Intervention design in public health: adaptive messaging in the Tanzanian National Sanitation Campaign.

Few case studies exist in the public health or design literatures showing how to create national scale messaging campaigns in low-income countries using design processes. In this paper, we describe how we used Behaviour Centred Design to develop Nyumba ni choo, the Tanzanian National Sanitation Campaign. The process involved multiple iterations of ideation and filtration by professional creatives, government staff, academics and sanitation specialists to create a branded mass communication campaign, which was refreshed annually. The campaign was based on the insight that Tanzania is modernizing rapidly, with people upgrading their homes, but leaving their outside toilets in a 'traditional' state. Built around the 'big idea' that a household is not fully modern without a good-quality, modern toilet, the campaign employed reality TV shows, live engagements and mass and digital media postings, all targeted at motivating both the government and general population to improve toilets. The campaign has made toilets a topic of national conversation and has led to a major uptick in the rate of toilet building. Efforts to improve public health-related behaviour can be enhanced by using systematic approaches that build on available evidence, understand behaviour in its common settings, employ psychological theory and engage creative expertise.

How does handwashing behaviour change in response to a cholera outbreak? A qualitative case study in the Democratic Republic of the Congo.

BACKGROUND: Handwashing with soap has the potential to curb cholera transmission. This research explores how populations experienced and responded to the 2017 cholera outbreak in the Democratic Republic of the Congo and how this affected their handwashing behaviour. METHODS: Cholera cases were identified through local cholera treatment centre records. Comparison individuals were recruited from the same neighbourhoods by identifying households with no recent confirmed or suspected cholera cases. Multiple qualitative methods were employed to understand hand hygiene practices and their determinants, including unstructured observations, interviews and focus group discussions. The data collection tools and analysis were informed by the Behaviour Centred Design Framework. Comparisons were made between the experiences and practices of people from case households and participants from comparison households. RESULTS: Cholera was well understood by the population and viewed as a persistent and common health challenge. Handwashing with soap was generally observed to be rare during the outbreak despite self-reported increases in behaviour. Across case and comparison groups, individuals were unable to prioritise handwashing due to competing food-scarcity and livelihood challenges and there was little in the physical or social environments to cue handwashing or make it a convenient, rewarding or desirable to practice. The ability of people from case households to practice handwashing was further constrained by their exposure to cholera which in addition to illness, caused profound non-health impacts to household income, productivity, social status, and their sense of control. CONCLUSIONS: Even though cholera outbreaks can cause disruptions to many determinants of behaviour, these shifts do not automatically facilitate an increase in preventative behaviours like handwashing with soap. Hygiene programmes targeting outbreaks within complex crises could be strengthened by acknowledging the emic experiences of the disease and adopting sustainable solutions which build upon local disease coping mechanisms.

How is hygiene behaviour affected by conflict and displacement? A qualitative case study in Northern Iraq.

This research aimed to qualitatively explore whether the determinants of handwashing behaviour change according to the duration of displacement or the type of setting that people are displaced to. We conducted an exploratory qualitative study in three different post-conflict settings in Northern Iraq-a long-term displacement camp, a short-term displacement camp, and villages where people were returning to post the conflict. We identified 33 determinants of handwashing in these settings and, of these, 21 appeared to be altered by the conflict and displacement. Determinants of handwashing behaviour in the post-conflict period were predominantly explained by disruptions to the physical, psychological, social and economic circumstances of displaced populations. Future hygiene programmes in post-conflict displacement settings should adopt a holistic way of assessing determinants and design programmes which promote agency, build on adaptive norms, create an enabling environment and which are integrated with other aspects of humanitarian response.

Psychometric Analysis of a Postulated Set of Evolved Human Motives.

