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IntroductionCounseling, together with iron and folic acid supplements, can improve hemoglobin levels in pregnant women, but few interventions have tested a virtual method of delivering counseling. We hypothesized that a virtual counseling intervention delivered via a mobile device (mHealth) would prevent and treat anemia, compared with routine antenatal care (ANC).MethodsVirtual antenatal intervention for improved diet and iron intake (VALID) was a non-blinded parallel group two-arm, individually randomized superiority trial (1:1 allocation). Participants were pregnant women who were married, aged 13–49 years, able to answer questions, 12–28 weeks’ gestation and living in Kapilvastu district, Nepal. Women were randomized to receive routine ANC (control arm), or ANC plus a virtual antenatal intervention of two problem-solving counseling sessions via video call. The primary outcome was iron folic acid (IFA) tablet compliance (consumption on 12 or more days of the previous 14 days). Secondary outcomes were dietary diversity, promoted food consumption, iron bioavailability enhancement, and knowledge of iron-rich foods. Primary logistic regression analysis was by intention-to-treat, adjusting for baseline values.ResultsWe enrolled 319 pregnant women (161 control, 158 intervention) from 23 January 2022 to 6 May 2022 and analyzed outcomes in 144 control and 127 intervention women. Compliance with IFA increased in both arms. In the intervention arm, compliance increased by 29.7 percentage points (pp) (49.0–78.7%) and 19.8 pp. in the control arm (53.8–73.6%). Despite the more significant increase in the intervention arm, we found no intervention effect upon IFA compliance (adjusted odds ratio [aOR] 1.33; 95% confidence interval [CI]: 0.75, 2.35; p = 0.334), dietary diversity, or ANC visits. The intervention increased knowledge of iron-rich foods (coefficient 0.96; 95% CI: 0.50, 1.41; p

Abstract Background Disparities in vaccination coverage exist in Somalia with Internally Displaced Persons (IDPs) being among the groups with the lowest coverage. We implemented an adapted Participatory Learning and Action (PLA) intervention, which focused on routine vaccinations among displaced populations living in Mogadishu IDP camps. The intervention was successful in improving maternal knowledge and vaccination coverage but unsuccessful in improving timely vaccination. We conducted a qualitative study to understand this result and analyze the multi-level barriers to routine childhood immunization uptake. Method In this qualitative study we used observation data from 40 PLA group discussions with female caregivers and purposively sampled nine vaccination service providers and six policy makers for interview. We also reviewed national-level vaccine policy documents and assessed the quality of health facilities in the study area. We used the socioecological framework to structure our analysis and analyzed the data in NVivo. Results The barriers to childhood vaccination among IDPs at the individual level were fear due to lack of knowledge, mistrust of vaccines, concerns about side effects and misinformation; opportunity costs; and costs of transportation. At the interpersonal level, family members played an important role as did the extent of decision-making autonomy. Community factors such as cultural practices, gender roles, and household evictions influenced vaccination. Organizational issues at health facilities such as waiting times, vaccine stock-outs, distance to the facility, language differences, and hesitancy of health workers to open multi-dose vials affected vaccination. At the policy level, confusion about the eligible age for routine vaccination and age restrictions for catch-up vaccination and certain antigens such as BCG were important barriers. Conclusion Complex and interrelated factors affect childhood vaccination uptake among IDPs in Somalia. Interventions that address multiple barriers simultaneously will have the greatest impact given the complex nature of vulnerabilities in this population. There is a need to strengthen the health system and connect it with existing community structures to increase demand for services. Our research highlights the importance of formative research before implementing interventions. Further research on the integration of health service strengthening with PLA to improve childhood vaccination among IDPs is recommended. Trial registration number ISRCTN-83,172,390. Date of registration: 03/08/2021.

Abstract Background Mental wellbeing encompasses life satisfaction, social connectedness, agency and resilience. In adolescence, mental wellbeing reduces sexual health risk behaviours, substance use and violence; improves educational outcomes; and protects mental health in adulthood. Mental health promotion seeks to improve mental wellbeing and can include activities to engage participants in sport. However, few high-quality trials of mental health promotion interventions have been conducted with adolescents, especially in low- and middle-income countries. We sought to address this gap by testing SMART (Sports-based Mental heAlth pRomotion for adolescenTs) in a pilot cluster-randomised controlled trial (cRCT) in Bardiya, Nepal. Methods The objectives of the trial are to assess the acceptability and feasibility of SMART, test trial procedures, explore outcome distributions in intervention and control clusters and calculate the total annual cost of the intervention and unit cost per adolescent. The trial design is a parallel-group, two-arm superiority pilot cRCT with a 1:1 allocation ratio and two cross-sectional census surveys with adolescents aged 12–19, one pre-intervention (baseline) and one post-intervention (endline). The study area is four communities of approximately 1000 population (166 adolescents per community). Each community represents one cluster. SMART comprises twice weekly football, martial arts and dance coaching, open to all adolescents in the community, led by local sports coaches who have received psychosocial training. Sports melas (festivals) and theatre performances will raise community awareness about SMART, mental health and the benefits of sport. Adolescents in control clusters will participate in sport as usual. In baseline and endline surveys, we will measure mental wellbeing, self-esteem, self-efficacy, emotion regulation, social support, depression, anxiety and functional impairment. Using observation checklists, unstructured observation and attendance registers from coaching sessions, and minutes of meetings between coaches and supervisors, we will assess intervention fidelity, exposure and reach. In focus group discussions and interviews with coaches, teachers, caregivers and adolescents, we will explore intervention acceptability and mechanisms of change. Intervention costs will be captured from monthly project accounts, timesheets and discussions with staff members. Discussion Findings will identify elements of the intervention and trial procedures requiring revision prior to a full cRCT to evaluate the effectiveness of SMART. Trial registration ISRCTN, ISRCTN15973986 , registered on 6 September 2022; ClinicalTrials.gov, NCT05394311 , registered 27 May 2022.

