Increasing physical activity (PA) among adolescents is an important health promotion goal. PA has numerous positive health effects, but the majority of Dutch adolescents do not meet PA requirements. The present paper describes the systematic development of a theory-based computer-tailored intervention, YouRAction, which targets individual and environmental factors determining PA among adolescents.The intervention development was guided by the Intervention Mapping protocol, in order to define clear program objectives, theoretical methods and practical strategies, ensure systematic program planning and pilot-testing, and anticipate on implementation and evaluation. Two versions of YouRAction were developed: one that targets individual determinants and an extended version that also provides feedback on opportunities to be active in the neighbourhood. Key determinants that were targeted included: knowledge and awareness, attitudes, self-efficacy and subjective norms. The extended version also addressed perceived availability of neighbourhood PA facilities. Both versions aimed to increase levels of moderate-to-vigorous PA among adolescents. The intervention structure was based on self-regulation theory, comprising of five steps in the process of successful goal pursuit. Monitoring of PA behaviour and behavioural and normative feedback were used to increase awareness of PA behaviour; motivation was enhanced by targeting self-efficacy and attitudes, by means of various interactive strategies, such as web movies; the perceived environment was targeted by visualizing opportunities to be active in an interactive geographical map of the home environment; in the goal setting phase, the adolescents were guided in setting a goal and developing an action plan to achieve this goal; in the phase of active goal pursuit adolescents try to achieve their goal and in the evaluation phase the achievements are evaluated. Based on the results of the evaluation adolescents could revise their goal or choose another behaviour to focus on. The intervention is delivered in a classroom setting in three lessons. YouRAction will be evaluated in a cluster-randomized trial, with classes as unit of randomization. Evaluation will focus on PA outcomes, cognitive mediators/moderators and process measures.The planned development of YouRAction resulted in two computer-tailored interventions aimed at the promotion of PA in a Dutch secondary school setting.NTR1923 Sufficient physical activity (PA) contributes to the prevention of a range of conditions such as overweight and obesity, cardiovascular diseases, cancers, depression and low bone mineral density ,2 and isA planned approach to intervention development is likely to increase the effectiveness of interventions , given tTo evaluate the additional effect of this environmental information, two versions of the computer-tailored intervention were developed. Both interventions are identical, and provide personalised feedback on individual determinants and change processes, whereas the extended version in addition provides feedback on the availability of PA opportunities in the home environment.In the first part of this paper we describe the results of the systematic development of the intervention following the intervention mapping (IM) protocol for goal directed, theory and evidence based development of interventions. In the second part we describe the evaluation protocol.The IM protocol describes six steps, in the process towards development of a theory-driven and evidence based intervention  Figure . IM has Carrying out a needs assessment is the first step in intervention development. In a needs assessment the discrepancy between the current situation and the desired situation in a given group of people is studied. Key points of the information generated in the needs assessment have already been described in the introduction section. To summarize, a sufficient level of MVPA is an important determinant for various diseases and health outcomes. MVPA may consist of activities such as brisk walking or cycling, leisure time physical activity  or (organized) sports. However, a majority of the adolescents living in the Netherlands do not meet the Dutch MVPA guideline. Levels of MVPA in adolescents vary according to socio-economic status, gender and ethnicity, with in general lower levels of PA among lower educated groups ,18 , girBased on the results of the needs assessment, we decided that the aim of this intervention was to achieve that an additional 10% of the adolescents meet the PA guidelines for moderate intensity physical activity for at least 60 minutes per day, at 6 months after exposure to the intervention." We deliberately stated this goal in such general terms, because it can be reached by engaging in a range of different PA sub-behaviours such as active transport, leisure time physical activity or participation in organized sports, recognizing the complexity and diversity of PA behaviour.Once the overall health behavioural aim of the intervention was set, we defined what adolescents actually would need to do to achieve the overall intervention goal. Basically, adolescents need to comply with the MVPA guideline. Therefore, the intervention was developed to increase MVPA among adolescents in such a way, that adolescents engage in moderate intensity PA for 60 minutes per day on 7 days per week. This can be achieved by engaging in the previously defined PA sub-behaviours.a goal-guidance process, occurring in iterative phases, that requires the self-reflective implementation of various change and maintenance mechanisms that are aimed at task- and time-specific outcomes." [Behaviours, especially complex behaviours - such as MVPA - can mostly not be changed directly, but have to be broken down in smaller, specific actions to be taken, for instance "identifying sub-behaviour which can be improved" or "setting challenging goals". These more specific actions required in the process towards overall PA behaviour change are called, "performance objectives" in IM. Performance objectives were stated for the three identified sub-behaviours, sports, active transport and leisure time physical activity. All performance objectives in our intervention were based on theories of self-regulation. Self-regulation has been defined as "tcomes." . We distAnother main task in the phase of developing specific intervention objectives is that important and changeable determinants of the target behaviours and sub-behaviours are identified. These important and modifiable determinants of physical activity in adolescents were selected based on a review of the literature and identification of additional constructs from theories. For the identification of additional constructs we consulted theories that are predominantly used in the field of PA and other health related behaviours, including the Theory of Planned Behaviour (TPB), the SocIn addition, one of the recent developments in the field physical activity is the interest in socio-ecological models to explain health behaviour. Some of these models propose an effect of the physical, socio-cultural, political and economic environment on PA directly or indirectly via cognitive variables ,12. ReseAs a final task in this step of IM, the selected determinants and performance objectives were integrated in matrices to define change objectives. Change objectives define what the participants need to learn or do, in order to achieve the performance objectives. For instance, in order to achieve the performance objective "Adolescents decide to increase sports participation", an important determinant is self-efficacy. One of the change objectives in terms of self-efficacy is "Adolescents identify difficult situations which may prevent them from participating in sports". In the intervention development process, the change objectives were used to select appropriate behaviour change methods and to produce the right content of the intervention. A selection of all the change objectives is shown in Table In the next step of Intervention Mapping, appropriate methods, derived from literature, to modify the determinants were selected for each specific change objective. These theoretical methods were translated into practical strategies that can be delivered in the intervention, by taking their parameters for use  into acThe program consists of three lessons of approximately 35 minutes, with homework assignments to be completed between the lessons. All lessons consist of one or more sections in which specific determinants were targeted. These sections are based on the general theme of the intervention: "YouR". The name of the intervention, YouRAction, is an acronym of Youths of Rotterdam in Action. Examples of section names include YouROpinion (targeting attitudes) and YouRSkills (targeting self-efficacy). A general outline of the intervention is shown in Figure The program is introduced by the teacher, after which the adolescents sign in to the program. They can than choose their personal guide, to increase attention for the messages throughout the program. Adolescents can choose between two "personal guides": Armin and Anna. This guide appears in movies, comics and throughout the program, mostly in an animated format.In the monitoring phase of self-regulation, adolescents are first made familiar with the terminology used throughout the intervention and learn about various levels of PA. Knowledge is targeted in the section "YouRKnowledge", by making use of the methodology of active learning. In practice, this means that interactive quizzes and feedback are used to test, and increase, their knowledge on concepts of PA and terminology used throughout the intervention. Before the actual monitoring starts, attitudes towards PA in general are addressed by linking physical activity with general values. Adolescents can pick two important values from a predefined list (e.g. "Nature and the environment important for me") on which feedback is provided how physical activity fits with that value.The section YouRBehaviour, deals with monitoring and awareness of personal PA levels. Personal feedback on behaviour and normative feedback are the main methods used to increase awareness of PA levels. A detailed questionnaire on PA sub-behaviours is used to monitor current PA status and is used to generate individualized tailored feedback on PA level and how this relates to the PA norms and PA level of peers. This feedback is shown in bar charts, with a textual explanation. Subsequently, more detailed feedback on performance in the three PA sub-behaviours  is provided, to indicate in which sub-behaviours improvements can be made.After completing the YouRBehaviour section, adolescents proceed to YouRMove, in which they have to make a decision whether or not to improve their PA-level and on which sub-behaviour they would like to focus, i.e., active transport, leisure time activity or sports . Subsequently, adolescents select their own pros and cons of the sub-behaviour. For instance, adolescents may perceive as pros for sports "I will have a relaxed feeling after playing sports", "Sports is healthy" or "I can meet (new) friends". Whereas, cons of sports may include "Sports makes me feel sweaty", "Sports causes muscle soreness" or "Sports is too time consuming". When