering HPV-based screening among 30-49-year-old women. DISCUSSION: The quality and outcomes of existing screening services, readiness to transition to HPV-based screening, challenges in providing and participating in the cervical cancer care continuum, and acceptability of screening and treatment approaches will be examined. The knowledge gained about the current system, as well as recognition of actions to be taken, will inform a stakeholder workshop to co-design and evaluate implementation approaches for HPV-based screening through a cluster randomised implementation trial.

Self-Collection Cervical Screening in the Asia-Pacific Region: A Scoping Review of Implementation Evidence.

PURPOSE: Although cervical cancer is a disease of inequity, it can be eliminated as a public health problem through vaccination, screening, and treatment. Human papillomavirus vaginal self-collection cervical screening is a high-performance test that can increase reach of screening. This review describes the different contexts and models of care used to pilot or implement self-collection within the Asia-Pacific, measures the extent that implementation outcome measures are reported and, where available, summarizes key implementation findings. METHODS: A scoping review was conducted by searching five databases of the peer-reviewed literature on June 20, 2022. Two researchers assessed eligibility and extracted data independently to the model of care used and the Conceptual Framework for Implementation Outcomes. A mixed-method consolidation of findings (quantitative: count and frequencies; qualitative: content analysis) was undertaken to narratively report findings. RESULTS: Fifty-seven articles, comprising 50 unique studies from 11 countries and two special autonomous regions, were included; 82% were conducted in trials. The implementation of self-collection was conducted in low- (2%), lower-middle- (32%), upper-middle- (32%), and high-income (35%) settings, with 10 different delivery models used; 80% delivered through practitioner-supported models with diversity in how samples were processed, and treatment was offered. Acceptability (73%) and appropriateness (64%) measures were most reported, followed by adoption (57%), feasibility (48%), and fidelity (38%). Only 7% of articles reported implementation cost or penetration measures. No articles reported sustainability measures. CONCLUSION: The literature confirms that self-collection cervical screening has been implemented within the Asia-Pacific region, with evidence demonstrating that it is acceptable and appropriate from the user's perspective. Well-designed, high-quality implementation trials and real-world evaluations of self-collection that report the breadth of implementation outcomes can support the progression toward the elimination of cervical cancer.

Screening practices for breast and cervical cancer and associated factors, among rural women in Vellore, Tamil Nadu.

BACKGROUND: Population-based screening coverage for breast and cervical cancer screening in the community is inadequately reported in India. This study assessed screening rates, awareness, and other factors affecting screening, among rural women aged 25-60 years in Vellore, Tamil Nadu. METHODS: Women aged 25-60 years, from five randomly selected villages of a rural block were included in this cross-sectional study in Vellore, Tamil Nadu. Households were selected by systematic random sampling, followed by simple random sampling of eligible women in the house. A semi-structured questionnaire was used to assess screening practices, awareness, and other factors related to cervical and breast cancer. RESULTS: Although 43.8% and 57.9% were aware of the availability of screening for cervical and breast cancer respectively, screening rates were only 23.4% (95% confidence interval [CI]: 18.4-28.4%) and 16.2% (95% CI: 11.9-20.5%), respectively. Adequate knowledge (score of ≥50%) on breast cancer was only 5.9%, with 27.2% for cervical cancer. Only 16.6% of women had ever attended any health education program on cancer. Exposure to health education (breast screening odds ratio [OR]: 6.89, 95% CI: 3.34-14.21; cervical screening OR: 6.92, 95% CI: 3.42-14.00); and adequate knowledge (breast OR: 4.69, 95% CI: 1.55-14.22; cervix OR: 3.01, 95% CI: 1.59-5.68) were independently associated with cancer screening. CONCLUSION: Awareness and screening rates for breast and cervical cancer are low among rural women in Tamil Nadu, a south Indian state with comparatively good health indices, with health education being an important factor associated with screening practices.

Nutritional status, cognitive achievement, and educational attainment of children aged 8-11 in rural South India.

BACKGROUND: Malnutrition among children is one of the most pressing health concerns middle- and low-income countries face today, particularly those in Sub-Saharan Africa and South Asia. Early-life malnutrition has been shown to affect long-term health and income. One hypothesized channel linking early-life malnutrition and long-term outcomes is cognitive development. However, there is limited empirical evidence on the relationship between nutritional status and cognitive achievement in middle childhood. STUDY DESIGN: As part of the South India Community Health Study (SICHS), we collected educational attainment and anthropometric data from 1,194 children in rural Vellore district of Tamil Nadu, India, and assessed their math and reading skills. We analyzed the relationship between continuous and binary anthropometric measures of nutritional status and three measures of cognitive achievement (reading, math, and grade level), adjusting for potential confounders, using a regression framework. RESULTS: Lower height-for-age and weight-for-age and their corresponding binary measures (stunting, underweight) were associated with lower reading scores, lower math scores, and lower grade level, with the exception of the association between weight-for-age and reading, which was marginally significant. A stunted child had one-third of a grade disadvantage compared to a non-stunted counterpart, whereas an underweight child had one-fourth of a grade disadvantage compared to a non-underweight counterpart. Lower BMI-for-age was associated with grade level and marginally associated with lower math scores, and its binary measure (thinness) was marginally associated with lower math scores. CONCLUSIONS: Acute and chronic malnutrition in middle childhood were negatively associated with math scores, reading scores, and educational attainment. Our study provides new evidence that cognitive achievement during middle childhood could be an important mechanism underlying the association between early-life malnutrition and long-term wellbeing.

Chronic periodontitis among diabetics and nondiabetics aged 35-65 years, in a rural block in Vellore, Tamil Nadu: A cross-sectional study.

