India remains home to nearly one-third of the world's children with severe and acute malnutrition (SAM). The present study looks at the function and implementation of a Community Management of Severe Acute Malnutrition (CMAM) programme for treatment of children with SAM in Odisha, an Indian state. A cross-sectional study design using qualitative techniques with direct observation of process and infrastructure was adopted to explore the views of stakeholders on the programme implementation. The study focuses on Kandhamal, a district in Odisha, and was conducted during June–August, 2015. Of the district and community level stakeholders involved in CMAM programme, 49 were selected as study participants using purposive sampling. In-depth interviews were conducted to obtain relevant information. Data was analyzed using data analysis software, atlas.ti version 7. The analysis demonstrated the overall acceptability, feasibility and economic viability of the programme. Additionally, the study identified several enablers  and barriers  linked to programme implementation. Interactions with beneficiaries and stakeholders also provided the real picture on the ground. The study emphasizes the need for stakeholders to work responsibly and in unison, and need for beneficiaries to accept, participate and contribute to the programme. In view of maximum impact, the study recommends that CMAM programmes be implemented with existing primary healthcare facilities. The study also outlines future scope for policy-level interventions and support to ensure sustainability of this healthcare delivery model. Nutrition for children has been a global priority for many years now. However, most countries regularly track only limited nutrition indicators while even fewer pay attention to the range of manifestations of malnutrition. As a result, nutrition policies and strategies are either only instruments, inadequately tailored to address multiple forms of malnutrition or too broadly devised, to offer concrete guidance on programme levers that could be organized to address nutrition problems.In the last decade, India has made impressive strides in improving a number of health indicators. At the same time, the decade has also witnessed increased inequality and uneven progress, especially on the fronts of health, education, and child nutrition. For example, wasting (low-weight-for-height), along with its increased risks for morbidity has remained a major health problem. Globally, wasting accounts for 4.7% deaths in children below 5 years of age with lower and middle income countries such as Nigeria, Pakistan and India reporting a wasting prevalence of >10% throughout the year . WastingOdisha is one of the coastal states in the eastern region of India. The state so far has been on the weaker side of desired nutrition outcomes. For example, the children <5 years with wasting in Odisha has increased from 19.6% in NFHS 3–20.4% in NFHS 4 . CMAM prIn 2015, the Odisha government piloted CMAM in tribal-dominated Kandhamal district to reduce malnutrition-related complications among children. It assumed significance as the district recorded the highest levels of under 5-year child mortality in the state in 2012–13. The programme was launched through the existing system of Anganwadi Centres, rural mother, and child care centers, under the Women and Child Development and Health and Family Welfare departments. A standard CMAM programme consists of treatment sites closer to the community where children with uncomplicated SAM can be seen weekly, and an inpatient facility that admits only children with SAM plus associated medical complications that require specialist medical attention and keeps them only until they recover enough to continue treatment as outpatients in the community.However, a major apprehension to the widespread adoption of this strategy in India including Odisha, is that the vast majority of evidence on the effectiveness of CMAM comes from non-Indian settings, where CMAM programmes have resulted in reducing malnutrition among children. This has not been explored very extensively in India and very few reports on the success of CMAM in India are documented . This isA cross-sectional study design using qualitative techniques with direct observation of process and infrastructure was employed to explore the views of various stakeholders in the CMAM programme.The study was carried out in Kandhamal district of Odisha. The district has 2 subdivisions, 12 blocks, 153 Gram Panchayat (village councils under blocks), 2,546 villages and 172,022 households. As per the 2011 census, Kandhamal had population of 733,110, of which male and female were 359,945 and 373,165 respectively.The present study was conducted during June-August, 2015.The study participants involved in the CMAM programme included stakeholders from state, district, block and community level. As this was a process implementation study of a pilot project initiated by the government, the participants were selected using purposive sampling using the principle of maximum diversity. They were interviewed at the intervention site as the sampling unit.It was ensured that participants represented multiple levels of stakeholders involved in CMAM implementation. Therefore, all stakeholders involved in the programme, for example, children, mothers, health department officials in charge of programme execution and management as well as ground level healthcare providers were considered. The final inclusion of the participants was based on individual interviews followed by their willingness to participate in the study. A total of 49 study participants were included.The sample included Chief District Medical Officer, Medical Officer, District Social Welfare Officer, District Programme Manager, District Nutrition Manager, Medical Officer In-Charge, Block Programme Manager, Public Health Emergency Officer, Health Worker Female, Accredited Social Health Activists, Anganwadi Workers, Child Development Project Officer, Lady Supervisor, Non-government organization Staffs, Panchayati Raj Institution members and parents of children <5 years who were beneficiaries of the CMAM programme.In-depth face-to-face interviews were conducted using a discussion guide, which covered the following range of topics: socio-demographic information , details of services provided in the CMAM programme, experiences of beneficiaries, perception about effect of the programme on children, involvement and working of various health workers in the programme and suggestions to strengthen the programme. Respondents were asked for their views on major factors which may be responsible for the success of the CMAM scheme. The discussion guide was piloted before using it in the study. After piloting, necessary corrections were made and a final semi-structured questionnaire was prepared . The intWe used qualitative data analysis software, atlas.ti version 7, to code, analyze thematically and draw inferences from the interviews . The proThe Ethics Committees of the Indian Institute of Public Health, Bhubaneswar approved the protocol for the study. All respondents were informed of the study objective and of their freedom to participate or withdraw from the study at any point. Respondents gave written consent to be interviewed and for the interviews to be audio-recorded. Recordings and transcripts were coded so that the origin of the respondents could not be identified. All steps were taken to ensure that confidentiality and anonymity are maintained at all times.The present study was aimed at assessing the implementation of a pilot scale CMAM programme in Odisha. An assessment of “when” the cases were detected under this programme revealed that all cases were detected at the village level during the Village Health Nutrition Day session. They were enrolled in the programme after rechecking by concerned staffs as per criteria fixed in the programme. The cases were enrolled immediately within two to three days. The whole process was done consultatively by both CMAM staff and the local medical officer. Most of the programme staff mentioned that they were satisfied with the cooperation extended by the parents. According to the programme personnel, initially, there was less response from the parents; which gradually increased later. The staff attributed it to increasing awareness among the beneficiaries about this programme.My child was detected during Village Health Nutrition Day before enrollment in the programme” - Mother of child with SAM“chhatua were given, with instructions that the pouches were to be prepared with warm water and consumed. The HCM diet included freshly prepared food at Anganwadi Centres (AWC) as per the menu, for which the child under treatment was also required to visit the AWC unlike the THR and EDNRF which could be administered at home by the mother herself. Initially the HCM, consisting of sujikhiri, chudakhiri, magajaladoo, rice with mixed vegetable curry and dal, was started in Tikabali block and the child had to consume it six times a day; but due to operational problems, it was later shifted to Daringibadi block and the frequency was reduced to four times a day. However, in Daringibadi block, hygienic conditions during preparation could not be maintained due to the non-availability of Anganwadi Workers and AWCs. Unsurprisingly, the mothers denied taking their children to AWCs for diet four times a day due to the widespread and hilly terrain of the area.The cases were mainly treated with the antibiotic amoxicillin, deworming agent albendazole, Vitamin–A and iron folic acid syrup along with nutritional rehabilitation. Nutritional treatment followed a 3-arm modality with (i) Modified Energy Dense Nutritional Food (EDNRF) (ii) Modified Hot Cook Meal (HCM) and (iii) Modified Take Home Ration (THR) Figure . In EDNRAll stakeholder interviewed were of the opinion that both the MUAC and body weight of the child with SAM improved during the course of the programme. Many of the children were faced with diarrhea after initial treatment due to indigestion which subsided by time. The weight gain by the child in the first week was less but increased in the latter part of the programme. The initial slow weight gain may possibly be attributed to diarrhea, less appetite in the child or consumption of less diet.As per the opinion of block and district level staff, the role of non-government organization (NGO) staff and Anganwadi Workers (AWW) were impressive. The NGO staff cross-checked the MUAC and weight of the child. They also took care of the supply part of logistics at the AWC. All of the AWW visited the child's house regularly. They also counseled mothers with the help of NGO staffs regarding the Infant and Young Child Feeding, breast feeding, hand washing, personal care, and hygiene practices. Most of the AWW agreed that the programme increased their workload but since they lived in the village, they could handle the same. The Accredited Social Health Activists (ASHAs) did the blood testing and supplied medicine under direct supervision of female health worker.When elder people demand for the diet/nutrient supplied by the government, we are giving it to them.” - Panchayati Raj Institution Members“We are unable to supervise always whether the baby taking the Supplementary Nutrition Programme or not” - Anganwadi Workers“The quality of the programme was mainly reviewed in the sector meeting, project meeting and joint convergent meetings of Health and Integrated Child Development Services (ICDS). The district and block level programme officers supervised through home visits, direct observation, crosschecking reports for MUAC measurement of SAM children, and talking to their mothers during Village Health Nutrition Day. The reports were prepared by the AWW and submitted to the Child Development Project Officer's office. The NGO was mainly involved in the report validation and