this balance is positive, the advantages of the behaviour are reinforced. In the case that this balance is negative, the cons are hypothetically discussed by a virtual panel of adolescents, aimed to shift the perspective of the adolescent (method: provide information on consequences). The initiation of these texts is from the initial perspective of the adolescent, meaning that the adolescent of the panel initially experienced the disadvantage too, but is now convinced that this perceived disadvantage is not a real disadvantage.The section in which self-efficacy is the central theme is called YouRSkills. Self-efficacy is targeted by three main methods: prompting identification of barriers, model or demonstrate behaviour and setting graded tasks ,35. FirsFeedback on the availability of PA facilities was used as the method to target self-efficacy and perceptions of the physical environment, in the section YouR'Hood. This was done by showing which PA facilities are available in an adolescent's neighbourhood environment using GoogleMaps. Environmental feedback was provided in various ways, depending on the PA sub-behaviour of interest. One of the applications is that adolescents can point out on the map where they can do the activity of their choice, e.g., where they can play tennis; this is applied to promote sports participation and leisure time physical activity. Another application is that adolescents can create routes to different places; this is applied to promote active transport. In the third strategy applied, all facilities in the neighbourhood are displayed on the map to give adolescents an overview of what is available in their neighbourhood; this is used to promote sports participation (i.e. sports facilities and sports clubs), leisure time physical activity and active transport (i.e. parks). Facilities can be selected and additional information about the location pops up, such as of contact details and web addresses of sports clubs, or information on quality of a park when a park was selected. Examples of these strategies can be viewed on several demo movies . They can click on the activity and a pop-up occurs in which they can state with whom and where they plan to do the activity . If they did not manage to overcome these barriers, the adolescents enter a problem solving module, in which failure when trying to do something new is attributed to something that may occur occasionally. Subsequently, they are stimulated to try to think of a way to overcome this barrier the next time and write it down in the program (method: Relapse prevention). In the third lesson this part is slightly modified, as adolescents are stimulated to monitor their behaviour on their own; for instance by making use of their (school) agenda.At the beginning of the third lesson, adolescents receive feedback on their performance during the past week, in YouRWeek (method: feedback on performance). Based on this feedback adolescents can choose either to 1) try to reach the same goal again 2) state a new goal on the same sub-behaviour 3) work on another sub-behaviour. Subsequently adolescents enter the motivational phase again, as can be seen in the feedback loop from Module 4 to Module 3  goals on moderate-to-vigorous physical activity and sports, using pre-defined goals. Subsequently, they create an action plan and explicitly state when they monitor their behaviour and which incentive they give themselves, when they are doing well in reaching their goal. These plans are synthesized to a behavioural contract. This contract will be signed by themselves and their teacher.The general program outline has already been described in the previous section. Therefore the focus of this section is on the very last part of intervention development: the production of the final materials and pretesting of the developed materials.YouRAction was developed in Tailorbuilder software. This software enables intervention developers to create their own web based computer tailored interventions. In order to be able to provide environmental feedback (i.e. show geographic information), extensions to the Tailorbuilder software had to be made. Building a system able to show geographic information from scratch would be very expensive. Instead, the Application Programming Interface (API) of GoogleMaps, provided by Google was used. This proved to be a reliable and efficient way to extent our Tailoring program.For incorporation of environmental information in our system, the same tailoring principle was used as in other tailoring. A score on a tailoring variable is used to select the relevant feedback messages from a computer database, which is subsequently shown on the screen. In other words, environmental feedback had to be tailored to the relevant tailoring variable: the postal code of the home address. The tailoring algorithms defined that all the PA facilities in a 5000 meter radius around the home address had to be selected from the message library and plotted on a map. Thus the geographic locations of opportunities to be active formed the tailored environmental feedback. The environmental information in the database/message library was retrieved from municipal websites and parks were observed by trained observers using an adapted and translated version of the POST audit Tool (POST) .The intervention was developed in collaboration with adolescents, teachers and behaviour change experts, who participated in a linkage group. This linkage group met twice in an official meeting and was contacted on a question-answer base by mail or phone. The adolescents and teachers were approached in several phases of the development process, to give feedback on specific intervention elements, such as the use of GoogleMaps, the use and placement of images and movies and the use of an activity planner.Materials were developed and pre-tested by members of the linkage group, adolescents and teachers. Adolescents were consulted to choose one of three intervention names and one of three logos. The web movies were shot in cooperation with adolescents, who played a role in these movies. Their input was also taken into account to shape the final script of the movies. The graphical design of the final website was developed by adolescent students of a school for graphic design Figure . The finWe specifically focussed on pre-testing the incorporation of GoogleMaps in the tailoring software, since this was an innovative element. First, we started with observing the use of GoogleMaps in a classroom. Based on these observations some adaptations to the use of GoogleMaps were made, such as fine-tuning the radius in which facilities were shown. Secondly, we pre-tested the GoogleMaps application with the adaptations made in a classroom setting (N = 51 adolescents). Adolescents rated the incorporation of GoogleMaps positively. Most adolescents found that 1) the instructions were clear, 2) the map was easy to use, 3) it was fun to work with the maps and 4) the information was complete.The efficacy of the regular and extended version of the computer-tailored intervention will be evaluated against an Internet delivered intervention that provides generic information about physical activity and nutrition. All three interventions have the same graphical design and lay-out and they all consisted of three lessons. The lessons will be given by teachers who are provided with a teacher manual, as a guide for using the program.The aim of the evaluation study is to evaluate achievement of the intervention goals that have been stated during the intervention development process. Furthermore, the aim is to identify whether changes in the outcome measures were mediated through changes in the underlying processes. Therefore, effects of the interventions on behavioural determinants, on PA behaviour and mediation of intervention effects by targeted determinants will be studied. The main outcome measures are compliance to the PA guidelines, time spent in PA and specific sub-behaviours and behavioural determinants. Additionally, the intervention will be evaluated on the process level on acceptability and implementation of the intervention.The main research question to be answered is whether 10% more adolescents in the intervention groups, as compared to the control group, comply with the MVPA norm at six months post intervention.The YouRAction intervention will be evaluated in a three-armed cluster-randomized trial, with school classes as the unit of randomization, using computer aided block-randomization with a block size of 9. In each arm, 17 classes with on average 22 respondents per class will be needed to detect a 10% difference in compliance with the MVPA norm at six months post intervention ). MeasuThe Medical Ethics Committee of Erasmus University Medical Center provided a declaration of "no objection" for this study.Self-reported PA, will be measured by means of the AQuAA  and a siOf all adolescents demographic information on age, gender, education and ethnic background will be collected. Adolescents will fill in a questionnaire at T0, T1 and T2 on cognitive determinants of MVPA, sports, walking, cycling and leisure time physical activity. The cognitive determinants assessed will include those determinants targeted in the intervention: awareness, attitudes, perceived behavioural control, subjective norm and intention, action planning and the perceived physical environment.Additionally at T1, a process evaluation will be conducted, to assess the intervention on acceptability, feasibility and implementation from the teacher's and adolescent's point of view. Teachers will be stimulated to fill in a log book on how much time each lesson took them in preparation and when they gave the lesson. Furthermore they will be stimulated to fill in an online questionnaire on their experiences with using the intervention.In some classes research staff will observe intervention implementation and make notes of their observations. Furthermore server logs will be analyzed to detect how often en when the intervention was used.Participants will be recruited in a two-step procedure. First, schools will be recruited by contacting health coordinators of schools. Second adolescents within the selected schools were recruited. School classes are eligible if they are first year classes, with the main language during teaching being Dutch. These schools should be located within the area of the Municipal Health Services Rotterdam and surroundings. All adolescents in the selected classes will be invited to participate. We will use a passive informed consent procedure, meaning that, after being fully informed about the study, its purpose and its procedures, the adolescent and/or their parents could refuse to participate.The planning process that we described in this study has resulted in an extensive, novel, PA promotion intervention for adolescents that can be implemented in a school setting. Theory and evidence based development of interventions increases the likelihood of an intervention to be effective . The preAlthough this intervention is developed based on theory and evidence, its effectiveness still needs to be evaluated in an evaluation study. Moreover, there is little known about the efficacy of computer tailored interventions among adolescents. Evidence from our evaluation