Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration.

Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis-apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India.

Marriage practices, decision-making process and contraception use among young married men in rural Odisha, India.

Research on sexual and reproductive health including contraception use has predominantly focussed on women's behaviour. Much less is known about men's behaviour. We investigated the links between marriage practices and decision-making about contraception use among young married men in rural Odisha. This cross-sectional study used a mixed methods design. Data were collected through household surveys and in-depth interviews. Study findings revealed that over half of men were ill prepared for marriage and lacked understanding about what it would entail. Familiarity and communication between spouses were higher in self-arranged marriages and this contributed considerably to contraception use, while negative attitudes and lack of access to contraceptive supply and counselling hindered it. Many young men shied away from seeking contraception services at community level since the majority of frontline health workers providing such services were female. Findings reinforce the need for health system change to actively engage and involve young married men in decision-making about contraception use as well as to introduce male frontline health workers who can reach out to young men on SRH issues.

Symposium report: breast cancer in India-trends, environmental exposures and clinical implications.

PURPOSE: Incidence of breast cancer (BC), particularly in young women, are rising in India. Without population-based mammography screening, rising rates cannot be attributed to screening. Investigations are needed to understand the potential drivers of this trend. METHODS: An international team of experts convened to discuss the trends, environmental exposures, and clinical implications associated with BC in India and outlined recommendations for its management. RESULTS: Panels were structured across three major BC themes (n = 10 presentations). The symposium concluded with a semi-structured Think Tank designed to elicit short-term and long-term goals that could address the challenges of BC in India. CONCLUSION: There was consensus that the prevalence of late-stage BC and the high BC mortality rates are associated with the practice of detection, which is primarily through clinical and self-breast exams, as opposed to mammography. Triple-Negative BC (TNBC) was extensively discussed, including TNBC etiology and potential risk factors, the limited treatment options, and if reported TNBC rates are supported by rigorous scientific evidence. The Think Tank session yielded long-term and short-term goals to further BC reduction in India and included more regional etiological studies on environmental exposures using existing India-based cohorts and case-control studies, standardization for molecular subtyping of BC cases, and improving the public's awareness of breast health.

The effect of intimate partner violence on women's mental distress: a prospective cohort study of 3010 rural Indian women.

PURPOSE: Intimate partner violence (IPV) encompasses physical, sexual, and psychological abuse, as well as controlling behavior. Most research focuses on physical and sexual abuse, and other aspects of IPV are rarely investigated. We estimated the effect of these neglected aspects of IPV on women's mental distress. METHODS: We used data from 3010 women living in rural tribal communities in Rajasthan, India. Women completed baseline interviews and were re-interviewed approximately 1.5 years later. We measured IPV with questions adopted from the Demographic and Health Survey's Domestic Violence Module, which asked seven questions about physical abuse, three questions about psychological abuse, and five questions about partner controlling behavior. Mental distress was measured with the 12-item General Health Questionnaire (score range 0-12). We used Poisson regression models to estimate the relation between changes in IPV and mental distress, accounting for time-fixed characteristics of individuals using individual fixed effects. RESULTS: Women reported an average of 2.1 distress symptoms during baseline interviews. In models that controlled for time-varying confounding (e.g., wealth, other types of abuse), experiencing psychological abuse was associated with an increase of 0.65 distress symptoms (95% CI 0.32, 0.98), and experiencing controlling behavior was associated with an increase of 0.31 distress symptoms (95% CI 0.18, 0.44). However, experiencing physical abuse was not associated with an increase in distress symptoms (mean difference = - 0.15, 95% CI - 0.45, 0.15). CONCLUSIONS: Psychological abuse and controlling behavior may be important drivers of the relation between IPV and women's mental health.

A theory of change for community interventions to prevent domestic violence against women and girls in Mumbai, India.

Background: We describe the development of a theory of change for community mobilisation activities to prevent violence against women and girls. These activities are part of a broader program in urban India that works toward primary, secondary, and tertiary prevention of violence and includes crisis response and counselling and medical, police, and legal assistance. Methods: The theory of change was developed in five phases, via expert workshops, use of primary data, recurrent team meetings, adjustment at further meetings and workshops, and a review of published theories. Results: The theory summarises inputs for primary and secondary prevention, consequent changes (positive and negative), and outcomes. It is fully adapted to the program context, was designed through an extended consultative process, emphasises secondary prevention as a pathway to primary prevention, and integrates community activism with referral and counselling interventions. Conclusions: The theory specifies testable causal pathways to impact and will be evaluated in a controlled trial.

Are work demands associated with mental distress? Evidence from women in rural India.