analysis. Some AWWs reported that initially they did not have the competency for reporting and had taken the help of peer AWW and NGO staff. Their skills improved through the support of peer workers and NGO.The AWWs reported that there were no annual action plans prepared but they followed the weekly action plans as per the screening report in that week. The reports were kept at three places: beneficiary, AWW and block office. The block and district level staff informed that they receive feedback from the grass root level workers and the action is taken accordingly. The grass roots level workers also opined that the supervision by higher authorities helped in building their confidence.The NGO staff helped us in the initial stage of project in report writing” – an Anganwadi Worker“The SAM children were discharged from the programme after 8 weeks, if they reached a MUAC of 115 mm. If the concerned child did not attain this desired outcome, they were again enrolled for another 8 weeks. They were further followed by regular visits by the AWW and ASHA, during which they were counseled along with weekly MUAC and weight checkups. During discharge, all mothers were advised to report to AWW or ASHA in case of problems.It was reported that the supply of the nutrients was not sufficient at the initial stages but became adequate later. It was also confirmed that blood testing kits and other medicines were available with all ASHAs and reporting formats were available with most of the AWWs.The main problems identified in the programme implementation were the vacancy in the AWW workforce and non-availability of their own AWC buildings. One of the district level staff and many of the ICDS supervisors opined that the AWWs had limited efficiency in providing the quantity of HCM as per the child's weight. In hard to reach areas, the mothers did not bring their children for the diet four times a day. Due to the non-availability of AWCs, the hygiene condition during the preparation of the diet was also compromised. The THR was often not consumed by the child if the mother was working. In the harvesting season, the cooperation by family members was not good. The AWWs expressed their work overload and had to remain in the center till night as well as work on Sundays. As per the CMAM guideline of Bangladesh, a child will not be enrolled into CMAM if his/her MUAC is not <115 mm, even though it comes within the red zone of the WHO growth chart . Non-enrThere is no availability of Anganwadi Workers and Anganwadi Centres in many places of Daringibadi block, so preparation of Hot Cook Meal was a problem” – District Nutrition Manager“Non-enrollment of child if MUAC more than 115 mm, even he comes in red zone of WHO growth chart, prevents many child from getting the benefits”- District ICDS Officer“All stakeholders interviewed mentioned that the children do achieve the desired weight after treatment and the MUAC also increases. The AWWs were of the view that the specially planned diet drastically improves the nutritional status. The nutritional supplements were available free of cost. The HCMs prepared at the AWC were mixed with vegetables to enable children to obtain balanced nutrition at the same time. Most of the stakeholders agreed that the child with SAM was identified at the right time before complications started, and the treatment was given in a domiciliary setup at the family level. The programme officer also reported a decrease in load of the Nutrition Rehabilitation Centers due to initiation of CMAM and the family members received appropriate care. All interviewees agreed that the involvement of Panchayati Raj Institution members, self-help group members, and village level leaders also gave positive impact to the programme.My child was so weak that he was unable to walk; but after treatment he can walk properly” - Mother of child with SAM“The treatment at home gives a social and moral support to the family members” - Chief District Medical Officer“The supply of cost-free diet is beneficial to child which a poor family cannot afford” - Mother of beneficiary“The overall framework for barriers and enablers identified from the situational analysis of the government initiative has been summarized in Table Childhood malnutrition is one of the major public challenges in India. Management of SAM requires adept public health measures to enhance dietary quality and quantity. The objective of this study was to assess the current situation of pilot CMAM implementation in Kandhamal district in Odisha.Our assessment of the CMAM programme suggests that programmatic implementation was as per the desired objectives. CMAM was an implementable and acceptable strategy, as reported by the beneficiaries and stakeholders involved. The assessment of barriers and enablers provides useful information on the health system preparedness of the district implementing CMAM. At the same time, it is equally important to have an understanding of the existing strengths as well as the areas that need further strengthening. During the course of the study, suggestions were also received by the respondents. The suggestion not only provides an assessment of on-the-ground challenges and limitations but also aids the identification of factors that need to be improved for creation of an enabling environment for programme implementation. A study on Village Health Nutrition Day implementation by the authors has also previously identified similar health system challenges .Most of the evidence on CMAM effectiveness is generated from African settings, such as Malawi, Ethiopia, Sudan, Nigeria, Ghana, Mozambique, Kenya, Zambia etc. , 14. A fThe CMAM model has several advantages over inpatient treatment and facility based treatment settings. For example, it provides a framework for integrating public health responses and various other interventions designed to reduce the incidence of malnutrition. The decentralized nature of such a programme enhances community participation and helps increase access to treatments. CMAM programmes for treatment of SAM have also been reported to minimize costs to families and to be highly cost effective , 20. In Data obtained in this study could only enumerate the barriers, enablers, and suggestion to improve. Since purposive sampling was used, this might not represent the whole population.As home to nearly one-third of the world's children with SAM, India's approach to treating SAM has relied almost exclusively on inpatient care, while community-based approaches have not been explored much or implemented fully. This paper describes the function of a CMAM programme in one of the tribal-dominant districts of Odisha, where CMAM has been an effective and economical strategy. CMAM therefore appears suitable for integration into mainstream healthcare system delivered at community level. However there is still some room for improvement.All the authors have made a substantial contribution to the conception and design and/or the analysis and interpretation of data, drafting the article as well as revising it critically for intellectual content.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


The year 2014 was a turning point for polio eradication in Nigeria. Confronted with the challenges of increased numbers of polio cases detected in rural, hard-to-reach (HTR), and security-compromised areas of northern Nigeria, the Nigeria polio program introduced the HTR project in four northern states to provide immunization and maternal and child health services in these communities. The project was set up to improve population immunity, increase oral polio vaccine (OPV) and other immunization uptake, and to support Nigeria’s efforts to interrupt polio transmission by 2015. Furthermore, the project also aimed to create demand for these services which were often unavailable in the HTR areas. To this end, the program developed a community engagement (CE) strategy to create awareness about the services being provided by the project. The term HTR is operationally defined as geographically difficult terrain, with any of the following criteria: having inter-ward/inter-Local Government Area/interstate borders, scattered households, nomadic population, or waterlogged/riverine area, with no easy to access to healthcare facilities and insecurity.We evaluated the outcome of CE activities in Kano, Bauchi, Borno, and Yobe states to examine the methods and processes that helped to increase OPV and third pentavalent (penta3) immunization coverage in areas of implementation. We also assessed the number of community engagers who mobilized caregivers to vaccination posts and the service satisfaction for the performance of the community engagers.Penta3 coverage was at 22% in the first quarter of project implementation and increased to 62% by the fourth quarter of project implementation. OPV coverage also increased from 54% in the first quarter to 76% in the last quarter of the 1-year project implementation.The systematic implementation of a CE strategy that focused on planning and working with community structures and community engagers in immunization activities assisted in increasing OPV and penta3 immunization coverage. With the Alma Ata Declaration in 1978, community engagement (CE)  has become a cardinal principle in primary healthcare (PHC) in Nigeria. The primary care agencies at the national, state, or local levels have the mandate to deliver PHC services in a manner that is community driven, community operated, and community owned . FurtherA number of studies on community mobilization for maternal and newborn child health have demonstrated how CE and participation are important for the delivery of community-based child survival interventions for the mother, newborn, and children –8. HowevAdditionally, poor CE planning combined low investment have been found to be responsible for poor health outcomes of the beneficiaries at both individual and communal particularly for marginalized communities such as the hard-to-reach (HTR) areas .The Government of Nigeria, with support from the World Health Organization (WHO) and funding from the Bill and Melinda Gates Foundation (BMGF), implemented the integrated maternal, newborn, and child health (MNCH) project in the HTR areas. In this context, the HTR areas are operationally defined as geographically difficult terrain, with any of the following criteria: having inter-ward, inter-Local Government Area (LGA), or interstate borders, scattered households, a nomadic population, or a waterlogged, riverine area, with no easy to access to healthcare facilities and insecurity.CE was implemented as a key component of the HTR project. The engagement was an ongoing interactive process that engaged beneficiary HTR communities in the planning and implementation of maternal, neonatal, and child health services in a manner that addressed the demand of side factors using existing community structures to improve coverage.In this paper, we describe the processes and methods for engaging the communities, and assess the performance of CE structures and their impact on improving immunization coverage in Bauchi, Borno, Kano, and Yobe states of northern Nigeria.Haemophilus influenza type B.We conducted a descriptive, retrospective study that reviewed HTR data from June 2014 to June 2015 to determine the contribution of CE interventions to increasing oral polio vaccine (OPV) and the third dose of the pentavalent vaccine (penta3) coverage. Pentavalent vaccine is a five-in-one vaccine used to protect children against diphtheria, tetanus, pertussis, hepatitis B, and The study locations for this study were the states of Kano, Borno, Yobe, and Bauchi. The aim of the study is to showcase the methods and processes used to improve immunization results in a time-bound project with a view to replicating it in routine immunization.We conducted a baseline survey in the four selected states using a focus