Many different general systems of human motives have been postulated in the psychological literature. However, as yet, no consensus on which motives should be nominated, nor how many there are, has emerged. Recently, we deduced the existence of a number of motives using a logical argument derived from evolutionary theory; that humans have evolved an independent psychological "engine" to respond to each kind of evolutionary problem set by a dimension of the human niche, or life-way. Here, we confirm the existence of 14 out of 15 of these postulated motives using factor analysis on a web-based sample of 500 respondents from the UK: Lust, Hunger, Fear, Disgust, Attract, Love, Nurture, Hoard, Create, Affiliate, Status, Justice, Curiosity, and Play. The items which loaded most strongly for each factor confirmed the expected core value of each motive. Comfort did not emerge, perhaps because it is more about satisfying specific physiological requirements than a cluster of activities linked semantically by the concept of attaining "comfort." We believe this analysis can form the foundation of a scale for use in applied psychological work ranging from personality testing to personnel selection to public health program design.

Cluster-randomised trial to test the effect of a behaviour change intervention on toilet use in rural India: results and methodological considerations.

BACKGROUND: Effective and scalable behaviour change interventions to increase use of existing toilets in low income settings are under debate. We tested the effect of a novel intervention, the '5 Star Toilet' campaign, on toilet use among households owning a toilet in a rural setting in the Indian state of Gujarat. METHODS: The intervention included innovative and digitally enabled campaign components delivered over 2 days, promoting the upgrading of existing toilets to achieve use by all household members. The intervention was tested in a cluster randomised trial in 94 villages (47 intervention and 47 control). The primary outcome was the proportion of households with use of toilets by all household members, measured through self- or proxy-reported toilet use. We applied a separate questionnaire tool that masked open defecation questions as a physical activity study, and excluded households surveyed at baseline from the post-intervention survey. We calculated prevalence differences using linear regression with generalised estimating equations. RESULTS: The primary study outcome was assessed in 2483 households (1275 intervention and 1208 control). Exposure to the intervention was low. Post-intervention, toilet use was 83.8% in the control and 90.0% in the intervention arm (unadjusted difference + 6.3%, 95%CI 1.1, 11.4, adjusted difference + 5.0%, 95%CI -0.1, 10.1. The physical activity questionnaire was done in 4736 individuals (2483 intervention and 2253 control), and found no evidence for an effect (toilet use 80.7% vs 82.2%, difference + 1.7%, 95%CI -3.2, 6.7). In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%). Process evaluation suggested that insufficient campaign intensity may have contributed to the low impact of the intervention. CONCLUSION: The study highlights the challenge in achieving high intervention intensity in settings where the proportion of the total population that are potential beneficiaries is small. Responder bias may be minimised by masking open defecation questions as a physical activity study. Over-reporting of toilet use may be further reduced by avoiding repeated surveys in the same households. TRIAL REGISTRATION: The trial was registered on the RIDIE registry ( RIDIE-STUDY-ID-5b8568ac80c30 , 27-8-2018) and retrospectively on clinicaltrials.gov ( NCT04526171 , 30-8-2020).

How to set up government-led national hygiene communication campaigns to combat COVID-19: a strategic blueprint.

While large-scale changes in population behaviour are required to reduce the transmission of the severe acute respiratory syndrome coronavirus 2 virus, the emergency context is not conducive to the sort of careful communications planning that would normally be required to meet such a task. Rapid strategic communications planning in a pandemic by governments is, however, possible and necessary. Steps include setting up a dedicated communications task force, mobilising partners and resources, developing a creative brief and theory of change and overseeing the creation, testing, roll out and revision of content. In this short guide, we argue that a minimum of strategic planning can be undertaken rapidly, and that good use can be made of simple principles of behaviour change, even during pandemics. Our aim here is to provide a blueprint that governments and their partners, especially in low-income settings, can follow to design, coordinate and resource national communications efforts to combat the COVID-19 pandemic immediately and for the longer term.

The determinants of handwashing behaviour in domestic settings: An integrative systematic review.