study will provide information on the efficacy of the intervention, potential mediating and moderating mechanisms and the added value of improving awareness of PA facilities in the environment. In addition, the study will provide insight in appreciation and implementation possibilities for the intervention in a school setting.One of the novelties of this intervention is the incorporation of environmental feedback in a computer tailored intervention. This is a novelty for adolescents, but has successfully been applied in a tailored intervention in adults by van Stralen et al. . Van StrIntervention Mapping was a useful tool in developing the YouRAction interventions, however, one of the main limitations was that the protocol is not clear in how to deal with complex behaviours like physical activity, in which various sub-behaviours can be chosen to achieve one overall goal. The aim of our intervention, increasing MVPA, could be reached by improving active transport, engagement in sports and leisure time activities - or in a combination of activities. However for each activity other determinants, change objectives and methods and strategies may be important. In order to be able to do so, we decided to create separate matrices of change objectives for each sub-behaviour, which enabled us to state specific change objectives for each sub-behaviour and select the appropriate methods and strategies to meet the change objectives. The technique of computer tailoring furthermore facilitated the development of a program consisting of such a flexible program. In fact, big parts of the interventions were tailored to the adolescents' selection of a PA sub-behaviour. However, creating programs which are too complex may need more tailoring algorithms, which may have negative impact on the speed of the program.To conclude, the development of YouRAction based on the Intervention Mapping protocol resulted in two theory and evidence based computer-tailored interventions with innovative elements like the incorporation of GoogleMaps. An evaluation study has to provide insight into the efficacy of the basic and extended intervention and will provide evidence for the additional effect of the provision of environmental feedback for computer-tailored PA interventions. If the evaluation study proves that the interventions are effective, two well-developed interventions will become available for the promotion of PA among adolescents.The authors declare that they have no competing interests.All authors contributed to drafting the manuscript and approved the final version. RGP, AO and JB designed the intervention and the evaluation study. All authors contributed to the development of the intervention. All authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/474/prepubDemo movie of an interactive map to explore the home neighbourhood. This movie shows strategies incorporated in the YouRAction intervention to actively explore possibilities to be physically active in the home neighbourhood.Click here for fileDemo movie of an interactive map showing availability of parks. This movie shows strategies incorporated in the YouRAction intervention to change perceptions of availability of parks in the neighbourhood by giving adolescents an overview of what is available.Click here for file


The World Health Organization (WHO) Global Program to Eliminate Lymphatic Filariasis relies on mass drug administration (MDA) of two drugs annually for 4 to 6 years. The goal is to reduce the reservoir of microfilariae in the blood to a level insufficient to maintain transmission by the mosquito vector. In 2008, the international medical aid organization Médecins Sans Frontières (MSF) performed the first round of a MDA in the high-burden area of Asmat district, in Papua, Indonesia. We report the challenges faced in this MDA on a remote Indonesian island and propose solutions to overcome these hurdles in similar future contexts.During the MDA, we encountered difficult challenges in accessing as well as persuading the patient population to take the antifilarial drugs. Health promotion activities supporting treatment need to be adapted and repetitive, with adequate time and resources allocated for accessing and communicating with local, seminomadic populations. Distribution of bednets resulted in an increase in MDA coverage, but it was still below the 80-85% target.MDA for lymphatic filariasis is how the WHO has planned to eliminate the disease from endemic areas. Our programmatic experience will hopefully help inform future campaign planning in difficult-to-access, high-burden areas of the world to achieve target MDA coverage for elimination of lymphatic filariasis. Wuchereria bancrofti, Brugia malayi, or Brugia timori. These parasites reside in lymphatic channels or lymph nodes where they remain viable for more than two decades. W. bancrofti is the most widely distributed, affecting an estimated 115 million people throughout the tropics and subtropics. The World Health Organization (WHO) estimates that 120 million people are currently infected and more than 1 billion people are at risk in 83 countries [Lymphatic filariasis (LF) is a parasitic disease transmitted by mosquito bites which causes disability and adversely impacts the economy of the developing countries where it is endemic. LF is the fourth most common cause of disability worldwide . It is cLF disease transmission can be stopped through a feasible, effective, and relatively inexpensive prevention strategy through mass drug administration (MDA) of two oral drugs to at-risk populations once a year -5. TheseFilariasis is an eradicable disease of high prevalence among several of the islands of Indonesia. Due to the high prevalence and remote distribution and diversity of filarial infections, filariasis elimination in Indonesia is a major challenge .In 2008, the international medical aid organization Médecins Sans Frontières (MSF) offered to carry out the first round of a MDA in the district of Asmat, Papua, Indonesia, where LF was found to be endemic. We report here our experience and the challenges faced in this MDA against LF in Asmat over an 11-week period from July to September 2008.2.The first MSF filariasis campaign took place in Asmat District from July 9, 2008, the date of the first MDA activity, to September 22, 2008, date of the last MDA activity. All the 7 subdistricts were covered, comprising 147 villages visited over 28,000 kmA total of 36,478 people took the drug treatment, giving an average coverage of 58% of the targeted population. The teams spent a total of about 1,000 hours on boats, consuming a total of 24 tons of fuel, representing an average of 1.5 people treated per liter of fuel used in this campaign.Because of their remoteness, the villages were not often visited by outsiders and were accessible only by boat. No radio, television, or newspaper media exist, ruling out advertising educational campaigns through the mass media. Due to this difficulty of accessing local populations, villagers were visited by local health workers about once a month. Workers went to the villages a few weeks before the MDA campaign, and the upcoming campaign was mentioned. Attempts were sometimes made to send out dates of the MDA through the District Health Office (DHO), but these notices were often not distributed.Local health workers however did not perform much health promotion, with most of this task handled by MSF. For example, some puskesmas  staff did not receive invitations for training since postal service is nonexistent in the villages of Asmat, though radio communication to the puskesmas was present at times. Messages were often conveyed word-of-mouth and depended on the next boat that arrived from Agat, the capital.In the village of Yahoi in Fayit, there had been some deaths from snakebites the previous 2 years, and the villages asked for antivenom. Later, on the day of MDA, some villagers were agitated that MSF was treating filariasis in people who had no obvious signs of the disease, when they needed basic health care for diseases like malaria and diarrhea. The physician happened to be there to explain to the people that filariasis can be eradicated with these drugs, but means to eradicate malaria and diarrhea, for instance, have not been found yet.MSF faced program difficulties in Sawa Erma, the subdistrict with the largest population. Rumors in the subdistrict included, "you drown if you take the drugs" and "someone died in Agat after taking the drugs." With the vastness of this subdistrict (Sawa Erma) and a little under 2 weeks allotted to it, we experienced a marked fall in drug administration compliance, averaging only 37% population coverage. Convincing the local population was difficult, as they had little trust in the MDA program. To try to remedy this, the village chief in Sawa took the drugs to demonstrate their safety (a practice often repeated throughout the campaign), but the people watching still would not register to take the drugs. Talking to reassure them was also not helpful. This difficulty was not encountered in other subdistricts.In other subdistricts, for instance in Atsy and Pantai Kasuari, where there was insufficient health care, people came to us and requested health care. Some people narrated the number of infant deaths from diarrhea in the previous year, or the high number of asthma cases in a village. When we explained that we were just working on filariasis in collaboration with the DHO, it was hard to gain trust. The population, rightly, had concerns about other diseases that were life-threatening. In the face of health care difficulties such as these, just telling the needy villagers we would pass the word along, and that our task here was only MDA, may have sounded superficial. This has been the experience in other MDA campaigns as well .The village headmen were often absent, so finding a person the villagers trusted, who would help convince them, was also a challenge. Villagers were sometimes absent from villages, lowering coverage. The reasons given were "they have gone to Agat" or "they are in the forest looking for food." Visits to bewaks (temporary river shelters) were not always fruitful since people were in the forest.Population numbers were often unreliable. The numbers provided by the DHO were projections from the 2000 census when Asmat was still part of the district of Merauke. No newer numbers were available at the time of the intervention. These numbers were found to be inflated when one talked to village authorities and tallied numbers. For instance, in the village of Yomoth, our population figure was 647, the village head told us 502, and a village elder told us only about 300 people actually lived in the village. A total of 180 people were treated with the drugs. Drug coverage could not therefore be accurately determined.One or two hours of health promotion, depending on village size, was not always sufficient to convince people of the importance of taking the drugs. Establishing trust took more time and effort than anticipated.No maps were available indicating each village's bewaks, probably because they are temporary structures. But accessing people living in bewaks was crucial to the success of a campaign of this nature, which necessitates high coverage. Knowing the locations of