group discussion (FGD) and key informant interviews (KIIs) to identify the needs of the community and the channels for reaching them with information regarding immunization services as part of planning with the community. The findings from FGDs and 174 KIIs conducted revealed that town announcers and community mobilizers were the best channels for mobilizing the communities for immunization.Based on findings from the baseline study, we developed a module to train HTR personnel, town announcers, and mobilizers to ensure that all personnel involved in the implementation of the project were familiar with the concept and importance of CE.The mobile HTR team leaders enumerated all households in selected settlements during a micro-plan process to ensure early planning and community involvement and participation in the project. During this process, mobile health teams (MHT) convened meetings with community leaders to identify qualified town announcers and community mobilizers to operate in each assigned settlement. We used such fora to identify days, dates, and locations of immunization posts and identified town announcers, community mobilizers, and other community structures such as village development committees (VDCs). This process was done in all the settlements selected for the HTR.Before the full implementation of the project, we trained the HTR personnel using the CE module on their roles and responsibilities in CE, the benefits, and the importance of ensuring community involvement in the implementation of the project.Before every session, each MHT leader met with community leaders, community-based organizations, town announcers, community mobilizers, women, youths, and VDC members to sensitize them on the importance and benefits of immunization. The need to track defaulters and the referral of newborns to vaccination posts was also discussed.Although VDCs were not available in all the 2311 settlements targeted for the project, where they were available the MHT encouraged them to have meetings to discuss issues of vaccine dropout, mobilization of the communities, and tracking of newborns.Before the commencement of each session, trained town announcers and community mobilizers went around their communities to mobilize caregivers to vaccination posts. The town announcers and mobilizers gave information about the dates, time, locations, and antigens provided at vaccination posts. As the town announcers went around the communities, the community mobilizers visited each house in the community to converse with caregivers about the HTR services and responded to the concerns of caregivers. Based on the orientation that was given to them, community mobilizers referred newborns and pregnant women to vaccination posts.Traditional leaders who served as the link between MHT and communities mobilized communities at mosques, churches, and public gatherings by informing their people about the dates and locations of immunization services.Where they existed, VDC members mobilized communities to mobile outreach sessions. The VDC helped to create awareness, stimulate demand, and convince noncompliant communities to accept immunization. The VDC members also tracked defaulters based on the data provided by the MHT.Data were collected weekly using supervisory checklists. All supervisors, including the team leader for the mobile outreach, transmitted data in real time to enable quick analysis and action. Hardcopies of the checklists were also collected and analyzed.Indicators such as the number of community mobilizers, town announcers involved in mobile sessions, the presence and activities of the community-based organizations, VDCs, and traditional leaders in mobilization were collated and analyzed to inform the program action. We conducted a mid-term review (MTR) in November 2015 to assess the progress of the HTR project. We administered structured questionnaires at the health facility and community levels to assess, among other issues, the level of CE and the utilization of services. We administered questionnaires to 2311 households and 231 traditional leaders.In the 2311 settlements selected to implement the HTR project  had visited their homes to mobilize them on health matters. Bauchi reported more community mobilizers (92%) visited their homes, followed by Kano (83%) and Borno (66%), with the lowest reports for Yobe (at 53%).With the introduction of the project in the first quarter, OPV coverage for children below 1 year of age was 44%; however, this figure reduced in the second quarter but steadily increased to 54 and 76% by the fourth quarter. There are, however, variations in the number of children vaccinated against OPV by each state. While some states such as Kano and Yobe started the year with low coverage , their coverage increased to 40 and 167% respectively by last quarter. Bauchi and Borno, on the other hand, started at 36 and 80%, respectively. Over the next three quarters, Bauchi coverage increased steadily to 48, 74, and 77% by the fourth quarter. However, Borno recorded a decrease from 80 to 61% by the fourth quarter.Penta3 coverage in the first quarter for all states was 22% but, by the last quarter of the first year of the project (2015), it rose to 62%. A similar trend in coverage was also observed across the four states, with Bauchi having the highest (28%) while Yobe recorded the lowest (6%) in the first quarter. However, by the second quarter the coverage in Yobe rose from 6 to 42%, while Bauchi recorded 41, 55, and 54% in the second, third, and fourth quarters, respectively. Similar to OPV coverage, Kano recorded  during the period under review since it engaged the highest number of town criers compared with all the other states. Some studies have reported that the use of community structures is the most cost-effective and cheapest means of passing information to caregivers. For example, a community study in southern Nigeria found that town announcers (often referred as town criers) can be as effective as community extension workers if properly supported .With regards to the presence and participation of VDCs in mobilizing communities for mobile outreach services, where these were available states took advantage of their existence to plan and implement mobile outreach sessions. A study from a project in Cambodia found that donor-funded projects need to work with “existing community-based organizations or agencies” to mobilize communities, particularly if the project has a short time frame . One of Although we identified some indicators at the beginning of the project that we used to assess the use of the community structures, we did not assess the impact or the outcome of these structures until the MTR was conducted in 2015. From the results of the MTR, caregivers have expressed satisfaction with the work of the community mobilizers recruited to mobilize their communities. Satisfaction for the work of community mobilizers was highest in Bauchi (63%) and lowest in Kano (26%). It is not surprising to observe that Bauchi recorded more beneficiary satisfaction since the state has the highest number of settlements and each settlement has a community mobilizer, town announcer, and traditional leader. Having a community mobilizer who is respected and resident in the community helped in the passage of the right information for caregivers to act by visiting vaccination posts. Perhaps the most important point about our CE approach was not just about raising awareness about the services of the HTR project, but also persuading community members to take action by visiting vaccination posts.We found out that CE interventions implemented in the HTR settlements were instrumental to the steady increase in immunization coverage in these areas. Implementation of community activities during the period under review showed improved routine immunization outcomes with an increase from 22% penta3 coverage in the first quarter to 62% by the fourth quarter within the first year of project implementation. When compared with the service satisfaction of clients about the HTR and the CE activities, the data analysis showed that Bauchi had met all three indicators. This is indicative of the fact that CE, when implemented alongside other interventions, has the potential to improve coverage, particularly for marginalized communities such as the HTR population , 12–15.One of the ways of monitoring immunization coverage is through the monitoring of penta3 vaccine administration to children less than 1 year old. As a proxy for routine immunization coverage, penta3 coverage increased dramatically in the HTR states from the first quarter, when penta3 coverage was 22, to 62% by the fourth quarter. These results varied across states, with Bauchi recording a realistic increment from 28 to 54% by the fourth quarter, followed by Borno which increased from 36% in the first quarter to 47% by the fourth quarter. The lowest in the first quarter was Yobe with 6%, but this steadily increased to 31% and was thus the state with the highest increase. While there was a steady increase in penta3 in all states, except for Kano where the increase was from 9 to 166%. This may be the result of data quality issues including denominator values. A tool developed by the WHO data quality audit (DQA) which assesses the quality and efficiency of immunization performance could have been used to identify the problems .Although there is no direct link with the coverage data, the evidence presented elsewhere shows that when CE interventions are planned and implemented properly it “can lead to improved health and health behaviours among disadvantaged populations” . StudiesOur report is subject to at least three major limitations to its generalization beyond our context. First, while we are aware that CE activities alone are not enough to increase coverage, we recognize that other extraneous factors such as the provision of incentives in the form of child survival interventions including treatment of minor ailments might have influenced the outcome of the results. A study of knowledge, attitude, and practice conducted in Borno revealed that incentives are a major influence in the decision of mothers to vaccinate their children . In addiSecondly, we are aware of the fact that routine immunization coverage data are not complete if they are not accompanied by an analysis of the dropout rate. Dropout determines the number of children that have started immunization but could not complete it for various reasons.Thirdly, the HTR project is an ongoing project, but we restricted our study to the period 2014 to 2015, the initial lifespan of the project. Other interventions and activities after June 2015 might have influenced the outcome of the findings of the MTR.For researchers to be able to demonstrate the direct impact of CE initiatives accurately, it is important to undertake further study to measure the direct impact of the CE activities on coverage and change in people’s behavior.With the current government plan to implement a “PHC under one roof” (PHCUR) policy, the lessons from this study will help to shed light on how communities in the HTR and other difficult areas can be included in planning for mobile outreach services. Similarly, other time-bound projects could learn from the methods of this project for ways they can harvest CE results to increase immunization coverage within a stipulated time.This paper describes the approach and processes that we adopted to engage communities of HTR areas. The step-by-step process approach not only yielded results regarding client service satisfaction, but also showed its effects on coverage of the two most important interventions of the project: OPV and penta. The lessons from the implementation of CE interventions in the areas that are HTR make a case for practitioners or groups to adopt the methods demonstrated in this study, particularly if the project is time bound.