BACKGROUND: Hygiene promotion interventions are likely to be more effective if they target the determinants of handwashing behaviour. Synthesis of the evidence on the determinants of handwashing behaviour is needed to enable practitioners to use evidence in hygiene promotion programming. PURPOSE: To identify, define and categorise the determinants of handwashing behaviour in domestic settings and to appraise the quality of this evidence. METHODS: We conducted an integrative review, searching three databases for terms related to handwashing and behaviour change determinants. Studies were summarised and their quality assessed against a pre-defined set of criteria for qualitative, quantitative and mixed-method studies. Data on determinants were extracted and classified according to a predefined theoretical taxonomy. The effect of each association between a determinant and handwashing behaviour was summarised and weighted based on the quality of evidence provided. Determinants that were reported more than three times were combined into a meta-association and included in the main analysis. Sub-analyses were done for studies conducted during outbreaks or humanitarian crises. RESULTS: Seventy-eight studies met the criteria. Of these, 18% were graded as 'good quality' and 497 associations between determinants and handwashing behaviour were extracted. We found that 21% of these associations did not clearly define the determinant and 70% did not use a valid or reliable method for assessing determinants and/or behaviour. Fifty meta-associations were included in the main analysis. The determinants of handwashing that were most commonly reported were knowledge, risk, psychological trade-offs or discounts, characteristic traits (like gender, wealth and education), and infrastructure. There was insufficient data to draw conclusions about the determinants of behaviour in outbreaks or crises. CONCLUSIONS: This review demonstrates that our understanding of behavioural determinants remains sub-optimal. We found that there are limitations in the way behavioural determinants are conceptualised and measured and that research is biased towards exploring a narrow range of behavioural determinants. Hygiene promotion programmes are likely to be most successful if they use multi-modal approaches, combining infrastructural improvement with 'soft' hygiene promotion which addresses a range of determinants rather than just education about disease transmission.

Explaining the outcomes of the 'Clean India' campaign: institutional behaviour and sanitation transformation in India.

INTRODUCTION: Many less developed countries are struggling to provide universal access to safe sanitation, but in the past 5 years India has almost reached its target of eliminating open defaecation. OBJECTIVE: To understand how the Indian government effected this sanitation transformation. METHODS: The study employed interviews with 17 actors in the government's 'Clean India' programme across the national capital and four states, which were analysed using a theory of change grounded in Behaviour Centred Design. RESULTS: The Swachh Bharat Mission (Gramin) claims to have improved the coverage of toilets in rural India from 39% to over 95% of households between 2014 and mid-2019. From interviews with relevant actors we constructed a theory of change for the programme, in which high-level political support and disruptive leadership changed environments in districts, which led to psychological changes in district officials. This, in turn, led to changed behaviour for sanitation programming. The prime minister set an ambitious goal of eliminating open defaecation by the 150th birthday of Mahatma Gandhi (October 2019). This galvanised government bureaucracy, while early success in 100 flagship districts reduced the scepticism of government employees, a cadre of 500 young professionals placed in districts imparted new ideas and energy, social and mass media were used to inform and motivate the public, and new norms of ethical behaviour were demonstrated by leaders. As a result, district officials became emotionally involved in the programme and felt pride at their achievement in ridding villages of open defaecation. CONCLUSIONS: Though many challenges remain, governments seeking to achieve the sustainable development goal of universal access to safe sanitation can emulate the success of India's Swachh Bharat Mission.

Theory-driven formative research to inform the design of a national sanitation campaign in Tanzania.