bewaks was difficult, especially in the largest subdistrict of Sawa Erma. Information on bewaks was not available, nor attempted to be obtained, at the time of MDA planning. Exploration was not done in this subdistrict since mobile clinics had been conducted here, but the populations who came for mobile clinics had sought medical attention for other ailments.The bewaks tended to be scattered and only villagers could take us to them, something not factored into the time frame of the campaign. In the time table for the campaign, one day was allotted for each village of a subdistrict. To return to base by 5:00 PM, a team may sometimes have to leave 2 hours beforehand, and that left no time to visit a large portion of the populations in bewaks. Also, bewaks were often inaccessible even when there was time to visit them for drug distribution.Population turnout and compliance was best in the 4 subdistricts where bednets were distributed Table . People Staying overnight in villages after drug distribution so adverse events could be examined and treated helped increase compliance. The adverse events noted were fever, nausea, and vomiting. When the team could stay on a little later after the end of drug distribution (being close to or in the base village), people's questions were answered, and adverse events could be ascertained and treated appropriately.Lessons learned to potentially apply to future MDA campaigns include:1. In remote locations with no media presence and with the difficulty of transportation to remote villages and their bewaks, accurate mapping must be carried out first.2. Adequate time must be allocated for studying the populations and devising effective health promotion techniques in collaboration with local health authorities and respected figures in the area. Such feedback is crucial. Visiting villages at least once before the start of the campaign to introduce it, meeting with village elders and establishing rapport, and returning to repeat and announce the campaign date may be effective strategies.3. Adequate time must be allotted to the actual MDA campaign so that (a) geographically most if not all the population can be reached; (b) villages can be revisited, if possible, to allow time for people to come from places such as bewaks; (c) lessons learned from villages covered early on in the campaign can be applied meaningfully to villages visited later; and (d) unforeseen events such as inappropriate weather or fuel shortages can be dealt with easily.4. Incentives to the LF-affected populations may be useful in improving compliance. These can be materials  or human resources .5. Polyvalent teams are more efficient :• The same team should do health promotion and MDA activities in one village• Optimal team is composed of one nurse, one health promoter, and one logistician• About 1.5 hours needed for health promotion activity in one village.• A MDA team (3 people) can cover approximately 60 patients/hour (suitable for a village), up to 500 people/day6. Local people within the staff can help reassure the populations during MDAReaching the seminomadic populations in Asmat for LF MDA was a challenge, as was convincing people to take the drugs. Coupled with remoteness of location, and no readily utilizable mass media, an effective MDA requires sufficient time, repeat visits, and high emphasis on health promotion and establishing trust with local populations. Eliciting direct help and guidance from local, respected, high-standing villagers and sometimes missionaries and local pastors can be useful. Taking the necessary time and effort to establish understanding and trust should be borne out in future MDA campaigns. Coupled incentives to populations, such as distributing bednets, may help increase compliance.Preventative MDA for a disease such as filariasis, which is chronic and has seemingly little effect on day-to-day life, is a major challenge. Filariasis affects parts of the world that are not industrialized and where people may not be generally aware of disease risk. Since MDA is done among the general population, the majority of whom have no symptoms of filariasis, compliance is the major hurdle. In this experience, when bednets were given with the drugs, compliance increased, indicating the potential importance of such incentives to populations when a non-life-threatening disease such as filariasis is targeted for intervention.2 and population of over 75,000. Asmat district has 7 subdistricts: Agats, Akat, Sawa Erma, Suator, Atsy, Fayit, and Pantai Kasuari.Papua is the second largest island in the world and is governed by two countries: Papua New Guinea in the east and Indonesia in the west. The district of Asmat in western Papua has an area of about 28,000 kmMSF provided mobile clinics in Agats, Akat, and Sawa Erma from 2006 to 2008. MSF staff were based in Agat, the center of Agats and the capital of Asmat, and in the village of Pos in Sawa Erma Figure . The MDAOff the Arafura Sea, Asmat district is remote, with access to villages only by boat via rivers that jut inland. The area is mainly swamp land and lacks electricity, roads, agriculture, and other modern facilities. The population is relatively poor and primarily has a middle-school level of education, with men tending to be educated at a higher level than the women. Fishing and foraging for wood for trade are the main occupations.The village population is divided between the actual village, and bewaks, temporary shelters built on rivers where groups of villagers go for a few months each year to forage in the forest for food and wood Figure . Bewaks Local health care is offered in the form of health centers called puskesmas, with one each in a subdistrict capital, and village health posts called pustus, run by a nurse and/or midwife. The DHO  is based in Agat, the district capital.W. bancrofti, 2 positive of B. malayi, and 2 mixed between W. bancrofti and B. malayi. All were from Sawa Erma subdistrict in 5 villages , which confirmed the clinical findings. The microfilaria rate was thus 2.03%, which exceeds the criteria of the Ministry of Health (MOH) and WHO (≥1%) to declare an area as endemic [Beginning in November 2006 over 2 years, MSF helped provide basic health care through mobile clinics. In February 2008, MSF launched a study comparing the performance of three malaria rapid diagnostic tests with that of microscopy (gold standard). A total of 492 patients were included in this study from 3 subdistricts  in which 245 (49.8%) were children under 5 years of age. Most of the patients came from Sawa Erma (60.2%). Microfilariae were found among 10 patients: 6 positive for In Asmat, both limb elephantiasis and hydrocele (enlargement of the scrotum with fluid due to obstruction of lymphatic drainage by the worm) are symptomatic manifestations of chronic filariasis. Occasionally, unilateral breast enlargement has also been observed.Because the district did not have the required budget to carry out a MDA campaign for filariasis, in 2008 MSF offered to perform the first round of MDA. The MOH and DHO committed to continuing the campaign for the remaining four rounds over the following 4 years.The filariasis MDA team was comprised of one field coordinator, one physician , 4 nurses, and 8 health promoters, in addition to the logistics staff  would be given three drugs for this purpose, two to treat the active and nascent disease  and the third (paracetamol) to reduce side effects. The team used flip charts and leaflets as educational aids, and hung posters explaining the disease cycle and drugs in simple terms. In subdistricts where MSF had not worked before, MSF newsletters were given to the village chief.Written materials were in Bahasa Indonesia, the national language of Indonesia. The team used microphones to walk around the village announcing the day of the MDA campaign, along with the venue advised by the village elders. The team met with midwives and/or kaders  to help with registrations.One to three days after the health promotion team visited a village , the MDA team arrived in the morning, set up base at the decided venue, briefly described the disease and treatment again, and proceeded to start MDA. When turnout was low, the team sometimes went door to door. Also, in such cases, they went to the bewaks close by, if accessible. The team was required to leave at a time that would allow them to return to the team base by 5:00 PM (since the boats did not have adequate equipment for navigation in the dark). The base was the central village where all the teams stayed while MDA was done in one subdistrict.At the end of each subdistrict, sweeping (the process of returning to a population with drugs where adequate coverage was not accomplished the first time) was done in 4 villages with the least coverage on the original MDA day. As an ancillary to the MDA, registration of hydrocele in men and malnutrition in children 2-5 years old was performed. At the end of the campaign, hydrocele repair was to be planned. This was done a few months after the end of the MDA campaign.In the subdistricts of Atsy, Suator, Fayit, and Pantai Kasuari, one bednet was given to each family administered drugs. Villagers were informed of this distribution on the day of health promotion, and it was made clear that bednets were not a cure for filariasis, but helped prevent malaria and could help with filariasis prevention to some degree as well. The bednets had already been distributed for malaria prevention in the other subdistricts over the last 2 years since MSF had had a presence there.Conducted by MSF, this first round of the MDA campaign was a collaboration with the DHO. Two doctors from the MOH arrived from Jakarta to help in the training of local health and MSF staff. Doctors from the 7 puskesmas of Asmat were invited, as were some ancillary health staff.The training lasted one day and covered:• History of MSF in the area and our past activities• How MSF decided to carry out the first round of MDA• MOH policy for implementing the filariasis program• Pathophysiology, symptoms, diagnosis, complications, prevention, and treatment of filariasis in the international context• Filariasis in Asmat• Health promotion strategies• MDA organization at health center level• Demonstration of drug distribution and MDA technique• Adverse reactions of drugs • Methods of reporting drug administration coverage• Security guidelinesHealth promotion training involved educating the patient populations of the ancillary effects of the filariasis drugs, such as the elimination of intestinal helminths and decreases in infant and maternal morbidity. Training of MSF staff was reinforced after 5 subdistricts were completed. Training was also improvised as we encountered patients who complained of limb pain, fever, and itching after drug treatment. The patients were told, for instance, that if adverse events were encountered, it meant the drugs were working (so they would not assume the drugs were making them sick and pass that on to other villagers), and to seek treatment for adverse events in the local health centers.The authors declare that they have no competing interests.NB and JM conceived and designed the study, acquired and analyzed the data, drafted and critically revised the manuscript, and read and approved the final manuscript.