Both National Comprehensive Cancer Network (NCCN) and ASCO published their respective first resource-stratified clinical practice guidelines with recommendations on alternative best treatment options for clinicians who practice in these countries.4 The ASCO guideline was developed on the basis of the review of existing guidelines or expert consensus opinions when evidence was not available.6 The European Society of Medical Oncology has also recently developed a cervical cancer guideline for clinicians who practice in Europe.7 On the resource-stratified guidelines, a four-tiered approach—basic, limited, enhanced, and maximal—was developed on the basis of recommendations by the Breast Health Global Initiative.8 The ASCO guideline was written by a panel of international experts from Africa, Asia, America, and Europe, including those in medical oncology, gynecologic oncology, radiation oncology, palliative care, health economics, obstetrics, and gynecology, as well as the patient advocacy group. They evaluated existing literature and similar guidelines and reviewed cost-effective analyses to determine how best to develop the guidelines for each tier. Of note, the recommendations are intended to complement, but not replace, local guidelines. The ASCO guideline is meant to help make an impact for women who are diagnosed with cervical cancer around the world and to facilitate the ability of local governments to stay abreast of what needs to be done and at what they should be aiming in patients with cervical cancer.Cervical cancer affects more women in low-resource than in high-resource countries. Globally, 85% of the 528,000 incident cases and 87% of the 266,000 deaths from cervical cancer occur in women from low-resource countries.ClinicalTrials.gov identifier: NCT00193739) are comparing NACT followed by surgery with primary chemoradiation for patients with stage IB2 to IIIA disease. Results of the NCT00193739 trial that was conducted in India was presented at the European Society of Medical Oncology in September 2017. It enrolled 633 patients to compare the outcomes of patients who underwent three cycles of NACT every 3 weeks followed by radical hysterectomy versus conventional chemoradiation (CCRT). Disease-free survival was 69.3% versus 76.7% in favor of CCRT; however, there were no differences in overall survival between the two regimens .9 This study may add impetus to the role of NACT in the management of cervical cancer. Significantly, in settings in which radiation therapy is not readily available, NACT followed by surgery may remain an alternative best option. For settings in which resources are available for patients to be treated in a timely fashion, CCRT is recommended for the management of locally advanced cervical cancer from stage IIB to IVA.In each tier on the resource-stratified guideline, and for each stage of cervical cancer, ASCO and NCCN recommendations discuss optimal therapy, which could include a combination of radiation, chemotherapy, and/or surgery, depending on the respective clinical settings and stages of the diseases, as well as palliative care and pain management. It is hoped that the guideline will serve as a tool for clinicians to show policymakers in their regions what is possible with their resources for women who are diagnosed with cervical cancer—often young women in their most productive roles in society. The guideline recommends less radical surgery, such as extrafascial hysterectomy or its modification, for patients with stage IA2, IB1, or IIA1 disease if the surgical capacity is present and the disease can be removed safely with negative margin. For more advanced-stage disease, neoadjuvant chemotherapy (NACT), followed by extrafascial hysterectomy with modification has been recommended when feasible. Two randomized phase III trials (European Organization for Research and Treatment of Cancer 55994 and 10 have published an important paper on the National Cancer Grid of India consensus guideline for the management of cervical cancer. This is a relevant paper in the context of addressing the burden of cervical cancer in India. According to a 2014 WHO report, implementation of standard of care is an important step in the management of the disease in the country, especially considering the operational framework for the management of common cancers, which includes cervical cancer.11 The guideline represents a consensus statement of the gynecologic cancer expert group with the hope of assisting in the homogenization of the management of cervical cancer in India. The consensus panel addressed the framework of the questions with the PubMed Database and the Cochrane database for systematic reviews. Although there was no formal tool used to score the evidence, recommendations were made on the basis of the best available evidence for the clinical context; recommendations by the expert panels were provided when there was a lack of level I evidence.With the article that accompanies this work, Chopra et al13 A second trial—the aforementioned NCT00193739 trial—compared NACT followed by surgery with concurrent CCRT recently reported by Gupta et al. On the basis of the finding of superior 5-year disease-free survival, although overall survival was similar, CCRT remains the standard treatment for patients with locally advanced cervical cancer.9 Absent is the discussion of the management of patients with cervical cancer when radiation therapy is not readily accessible. Should NACT be considered as an acceptable alternative? A critical question raised was whether the recommended guideline for cervical cancer radiation in India can be adequately implemented given the relative shortage of radiation machines and accessibility for financially deprived patients. The authors state that, because less than one half of patients received CCRT in India, the judicious use of chemotherapy during radiation therapy should be encouraged to improve survival outcomes. However, it should be noted that radiation therapy should not be delayed if chemotherapy is not readily available.14In this Indian National Cancer Grid guideline, magnetic resonance imaging and contrast-enhanced computed tomography scan were recommended as optimal and minimal options, respectively, for imaging in patients with early and locally advanced cervical cancer. This is in agreement with recommendations in the ASCO and NCCN guidelines on the work-up for high-resource settings. Positron emission tomography scan was not recommended as it does not have specificity over computed tomography scan in predicting nodal metastasis. The guideline provides templates for magnetic resonance imaging and histopathology reports with the intention of maintaining a high standard for clinical practice. Completion of 8 weeks of radiation was emphasized, which is vital as survival outcomes are associated with prolonged radiation therapy for patients with cervical cancers. Furthermore, data from Indian trials were included to support the recommendations in the guideline. For example, intensity-modulated radiation therapy was compared with three-dimensional conformal radiation. Although the outcome was in favor of intensity-modulated radiation therapy, as it is associated with a reduced incidence of late bowel toxicity, the difference was not statistically significant.15 In the WHO country cancer profiles published in 2014, there were 0.4 high-energy teletherapy units per million inhabitants, with a total of 353 radiation oncologists working in 314 radiotherapy centers in India.16 Both radiotherapy and chemotherapy are mostly available, whereas oral morphine is not generally available in the public health system. This is in contrast to five high-energy teletherapy units per million inhabitants, with 161 radiation oncologists working in 69 radiotherapy units in the United Kingdom.17 The annual incidence of cervical cancer in 2012 was 122,844 with an age-standardized rate of 22 in India, whereas it was 2,659 with an age-standardized rate of 7.1 in the United Kingdom. This would translate into ten-fold more patients treated at each center in India than in the United Kingdom; therefore, the burden of disease is significantly higher and the centers that can offer treatment are fewer in India than in any other high-resource country. One of India’s major public health challenges has been affordable and equitable cancer care infrastructures. The guideline proposed by the authors is notable as it sets the standard for the best care that can be provided to women with cervical cancer in India.18 There remain challenges in linking the recommendations and guidelines to the reality of Indian cervical cancer care; reality is reflected in the limited number of centers that provide radiation therapy to address the high burden of disease. The authors hold that CCRT remains the standard of care in India and perhaps in all settings where radiation machines are available. One may consider NACT followed by surgery as acceptable in selected patients in settings where radiation therapy is still not readily available in India or in other regions of the world, such as Africa. The authors relate that efforts are being made to audit and report compliance within the Indian institutions that participated in the development of this guideline. This is an excellent approach and much emphasis is needed on improving treatment capacity, including increases in the numbers of radiation machines and radiation oncologists. This guideline will serve as a wake-up call for policymakers in India to increase radiation capacity, at least doubling what is available today to reach a minimum of one teletherapy unit per million inhabitants.19 Ultimately, improving the survival rate will depend on diagnosing cervical cancer during the earlier stages of the disease. Downstaging of the disease or reducing the incidence of cervical cancer will rely on human papillomavirus vaccination and cervical cancer screening, which are crucial for improving survival.20The number of new cancer cases in India has been rising rapidly. In 2008, the number was 0.95 million, but is projected to increase to 1.7 million by 2035. Although the incidence of cancer in India is lower than that in Europe and North America, the mortality rate is higher, which suggests low effectiveness in health care.