Abstract Background Anemia is estimated to cause 115,000 maternal deaths each year. In Nepal, 46% of pregnant women have anemia. As part of an integrated anemia-prevention strategy, family engagement and counseling of pregnant women can increase compliance to iron folic acid tablets, but marginalized women often have lower access to these interventions. We implemented the VALID (Virtual antenatal intervention for improved diet and iron intake) randomized controlled trial to test a family-focused virtual counseling mHealth intervention designed to inclusively increase iron folic acid compliance in rural Nepal; here we report findings from our process evaluation research. Methods We conducted semi structured interviews with 20 pregnant women who had received the intervention, eight husbands, seven mothers-in-laws and four health workers. We did four focus groups discussions with intervention implementers, 39 observations of counseling, and used routine monitoring data in our evaluation. We used inductive and deductive analysis of qualitative data, and descriptive statistics of monitoring data. Results We were able to implement the intervention largely as planned and all participants liked the dialogical counseling approach and use of story-telling to trigger conversation. However, an unreliable and inaccessible mobile network impeded training families about how to use the mobile device, arrange the counseling time, and conduct the counseling. Women were not equally confident using mobile devices, and the need to frequently visit households to troubleshoot negated the virtual nature of the intervention for some. Women’s lack of agency restricted both their ability to speak freely and their mobility, which meant that some women were unable to move to areas with better mobile reception. It was difficult for some women to schedule the counseling, as there were competing demands on their time. Family members were difficult to engage because they were often working outside the home; the small screen made it difficult to interact, and some women were uncomfortable speaking in front of family members. Conclusions It is important to understand gender norms, mobile access, and mobile literacy before implementing an mHealth intervention. The contextual barriers to implementation meant that we were not able to engage family members as much as we had hoped, and we were not able to minimize in-person contact with families. We recommend a flexible approach to mHealth interventions which can be responsive to local context and the situation of participants. Home visits may be more effective for those women who are most marginalized, lack confidence in using a mobile device, and where internet access is poor.

Abstract Background Engaging communities is an important component of multisectoral action to address the growing burden of non-communicable diseases (NCDs) in low- and middle-income countries. We conducted research with non-communicable disease stakeholders in Bangladesh to understand how a community-led intervention which was shown to reduce the incidence of type 2 diabetes in rural Bangladesh could be scaled-up. Methods We purposively sampled any actor who could have an interest in the intervention, or that could affect or be affected by the intervention. We interviewed central level stakeholders from donor agencies, national health policy levels, public, non-governmental, and research sectors to identify scale-up mechanisms. We interviewed community health workers, policy makers, and non-governmental stakeholders, to explore the feasibility and acceptability of implementing the suggested mechanisms. We discussed scale-up options in focus groups with community members who had attended a community-led intervention. We iteratively developed our data collection tools based on our analysis and re-interviewed some participants. We analysed the data deductively using a stakeholder analysis framework, and inductively from codes identified in the data. Results Despite interest in addressing NCDs, there was a lack of a clear community engagement strategy at the government level, and most interventions have been implemented by non-governmental organisations. Many felt the Ministry of Health and Family Welfare should lead on community engagement, and NCD screening and referral has been added to the responsibilities of community health workers and health volunteers. Yet there remains a focus on reproductive health and NCD diagnosis and referral instead of prevention at the community level. There is potential to engage health volunteers in community-led interventions, but their present focus on engaging women for reproductive health does not fit with community needs for NCD prevention. Conclusions Research highlighted the need for a preventative community engagement strategy to address NCDs, and the potential to utilise existing cadres to scale-up community-led interventions. It will be important to work with key stakeholders to address gender issues and ensure flexibility and responsiveness to community concerns. We indicate areas for further implementation research to develop scaled-up models of community-led interventions to address NCDs.