INTRODUCTION: There are gaps in global understanding about how to design and implement interventions to improve sanitation. This formative study provided insights for the subsequent redesign of a government-led national sanitation campaign targeting rural populations in Tanzania. METHODS: The Behaviour Centred Design approach was used to investigate the determinants of toilet building, improvement and use. Varied, novel, and interactive research tools were employed in fifty-five households in two regions of rural Tanzania. Results were analysed to articulate a Theory of Change, which then informed intervention design. RESULTS: Participants valued hard work, enterprise, and improving their lives over many years. They wanted better toilets but felt no urgency to act quickly. A common emotional motivator for improving toilets was to protect children from disease (Nurture) but this was insufficient to drive rapid change. Disgust with traditional toilets meant they were built at a distance from the house: an 'out of sight, out of mind' attitude. Other powerful motives included the desire to improve living conditions (Create), and to become a modern Tanzanian (Status), albeit without 'showing off'. Construction costs and water scarcity were the main stated barriers. Receiving information about realistic costs, support accessing materials, and visiting better latrines elsewhere were commonly reported reasons for improving latrines. CONCLUSIONS: The resulting Theory of Change recommended that the intervention should surprise people with a novel conversation about toilets, promote toilets as a means of conferring status, and introduce a perceived urgency to 'act now'. It should suggest that modest improvements would lead to a better life. Feelings of disgust and fear with poor quality toilets should be amplified, and barriers lessened through promoting transformational toilet improvements, and improving access to modern toilet products. This research provided considerable insight into sanitation behaviours in rural Tanzania, which informed creative intervention design.

Behaviour settings theory applied to domestic water use in Nigeria: A new conceptual tool for the study of routine behaviour.

RATIONALE: Many behaviours relevant to public health are part of everyday routines. However, few tools exist to study such behaviours. Here we re-introduce the behaviour setting, an ecological psychological concept developed in the 1950s, as an approach to the study of routine behaviour. The setting concept bridges theoretical and applied approaches in sociology, psychology and social practice; its components include stage, infrastructure, props, roles, norms, competencies, objectives and resultant routines. METHODS: We applied settings theory to health-related water use behaviour in rural Nigeria. We captured the dimensions of water use behaviour settings in 23 households at varying distances from newly-introduced kiosks selling purified water. RESULTS: We found that routines concerning drinking, laundering, dish washing and handwashing were stable in their settings, varying little between households or by type of water source. Hygiene routines were suboptimal but drinking water was carefully segregated. The majority of water use behaviour was governed, not by an immediate desire to maximise health, but by long-established routines embedded in the social, technical and physical environment. Water kiosks are making only marginal improvements to the quantity and quality of water being used in homes. CONCLUSIONS: Improving public health will require the disruption of settings, for example, through bringing water infrastructure directly to the home, through the sale of new props that facilitate hygienic routines, or in the disruption of gender roles via the promotion of new norms. Settings are an ecologically valid, meso-level theoretical approach that link social and techno-physical environmental factors to behaviour. They provide a comprehensive framework within which to judge avenues for changing routine behaviours. The behaviour settings tool we developed was easy to use, provided a systematic means of capturing the determinants of routine behaviour, and the findings offered insight into methods for disrupting such behaviour.

Using a theory-driven creative process to design a peri-urban on-site sanitation quality improvement intervention.

BACKGROUND: Behavior change interventions have been developed by drawing from many different theories using design processes of varying specificity. We describe the development of a behavior change intervention to improve on-site peri-urban sanitation quality in Lusaka, Zambia using the Behavior Centered Design (BCD) framework to explain the results of the process applied to improving the quality of shared peri-urban sanitation and compare them to similar interventions. METHODS: We used the BCD behavioral determinants model to synthesize the data from our literature review and formative research. Then, we partnered with creative professionals using a design process to develop a theory-driven on-site peri-urban sanitation intervention. Particular attention was paid to the implications of using BCD for intervention development on improving its effectiveness, increasing the contributions to knowledge for other behaviors and settings, and advancing the discipline of applied behavioral science. RESULTS: Based on findings from a literature review and formative research, we designed an intervention to encourage landlords to improve their toilets by making them more accessible, desirable, hygienic, and sustainable. The intervention involved landlords meeting in facilitated groups every 2 weeks with individual follow-up after each meeting. The meetings presented surprising "hidden camera"-style videos to reveal tenants' perspectives, used participatory activities to help landlords reevaluate the benefits they would derive from improving sanitation on their plots, and provided practical guidance and mechanisms to facilitate the performance of construction and cleaning behaviors. CONCLUSIONS: Using the BCD framework provided an easy-to-follow intervention design process. The resulting intervention is highly creative and multi-faceted, with each element having a theoretical role in an explicit theory of change. The development of this theory-driven intervention advances applied behavioral science by facilitating evaluation of each of the behavior change techniques and the overall delivery mechanism hypothesized to change the target behaviors. This informs the adaptation of these findings to improving on-site sanitation in other settings and the iterative development of the BCD model, which can be used to more effectively change other behaviors.