A matched-pair cluster randomized controlled trial was conducted on ten worksites (five intervention (n = 324); five control sites (n = 283)). Worker surveys were collected at all sites pre- and post- exposure at one- and six-months. Linear and logistic regression models evaluated the effect of the intervention on pain and injury, dietary and physical activity behaviors, smoking, ergonomic practices, and work limitations. Worker focus groups and manager interviews supplemented the evaluation. After controlling for matched intervention and control pairs as well as covariates, at one-month following the ergonomics program we observed a significant improvement in ergonomic practices , and a reduction in incidences of pain and injury  in the intervention group. At six months, we observed differences in favor of the intervention group for a reduction in physically demanding work , increased recreational physical activity  and higher consumption of fruits and vegetables . Process evaluation revealed barriers to intervention implementation fidelity and uptake, including a fissured multiemployer worksite, the itinerant nature of workers, competing production pressures, management support, and inclement weather. The All the Right Moves program had a positive impact at the individual level on the worksites with the program. For the longer term, the multi-organizational structure in the construction work environment needs to be considered to facilitate more upstream, long-term changes.This study evaluated the efficacy of an integrated Total Worker Health Internationally, construction workers have higher rates of musculoskeletal disorders, and chronic diseases related to obesity, lack of physical activity and smoking than workers in other industries ,2,3,4. IConstruction workers also have high rates of chronic health issues. Over 70% of construction workers are overweight . Obese cExtensive research has linked these injury and poor health outcomes to individual factors, as well as the conditions of work, including job demands, physical work environment and psychosocial work factors  . ConstruWhile these factors are prevalent in the construction industry, the complex work organization of construction work provides additional challenges for implementing traditional workplace prevention programs. The hierarchical structure between the site owners, general contractors, and subcontracting companies results in a fissured workplace . The dyn® program. Such approaches target the conditions of work that affect workers injuries and health outcomes  would have to financially support the program running on their site.”The goal of this study was to evaluate the efficacy of a construction worksite-based integrated intervention targeting both the conditions of work, and workers’ health behaviors, simultaneously. We observed short-term improvements in ergonomic practices and in incidences of pain and injury after an injury prevention program. We also observed an improvement in physical activity and healthier dietary behaviors, such as increased consumption of fruits and vegetables, after a health promotion Health Week program.At the individual level, we found a significant improvement in ergonomic practices, and a reduction in incidences of pain and injury, which supported the hypothesized pathways for the program. As promoted by NIOSH, ergonomic practices focus on workers modifying or establishing work procedures to reduce the risk of injuries ,49. WhilWhile we were encouraged that an improvement in ergonomics practices occurred, results also indicated that the program was not successful at addressing system level components. For example, while we saw ergonomics practices improve, we saw no significant change in the physical demands on the workers. Hence, we suspect that the intervention changed the way people completed their work but had limited effect on the physical demands of the job. In addition, the process evaluation revealed several important barriers and facilitators to our program at the organizational level. First, management and worker buy-in were identified to be integral to the success of the soft tissue injury prevention program. This was perceived to be key in a work environment that is fast-paced, unpredictable, and with tight production schedules tied to the requirements of the general contractor. For example, there was little time to complete task preplanning or for the safety manager to complete inspection protocols for injury hazards and ergonomic solutions. When management support for health and safety programs is not observed by the workers, other competing factors are often prioritized over health and safety, especially ergonomic practices . This waWhile we have had past success with a worksite safety program integrated within the complex structure associated with multiple employers, a large barrier to a systems approach ergonomics program was the challenge faced by subcontractors to make changes, even those changes that could improve site safety on their own worksite. Unlike our previous program that was designed to re-enforce existing safety practices , the ARMMoreover, system-level changes require better upfront planning before construction begins, such as during the bidding process for a job by setting out requirements from the multiple employers, and in the contracts for the jobs. The key informant interviews supported this concept. Expectations regarding safety programs in the contract is standard procedure in larger projects, especially owner-insured programs. An example is with respect to safety training, in which owners, especially public entities, require that construction workers have a minimum of OSHA-10 training to be onsite . Whilst Other researchers in the construction industry have also found mixed findings with respect to improvements in pain and injury and perceived physical effort after implementing ergonomic interventions, including participatory ergonomics programs ,56,57,58In contrast, the Health Week had many successes in overcoming some of these barriers associated with the multiemployer structure. For one, it simply required the participation of the workers and little, if any, infrastructure. In theory, the Health Week might have addressed some conditions of work regarding psychosocial factors around health, like supervisor or co-worker support. Anecdotally, we observed foremen and co-workers being supportive of ensuring their co-workers signed up for health coaching or NRT. Some foremen would cover for their workers to allow them to participate in the week’s activities. We also observed workers talking about eating healthier food with their coworkers during the week.Another major strength of the Health Week was how it aligned with companies’ current practices on the worksite and also with the interests and goals of the workers. This was also found in previous formative work we completed that found that policies, programs and practices are supported by management and workers alike if they can be easily integrated into company’s business structures and align with workers’ goals and needs ,60. HealResearch in construction has challenges with loss to follow up due to the dynamic nature of construction with workers coming and going on worksites as the construction job requires specific trades during the timeline of the study ,36. The Another challenge was the success of integrating the injury prevention and health promotion activities in this environment. Integration was achieved by linking the two programs by name and key messaging in the planning and implementation phases. In addition, messaging around Health Week included training on both injury prevention and health promotion giving workers the tools to improve their working conditions, as well as giving them control for their health. The ergonomics program prior to Health Week did have health messaging but without any specific health promotion activities.One limitation was that our intervention depended on the participation of the general contractor safety managers, whose involvement and dedication to the study varied across sites and between general contractors. This aspect of the intervention was by design, as we considered it important for integration and sustainability into current company processes, that the ergonomics inspections were performed by the safety managers. Giving the safety managers latitude to decide how invested they were in the program allowed us to assess the feasibility of the intervention being adopted without the aid of study staff. This would ensure that our observations were realistic and representative of barriers and facilitators to the intervention’s delivery by non-study staff.Further, this study involved worksites in commercial construction only. Thus, the results may not be generalizable to other types of construction . However, commercial construction accounts for a large portion of U.S. construction activities, and represents an important area for injury prevention research. Similarly, the construction workforce in the Boston metropolitan area may not be representative of commercial construction workers in other parts of the country or world, where work practices, demographics, and union membership differ.Despite these limitations, our study had several strengths, most notably the study design and the wide variety of general contractors and sites recruited into the study. The cluster randomized control trial design is a novel approach in commercial construction. Typically, approaches to improve the health and safety of construction workers have often focused on the individual worker, targeting workers when they are enrolled in apprentice programs ,65, targThe ergonomics inspection and communication protocol provided a method to identify broad areas for improving ergonomics in the dynamic construction work environment. It is important to understand the challenges and successes of intervention delivery in order to inform and improve future worksite-based interventions. It appears that the largest barriers to the success of the intervention were the inability of subcontractors to make changes to their worksite and the variability in the involvement and dedication to the study across different worksites and general contractors. These are real-world, as well as research study challenges. Subcontractors did not have the systems in place, or the available tools, to assist in changing their working conditions. Competing safety and production priorities also influenced the level of management commitment to the study. Additionally, construction safety research may have broader implications for an increasing number of industries that are becoming as dynamic and variable as construction, as more services once housed in a single facility are outsourced to multiple employers .The ARM program had a positive impact at the individual level on the worksites that implemented the program. The trial saw improved ergonomics practices, as well as, reduction in new pain and injury, and improved diet and physical activity, as reported by the workers. A number of obstacles were encountered which made integrating a health promotion and injury prevention intervention into the multi-employer, outcome-driven, dynamic work environment challenging. Process tracking suggested that our intervention had less impact at the systems/organizational level in terms of changing organizational programs and practices, due to the complex organizational structures on site. For the longer term, more organizations in the multiple employer environment should be involved in the implementation to facilitate more upstream changes.


The World Health Organisation (WHO) recommends that children living with HIV should be informed about their HIV status within the ages of 6 to 12 years using age-appropriate resources. The aim of this study was to assess the socio-demographic, clinical and psychosocial factors associated with primary caregivers’ decisions to disclose HIV to children living with HIV aged 6 to 12 years in Malawi. A cross-sectional study of 429 primary caregivers of children living with HIV were systematically recruited from all regions of the country. Information on HIV disclosure, family and child socio-demographic characteristics, child clinical characteristics, and child and family psychosocial characteristics was collected using validated instruments. Logistic regression was used to analyse data. The prevalence of non-disclosure of HIV status to children was 64 per cent. Concerns about the child’s inability to cope with the news (29%), a lack of knowledge on how to disclose HIV status (19%), and fear of stigma and discrimination (17%) were the main reasons for non-disclosure. On multivariate analysis, the odds of non-disclosure were higher among primary caregivers who were farmers , in younger children (6–8 years) , in children who were in WHO HIV clinical stage one , and in children who were not asking why they were taking ARVs . On the other hand, nondisclosure of HIV status was less likely in underweight children . Many children living with HIV in Malawi are unaware of their HIV status. Non-disclosure is associated with a number of clinical and demographic characteristics. The findings highlight the need to provide guidance and support to primary caregivers to help them to effectively disclose HIV status to their children. In 2015, the United Nations programme for HIV/AIDS (UNAIDS) estimated that one million people of all age groups, 6.7 per cent of the total population, were living with HIV in Malawi [The increase in coverage of anti-retroviral (ARV) medications among infected women in Malawi has led to a 71% decline in new infections among children from 16,000 cases in 2009 to 4800 in 2015 . DespiteAccording to the