Abstract The “Diabetes: Community-led Awareness, Response and Evaluation” (D:Clare) trial aims to scale up and replicate an evidence-based participatory learning and action cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. The trial was originally designed as a stepped-wedge cluster randomised controlled trial, with the interventions running from March 2020 to September 2022. Twelve clusters were randomly allocated (1:1) to implement the intervention at months 1 or 12 in two steps, and evaluated through three cross-sectional surveys at months 1, 12 and 24. However, due to the COVID-19 pandemic, we suspended project activities on the 20th of March 2020. As a result of the changed risk landscape and the delays introduced by the COVID-19 pandemic, we changed from the stepped-wedge design to a wait-list parallel arm cluster RCT (cRCT) with baseline data. We had four key reasons for eventually agreeing to change designs: equipoise, temporal bias in exposure and outcomes, loss of power and time and funding considerations. Trial registration ISRCTN42219712 . Registered on 31 October 2019.

IntroductionIntersecting vulnerabilities of disability, low socio-economic status, marginalization, and age indicate that adolescents with disabilities in low-and middle-income countries were uniquely affected by the COVID-19 pandemic. Yet, there has been limited research about their experience. We conducted participatory research with adolescents with disabilities in rural, hilly Nepal to explore their experience of the pandemic and inform understanding about how they can be supported in future pandemics and humanitarian emergencies.MethodsWe used qualitative methods, purposively sampling adolescents with different severe impairments from two rural, hilly areas of Nepal. We collected data through semi-structured interviews with five girls and seven boys between the age of 11 and 17 years old. Interviews used inclusive, participatory, and arts-based methods to engage adolescents, support discussions and enable them to choose what they would like to discuss. We also conducted semi-structured interviews with 11 caregivers.ResultsWe found that adolescents with disabilities and their families experienced social exclusion and social isolation because of COVID-19 mitigation measures, and some experienced social stigma due to misconceptions about transmission of COVID-19 and perceived increased vulnerability of adolescents with disabilities to COVID-19. Adolescents who remained connected with their peers throughout lockdown had a more positive experience of the pandemic than those who were isolated from friends. They became disconnected because they moved away from those they could communicate with, or they had moved to live with relatives who lived in a remote, rural area. We found that caregivers were particularly fearful and anxious about accessing health care if the adolescent they cared for became ill. Caregivers also worried about protecting adolescents from COVID-19 if they themselves got ill, and about the likelihood that the adolescent would be neglected if the caregiver died.ConclusionContextually specific research with adolescents with disabilities to explore their experience of the pandemic is necessary to capture how intersecting vulnerabilities can adversely affect particular groups, such as those with disabilities. The participation of adolescents with disabilities and their caregivers in the development of stigma mitigation initiatives and strategies to meet their needs in future emergencies is necessary to enable an informed and inclusive response.

Abstract Background Anaemia in pregnancy remains prevalent in Nepal and causes severe adverse health outcomes. Methods This non-blinded cluster-randomised controlled trial in the plains of Nepal has two study arms: (1) Control: routine antenatal care (ANC); (2) Home visiting, iron supplementation, Participatory Learning and Action (PLA) groups, plus routine ANC. Participants, including women in 54 non-contiguous clusters (mean 2582; range 1299–4865 population) in Southern Kapilbastu district, are eligible if they consent to menstrual monitoring, are resident, married, aged 13–49 years and able to respond to questions. After 1–2 missed menses and a positive pregnancy test, consenting women

Introduction Despite evidence that iron and folic acid (IFA) supplements can improve anaemia in pregnant women, uptake in Nepal is suboptimal. We hypothesised that providing virtual counselling twice in mid-pregnancy, would increase compliance to IFA tablets during the COVID-19 pandemic compared with antenatal care (ANC alone.Methods and analysis This non-blinded individually randomised controlled trial in the plains of Nepal has two study arms: (1) control: routine ANC; and (2) ‘Virtual’ antenatal counselling plus routine ANC. Pregnant women are eligible to enrol if they are married, aged 13–49 years, able to respond to questions, 12–28 weeks’ gestation, and plan to reside in Nepal for the next 5 weeks. The intervention comprises two virtual counselling sessions facilitated by auxiliary nurse midwives at least 2 weeks apart in mid-pregnancy. Virtual counselling uses a dialogical problem-solving approach with pregnant women and their families. We randomised 150 pregnant women to each arm, stratifying by primigravida/multigravida and IFA consumption at baseline, providing 80% power to detect a 15% absolute difference in primary outcome assuming 67% prevalence in control arm and 10% loss-to-follow-up. Outcomes are measured 49–70 days after enrolment, or up to delivery otherwise. Primary outcome: consumption of IFA on at least 80% of the previous 14 days. Secondary outcomes: dietary diversity, consumption of intervention-promoted foods, practicing ways to enhance bioavailability and knowledge of iron-rich foods. Our mixed-methods process evaluation explores acceptability, fidelity, feasibility, coverage (equity and reach), sustainability and pathways to impact. We estimate costs and cost-effectiveness of the intervention from a provider perspective. Primary analysis is by intention-to-treat, using logistic regression.Ethics and dissemination We obtained ethical approval from Nepal Health Research Council (570/2021) and UCL ethics committee (14301/001). We will disseminate findings in peer-reviewed journal articles and by engaging policymakers in Nepal.Trial registration number ISRCTN17842200.