Effect of a behaviour change intervention on the quality of peri-urban sanitation in Lusaka, Zambia: a randomised controlled trial.

BACKGROUND: Poor sanitation in peri-urban areas is a growing public health problem. We tested a scalable, demand-side behaviour change intervention to motivate landlords to improve the quality of shared toilets within their plots. METHODS: We did a residential plot-randomised controlled trial in a peri-urban community in Lusaka, Zambia. We enrolled adult resident landlords on plots where at least one tenant lived. We allocated landlords 1:1 to intervention and control arms on the basis of a random number sequence. The intervention was developed using the Behaviour Centred Design approach and consisted of a series of group meetings designed to motivate sanitation quality improvement as a way to build wealth and reduce on-plot conflict; no subsidies or materials were provided. The control group received no intervention. The four primary outcomes were having a rotational cleaning system in place (to improve hygiene); having a solid door on the toilet used by tenants with an inside lock (for privacy); having an outside lock (for security); and having a sealed toilet (to reduce smell and contamination). We measured outcomes 1 month before the start of the intervention and 4 months after the end of the intervention. Data collectors measuring outcomes were blinded to group assignment. We analysed outcomes by intention to treat, including all landlords with study-end results. Because the outcomes were assumed to not be independent, we used a family-wise error rate of 0·05 to calculate an adjusted significance level of 0·0253. This study was registered with ClinicalTrials.gov, number NCT03174015. FINDINGS: Between June 9 and July 6, 2017, 1085 landlords were enrolled and randomly assigned to the intervention (n=543) or the control group (n=542). The intervention was delivered from Aug 1, 2017, and evaluated from Feb 15 to March 5, 2018. Analysis was based on the 474 intervention and 454 control landlords surveyed at study end. The intervention was associated with improvements in the prevalence of cleaning rotas (relative risk 1·16, 95% CI 1·05-1·30; p=0·0011), inside locks (1·34, 1·10-1·64; p=0·00081), outside locks (1·27, 1·06-1·52; p=0·0028), and toilets with simple covers or water seals (1·25, 1·04-1·50; p=0·0063). INTERPRETATION: It is possible to improve the structural quality and cleanliness of shared sanitation by targeting landlords with a scalable, theory-driven behaviour change intervention without subsidy or provision of the relevant infrastructure. FUNDING: Sanitation and Hygiene Applied Research for Equity.

Effect of a School-Based Hygiene Behavior Change Campaign on Handwashing with Soap in Bihar, India: Cluster-Randomized Trial.

Changing hand hygiene behavior at scale in the community remains a challenge. The objective of this study was to estimate the effect of Unilever's school-based "School of 5" handwashing campaign on handwashing with soap (HWWS) in schoolchildren and their mothers in the Indian state of Bihar. We conducted a cluster-randomized trial in two districts. We randomized a total of 32 villages with at least one eligible school to intervention and control groups (1:1) and recruited 338 households in each group for outcome measurement. We used structured observation in households to measure HWWS at target occasions (after defecation, soap use during bathing, and before each main meal) in schoolchildren and their mothers. Observers were blinded to intervention status. We observed 636 target occasions (297 in the intervention arm and 339 in the control arm) in mothers and school-going children. After the intervention, HWWS prevalence at target occasions was 22.4% in the control arm and 26.6% in the intervention arm (prevalence difference +4.4%, 95% confidence interval: -4.0, 12.8). The difference was similar in children and mothers. Observers appeared to be adequately blinded to intervention status, whereas observed households were successfully kept unaware of the purpose of observations. To conclude, we found no evidence for a health-relevant effect of the School of 5 intervention on HWWS in schoolchildren and their mothers. Qualitative research suggested that reasons for the low impact of the intervention included low campaign intensity, ineffective delivery, and a model possibly not well tailored to these challenging physical and social environments.