PURPOSE: High work demands might be a determinant of poor mental health among women in low- and middle-income countries, especially in rural settings where women experience greater amounts of labor-intensive unpaid work. Research originating from such settings is lacking. METHODS: We estimated the cross-sectional association between work demands and mental distress among 3177 women living in 160 predominantly tribal communities in southern Rajasthan, India. A structured questionnaire captured the number of minutes women spent on various activities in the last 24 h, and we used this information to measure women's work demands, including the total work amount, nature of work (e.g., housework), and type of work (e.g., cooking). Mental distress was measured with the Hindi version of the 12-item General Health Questionnaire. We used negative binomial regression models to estimate the association between work demands (amount, nature, and type) and mental distress. RESULTS: On average, women spent more than 9.5 h a day on work activities. The most time, intensive work activity was caring for children, the elderly, or disabled (149 min). In adjusted models, we found a U-shaped association between work amount and mental distress. High amounts of housework were associated with higher distress, whereas paid work and farmwork amount were not. Certain types of housework, including collecting water and cleaning, were associated with increased distress scores. CONCLUSIONS: We found an association between aspects of work demands and mental distress. Research in other contexts where women perform high amounts of unpaid work, particularly within the home or farm, is warranted.

Psychosocial framework for understanding psychological distress among survivors of the November 26, 2008 Mumbai terror attack: beyond traumatic experiences and emergency medical care.

The field of "Public Health in Disasters and Complex Emergencies" is replete with either epidemiological studies or studies in the area of hospital preparedness and emergency care. The field is dominated by hospital-based or emergency phase-related literature, with very little attention on long-term health and mental health consequences. The social science, or the public mental health perspective, too, is largely missing. It is in this context that the case report of the November 26, 2008 Mumbai terror attack survivors is presented to bring forth the multi-dimensional and dynamic long-term impacts, and their consequences for psychological well-being, two years after the incident. Based on literature, the report formulates a theoretical framework through which the lived experiences of the survivors is analyzed and understood from a social science perspective. This report is an outcome of the ongoing work with the survivors over a period of two years. A mixed methodology was used. It quantitatively captures the experience of 231 families following the attack, and also uses a self-reporting questionnaire (SRQ), SRQ20, to understand the psychological distress. In-depth qualitative case studies constructed from the process records and in-depth interviews focus on lived experiences of the survivors and explain the patterns emerging from the quantitative analysis. This report outlines the basic profile of the survivors, the immediate consequences of the attack, the support received, psychological consequences, and the key factors contributing to psychological distress. Through analysis of the key factors and the processes emerging from the lived experiences that explain the progression of vulnerability to psychological distress, this report puts forth a psychosocial framework for understanding psychological distress among survivors of the November 26, 2008 Mumbai terror attack.

Listening to mothers: qualitative studies on motherhood and depression from Goa, India.

There is little qualitative research on depression in motherhood from non-Western societies. The objective of the study described in this paper was to use qualitative methods to investigate the cultural validity of the construct of post-natal depression (PND) and its social and cultural contexts. The study was nested in a cohort of mothers recruited to study the risk factors and outcome of PND in Goa, India. In-depth interviews were carried out with 39 mothers (19 of whom were found to be suffering from PND as defined by a cut-off score on the Edinburgh PND scale) and their husbands purposively recruited from the cohort. An illness narrative was conducted with mothers who were categorized as suffering from PND and their husbands to elicit their explanatory models. The two groups (PND and non-PND) of mothers were comparable in terms of socio-demographic characteristics. PND mothers had lower levels of practical help and emotional support. The symptoms reported by PND mothers were similar to those recorded in studies with women in other cultures suggesting a universal clinical presentation of PND. Causal attributions for the experience of depression focused on economic difficulties and poor marital relationship. All mothers expressed the need for more practical help and support during the period after childbirth; husbands in both groups were often disengaged from baby care or supporting the mother. The study provides validity for the construct of PND in an Indian setting, but also shows that the emotional distress is interpreted from the context of social adversity, poor marital relationships and cultural attitudes towards gender rather than a biomedical psychiatric category. Contrary to the assumption that socio-cultural contexts associated with childbirth in non-Western societies protect mothers from depression, factors unique to the culture such as gender preference and the low involvement of husbands in child-care are major causes of stress to mothers.

Measuring mental health in a cost-effective manner.

Mental health has been found to contribute significantly to the global burden of disease. This has raised the profile of mental health in developing countries. Many countries still do not have mental health policies, nor do they incorporate mental health in their primary care package. Community mental health profiles are needed to inform policy. There is a demand for more studies of mental health and the inclusion of mental health measures in more general, comprehensive, population-based health surveys. This article reviews the use and performance of a World Health Organization-endorsed instrument known as the Self-Reporting Questionnaire 20 items (SRQ20). The paper concludes that the high face and criterion validity, ease of use and suitability for administration by lay workers support the use of the SRQ20 as a cost-effective instrument with which to measure community mental health.