The COVID-19 pandemic affected access to antenatal care in low and middle-income countries where anaemia in pregnancy is prevalent. We analyse how health workers provided antenatal care and the factors affecting access to antenatal care during the COVID-19 pandemic in Kapilvastu district in the western plains of Nepal. We used qualitative and quantitative methodologies, conducting eight semi-structured interviews with health workers who provided antenatal care during the pandemic, and a questionnaire containing open and closed questions with 52 female community health volunteers. Antenatal care was severely disrupted during the pandemic. Health workers had to find ways to provide care with insufficient personal protective equipment and guidance whilst facing extreme levels of stigmatisation which prevented them from providing outreach services. Pregnant women were fearful or unable to visit health institutions during the pandemic because of COVID-19 control measures. Pre-pandemic and during the pandemic health workers tried to contact pregnant and postpartum women and families over the phone, but this was challenging because of limited access to phones, and required pregnant women to make at least one antenatal care visit to give their phone number. The pandemic prevented new pregnancies from being registered, and therefore the possibilities to provide services over the phone for these pregnancies were limited. To reach the most marginalised during a pandemic or other health emergency, health volunteers and households need to exchange phone numbers, enabling proactive monitoring and care-seeking. Strengthening procurement and coordination between the municipal, provincial, and federal levels of government is needed to ensure adequacy of antenatal supplies, such as iron folic acid tablets, in health emergencies. Community engagement is important to ensure women and families are aware of the need to access antenatal care and iron folic acid, and to address stigmatisation of health workers.

Background The COVID-19 pandemic and other humanitarian emergencies exacerbate pre-existing inequalities faced by people with disabilities. They experience worse access to health, education, and social services, and increased violence in comparison with people without disabilities. Adolescents with disabilities are amongst those most severely affected in these situations. Using participatory research methods with adolescents can be more effective than other methods but may be challenging in such emergency contexts. Objectives We conducted a scoping review to: 1) describe the literature and methods used in peer-reviewed and grey literature on adolescents (aged ten to nineteen) with disabilities’ experience of COVID-19 and other humanitarian emergencies in low- and middle-income countries, and 2) identify research gaps and make recommendations for future research. Methods The review followed a protocol developed using PRISMA guidelines and the Arksey and O’Malley framework. We searched grey and peer-reviewed literature between 2011 and 2021. Results Thirty studies were included. Twelve were peer-reviewed, and of those seven used participatory methods. Humanitarian emergencies had adverse effects on adolescents with disabilities across health, education, livelihoods, social protection, and community participation domains. Surprisingly few studies collected data directly with adolescents with disabilities. Twenty-three studies combined data from non-disabled children, caregivers, and disabled adults which made it challenging to understand adolescents with disabilities’ unique experience. Conclusions Our review highlights both the scarcity of literature and the importance of conducting research with adolescents with disabilities in humanitarian contexts. Despite challenges, our review shows that it has been possible to conduct research with adolescents with disabilities to explore their experiences of humanitarian emergencies, and that these experiences were different from those of non-disabled adolescents. There is a need to disaggregate findings and support the implementation and reporting of rigorous research methods. Capacity development through partnerships between non-governmental organisations and researchers may improve reporting of methods.

Abstract Background Type 2 diabetes mellitus poses a major health challenge worldwide and in low-income countries such as Bangladesh, however little is known about the care-seeking of people with diabetes. We sought to understand the factors that affect care-seeking and diabetes management in rural Bangladesh in order to make recommendations as to how care could be better delivered. Methods Survey data from a community-based random sample of 12,047 adults aged 30 years and above identified 292 individuals with a self-reported prior diagnosis of diabetes. Data on health seeking practices regarding testing, medical advice, medication and use of non-allopathic medicine were gathered from these 292 individuals. Qualitative semi-structured interviews and focus group discussions with people with diabetes and semi-structured interviews with health workers explored care-seeking behaviour, management of diabetes and perceptions on quality of care. We explore quality of care using the WHO model with the following domains: safe, effective, patient-centred, timely, equitable and efficient. Results People with diabetes who are aware of their diabetic status do seek care but access, particularly to specialist diabetes services, is hindered by costs, time, crowded conditions and distance. Locally available services, while more accessible, lack infrastructure and expertise. Women are less likely to be diagnosed with diabetes and attend specialist services. Furthermore costs of care and dissatisfaction with health care providers affect medication adherence. Conclusion People with diabetes often make a trade-off between seeking locally available accessible care and specialised care which is more difficult to access. It is vital that health services respond to the needs of patients by building the capacity of local health providers and consider practical ways of supporting diabetes care. Trial registration ISRCTN41083256 . Registered on 30/03/2016.