American Academy of Paediatrics and the World Health Organisation (WHO), the early and progressive disclosure of HIV status to children aged between 6 and 12 years is critically important for their wellbeing , 10. In Despite this recommendation, many children in Sub-Saharan Africa remain unaware of their HIV status . There aAlthough Malawi has a large population of children living with HIV, there is limited evidence regarding the practice of HIV disclosure to children. In one of the few studies conducted in Malawi, it was revealed that parents were unwilling to have a conversation about HIV with their child because it was not culturally appropriate to talk to children about sexual issues . In otheIt is thus crucially important to estimate the current prevalence of HIV disclosure in Malawi and to identify socio-demographic and psychosocial characteristics of families and children associated with disclosure and non-disclosure. The aim of this study was to assess the sociodemographic, clinical, and psychosocial factors associated with primary caregiver’s decision to disclosure HIV to a child in Malawi.This study was a cross-sectional study conducted in Malawi between March and June 2015. The study sites for primary caregivers were selected from the three administrative regions in Malawi, namely Northern, Central, and Southern regions. For administrative purposes, the country is further divided into 28 districts. Eight districts  were selected as study sites using a systematic approach. Districts were grouped under their respective Regions before assigning them numbers according to the number of districts in the Regions. Random numbers were then generated corresponding to the number of districts required in the region. The number of districts selected from each region as study sites was determined by the total number of districts in the region. In Malawi, each district has a district hospital which acts as a referral facility for all health centres and community hospitals within that district. In addition, each district hospital has an ART clinic. Normally children and their primary caregivers visit the clinics every two to three months to collect their ARV medication. Survey data were collected from primary caregivers at these ART clinics.https://www.stat.ubc.ca/~rollin/stats/ssize/b2.html. This sample size calculating formula was based on the estimation of sample size and power for comparing two binomial proportions in Bernard Rosner's Fundamentals of Biostatistics [The sample size was calculated on the basis that the rate of HIV status disclosure to children in Malawi may be either high or low. In a recent study conducted in Kenya, Vreeman and colleagues  reportedatistics . A samplatistics . AssuminParticipants were eligible for the study if they met all of the following selection criteria: (a) the child was aged between 6 and 12 years and had been diagnosed with HIV and (b) the primary caregiver had cared for the child at least six months, was aged 18 years or older, had the ability to provide informed consent, and had not been diagnosed with a psychiatric illness. On the clinic day, study participants were recruited using a systematic approach. A member of the research team who was not part of the clinic staff gave the potential participants information related to aims, procedure, outcomes, benefits and risks of the study as well as their rights in relation to participation or withdraw from the study. Those who were willing to participate in the study were given consent forms to sign or put their thumbprint, if they could not read or write. The potential participants were also assured that their information will kept confidential, and that only members of the research team will have access to it. Potential participants were assigned an odd or even number starting from one based on the time of their arrival at the clinic. Those who were assigned an odd number were screened according to the inclusion/exclusion criteria prior to their participation in the study. We collected data of oldest child with HIV within the age range of 6–12 years if a primary caregiver had two or more children living with HIV in this age group.The research team was assigned a room for data collection within each ART clinic. Research assistants with a background in nursing, public health, and clinical medicine who were not part of the clinic staff were recruited to assist with data collection. The research assistants were trained on data collection procedures prior to data collection. The normal waiting time for primary caregivers at the antiretroviral therapy clinic was two to three hours depending on the number of patients in attendance on that day. Data collection took place during the waiting time or after participants had been attended to by healthcare workers. To prevent inadvertent HIV status disclosure to children, they were separated from their primary caregivers during data collection and were entertained with cartoon shows on a portable DVD player in a separate room. One of the research assistants was assigned to look after the children while they were watching the cartoon. Face to face interviews were used to collect data from study participants. The first author, or one of the research assistants, asked the questions detailed in the questionnaire and recorded participants’ responses. The data collection process for each study participant took 30 to 40 minutes to be completed. The study participants were given a one-kilogram packet of sugar at the end of the interviews as a gift to compensate them for their time. The participants were not told about the gift until the interviews were completed so that it would not be an inducement to participate.Ethics approvals were obtained from the Curtin University Human Research Ethics Committee and the Malawi Government National Health Science Research Committee prior to the commencement of data collection. Written informed consent was sought from the study participants prior to data collection.The questionnaire contained validated instruments to collect data about knowledge and practice of HIV disclosure, family socioeconomic and demographic characteristics, child demographic and clinical characteristics, child behavioural and emotional well-being , the burParticipants were asked questions regarding their knowledge, practice, barriers and facilitators of HIV disclosure to children see .The primary caregiver was asked questions relating to their socio-demographic status. Socio-economic status was assessed through the Wealth Index tool. The Wealth Index tool was developed by the World Bank to measure the socioeconomic status of people in developing countries using questions about the type of dwelling, availability of household goods, television, toilet facilities, the source of drinking water . A compoThe primary caregiver was asked questions about the child including the child’s age, gender, child’s WHO HIV clinical stage , and child’s anthropometric measures see . The 200The Strengths and Difficulties Questionnaire (SDQ) was used to assess the behavioural and emotional wellbeing of children . The SDQThe level of burden associated with caring for a child with HIV was assessed using the Impact on the Family Scale . The scaStressful life events experienced by the primary caregiver’s family were measured using the Life Stress Scale adapted from Tennant and Andrews . The insThe level of family support was assessed using the Support Function Scale . The insThe main outcome of the study was HIV non-disclosure to children. The prevalence of child and family factors as well as the practice of HIV disclosure were tabulated. Bivariate analyses were conducted to assess the likelihood, or odds, of all child and family socioeconomic, demographic, clinical, and psychosocial variables being associated with HIV non-disclosure. Variables that were significantly associated with non-disclosure, with p-values of ≤ 0.25 in bivariate analysis  were entA total of 432 primary caregivers were approached to participate in the study. Three primary caregivers declined to participate; two were teachers on their way to school, while one needed to attend to family matters at home. A total of 429 primary caregivers were finally recruited into the study representing a response rate of 99.3 per cent.The prevalence of family sociodemographic and child characteristics are presented in In terms of the child characteristics, The association between child and family psychosocial factors and non-disclosure of HIV status are presented in In this study, the prevalence of non-disclosure among six to 12-year-old Malawian children living with HIV was 64%. The main reasons for non-disclosure were concerns about the child’s ability to cope with the news about his/her HIV status, lack of knowledge on disclosure, and fear of stigma and discrimination. Primary caregivers who were engaged in farming, resident in Northern Malawi, or living with two or fewer children older than 12 years had a higher likelihood of non-disclosure. In addition, non-disclosure of HIV status was more likely for children who were younger, in stage one of the WHO HIV clinical stage, and those who were not asking why they were taking ARVs. On the other hand, non-disclosure was less likely in children who were underweight. Child/family psychosocial factors, family wealth and parents' level of education were not associated with non-disclosure.The prevalence of HIV non-disclosure in this study (64%) is similar to those reported in studies conducted in Tanzania , Zambia On the other hand, the prevalence of non-disclosure in our study is higher than those reported in two studies conducted in Uganda, where the non-disclosure rate was found to be 49 per cent  and 44 pThere is evidence that primary caregivers perceive younger children to lack the emotional and cognitive maturity to cope with knowledge of their HIV status . PrimaryConversely, three recent studies conducted in Burkina Faso, Uganda, and The Democratic Republic of Congo found that despite children’s curiosity to know about their disease, primary caregivers felt that they were too young to be engaged in conversation about their HIV status and opted for deception and threats as a way of protecting the children from the perceived negative consequences of disclosure , 52–54. Our finding that primary caregiver’s farming occupation was independently associated with non-disclosure is in contrast to the findings of two recent studies conducted in Tanzania and Rwanda, where farming occupation of parents was not significantly associated with non-disclosure of HIV status to children , 50. TheIn addition, our study found that participants from the Northern Region of Malawi were more likely to have children who were unaware of their HIV status compared to their Central Region counterparts. This difference in non-disclosure may be due to the provision of comprehensive care to children living with HIV by Baylor College of Medicine Children’s Foundation in several districts in the Central Region. Baylor College of Medicine Children’s Foundation, which is a privately funded medical facility, only support HIV paediatric care in Government hospitals in the Central Region. In contrast, the Government hospitals in the Northern Region rely on Government for funding and have fewer resources to effectively promote disclosure of HIV status to children.Furthermore, we found that living with less than three children older than 12 years was associated with non-disclosure. In Malawi, as in South Africa, older children are becoming a source of social support to their siblings and primary caregivers in families affected by HIV . Since hOur study is one of the few in sub-Saharan Africa where the association between psychosocial factors and non-disclosure of HIV status to children was assessed , 63. WhiThe main reasons for non-disclosure reported in this study concur with accounts in other studies conducted in sub-Saharan Africa , 64, 65.With regard to HIV stigma and discrimination, three qualitative studies conducted in Malawi show that these are still major problems despite the increased coverage of health promotion campaigns against such practices , 17, 69.Primary caregivers’ lack of confidence in their ability to disclose appropriately is another major barrier to HIV disclosure that has been reported in previous studies –72. ThesThis study has a number of strengths. First, the study had a fairly representative data collected from the three regions of Malawi. Nonetheless, it may have biases considering that it excluded primary caregivers whose wards were receiving care at lower-level health centres and private hospitals. Primary caregivers of children receiving care in health centres were excluded because the centres do not have specialised HIV clinics and are situated in remote localities. Primary caregivers in private hospitals were excluded because only a small proportion of children living with HIV receive care in private hospitals. Second, this study assessed disclosure of HIV to children younger than 13 years as such it provides a good benchmark for evaluation of the implementation of the WHO guideline for HIV disclosure . NotwithThe prevalence of non-disclosure in Malawi is high. It is clear that primary caregivers in all socioeconomic and demographic groups struggle with the task. There are many reasons why caregivers choose not to disclose, especially to younger children. The results of this study indicate that providing age appropriate disclosure is a complex process for primary caregivers. There is some evidence from previous studies that healthcare workers can make this task easier for primary caregivers by providing appropriate guidance and support , 74. We S1 File(DOCX)Click here for additional data file.