The United Nations Millennium Development Goals look to substantial improvements in child and maternal survival. Morbidity and mortality during pregnancy, delivery and the postnatal period are prime obstacles to achieving these goals. Given the increasing importance of urban health to global prospects, Mumbai's City Initiative for Newborn Health aims to improve maternal and neonatal health in vulnerable urban slum communities, through a combination of health service quality improvement and community participation. The protocol describes a trial of community intervention aimed at improving prevention, care seeking and outcomes.To test an intervention that supports local women as facilitators in mobilising communities for better health care. Community women's groups will build an understanding of their potential to improve maternal and infant health, and develop and implement strategies to do so.Cluster-randomized controlled trial.The intervention will employ local community-based female facilitators to convene groups and help them to explore maternal and neonatal health issues. Groups will meet fortnightly through a seven-phase process of sharing experiences, discussion of the issues raised, discovery of potential community strengths, building of a vision for action, design and implementation of community strategies, and evaluation.The unit of allocation will be an urban slum cluster of 1000–1500 households. 48 clusters have been randomly selected after stratification by ward. 24 clusters have been randomly allocated to receive the community intervention. 24 clusters will act as control groups, but will benefit from health service quality improvement. Indicators of effect will be measured through a surveillance system implemented by the project. Key distal outcome indicators will be neonatal mortality and maternal and neonatal morbidity. Key proximate outcome indicators will be home care practices, uptake of antenatal, delivery and postnatal care, and care for maternal and neonatal illness.Data will be collected through a vital registration system for births and deaths in the 48 study clusters. Structured interviews with families will be conducted at about 6 weeks after index deliveries. We will also collect both quantitative and qualitative data to support a process evaluation.Current controlled trials ISRCTN96256793 After a decade of relative stagnation, the child survival agenda has been reinvigorated by a series of calls for action and the agreement of a set of United Nations Millennium Development Goals. The fourth and fifth goals are linked explicitly with maternal and child survival targets.,2 11 milAlthough many countries are unlikely to achieve the goals, India may yet do so. India's We will live on a planet of slums. Half theSlum populations rank among the poorest, most underserved and most vulnerable to shocks and health threats. Health iBecause pregnancy and the neonatal period have been invisible over much of the world, recognizing problems, deciding to act on them, reaching a point of care and receiving appropriate care are all problematic. Care for women during pregnancy, and for newborn infants, has not figured explicitly on the agenda of health care providers until recently. In Delhi slums, only 13% of newborn infants with symptoms requiring hospitalisation were referred to hospitals, and when they arrived they were often turned away or managed inappropriately. AlthoughInformation on maternity practices and care-seeking is available from a cross-sectional study undertaken by our group in collaboration with Monitoring and Research Systems, Mumbai. The study interviewed women in Dharavi, familiar to many as Asia's largest slum area, which has seen successive waves of development and community action. 56% of respondents had been married by the age of 18 and 63% had three or more children. 35% of women slum residents were illiterate and most (91%) did not work outside their cramped homes. Registration of pregnancy was high (95%), but late, and only 18% of women had been visited by a health worker during pregnancy. In case of illness, 52% of women had consulted private practitioners and 34% government services. 35% of women reported eating less than normal during pregnancy and 60% reported no change in the amount of rest they took. Although 91% of women had delivered in a health facility – where attendance by health care professionals was relatively swift and appropriate examination and advice had usually been given – a third had arrived less than an hour before delivery. About one third of infants were recorded as having low birth weight, and breastfeeding was almost universal but not exclusive.Participatory approaches have long been advocated in order to build links between primary services and their users,,27 and tThe Warmi project, implemented in Bolivia in a poor, rural population of 15,000 with little health system infrastructure, worked with women's groups to encourage participatory planning for mother and infant care, and docuBuilding on this example, we conducted the MIRA Makwanpur trial in a population of 170,000 in a mountainous rural district of Nepal. One woman facilitator per population cluster of 7000 facilitated monthly meetings with women's groups to address the issues of pregnancy, childbirth and newborn health. Each group moved through a participatory planning cycle to explore perinatal care strategies and solutions.,35 The lDespite several studies, assumptions and advocacy, the maternal and neonatal situation in slum communities has not been adequately described. Hard indicators – particularly mortality rates – and patterns of care and service usage have been inferred rather than measured. The Municipal Corporation of Greater Mumbai collects vital registration data from hospitals, crematoria and ward offices, and its epidemiological cell is able to derive fairly robust estimates of maternal and infant mortality at city level. Comparisons between areas, particularly between slum and non-slum, are difficult, however, because of the nature of the data.The particular characteristics of the City Initiative trial in Mumbai are its urban setting, a focus on the poorest groups, an examination of health vulnerability and a multisectoral research partnership. The MIRA Makwanpur trial was conducted in rural Nepal and its external validity requires examination. Key questions include: (1) Will community-based action groups reduce neonatal mortality in urban settings? (2) Is the intervention even feasible in the urban context? (3) Can the intervention model be modified to improve cost-effectiveness? (4) How can government be engaged in research to leverage policy change or adoption? (5) Can community group activities stimulate changes in other outcomes? (6) Can the momentum of change be sustained by community ownership of the process? Amid a wealth of discussion of urbanisation, the project will examine the health of women and children in a hallmark urban context. It represents applied research in a developing country and accords with an agenda to conduct effectiveness studies of interventions, collaborate cross-sectorally, and develop public health research capacity in partner organizations.To improve the survival and health of mothers and newborn infants in slum communities in Mumbai, India.To test an intervention that mobilises communities for better health care, in which local women's groups build an understanding of their potential to improve maternal and infant health and develop and implement strategies to do so.To test the effect of a participatory intervention using action research cycles with community groups, on:(a) Care practices and health care seeking behaviour for women in the antenatal, delivery and postpartum periods, and for infants in the neonatal period.(b) Neonatal and maternal morbidity.(c) Neonatal mortality.(d) To document and evaluate the process for potential replicability and sustainability.The intervention will be evaluated in a cluster-randomised controlled trial. A cluster design has been chosen because the allocation and loci of delivery of the interventions (community clusters) are groups rather than individuals. 48 vulnerable slum clusters have been identified. 24 have been allocated to receive the intervention and 24 will act as controls. An independent surveillance system for outcomes – births, morbidity, mortality, and care seeking – has been designed and implemented in all 48 clusters, covering a population of 350,000.Will a community mobilisation intervention improve maternal and neonatal home care, service uptake, morbidity and mortality in slum communities of Mumbai?What are the patterns of maternal and neonatal care in vulnerable slum communities in Mumbai?What are the neonatal mortality rates in vulnerable slum communities?How can we assess health vulnerability, how does a cluster-level classification compare with an individual-level one, and is this classification associated with health outcomes?Community group activities will lead to: better home care; increased service uptake for routine antenatal, delivery, postnatal and neonatal care; increased care seeking at appropriate facilities for maternal and neonatal illness; reduced neonatal and maternal morbidity; reduced neonatal mortality.The study will have three tiers of outcomes Figure .Tier 1: proximate outcomes at community level. Patterns of routine antenatal, delivery and postnatal care will be described, whether at home or in the informal, public or private sector. In the event of illness, we shall document care at home and care seeking in both private and public sectors.Tier 2: proximate outcomes at health service level. Patterns of antenatal, delivery and postnatal care will be described in terms of the uptake of public health services. Care seeking for maternal and neonatal illness will be described as it relates to public sector services and facilities.Tier 3: distal impacts. Incidence, type and outcome of maternal and neonatal morbidity will be described. Neonatal mortality rates, causes and care seeking will be described. Sample size has been estimated to capture changes in mortality rates in particular.India's most populous city, Mumbai has over 16 million residents and a social heterogeneity which cuts across regional, ethnic, cultural and linguistic lines. The city is divided administratively into 24 municipal wards, within which more than half the population live in slums. The study will be conducted in 6 municipal wards which define the population for a larger cross-sectoral initiative. The City Initiative for Newborn Health is a collaboration between government , a non-government organisation , an Indian private entity , and an academic research group . The Initiative has two threads, on the demand and supply sides: community mobilisation activities – the evaluation of which is the subject of the proposal – and improvement of antenatal, delivery and postnatal care at municipal health posts, maternity homes, peripheral hospitals and tertiary hospitals. The initiative is also working on improving the communication and referral procedures between health facilities. The Initiative's approaches are to work with existing systems, to forge partnerships, to build and test replicable models, to focus on current strengths through a participatory approach, to examine the issues of social capital and empowerment in vulnerable groups, and to advocate for policy change.Key participants will be women who join community groups. We will try to involve young women and mothers in group activities, but older women may also become involved. Group members will reach out to other women and key stakeholders in their neighbourhoods. Since the aim is to improve the health of pregnant women and their newborn infants, any participant who may influence this situation may be involved. Particular stakeholders may be older women, male community members and leaders, health workers and local opinion formers. The project outcomes will be measured by a surveillance system for births and deaths in 48 intervention and control slum clusters. All women and their newborn infants will be eligible to participate in the data collection exercise, for which enrolment will occur as close to delivery as possible.In each intervention cluster, a facilitator  will convene community groups to explore maternal and neonatal health issues. Group origin and composition will vary: existing groups who meet to discuss issues such as microfinance, slum improvement, cultural issues and specific agendas, as well as newly convened groups. Although women of childbearing age will be a particular focus of group membership, it is likely that mothers-in-law, men and community leaders will be involved.Groups will meet fortnightly and move through action research cycles Figure . The modIn the first phase, group members will discuss the experience of pregnancy, childbirth and infant care in their own communities. We will take a particular interest in local practices. They will ventilate and bring into the group space the rich variety of their