The structure and function of pathogen disgust.

Researchers have long noted that many of the multiple elicitors of disgust have some relation to infectious disease. There is an emerging consensus that disgust evolved in Animalia to direct the behaviours that reduce risk of infection, so-called 'parasite avoidance theory'. If this is correct, then the disgust motive should be structured in a manner that reflects the ways in which infectious disease can be avoided. In this study, we generated a set of items based on the epidemiology of disease transmission. These were then rated for their capacity to elicit disgust by a large, predominantly North American/UK sample and subjected to factor analysis to identify latent variables. While a number of plausible factor solutions emerged, Velicer's MAP (minimum average partial) test suggested six domains: atypical appearance, lesions, sex, hygiene, food and animals. This structure did not exactly mirror the transmission routes of infections, as we initially predicted, but it may rather reflect distinct kinds of behavioural tasks involved in avoiding disease. This finding makes sense from the perspective of a cognitive system that evolved under selection for a behavioural response to threats from the social and biological environment. We suggest that regularly occurring types of infectious disease problems have produced regularities in the domain structure of pathogen disgust and discuss the implications of these results for understanding the structure, function and measurement of motives such as disgust in humans and other animals.This article is part of the Theo Murphy meeting issue 'Evolution of pathogen and parasite avoidance behaviours'.

Evolution of pathogen and parasite avoidance behaviours.

All free-living animals are subject to intense selection pressure from parasites and pathogens resulting in behavioural adaptations that can help potential hosts to avoid falling prey to parasites. This special issue on the evolution of parasite avoidance behaviour was compiled following a Royal Society meeting in 2017. Here we have assembled contributions from a wide range of disciplines including genetics, ecology, parasitology, behavioural science, ecology, psychology and epidemiology on the disease avoidance behaviour of a wide range of species. Taking an interdisciplinary and cross-species perspective allows us to sketch out the strategies, mechanisms and consequences of parasite avoidance and to identify gaps and further questions. Parasite avoidance strategies must include avoiding parasites themselves and cues to their presence in conspecifics, heterospecifics, foods and habitat. Further, parasite avoidance behaviour can be directed at constructing parasite-retardant niches. Mechanisms of parasite avoidance behaviour are generally less well characterized, though nematodes, rodents and human studies are beginning to elucidate the genetic, hormonal and neural architecture that allows animals to recognize and respond to cues of parasite threat. While the consequences of infection are well characterized in humans, we still have much to learn about the epidemiology of parasites of other species, as well as the trade-offs that hosts make in parasite defence versus other beneficial investments like mating and foraging. Finally, in this overview we conclude that it is legitimate to use the word 'disgust' to describe parasite avoidance systems, in the same way that 'fear' is used to describe animal predator avoidance systems. Understanding disgust across species offers an excellent system for investigating the strategies, mechanisms and consequences of behaviour and could be a vital contribution towards the understanding and conservation of our planet's ecosystems.This article is part of the Theo Murphy meeting issue 'Evolution of pathogen and parasite avoidance behaviours'.

Disentangling the effects of a multiple behaviour change intervention for diarrhoea control in Zambia: a theory-based process evaluation.