Abstract Background An estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context-appropriate interventions to prevent type 2 diabetes mellitus (T2DM), the ‘Diabetes: Community-led Awareness, Response and Evaluation’ (D:Clare) trial will rigorously evaluate the replication and scale-up of a participatory learning and action (PLA) cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. Methods This is a stepped-wedge cluster randomised controlled trial, with integrated process and economic evaluations, conducted from March 2020 to September 2022. The trial will evaluate a community-based four-phase PLA cycle intervention focused on prevention and control of T2DM implemented over 18 months, against a control of usual care. Twelve clusters will be randomly allocated (1:1) to implement the intervention at project month 1 or 12. The intervention will be evaluated through three cross-sectional surveys at months 1, 12 and 24. The trial will be conducted in Alfadanga Upazila, Faridpur district, with an estimated population of 120,000. Clusters are defined as administrative geographical areas, with approximately equal populations. Each of the six unions in Alfadanga will be divided into two clusters, forming 12 clusters in total. Given the risk of inter-cluster contamination, evaluation surveys will exclude villages in border areas. Participants will be randomly sampled, independently for each survey, from a population census conducted in January 2020. The primary outcome is the combined prevalence of intermediate hyperglycaemia and T2DM, measured through fasting and 2-h post-glucose load blood tests. A total of 4680 participants provide 84% power to detect a 30% reduction in the primary outcome, assuming a baseline of 30% and an ICC of 0.07. The analysis will be by intention-to-treat, comparing intervention and control periods across all clusters, adjusting for geographical clustering. Discussion This study will provide further evidence of effectiveness for community-based PLA to prevent T2DM at scale in a rural Bangladesh setting. However, we encountered several challenges in applying the stepped-wedge design to our research context, with particular consideration given to balancing seasonality, timing and number of steps and estimation of partial versus full effect. Trial registration ISRCTN: ISRCTN42219712 . Registered on 31 October 2019

Abstract Background Engaging citizens and communities to make services accountable is vital to achieving health development goals. Community participation in health management committees can increase public accountability of health services. We conducted a cluster randomised controlled trial to test the impact of strengthened health management committees (HMCs) and community mobilisation through women’s groups on institutional deliveries and deliveries by trained health workers in rural Nepal. Methods The study was conducted in all Village Development Committee clusters in the hills district of Makwanpur (population of 420,500). In 21 intervention clusters, we conducted three-day workshops with HMCs to improve their capacity for planning and action and supported female community health volunteers to run women’s groups. These groups met once a month and mobilised communities to address barriers to institutional delivery through participatory learning and action cycles. We compared this intervention with 22 control clusters. Prospective surveillance from October 2010 to the end of September 2012 captured complete data on 13,721 deliveries in intervention and control areas. Analysis was by intention to treat. Results The women’s group intervention was implemented as intended, but we were unable to support HMCs as planned because many did not meet regularly. The activities of community based organisations were systematically targeted at control clusters, which meant that there were no true ‘control’ clusters. 39% (5403) of deliveries were in health institutions and trained health workers attended most of them. There were no differences between trial arms in institutional delivery uptake (1.45, 0.76–2.78) or attendance by trained health workers (OR 1.43, 95% CI 0.74–2.74). Conclusions The absence of a true counterfactual and inadequate coverage of the HMC strengthening intervention impedes our ability to draw conclusions. Further research is needed to test the effectiveness of strengthening public accountability mechanisms on increased utilisation of services at delivery. Trial registration Current Controlled Trials ISRCTN99834806 . Date of registration:28/09/10.

Prevalence of non-communicable diseases (NCDs) is high in rural Bangladesh. Given the complex multi-directional relationships between NCDs, COVID-19 infections and control measures, exploring pandemic impacts in this context is important. We conducted two cross-sectional surveys of adults ≥30-years in rural Faridpur district, Bangladesh, in February to March 2020 (survey 1, pre-COVID-19), and January to March 2021 (survey 2, post-lockdown). A new random sample of participants was taken at each survey. Anthropometric measures included: blood pressure, weight, height, hip and waist circumference and fasting and 2-hour post-glucose load blood glucose. An interviewer-administered questionnaire included: socio-demographics; lifestyle and behavioural risk factors; care seeking; self-rated health, depression and anxiety assessments. Differences in NCDs, diet and exercise were compared between surveys using chi2 tests, logistic and linear regression; sub-group analyses by gender, age and socio-economic tertiles were conducted. We recruited 950 (72.0%) participants in survey 1 and 1392 (87.9%) in survey 2. The percentage of the population with hypertension increased significantly from 34.5% (95% CI: 30.7, 38.5) to 41.5% (95% CI: 38.2, 45.0; p-value = 0.011); the increase was more pronounced in men. Across all measures of self-reported health and mental health, there was a significant improvement between survey 1 and 2. For self-rated health, we observed a 10-point increase (71.3 vs 81.2, p-value = 0.005). Depression reduced from 15.3% (95% CI: 8.4, 26.1) to 6.0% (95% CI: 2.7, 12.6; p-value = 0.044) and generalised anxiety from 17.9% (95% CI: 11.3, 27.3) to 4.0% (95% CI: 2.0, 7.6; p-value