individual experiences in varied settings. This will be the first step to peer sharing and learning. In the second phase, picture cards will be used to build perceptions of members on all possible problems and illnesses encountered during maternity and the neonatal period. The discussion will stimulate awareness of local names, symptoms, contributory factors, prevention, care practices and possible treatment. The third phase involves a discovery of the strengths of individual members, their families and communities so as to build the energy for designing and implementing experience-based strategies. In previous programmes we have recommended a problem-focused approach to this, but the intervention will take an appreciative approach based on the vision of a positive experience. In this it has something in common with positive deviance approaches, and will lead to identification of the particular local health issues and challenges. In the fourth phase, group members will construct a dream vision for their slum communities, with an emphasis on maternal and child health. This may involve wider community meetings and efforts to build community commitment and ownership. The vision will in turn lead to design of strategies in the fifth phase, their implementation in the sixth phase and finally their evaluation – by groups themselves – in the seventh phase. Once a primary cycle of meetings has been completed, part of it may be repeated with the larger community group, involving multiple stakeholders and building the sustainability of the process and ownership of outcomes. Work with the original groups may continue, and new cycles may be set up with other groups.The programme inputs can be itemised as: (1) recruitment, training, supervision and remuneration of facilitators. The role of the facilitator is to activate and strengthen groups, support them in identifying strengths and focal themes for intervention based on past experiences and collective wisdom, help to plan possible strategies and support their implementation and monitoring in the community. Although she requires a grasp of health issues and some knowledge of potential interventions, she needs to be a facilitator rather than a teacher. As such, she may act as a broker of information and communication but her prime importance is as a catalyst for community mobilisation; (2) development of tools and monitoring mechanisms for conducting group meetings, process evaluation and documentation; (3) recruitment, training, supervision and remuneration of a supervisory cadre to support the community-based facilitators; (4) knowledge and communication with other actors such as local non-government organisations and allied sectoral services; (5) collection of cost data to allow for economic evaluation of the model.The sampling frame for the trial contains the most vulnerable areas of slums in the 6 urban wards covered by the City Initiative for Newborn Health . These 6 wards were selected purposively for accessibility to the implementing partners and to reflect a range of infant mortality rates according to Municipal Corporation estimates. Criteria for health vulnerability were developed from discussion with key informants and the literature. These included likelihood of demolition and migration, health service access and utilization, socioeconomic factors , and environmental factors . In a two-stage process Figure , the 6 wFor equity across the wider initiative, randomisation was stratified by municipal ward. Eight slum clusters in the catchment areas of each of the 24 health posts involved in the City Initiative for Newborn Health were selected randomly from each of the 6 wards in the sampling frame, giving a total of 48 clusters. Four clusters per ward were allocated randomly to the intervention group, and four to the control group. Allocation was not concealed because of the nature of the intervention. However, evaluation teams and intervention teams conduct their activities independently and no primary outcome results will be fed back to inform the intervention.k – the between-cluster coefficient of variation – equal in intervention and control groups, and the addition of 2 to the estimated cluster number to account for loss of degrees of freedom consequent on stratification. The value of k was set at 0.3 on the basis of (a) available estimates of infant mortality rate in 24 wards of Mumbai from 2003 municipal data, and (b) estimates of neonatal mortality rate from the Makwanpur study in Nepal. Sample size was estimated for a range of births per cluster (200–350) and a range of possible reductions in neonatal mortality rate. At 80% power and two-tailed 5% significance level, the sample size will allow us to detect a reduction in neonatal mortality rate from 30 to 20 per thousand live births. We are aware of a secular trend to decreasing mortality in urban India, and have provisionally analysed vital events for the inception year of the project. If neonatal mortality rates are lower than suggested by the available figures, the sample size will allow us to detect a fall from 20 to 12 per thousand live births at 80% power. Both estimates project significance for a fall of roughly a third in neonatal mortality rate.We aim to accumulate data on 300 births per cluster over 3 years, which implies a cluster size of 900–1400 households on the basis of municipal demographic data. The surveillance of births and birth outcomes will be carried out in 48 clusters of 1000–1500 households. Sample size was predicated on the primary outcome of neonatal mortality rate. Calculations were based on the equations of Hayes and Bennett, assumingAn independent project vital registration system has been set up in the 48 study clusters. The system is a modification of one that was successful in the Makwanpur study, the modifications being based on experiences of running less intensive systems in Bangladesh, Jharkhand and Orissa. All births, female deaths, stillbirths, neonatal and infant deaths will be monitored by local resident enumerators. These enumerators will communicate with interviewers, who will confirm each event and visit women and their families in their homes to deliver a postnatal interview at about 6 weeks after delivery. The interview will describe the respondent's demographic background, socioeconomic status and maternity history. Subsequent sections will cover antenatal, delivery, postnatal and neonatal care, as well as responses to illness in mother or infant. In the event of maternal death, stillbirth or neonatal death, supervisory staff will collect verbal autopsy information from family members and triangulate it with information available from health care facility documents.Hard copy questionnaires are transferred to the central office weekly. Two types of data are entered into electronic relational database management systems in Microsoft Access. Births and deaths are entered into a database dedicated to tracking follow-up and generating mortality rate outcomes. Interview questionnaires are entered into a separate database. Both databases include validation constraints and enforce referential integrity. All information provided by participants remains confidential. Access is restricted to interviewers, supervisors, data auditors, and officers, and research staff at the analytical level. No analyses or outputs include the names of participants.th interview and to ensure valid responses to queries arising from crosschecking, and make random visits to observe interviews. Every third interview tool is crosschecked by a project officer. Supervisors and officers meet weekly to review progress and issues arising. All questionnaires and memoranda are crosschecked at the central office. Data entry includes internal validation rules. Entered data are internally crosschecked by the data management officer for every 10th questionnaire, and externally crosschecked against every 15th questionnaire.The trial is headed by a project coordinator. Data collection activities are managed by 2 project officers, each responsible for 3 urban wards. 99 female residents of the project clusters are tasked with identifying births and deaths in their areas. Each event is crosschecked by a female cluster interviewer responsible for 4 clusters, who visits the home to verify it and to discuss a follow-up visit with family members. This process is quality controlled by a further visit by a female supervisor responsible for 8 clusters (1 ward) to confirm every fifth event. When interviews are completed, each is checked by the interviewer in the field and by a supervisor. Supervisors also visit homes to crosscheck the data from every 10Although all trials have to deal with loss-to-follow-up, slum communities in Mumbai have some special features. Our estimates suggest that some areas experience 25% annual in- and out-migration. Further, many residents retain connections with their family homes in other parts of India. A number of specific problems arise for birth outcome tracking: (a) residents of other places may come to the city for delivery; (b) residents of slum areas may go to their family homes for delivery (within or outside Mumbai), or for a variable period shortly after it; and (c) instability of tenure and livelihood may contribute to mobility within and outside slum areas; (d) working women may not be available for interview; (e) demolition of parts of or whole slum areas as part of urban infrastructure initiatives. We are attempting to deal with these issues in the trial, by three main methods. First, we have designed the household surveillance in order to achieve 100 annual births per cluster after potential loss-to-follow-up of 25%. Second, interview times will be flexible and multiple visits have been planned for. Third, the parallel database systems optimise the available information: for a large number of deliveries, we are able to ascertain the outcome at one month postpartum, even if the interviewers do not succeed in completing an interview. This allows us to generate mortality rates from a larger tranche of data, while using interview data from a smaller tranche for the secondary outcomes.analysis of baseline findings, particularly neonatal mortality and care-seeking practices. The analysis will not look at outcomes in terms of allocation. The results will provide us with estimates of neonatal mortality rates on the basis of which cluster size will be reviewed. (2) An interim analysis of outcomes. This will be conducted in late 2008. The analysis will look at the outcomes in terms of allocation. At this point a Data Safety Monitoring Board (DMB) will be convened according to the DAMOCLES statement.[There will be two types of interim analysis. (1) An tatement. The DMB The analysis will be undertaken as intention-to-treat at both cluster and participant levels. Participants who begin the trial as residents of a given cluster will be retained as residents even if they move to another cluster during the trial period. Within the prospective cohort, stillbirth and neonatal mortality rates will be compared in control and intervention groups, taking account of clustering, with hierarchical logistic models. Intraclass correlation coefficients will be estimated from preliminary surveillance of neonatal mortality and stillbirth data by analysis of variance. Secondary outcomes and process indicators will also be compared with adjustment for clustering. All estimates will be presented with 95% confidence intervals.Alongside the impact evaluation that determines the trial design, we will carry out process evaluation activities. The objectives will be to describe the social context in which the intervention was implemented, what was planned, what was actually delivered, what participants received and how they responded. We will cover planned programme inputs and their iterative development through dialogue with project personnel and community participants. We are particularly interested in the activities of the community-based facilitators: who they are, to what degree they represent their areas, how they respond to their training and work, how able they are to create and sustain viable groups and what they think of the intervention. We will take a similar approach to groups themselves: their size, membership and representativeness, their progress through the groupwork process, their understanding and interest in group activities, and the degree of behaviour change in both group members and the wider community. The spread of knowledge, strategies and behaviour change are of particular interest, and we will explore the possibilities for social network mapping and qualitative research on communication. We will put in place a data collection system to document group attendance, demographics and progress through the intervention cycle. Alongside this – predominantly quantitative – approach, we will conduct qualitative research; the main methods of which will be focus group discussions and semi-structured interviews with project officers, facilitators and community group members.We will conduct