Little is known about the structural patterns and dynamics of the first global trading market (FGTM), which emerged during the sixteenth century as a result of the Iberian expansion, let alone how it compares to today's global financial markets. Here we build a representative network of the FGTM using information contained in 8725 (handwritten) Bills of Exchange from that time—which were (human) interpreted and digitalized into an online database. We show that the resulting temporal network exhibits a hierarchical, highly clustered and disassortative structure, with a power-law dependence on the connectivity that remains remarkably robust throughout the entire period investigated. Temporal analysis shows that, despite major turnovers in the number and nature of the links—suggesting fast adaptation in response to the geopolitical and financial turmoil experienced at the time—the overall characteristics of the FGTM remain robust and virtually unchanged. The methodology developed here demonstrates the possibility of building and analysing complex trading and finance networks originating from pre-statistical eras, enabling us to highlight the striking similarities between the structural patterns of financial networks separated by centuries in time. As a result, BoEs provide crucial information regarding the paths and characteristic times that accrue to the money transfers associated with most financial transactions. Similar to the global financial market (GFM) of today, following the money transfers in the sixteenth century allows us to characterize the FGTM, the overall structure of which remains essentially unknown to date.The navigating routes established by the Portuguese and Spaniards during the sixteenth century linked all continents –12. Lisb. By all measures, this is a rare dataset, given the obvious limitations of dealing with historical data from this pre-statistical period. Despite the fact that the FGTM was here built upon BoEs of a single merchant (not many such data sources survived to date), the resulting network spans the entire world, as SR maintained contacts with merchants settled both inside and outside Europe. It is also noteworthy that the trading partners of SR include a significant part of the main trading merchants and bankers that were active during this period of early modern history, such as the Fugger, the Grimaldi or the Spínola, and other powerful Genoese merchant–bankers [To this end, we used information contained in an online database recently created  accumula–bankers . In Euro–bankers . Out of –bankers –23 of fiFrom a network perspective, each BoE leads to the appearance of at least one triangular motif in the network, linking the drawer(s), payee(s) and drawee(s)—associated with each transaction, as illustrated in 2.The network was built from data present in 8725 handwritten BoEs  (coverinD(k)), average path length (APL), degree assortativity (knn(k)) and clustering coefficient (CC), following the usual definitions [The data consist of a list of individuals and the roles assigned to them in each BoE. Using this information, the links between individuals were established according to the scheme depicted in initions ,25. Hierinitions .Table 13.Being a relevant player of the FGTM, SR was active for an unusually long period of over 40 years 1553–1597) during which he traded not only with all the other key players of the FGTM 553–1597 ,14 but aFurthermore, the fact that SR conducted his activity in a period of great turmoil in Europe means that the types of commodities traded by SR were very different. While he started his business affairs as an importer of French textiles into the Peninsula market (possible because of the Treaty of Cateau-Cambrésis), he subsequently invested in American Indies commodities (until the crisis in Seville during the 1560s) and informally in spices and slaves jointly with his Portuguese partners . As an easientos to support the Castilian wars with the Protestant Low Countries, although the first contract with the Consejo de Hacienda was only signed in 1576 [asientos of Flanders to the asientos of Madrid, investing higher amounts, but obtaining greater profits, namely obtaining silver licencias de saca outside Spain. When after 1578–1580, the Genoese recovered their role as the main financiers of the Spanish Crown, SR realized that he could not compete with them and joined them in their consortium until the end of the 1580s, especially owing to the decline of Lyon as a financial centre, where his traditional major partners were struggling to survive the Wars of Religion in France.After 1574, SR tried to offer the Castilian Crown his accumulated capital to invest in  in 1576 . Until tGrandes of Spain, among them the Duke of Bejar, the Count of Portalegre, the Count of Nájera or the Duke of Aveiro. He also transferred money between religious institutions. After the mid-1580s, SR invested in a new financial opportunity: the curial market in Rome, i.e. the market of ecclesiastical licences and benefits, for which the Iberian Peninsula had the largest demand in all Christianity [SR also invested in lending to some private persons, such as some of the stianity . Howeverstianity ,32–35. TBy keeping track of the first and last date at which BoEs were established by the same two nodes, our analysis leads to an exponential distribution of link duration, with a characteristic lifetime for business associations of approximately 9 years. Moreover, links that last longer are those that connect those individuals with a higher number of partnerships in the financial network —that correspond to those depicted in trust was found [Given that as found ,36–38 toC(k) in As In the electronic supplementary material, we show that these features remain robust to changes of the template motif used in building the FGTM. The variant of the FGTM obtained by merely following money transfers  exhibits the same fat-tailed distributions with the same exponents already provided in All macroscopic features of the FGTM are remarkably similar to what is known for present-day interbank transactions around the globe –45. It iInterestingly, all these contemporary networks exhibit features very similar to each other and, importantly, also with the representative sample of the FGTM that we built here based on the SR records. In particular, and similar to the FGTM, they portray a power-law degree distribution and a power-law dependence of the clustering coefficient, the latter suggesting a hierarchical nature . This bePprevious and Pactual shown in Pactual who were not neighbours of SR during Pprevious. This number is subsequently normalized via division by the total number of first neighbours during Pactual.During the 40 years of activity of SR, Europe witnessed four major country bankruptcies and was immersed for most of the time in wars that severely delayed the occurrence of international fairs  , despite the fact that such a dynamic network has a direct impact on the nature of the goods traded and money transfer circuits explored, possibly reflecting a rapidly changing geopolitical scenario. These network features also find echo in historiographical records: the turbulent events occurring in the second half of the sixteenth century provided significant differences between the two periods, as shown in asientos and sustain the Habsburg conflicts in Europe by investing in public debt [In fact, the historical conjuncture had so much impact upon the number of nodes and links involved in the structures of BoEs that in the Spanish Treasure bankruptcy of 1596 and in the years before and after, the number of individuals and the number of BoEs decreased , affecting the preference of partnerships with some business groups. The preference for Portuguese traders was because of their relative immunity from the financial disaster of the Piacenza fairs (led by the Genoese) and their disposable capital in Antwerp, so that SR continued to participate in lic debt ,35 (see lic debt ,34. Also4.Although there are no similar topological studies of other early modern financial networks, historians have already underlined the use of similar strategies during the seventeenth and the eighteenth centuries. Even with public banks already functioning as in eighteenth century France, the spreading of investments in different types of business and using different partners in order to reduce risk, as well as the establishment of hierarchical networks in which older partners are more reliable and whose relationships are more stable in time, continued to persist ,52.Our results impact different dimensions of our knowledge of the historical origins of economic globalization. On the one hand, we show how a combination of historical analysis and a quantitative analysis of the complexity of historical financial patterns—through modern network science and other methods—may provide a means to circumvent the natural lack of consistent data, enabling also a comparison across distinct periods. On the other hand, our comparison between branches of the sixteenth century FGTM and branches of the present-day GFM led to striking structural similarities at the macro-scale. Historically, the fundamentally disruptive effect that the navigating routes first established by the Portuguese and Spaniards during the sixteenth century had on humanity led to a reconfiguration of the world economy, to the adaptation of existing financial and information circulation mechanisms and to the establishment of trans-national, trans-religious and trans-cultural networks which allowed the circulation of capital at a global level, such as what we have today ,53–55. T


Promoting the use of generic drugs can constitute a core instrument for countries’ national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil. To reduce the price of prescription medications, the World Health Organization (WHO) recommends that generic drug substitution be a component of every country’s National Pharmaceutical Policy . To thatA great deal is known about the various policy instruments and mechanisms that countries can use to promote the demand for and supply of generic drug products –3. And, To understand the diversity of national practices regarding promotion and regulation of generic medicines, certain key questions must be considered. For example, how have generic drug products been demonstrated to be therapeutically equivalent to originator products ? Are generic products allowed to display brand names (labeling)? Should doctors prescribe using the generic name or can they use a brand name (prescription)? Are pharmacists authorized to substitute a generic product for an innovator product (substitution)? These four dimensions are crucial to any evaluation i.e.: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. The significance of these dimensions are explored below.Regulatory authorities set standards that determine which drugs need to be therapeutically equal to reference products, and how such equivalence is demonstrated. For drugs that need to demonstrate equivalency, this requires tests of bioavailability (BA) and bioequivalence(BE). BA measures the extent to which a drug is absorbed into the body and is available to act upon its intended target (the site of action). BE considers whether or not there is any significant difference in the rate and extent of availability of two drugs over a period of time, at the same dose and under the same conditions. Follow-on products that have the same BA as the reference product are regarded as “generic” products, while those with differing BA are not .Demonstrating BE is essential for generic drugs. A small difference in bioavailability may alter a drug’s effect, and if so, cannot be considered equivalent. The establishment of BE is particularly crucial when considering medicines with highly toxic ingredients or in a Narrow Therapeutic Range (NTR),The second dimension for comparison pertains to a country’s regulations regarding labeling and packaging of generic products. Use of the generic name or