BACKGROUND: Chronic periodontitis is a common cause of poor oral health globally. Those at higher risk of this preventable and easily treatable condition need to be identified so that efforts can be taken to decrease disease burden and subsequent consequences. AIMS: The aims of the study were (1) To compare the prevalence of chronic periodontitis among individuals with and without type 2 diabetes, aged 35-65 years from a rural block in Vellore, Tamil Nadu and (2) to assess risk factors for chronic periodontitis among individuals with diabetes. SETTINGS AND DESIGN: A cross-sectional study was done in nine villages of Kaniyambadi block, Vellore, between October 2015 and July 2016 among participants aged 35-65 years of a previous cross-sectional survey which had identified individuals with and without type 2 diabetes. MATERIALS AND METHODS: Chronic periodontitis was assessed using the Community Periodontal Index and Treatment Needs index. Oral hygiene was assessed clinically using the Simplified Oral Hygiene Index. Diabetes was defined as on medication for type 2 diabetes or detected to have fasting blood glucose ≥126 mg/dl (in a previous survey). STATISTICAL ANALYSIS: Chi-square test and odds ratios (adjusted using logistic regression) were used to study risk factors for periodontitis among those with diabetes. RESULTS: Prevalence of chronic periodontitis was 45.9% (95% confidence interval [CI]: 40.88%-50.9%) among 98 individuals with diabetes and 35.6% (95% CI: 30.91-40.29%) among 104 individuals without diabetes. Poor oral hygiene (odds ratio: 8.33, 95% CI: 3.33-25.00), low socioeconomic status (odds ratio: 3.19, 95% CI: 1.00-10.12), and smoking (odds ratio: 3.51, 95% CI: 1.17-10.51) were associated with periodontitis among diabetics. CONCLUSIONS: Individuals with type 2 diabetes have a higher prevalence of periodontitis. As poor oral hygiene is a strong risk factor for periodontitis, there is a need for targeted education regarding dental hygiene to reduce this preventable condition.

Rising trend of cardiovascular risk factors between 1991-1994 and 2010-2012: A repeat cross sectional survey in urban and rural Vellore.

BACKGROUND: Repeat cross sectional surveys document the trend of prevalence rates for non-communicable diseases and their risk factors. In this study, we compare the prevalence rates for risk factors for cardiovascular disease in urban and rural Vellore between 1991-1994 and 2010-2012. METHODS: Cross sectional survey was carried out in 1991-1994 in a rural block in Vellore district and in Vellore town, to study the prevalence of cardiovascular risk factors among adults aged 30-60 years. A repeat survey was done in 2010-2012 using the WHO STEPS method. In both surveys, socio-demographic and behavioral history, physical measurements, biochemical measurements, and medical history were obtained. Age adjusted rates were used to compare the rates in the two surveys. RESULTS: In the rural areas, there was a three times increase in diabetes and body mass index (BMI) ≥25kg/m(2) (overweight/obese) with a doubling of the prevalence of hypertension. In urban areas there was a tripling of diabetes, doubling of proportion with BMI≥25kg/m(2) and 50% increase in prevalence of hypertension. While the proportion of male current smokers reduced by 50% in both rural and urban Vellore, lifetime abstainers to alcohol decreased in the rural area from 46.8% to 37.5% (p<0.001). CONCLUSIONS: There has been an alarming rise in diabetes, hypertension, and overweight/obese with an even greater increase in rural areas. Alcohol use is increasing while smoking is on the decline. Primary prevention programs are required urgently to stem the rising incidence of non-communicable diseases in India.

Prevalence of risk factors for non-communicable diseases in rural & urban Tamil Nadu.

BACKGROUND & OBJECTIVES: Surveillance of risk factors is important to plan suitable control measures for non-communicable diseases (NCDs). The objective of this study was to assess the behavioural, physical and biochemical risk factors for NCDs in Vellore Corporation and Kaniyambadi, a rural block in Vellore district, Tamil Nadu, India. METHODS: This cross-sectional study was carried out among 6196 adults aged 30-64 yr, with 3799 participants from rural and 2397 from urban areas. The World Health Organization-STEPS method was used to record behavioural risk factors, anthropometry, blood pressure, fasting blood glucose and lipid profile. Multiple logistic regression was used to assess associations between risk factors. RESULTS: The proportion of tobacco users (current smoking or daily use of smokeless tobacco) was 23 per cent in the rural sample and 18 per cent in the urban, with rates of smoking being similar. Ever consumption of alcohol was 62 per cent among rural men and 42 per cent among urban men. Low physical activity was seen among 63 per cent of the urban and 43 per cent of the rural sample. Consumption of fruits and vegetables was equally poor in both. In the urban sample, 54 per cent were overweight, 29 per cent had hypertension and 24 per cent diabetes as compared to 31, 17 and 11 per cent, respectively, in the rural sample. Physical inactivity was associated with hypertension, body mass index (BMI) ≥25 kg/m[2], central obesity and dyslipidaemia after adjusting for other factors. Increasing age, male sex, BMI ≥25 kg/m[2] and central obesity were independently associated with both hypertension and diabetes. INTERPRETATION & CONCLUSIONS: Diabetes, hypertension, dyslipidaemia, physical inactivity and overweight were higher in the urban area as compared to the rural area which had higher rates of smokeless tobacco use and alcohol consumption. Smoking and inadequate consumption of fruits and vegetables were equally prevalent in both the urban and rural samples. There is an urgent need to address behavioural risk factors such as smoking, alcohol consumption, physical inactivity and inadequate intake of fruits and vegetables through primary prevention.