an economic evaluation along the lines of the cost-effectiveness work that we have previously published. Trial exThe trial has been approved by the Municipal Corporation of Greater Mumbai, the Independent Ethics Committee for Research on Human Subjects , and the ethics committee of the Institute of Child Health and Great Ormond Street Hospital for Children. It is registered with ISRCTN96256793 and appears on the Wellcome Trust register, hosted in the meta-Register of Controlled Trials (reference 081052).After a full explanation of the data collection activities, participants will be asked for verbal consent to interview and assured of the confidentiality of data. Data will be treated anonymously. All community-based members of the study team will be recruited locally. Team members who encounter illness in mothers or infants will facilitate attendance at appropriate health facilities, and in cases of severe illness will have an ethical responsibility to recommend and advise on attendance at an appropriate health facility, irrespective of allocation. Group members will be advised that their attendance depends entirely on their own wishes, and that they may choose to attend or leave at any time.We have equipoise on the intervention under test. Community group activities as a means of addressing maternal and newborn survival have been insufficiently tested for us to have an opinion as to whether they may be successful in the urban context. Since the trial is part of the City Initiative for Newborn Health, control areas will benefit from the initiative's other activities: improvement of provision and quality of maternity and newborn services at health posts, maternity homes, peripheral hospitals and tertiary hospitals. The sampling frame for the trial has been designed to maximise the benefits to communities of supply side activities. Residents of the urban slum clusters involved in the trial fall under the catchment areas of municipal health care facilities involved in these activities.The basic framework of the phases and the choice of appreciative inquiry as the primary approach and guiding philosophy were finalized after a trial run of the intervention in a slum area not covered by the project. The detailing of the content for each meeting within each phase of the model will be developed iteratively with the ongoing participation of the facilitators in their weekly meetings. The model is necessarily evolving and this is the foundation for its sustainability. We hope that the methodology ensures that the processes are internalised by the local facilitators and can be replicated to focus on issues other than newborn care. We also hope that outreach by group members to other women and stakeholders in their immediate neighbourhoods build ownership and sustainability for the initiative. The 8–10 women's groups in each cluster may choose to integrate into a large community group and act as representatives for the entire community. This may further evolve into a slum health committee that takes over part remuneration for the facilitator, individual women in the slum paying her services. Community support systems may take time to develop given the existing low levels of social networking. The primary health care centres run by the Municipal Corporation will be responding to the introduction of the national Urban Reproductive and Child Health Programme, and if the intervention is successful we will advocate the assignation of the facilitator role to the community health volunteers it employs. Local non-government organisations focusing on health may also be persuaded to review their present activities and assimilate the model into their agendas if impact is shown. Necessarily and ethically, control areas will be the first candidates for scaling-up.The project will follow the Towards4+5 research programme consortium communication policy (available on request). We will review the literature on urban maternal and neonatal health care and slums. We will link dissemination with implementation by embedding the project in the public health care system and slum communities, identify potential users in civil society and the public and private sectors, and consider which issues are of interest to them and the type of evidence they prefer. Findings will be disseminated at community level, and the processes of data collection and handling may be opened to community ownership and management at a later date.We will use a range of copy platforms: a user-friendly protocol, articles in mass media, websites, vernacular summaries in English, Hindi and Marathi. We will exploit opportunities for discussion, particularly public network meetings, academic conferences and local events onto which dissemination can be piggy-backed. We will seek to institutionalise learnings through policy changes, through dialogue with municipal policymakers. We will discuss methodology and findings with researchers and educationists at Indian institutes of excellence, and place and supervise Indian postgraduate students within the project. The results of the trial will be published in an open access academic journal. Summaries will be prepared for dissemination to lay readers and policy makers.SNEHA was founded in 1999 as a voluntary, secular, non-profit organization registered under the Bombay Trust Act of 1950. Its mandate is to work to improve the lives of women and children in urban slum settings, with a specific focus on health and nutrition. Team members have a range of clinical, social work and administrative backgrounds, with an emphasis on equal opportunities and local recruitment. SNEHA has collaborated with the UCL Centre for International Health and Development since 2003, as a result of which research activities and capacity have been consolidated. Responsibility for implementation of the trial rests with SNEHA. The administrative structure is shown in Figure A trial steering committee meets annually to review the conduct and progress of all City Initiative activities. The committee includes representatives from the All India Institute of Medical Sciences, the national Urban Health Resource Centre, UNICEF, the Tata Institute for Social Sciences, the Municipal Corporation of Greater Mumbai, UCL Centre for International Health and Development, and the ICICI Social Initiatives Group.The author(s) declare that they have no competing interests.NSM is the project coordinator, contributed to the design of the study, will be responsible for the management of the trial, and will participate in the analysis and interpretation of data. UB, SD and BK contributed to the design of the study, will be responsible for the collection and management of surveillance data, and will participate in their analysis and interpretation. SP, MP and LV contributed to the design of the intervention, will be responsible for its implementation, and will participate in the analysis and interpretation of data. AF is the director of SNEHA, contributed to the design of the study, and will have overall responsibility for the trial in Mumbai. AC is the director of the UCL Centre for International Health and Development, contributed to the design of the study, and will have overall responsibility for UK partner contributions. SB contributed to the design of the study and the process evaluation, and will participate in the analysis and interpretation of data. DO wrote the first draft of the protocol and, with NSM, coordinated its development and gave final approval for the version to be published. AC, AF, SB, NSM and DO obtained grant funding. All authors contributed to critique and modification of the manuscript.


First, some brief conceptual and empirical descriptions are provided of Australia's mental health services, both as a total system, and of its two principal components, viz. public psychiatric institutions and private psychiatry services. Expenditures on public psychiatric hospitals clearly demonstrate the effect of deinstitutionalisation. Data from 1984 on private practice psychiatry indicate that per capita utilisation rates peaked in 1996 and have since fallen. Generally, since 1984 gross fees have not risen. However, for both utilisation and fees, there is evidence  that there are significant differences between the states of Australia, in these two variables (utilisation and fees). Emphasis is also placed on the economic incentives that arise from health insurance and the heterogeneous nature of mental illness. The effects of these incentives are regarded as by-products of the health insurance mechanism; and another effect, "unmet need" and "met non-need", is a somewhat unique problem of an informational kind. Discussion of many of these issues concludes on a somewhat negative note, e.g. that no empirical results are available to quantify the particular effect that is discussed. This is a manifestation of the lacunae of economic studies of the mental health sector.This article is concerned with the  Mental illnesses and conditions are amongst the most important chronic diseases in populations internationally , and in draw attention to the major economic features of Australia's mental health system or sector. The initial Section emphasises the heterogeneity of the sector using a Venn diagram that depicts the main sets, i.e. the components of the system. The Section also presents some data on how the size of public psychiatric institutions has changed through time, as well as providing an overview of the key economic features of private psychiatry services. Emphasis is then placed on the incentives or motivations of participants in the health system: this discussion is centred on issues associated with health insurance per se, viz. moral hazard and two issues of an informational kind (adverse selection and an imperfect agency relationship), as well as the twin issues of "unmet need" and "met non-need". Another Section considers the importance of the range in the severity of diagnoses, as well as heterogeneity in general, and the implications for mental health services. There is a brief conclusion that highlights the paucity of economic studies of mental health in Australia.The purpose of this article is to Heterogeneity characterises Australia's mental health system: multiplicities of services are provided, and there are multiplicities of localities where these services are provided. No "norm" ought necessarily be concluded from casual observation.Another characteristic is that the boundaries of the segments are somewhat arbitrary when one attempts to comprehend the system. A "narrow", "traditional" or "conventional" focus on the system is available by applying National Health Accounting conceptions. These conceptions were defined by Abel-Smith , the arcThe multiplicity of service providers is depicted conceptually as a Venn diagram in Figure The Figure indicates that services are provided in a number of locations. Although location can largely be simplified to "in-hospital" and "out-of-hospital", there is an important distinction to be made between dedicated public psychiatric hospitals that provide long-term care for the chronically ill, and short-term hospital services for the acutely ill. . Note also that the provision of long-term care has decreased since the advent of the deinstitutionalisation movement, which resulted in community-based service provision. Deinstitutionalisation is not a recent phenomenon: Australia's experience began in the mid-1950s . Figure Although Figure Despite Figure One partial expenditure estimate of the size of the "system" is available for 2000–01 from the Australian Institute of Health and Welfare (AIHW), as part of an estimation exercise of ("direct") or "accounting" health expenditures by disease groups ,11. MentSome numerical time-series data on patients in public mental hospitals from 1906 are available for Australia . Some StFigure Figure The psychiatry services industry in Australia involves psychiatrists in private and public practice who work in the mental health sector. Although medical practitioners in "general practice" (GPs) also provide some services of a psychiatry kind, private psychiatry is defined (as an industry) by post-graduate education in psychiatry theory and practice, and examined by a specialist College. When the required level of education is attained, a medical practitioner may be admitted to College membership (the "guild"). "Guild" is an historical term, but is used quite deliberately by some authors in regard to the health sector, e.g. Enthoven . In AustIn terms of producing services that require prescriptions for pharmaceuticals, the entry requirements into the industry involve the aforementioned medical qualifications (from a university) and the required periods of supervised practice, as well as registration with a Medical Board. Then, for consumers to claim a subsidy under Australia's health funding arrangements (Medicare), a psychiatrist requires a Provider Number issued by Medicare Australia. These requirements apply in both public and private medical practice, except that in the public sector