Abstract Background Diabetes is 7th largest cause of death worldwide, and prevalence is increasing rapidly in low-and middle-income countries. There is an urgent need to develop and test interventions to prevent and control diabetes and develop the theory about how such interventions can be effective. We conducted a participatory learning and action (PLA) intervention with community groups in rural Bangladesh which was evaluated through a cluster randomised controlled trial. There was a large reduction in the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the PLA group compared with the control group. We present findings from qualitative process evaluation research to explore how this intervention was effective. Methods We conducted group interviews and focus group discussions using photovoice with purposively sampled group attenders and non-attenders, and intervention implementers. Data were collected before the trial analysis. We used inductive content analysis to generate theory from the data. Results The intervention increased the health literacy of individuals and communities - developing their knowledge, capacity and self-confidence to enact healthy behaviours. Community, household and individual capacity increased through social support and social networks, which then created an enabling community context, further strengthening agency and enabling community action. This increased opportunities for healthy behaviour. Community actions addressed lack of awareness about diabetes, gendered barriers to physical activity and lack of access to blood glucose testing. The interaction between the individual, household, and community contexts amplified change, and yet there was limited engagement with macro level, or ‘state’, barriers to healthy behaviour. Conclusions The participatory approach enabled groups to analyse how context affected their ability to have healthy behaviours and participants engaged with issues as a community in the ways that they felt comfortable. We suggest measuring health literacy and social networks in future interventions and recommend specific capacity strengthening to develop public accountability mechanisms and health systems strengthening to complement community-based interventions. Trial registration Registered at ISRCTN on 30th March 2016 (Retrospectively Registered) Registration number: ISRCTN41083256.

Abstract Introduction There is an urgent need to address the growing type 2 diabetes disease burden. 20–30% of adults in rural areas of Bangladesh have intermediate hyperglycaemia and about 10% have diabetes. We report on the implementation and fidelity of a Participatory Learning and Action (PLA) intervention, evaluated through a three-arm cluster randomised controlled trial which reduced the incidence of diabetes and intermediate hyperglycaemia in rural Bangladesh. PLA interventions have been effective in addressing population level health problems in low income country contexts, and therefore we sought to use this approach to engage communities to identify and address community barriers to prevention and control of type 2 diabetes. Methods We used a mixed methods approach collecting quantitative data through field reports and qualitative data through observations and focus group discussions. Through descriptive analysis, we considered fidelity to the participatory approach and implementation plans. Results One hundred twenty-two groups per month were convened by 16 facilitators and supervised by two coordinators. Groups worked through a four phase PLA cycle of problem identification, planning together, implementation and evaluation to address the risk factors for diabetes – diet, physical activity, smoking and stress. Groups reported a lack of awareness about diabetes prevention and control, the prohibitive cost of care and healthy eating, and gender barriers to exercise for women. Groups set targets to encourage physical activity, kitchen-gardening, cooking with less oil, and reduced tobacco consumption. Anti-tobacco committees operated in 90 groups. One hundred twenty-two groups arranged blood glucose testing and 74 groups organized testing twice. Forty-one women’s groups established funds, and 61 communities committed not to ridicule women exercising. Experienced and committed supervisors enabled fidelity to a participatory methodology. A longer intervention period and capacity building could enable engagement with systems barriers to behaviour change. Conclusion Our complex intervention was implemented as planned and is likely to be valid in similar contexts given the flexibility of the participatory approach to contextually specific barriers to prevention and control of type 2 diabetes. Fidelity to the participatory approach is key to implementing the intervention and effectively addressing type 2 diabetes in a low-income country.

Abstract Background Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. Although there is increasing recognition that qualitative methods can and should be integrated into RCTs, few frameworks and practical guidance highlight which qualitative methods should be integrated and for what purposes. As a result, qualitative methods are often poorly or haphazardly integrated into existing trials, and researchers rely heavily on interviews and focus group discussions. To improve current practice, we propose a framework for innovative qualitative research methods that can help address the challenges of RCTs for complex public health interventions. Methods We used a stepped approach to develop a practical framework for researchers. This consisted of (1) a systematic review of the innovative qualitative methods mentioned in the health literature, (2) in-depth interviews with 23 academics from different methodological backgrounds working on RCTs of public health interventions in 11 different countries, and (3) a framework development and group consensus-building process. Results The findings are presented in accordance with the CONSORT (Consolidated Standards of Reporting Trials) Statement categories for ease of use. We identify the main challenges of RCTs for public health interventions alongside each of the CONSORT categories, and potential innovative qualitative methods that overcome each challenge are listed as part of a Framework for the Integration of Innovative Qualitative Methods into RCTs of Complex Health Interventions. Innovative qualitative methods described in the interviews include rapid ethnographic appraisals, document analysis, diary methods, interactive voice responses and short message service, community mapping, spiral walks, pair interviews and visual participatory analysis. Conclusions The findings of this study point to the usefulness of observational and participatory methods for trials of complex public health interventions, offering a novel contribution to the broader literature about the need for mixed methods approaches. Integrating a diverse toolkit of qualitative methods can enable appropriate adjustments to the intervention or process (or both) of data collection during RCTs, which in turn can create more sustainable and effective interventions. However, such integration will require a cultural shift towards the adoption of method-neutral research approaches, transdisciplinary collaborations, and publishing regimes.