international non-proprietary name (INN), usually a simplified version of the chemical name, can remove the obscurities that brand names create. Not only may the INN be displayed on the pharmaceutical packaging, but also font size and presentation will differ according to local regulations. For instance, some countries require the INN to be no less than 30% – 50% smaller than the font size of the brand name; some require that it be of equal size; while others still have banned the .use of brand names altogether . RegulatPrescription and substitution are the third and fourth dimensions of this taxonomy. The use of the generic name facilitates the prescription and dispensing of pharmaceuticals to patients, as well as communication among health professionals and scientists . It alsoThis discussion of prescription and regulation is, of course, closely tied to the previous discussion of labeling and packaging. After all, pharmaceutical firms invest heavily in distinguishing their brands, and actively promote their brands among physicians, pharmacists, and patients. These promotional efforts can create incentives to prescribe or substitute one product for another. Even if health professionals have no doubts about the quality of generic medicines, they may be disinclined to prescribe them, as may pharmacists .Through the lens of the proposed taxonomy, the study examined the generic drug policies of Brazil. Findings were based on empirical data collected in 2007 – 2015, including national government documents  and more than 400 newspaper articles and scientific papers. These data were supplemented by 60 interviews with key informants who had participated in designing and implementing Brazil’s generic drug policies, e.g., regulators, government officials, and representatives of local and multinational pharmaceutical companies.Brazil is a case study that is crucial to understanding the regulation of interchangeable pharmaceutical products. Among Latin American countries, Brazil has the largest generic drug sector, representing almost 28% of the country’s pharmaceutical sales. While Brazil has witnessed high levels of generic market penetration, the process has been accompanied by a number of conflicts and challenges.In 1999, the Ministry of Health of Brazil took a decisive step in promoting generic equivalents by enacting the Generic Drug Act . This leBrazil requirements are relatively stringent compared to those of other Latin American countries. A study conducted by the Pan American Health Organization (PAHO) concluded that of the 86 drugs analyzed in Latin American countries, 51 required demonstration of bioequivalence in Brazil . No otheMany local firms not only managed to adapt to the new requirements, but became market leaders in the pharmaceutical sector . The firThanks to the gains in industry capabilities brought on by the BE resolution, and the increased importance of local producers, the national pharmaceutical sector became a policy priority. Pharmaceutical sector representatives assisted the Government of Brazil in identifying bottlenecks to the sector’s expansion . Since BFirst, in the early 1990s, an unsuccessful Congressional initiative (PL 2022/1991) proposed banning the use of brand names from all pharmaceutical products. At that time, there were two types of products in the market: reference products  and similar medicines , both types commercialized under their respective brand names. This proposal, which was motivated by the fact that 50 million people had limited access to medicines, would have required all pharmaceutical products in Brazil to be prescribed and commercialized using the INN, or in cases where INN was not available, the Brazilian non-proprietary name (BNN). Expecting that a reduction in the use of brand names would lower costs and facilitate interchangeability, the proposal would have only allowed brand names to be included on packages if they were presented in a font size smaller than the generic name; all public health service prescriptions would use the generic name.The regulation of labeling of pharmaceutical products is not a recent issue in Brazil. Three attempts to regulate packaging and non-proprietary names have raised heated political debates.In 1993, and concurrent to Congressional negotiations, the Ministry of Health promoted a second attempt to regulate the labeling and packaging of generic drugs. The Ministry of Health sponsored Presidential Decree 793/1993, which required, among others, that the fonts used for brand names be no greater than one-third the size of the generic name, and that all drugs prescribed and procured by the National Health System use generic names. The pharmaceutical industries and drug retailers promptly reacted through the courts, arguing these requirements would harm their businesses .It was only with the passage of the Generic Drug Law in 1999 that discussions on INN and labeling progressed. The Law also stipulates that all generic drugs provide only the INN, and that packaging include a yellow stripe with the letter “G” to indicate the product is interchangeable. In contrast, for the labeling of innovator products, the trademark can be displayed in a larger font size, with the INN or BNN immediately below, in a font no less than half the size of the brand name. The packaging of similar drugs would have the same regulatory standards as the innovator products, but would not be interchangeable because, unlike generic products, they did not have equivalence test results available.During the debates in Congress that led to the Generic Drug Law, the prescription rules for physicians were highly controversial. The Government and national and multi-national pharmaceutical industries, all disagreed starkly on this component of the bill. The multinational pharmaceutical industry demanded that generic drug substitution only be allowed by a doctor’s written request. However, the Government did not agree to negotiate this aspect of the bill; thus, if doctors do not agree with substitution, they must indicate “substitution not allowed” on the prescription . While dThe prescription of generic medicines by INN is still low, but has increased over time, representing 20.9% of total prescriptions in 2006, compared to 11.8% in 2002 22) ( (22). DeIn terms of generic drug prescription, academic studies, market assessments and a number of newspaper articles point out that health professionals still resist prescribing generic drugs , 27. ForIn response to the lack of confidence in generic and similar medicines among public and health professional, in 2014 the Government of Brazil proposed new regulation to clarify which pharmaceutical products are therapeutically equivalent. At the suggestion of the Ministry of Health, the National Regulatory Agency (ANVISA) proposed a new resolution to modify the packaging of pharmaceutical products . The newTo understand the challenges facing health policymakers in Brazil, keep in mind that, in contrast to the situation prior to the launch of the generics policy, most non-originator drugs have demonstrated bioequivalence. Most similar drugs are now BE; very few drugs that have not demonstrated BE remain on the market. Yet most of these non-originator BE drugs continue to have brand names. These branded BE drugs, essentially like “branded generics” commercialized in retail markets in the United States of America and the United Kingdom, represent 47% of the pharmaceutical market (units), while formally “generic” drugs  represent 27% . Yet, suIn suggesting the use of “EQ,” health authorities argued that this would increase consumer options among products with proven therapeutic equivalence, thereby reducing price. The Government maintains that this regulation is a logical follow-up and response to Resolutions 133 and 134 passed in 2001 that established the year 2014 as the deadline for similar medicines to submit bioequivalent testing for agency approval. Different from the discussion in the early 2000s that centered on quality and manufacturing processes, the EQ debate was only concerned with the labeling of pharmaceuticals. The announcement was made in January 2014 by the Minister of Health and this sparked heated debate among pharmaceutical industry representatives. Technically, they argued, it was reasonable, since all products are the same and have the same active ingredients and therapeutic responses . However, the EQ label would commodify reference products and similar medicines. Because these are brand-name products, they rely on strong marketing strategies.Therefore, pharmaceutical firms—national and multinationals–that sell their products under brand names feared that they would be adversely affected by this regulation, that the presence of EQ on the label would essentially send a message to ignore brand markings. After much discussion, a resolution was issued in October 2014, responding to the demands of the pharmaceutical industries: no EQ symbol would be added to labels, but rather, the leaflets found inside of pharmaceutical packaging would indicate if the product was interchangeable. As a result of this compromise, however, this information will not be available until the product had already been purchased and opened.The debate over the EQ resolution is important for two reasons. The resolution intended to diminish the role of branding by emphasizing the equivalence of equivalent products. In doing so it would increase the scope of substitution, and it was expected, reduce the price of drugs. Although the idea behind the EQ proposal has a strong public health rationale, the structure of the pharmaceutical market in Brazil creates economic interests that were able to di-lute the measure—and may yet subvert this policy instrument. The debate also illustrates how Brazil innovates in generic regulation, not just using traditional instruments of interchangeability , but with additional information in the package leaflet.This analysis draws attention to the various dimensions of national generic drug regulations and their core policy instruments; it contributes to the literature by building new conceptual and empirical evidence on developing countries’ compliance with generic drug guidelines. To understand regional differences and regulatory choices, one must clarify the incentives and public health interests of these instruments and the institutional marketing opportunities.In the Brazil case, these relationships were demonstrated through the regulation of INN and prescription rules, and bioequivalence and pharmaceutical packaging. The case of Brazil also demonstrates that these are not just technical concepts, but rather, highly contested political decisions. The Generic Drug Law of 1999 was an opportunity to foster the use of the INN in Brazil as a prescription rule and improve the pharmacology requirements to register non-patent drugs. This paper also pointed to the strong political conflicts that can be generated by efforts to apply new regulations regarding generic drug instruments.Taking a step back, core lessons and implications from applying the proposed taxonomy to the Brazil case study are twofold. First, the diverse interests of the public and private sectors stakeholders shape the design and implementation of the core dimensions of any national generic drug regulation. Regulations that are effective and long lasting are designed with an understanding of the politics of drug substitution, i.e., their effects on public health, business concerns, and strategies. And secondly, that the task ahead is to think more clearly about the set of dimensions that influence national generic drug systems. This paper provides an initial step that is expected to encourage other scholars to evaluate, refine and apply the learnings in other contexts.EMF receives funding from the São Paulo State Research Foundation (Grant No 2014/07725-3 and 2015/18604-5).RPSP/PAJPH and/or PAHO.Authors hold sole responsibility for the views expressed in the manuscript, which may not necessarily reflect the opinion or policy of the