BACKGROUND: Diarrhoea is a leading cause of child death in Zambia. As elsewhere, the disease burden could be greatly reduced through caregiver uptake of existing prevention and treatment strategies. We recently reported the results of the Komboni Housewives intervention which tested a novel strategy employing motives including affiliation and disgust to improve caregiver practice of four diarrhoea control behaviours: exclusive breastfeeding; handwashing with soap; and correct preparation and use of oral rehydration salts (ORS) and zinc. The intervention was delivered via community events (women's forums and road shows), at health clinics (group session) and via radio. A cluster randomised trial revealed that the intervention resulted in a small improvement in exclusive breastfeeding practices, but was only associated with small changes in the other behaviours in areas with greater intervention exposure. This paper reports the findings of the process evaluation that was conducted alongside the trial to investigate how factors associated with intervention delivery and receipt influenced caregiver uptake of the target behaviours. METHODS: Process data were collected from the eight peri-urban and rural intervention areas throughout the six-month implementation period and in all 16 clusters 4-6 weeks afterwards. Intervention implementation (fidelity, reach, dose delivered and recruitment strategies) and receipt (participant engagement and responses, and mediators) were explored through review of intervention activity logs, unannounced observation of intervention events, semi-structured interviews, focus groups with implementers and intervention recipients, and household surveys. Evaluation methods and analyses were guided by the intervention's theory of change and the evaluation framework of Linnan and Steckler. RESULTS: Intervention reach was lower than intended: 39% of the surveyed population reported attending one or more face-to-face intervention event, of whom only 11% attended two or more intervention events. The intervention was not equally feasible to deliver in all settings: fewer events took place in remote rural areas, and the intervention did not adequately penetrate communities in several peri-urban sites where the population density was high, the population was slightly higher socio-economic status, recruitment was challenging, and numerous alternative sources of entertainment existed. Adaptations made by the implementers affected the fidelity of implementation of messages for all target behaviours. Incorrect messages were consequently recalled by intervention recipients. Participants were most receptive to the novel disgust and skills-based interactive demonstrations targeting exclusive breastfeeding and ORS preparation respectively. However, initial disgust elicitation was not followed by a change in associated psychological mediators, and social norms were not measurably changed. CONCLUSIONS: The lack of measured behaviour change was likely due to issues with both the intervention's content and its delivery. Achieving high reach and intensity in community interventions delivered in diverse settings is challenging. Achieving high fidelity is also challenging when multiple behaviours are targeted for change. Further work using improved tools is needed to explore the use of subconscious motives in behaviour change interventions. To better uncover how and why interventions achieve their measured effects, process evaluations of complex interventions should develop and employ frameworks for investigation and interpretation that are structured around the intervention's theory of change and the local context. TRIAL REGISTRATION: The study was registered as part of the larger trial on 5 March 2014 with ClinicalTrials.gov: NCT02081521 .

'Unfit for human consumption': a study of the contamination of formula milk fed to young children in East Java, Indonesia.

OBJECTIVES: To examine levels of bacterial contamination in formula feeding bottles in Sidoarjo, East Java, and to assess the preparation practices that may have been responsible. METHODS: A cross-sectional study was conducted among 92 randomly selected households with children under the age of two who were bottle-fed formula. In each household, we carried out video observation of mothers/caregivers preparing bottles, and examined samples of formula for coliform bacteria and Escherichia coli (E. coli). In-depth interviews were conducted with a subsample of 20 mothers. RESULTS: A total of 88% of the formula feeds were contaminated with total coliforms at a level >10 MPN/ml, and 45% contained E. coli. These feeds were defined as 'unfit for human consumption'. In the video observations, none of the mothers complied with all five WHO-recommended measures of hygienic formula feed preparation. Only two mothers washed their hands with soap prior to formula preparation. Most mothers also failed to clean or sterilise the bottle and clean the preparation area. In-depth interviews confirmed that such suboptimal hygiene practices were common. CONCLUSION: The high levels of contamination found highlight that bottles are an important faecal-oral exposure pathway resulting from poor hygiene practices during bottle preparation.