Abstract Background A consensus is developing on interventions to improve newborn survival, but little is known about how to reduce socioeconomic inequalities in newborn mortality in low- and middle-income countries. Participatory learning and action (PLA) through women’s groups can improve newborn survival and home care practices equitably across socioeconomic strata, as shown in cluster randomised controlled trials. We conducted a qualitative study to understand the mechanisms that led to the equitable impact of the PLA approach across socioeconomic strata in four trial sites in India, Nepal, Bangladesh, and Malawi. Methods We conducted 42 focus group discussions (FGDs) with women who had attended groups and women who had not attended, in poor and better-off communities. We also interviewed six better-off women and nine poor women who had delivered babies during the trials and had demonstrated recommended behaviours. We conducted 12 key informant interviews and five FGDs with women’s group facilitators and fieldworkers. Results Women’s groups addressed a knowledge deficit in poor and better-off women. Women were engaged through visual learning and participatory tools, and learned from the facilitator and each other. Facilitators enabled inclusion of all socioeconomic strata, ensuring that strategies were low-cost and that discussions and advice were relevant. Groups provided a social support network that addressed some financial barriers to care and gave women the confidence to promote behaviour change. Information was disseminated through home visits and other strategies. The social process of learning and action, which led to increased knowledge, confidence to act, and acceptability of recommended practices, was key to ensuring behaviour change across social strata. These equitable effects were enabled by the accessibility, relevance, and engaging format of the intervention. Conclusions Participatory learning and action led to increased knowledge, confidence to act, and acceptability of recommended practices. The equitable behavioural effects were facilitated by the accessibility, relevance, and engaging format of the intervention across socioeconomic groups, and by reaching-out to parts of the population usually not accessed. A PLA approach improved health behaviours across socioeconomic strata in rural communities, around issues for which there was a knowledge deficit and where simple changes could be made at home.

Abstract Maternal anaemia prevalence in low‐income countries is unacceptably high. Our research explored the individual‐, family‐ and community‐level factors affecting antenatal care uptake, iron folic acid (IFA) intake and consumption of micronutrient‐rich diets among pregnant women in the plains of Nepal. We discuss how these findings informed the development of a home visit and community mobilisation intervention to reduce anaemia in pregnancy. We used a qualitative methodology informed by the socio‐ecological framework, conducting semi‐structured interviews with recently pregnant women and key informants, and focus group discussions with mothers‐in‐law and fathers. We found that harmful gender norms restricted women's access to nutrient‐rich food, restricted their mobility and access to antenatal care. These norms also restricted fathers' role to that of the provider, as opposed to the caregiver. Pregnant women, mothers‐in‐law and fathers lacked awareness about iron‐rich foods and how to manage the side effects of IFA. Fathers lacked trust in government health facilities affecting access to care and trust in the efficacy of IFA. Our research informed interventions by (1) informing the development of intervention tools and training; (2) informing the intervention focus to engaging mothers‐in‐law and men to enable behaviour change; and (3) demonstrating the need to work in synergy across individual, family and community levels to address power and positionality, gender norms, trust in health services and harmful norms. Participatory groups and home visits will enable the development and implementation of feasible and acceptable strategies to address family and contextual issues generating knowledge and an enabling environment for behaviour change.

Background Forced evictions are common in conflict-affected settings. More than 500 internally displaced persons (IDPs) are evicted daily in Mogadishu. Context specific research is necessary to inform responsive humanitarian interventions and to monitor the effective- ness of these interventions on IDPs health. Objective This study explored the causes of forced evictions and their health impacts among IDPs in southern Somalia. Methods We used a qualitative approach, conducting 20 semi-structured interviews, six key informant interviews and four focus group discussions. We used maximum variation sampling to include a wide range of participants and used the framework approach and Nvivo software to analyse the data. Results In this context, landlords often rented land without proper tenure agreements, resulting in risk of forced evictions. Informal tenure agreements led to fluctuations in rent, and IDPs were evicted because tenancy laws were inadequate and failed to protect their rights. IDP settlements often increased the value of land by clearing scrub, and landlords often sought to profit from this by evicting IDPs at short notice if a buyer was found for the land. The effect of eviction on an already marginalised population was wide ranging, increasing their exposure to violence, loss of assets, sexual assault, disruption of livelihoods, loss of social networks, and family separation. Evicted IDPs reported health issues such as diarrhoea, malaria, pneumonia, measles and skin infections, as well as stress, anxiety, psychological distress and trauma. Conclusion Forced evictions remain one of the biggest challenges for IDPs as they exacerbate existing vulnerabilities. Prioritizing implementation of legal protection for IDP tenure rights is necessary to prevent unlawful evictions of IDPs. Humanitarian agencies should aim to respond more effectively to protect evictees and provide support to prevent poor health outcomes. Further quantitative research is needed to examine the relationship between forced evictions and health outcomes.