medical practitioners do not need a Provider Number.Medicare Benefits Scheduleore equitable financing arrangements, a redistribution of income to the poorer members of the community, the extension of benefits to people not previously covered, a greater measure of influence over the fees charged by doctors, more efficient administrative procedures and an improved information system for the monitoring of medical service provision" [The viz. incentives created by insurance per se, and secondly the particular context of  Medicare.We now turn to a discussion of some economic side effects of health insurance. This discussion is directed to two specific issues, viz. the uncertainty of illness (particularly catastrophic expenses associated with some illness), leads to insurance. This is a commonly applied mechanism to handle uncertainty in economic affairs, whether the uncertainty arises in the events of car accidents, illness, death, theft, fire etc. Although insurance improves people's welfare , other problems are associated with insurance per se. The two major problems are referred to as moral hazard and adverse selection; and both of these problems are associated with people's incentives.There is a long-standing literature in economics, stemming from Arrow's seminal paper , that heMoral hazard refers to the situation that arises when, because of insurance coverage, the out-of-pocket price of health services falls and, as a result of this price fall, consumers purchase more health services than they would have done in the absence of health insurance . Whether or not this behaviour is "moral" can be debated elsewhere; what is of significance here is that this behaviour is the predictable response of a consumer to a price fall, and that a higher quantity demanded results when a particular set of incentives are operational under health insurance coverage. This behaviour of increasing consumption when price falls, when summed across a population, leads to non-trivial welfare effects in the long run. This phenomenon can be likened to the case where a small act of, say, littering or pollution by a single individual has a trivial effect, but the sum total of widespread small acts of littering or pollution by all individuals is not trivial: these acts impose major impacts that a community bears jointly. For some of the contrasting moral issues, see the perspectives of Pauly  and, in There are no empirical studies of the welfare cost associated with moral hazard in mental health services in Australia, and one of the key variables, the value of the own-price elasticity of demand for mental health services, is also not known in Australia. Thus, quantification of these phenomena is an item outstanding on the research agenda.The second problem mentioned above, adverse selection, arises from the fact that health insurance attracts people who are likely to be large or "heavy" consumers of health services, generally people with low health status, whereas people with high health status are not inclined to buy such insurance. Once more, there is an incentive effect. This issue arises since consumers possess more information about their health status and their personal demand for health services than do insurance carriers. This is true for both "the ill" and "the healthy". Thus, we have a case of asymmetric information, having the effect that the people with higher health risks tend to drive the low risks from the health insurance market. If the low risks stay in the market, there will then be a redistribution of income (in terms of the difference between the amount of premium that a member pays and the benefits received) from the low risks to the high risks.Under the compulsory membership arrangements of Medicare, adverse selection does not exist, but it does exist under private health insurance arrangements in Australia. Nobody in Australia discusses, let alone investigates, adverse selection with respect to the use of mental health services. Quantification of this phenomenon is another outstanding item for an economic research agenda about Australia's mental health system.There is yet another informational problem that arises in the health sector, which is appropriately described as one of imperfect information. Generally, consumers possess less information than medical professionals about diagnosis and appropriate therapy. The presence of information differentials over the daily problems of living explains why consumers consult professionals of various kinds , as well as health professionals. The common characteristic of all such relationships is that of agency, i.e. where a "principal" (such as a patient) employs an agent  to act on his/her behalf, for a fee. These conceptions quickly lead to consideration of whether the agency relationship is perfect or imperfect. A perfect relationship is one in which the agent aligns his/her decision-making with the principal's (consumer's) preferences: where there is a conflict between the producer's interest and the consumer's interests, the perfect agent will implement actions in line with the consumer's (i.e. agent's) preferences. An imperfect relationship, on the other hand, arises when the producer (agent) makes decisions for the principal (consumer) that serve the interests of the producer. These issues are discussed in various texts, such as Folland, Goodman and Stano  and Phelgenre has been undertaken on Australian data by Richardson [This imperfect agency relationship lies at the heart of the supplier-induced demand hypothesis, introduced to the health insurance literature by Fuchs and Kramer  and Evanchardson .Supplier-induced demand has been one of the most contentious areas of research in health economics. Space precludes a survey of this extensive literature, but it is useful to note that replication of the major studies that brought this hypothesis on to research agendae has cast serious doubt on it. Consider this statement by Ramsay and Wasow :The empirical findings of the early researchers on the issue of supplier induced demand are most likely the result of improperly specified and inadequately analysed regression models. No, or certainly very few, useful empirical generalisations can be drawn from any of the models as currently formulated and estimated. In this sense, the anomalous empirical findings are statistical artefacts (p. 67).It must be noted that, just as there is no empirical evidence on moral hazard and asymmetric information, with respect to Australia's mental health sector, there is no empirical evidence on this third issue, just discussed.However, there are some studies that can be interpreted as shedding some light into these various "dark corners" of the economics of the mental health sector. In 1996, the Australian Government placed financial constraints on the number of consultations that specialist psychiatrists could have with an individual patient in a calendar year. In one case, reported in the House of Representatives by the (then) Minister for Health, a psychiatrist had 747 individual consultations with a single patient in a particular year. Essentially, the changes introduced at that time restricted consumers to 50 such consultations per year, under standard Medicare subsidies, and any consultations in excess of 50 entailed a quite different subsidy/rebate arrangement. An evaluation of the effectiveness of these arrangements is now available .Medicare Benefits Schedule in 1996 involved the self-interest of these psychiatrists who were "over-servicing" a small number of patients under Australia's FFS system of remuneration of private practice medicine. Such a view is too simplistic. Some patients do require, at certain times, intensive consultations with mental health professionals, a point recognised by the Australian Government with the introduction of Item 319 into the Medicare Benefits Schedule. In addition, numerous consultations with psychiatrists may be patient-initiated and motivated by the patient's preferences. A third possibility is that such numerous consultations may be a manifestation of a symbiotic consumer-producer relationship. However there is no empirical study which has "unscrambled" this "omelette", and hence any comment amounts to speculation.It could be argued that the background to these changes to the Mental Health and Wellbeing...[without mental illness. This has led to some analysis using concepts of "unmet need" and "met non-need" etc. Such work by Andrews [There are some epidemiological data  which i Andrews  indicate Andrews . Further Andrews . The incThere is a dearth of Australian studies that engage in descriptive economic science about the impact of Medicare in the mental health sector. We now turn to some economic outcomes of Australia's private FFS psychiatry services under Medicare.Medicare Benefits Schedule [In this section two variables of interest are examined using quarterly economic data, supplied by the (then) Commonwealth Department of Health and Ageing (CDHA) for the period between the start of Medicare in 1984 and 2001 . The twoSchedule . While oTo provide a general context, Table Table The data summarised in Table et al. [et al. [The utilisation rates, just reported, for private psychiatry services across the regions of Australia during the Medicare period need to be considered in the light of epidemiological information. The studies of Burgess, Pirkis, Buckingham et al. , Blazer, [et al. , and Ken [et al.  all demoIt is also relevant to ask what is known about gross prices for private psychiatry services at the regional level. Summary statistics are reported in Table These quarterly gross price data since 1984 for the six regions of Australia have also been analysed statistically . Figure It should be noted that economic issues can also be studied in the sub-sets of psychiatry Items in the Medicare Schedule. For example, a single economic study is available for private sector ECT utilisation rates across the regions of Australia .Much additional analysis is required of Medicare data from a range of economic perspectives. Apart from developing explanatory models using regression analysis to determine the factors that explain utilisation patterns, such as those already described, the analysis of the data at a lower level of geographical aggregation than the broad state/territory regions of Australia is important. Doing so will measure the likely extent of differences in utilisation between metropolitan, minor city, rural and remote regions of Australia. The same applies to gross and net prices. Note also that the construction of price indices for psychiatry services is possible also from Medicare data. Moreover, the application of the conventional measures of economic inequality and concentration employed by economists to mental health variables is relevant.The available economic studies on Australian mental health issues are extensively reviewed in Williams and Doessel ,45. The Having described some economic dimensions of Australia's mental health system, the focus will turn to a brief discussion of the relationship between mental illness and the mental health sector.Mental disorders involve a broad spectrum of illnesses and conditions whose impact ranges from being extremely disabling to quite mild ,47. As pA stylisation of the groups described in the previous paragraph is provided in Figure It is often suggested that allocated resources to Australia's mental health system are inadequate. However, the concern that Andrews  and WhitThis paper has addressed a relatively small number of questions associated with Australia's mental health sector, and the approach taken is, in large part, from the discipline of economics. For example, the emphasis placed on incentives is well established as an approach relevant to the scope of economics. This is not to suggest that other approaches, say, that of a health services research kind, are not relevant. It has been argued elsewhere that these are complementary (not substitutable) ways of analysing mental health issues . These tMental health clearly is a relatively untilled field for economists. Many empirical gaps exist in regard to both the private and public sectors. Also, work at a more conceptual level is very relevant to publicly provided mental health services, such as LeGrand's analyses with respect to the types of structural changes appropriate to the (non-market) National Health Service (NHS) in Britain -57.Researchers of the economics of Australia's mental health system are likely to find no shortage of topics, but conceptual and practical problems are more intractable in the analysis of mental health than in health care generally. The crafting of research questions is of paramount importance. Also, some of the characteristics of mental health services have more in common with markets for disability services than medical services.The authors declare that they have no competing interests.RFGW and DPD contributed jointly to the conception, design, coordination, participation and the writing process. RFGW and DPD read and approved of the final version.