Discriminatory practices related to menstruation affect the social, mental and physical wellbeing of girls in many low-and middle-income countries. We conducted mixed methods research in five districts of Nepal to explore how menstruation affected girls’ ability to fully participate in school and community life. We conducted 860 structured interviews, 26 group interviews and 10 focus group discussions with schoolgirls in rural areas,14 semi-structured interviews with girls’ mothers, and 10 interviews with health teachers. Girls in all districts experienced social, material and information barriers to confident menstrual management. Menstrual blood was believed to carry diseases, and girls’ movement was restricted to contain ritual pollution and protect them from illness, spirit possession, and sexual experiences. Taboos prevented girls from worshipping in temples or in their home, and some girls were not allowed to enter the kitchen, or sleep in their home while menstruating. Teachers and parents felt unprepared to answer questions about menstruation and focused on the maintenance of restrictions. Teachers and students were embarrassed discussing menstruation in school and classes were not question-driven or skills-based. Gender disaggregated teaching of menstruation and engagement of health facility staff may have positive effects. Community participatory approaches that engage girls, their families and the wider community are necessary to address harmful cultural practices. Cross-sectoral approaches to provide clean, private, safe spaces for girls and increased availability of preferred materials could enable confident menstrual management.

Abstract Background The prevalence of acute malnutrition is often high in emergency-affected populations and is associated with elevated mortality risk and long-term health consequences. Increasingly, cash transfer programmes (CTP) are used instead of direct food aid as a nutritional intervention, but there is sparse evidence on their nutritional impact. We aim to understand whether CTP reduces acute malnutrition and its known risk factors. Methods/design A non-randomised, cluster-controlled trial will assess the impact of an unconditional cash transfer of US$84 per month for 5 months, a single non-food items kit, and free piped water on the risk of acute malnutrition in children, aged 6–59 months. The study will take place in camps for internally displaced persons (IDP) in peri-urban Mogadishu, Somalia. A cluster will consist of one IDP camp and 10 camps will be allocated to receive the intervention based on vulnerability targeting criteria. The control camps will then be selected from the same geographical area. Needs assessment data indicates small differences in vulnerability between camps. In each trial arm, 120 households will be randomly sampled and two detailed household surveys will be implemented at baseline and 3 months after the initiation of the cash transfer. The survey questionnaire will cover risk factors for malnutrition including household expenditure, assets, food security, diet diversity, coping strategies, morbidity, WASH, and access to health care. A community surveillance system will collect monthly mid-upper arm circumference measurements from all children aged 6–59 months in the study clusters to assess the incidence of acute malnutrition over the duration of the intervention. Process evaluation data will be compiled from routine quantitative programme data and primary qualitative data collected using key informant interviews and focus group discussions. The UK Department for International Development will provide funding for this study. The European Civil Protection and Humanitarian Aid Operations will fund the intervention. Concern Worldwide will implement the intervention as part of their humanitarian programming. Discussion This non-randomised cluster controlled trial will provide needed evidence on the role of unconditional CTP in reducing the risk of acute malnutrition among IDP in this context. Trial registration ISRCTN29521514 . Registered 19 January 2016.

Background: mHealth interventions have huge potential to reach large numbers of people in resource poor settings but have been criticised for lacking theory-driven design and rigorous evaluation. This paper shares the process we developed when developing an awareness raising and behaviour change focused mHealth intervention, through applying behavioural theory to in-depth qualitative research. It addresses an important gap in research regarding the use of theory and formative research to develop an mHealth intervention. Objectives: To develop a theory-driven contextually relevant mHealth intervention aimed at preventing and managing diabetes among the general population in rural Bangladesh. Methods: In-depth formative qualitative research (interviews and focus group discussions) were conducted in rural Faridpur. The data were analysed thematically and enablers and barriers to behaviour change related to lifestyle and the prevention of and management of diabetes were identified. In addition to the COM-B (Capability, Opportunity, Motivation-Behaviour) model of behaviour change we selected the Transtheoretical Domains Framework (TDF) to be applied to the formative research in order to guide the development of the intervention. Results: A six step-process was developed to outline the content of voice messages drawing on in-depth qualitative research and COM-B and TDF models. A table to inform voice messages was developed and acted as a guide to scriptwriters in the production of the messages. Conclusions: In order to respond to the local needs of a community in Bangladesh, a process of formative research, drawing on behavioural theory helped in the development of awareness-raising and behaviour change mHealth messages through helping us to conceptualise and understand behaviour (for example by categorising behaviour into specific domains) and subsequently identify specific behavioural strategies to target the behaviour.

BackgroundSomalia has been affected by conflict since 1991, with children aged Methods and findingsWe implemented a non-randomised cluster trial in internally displaced person (IDP) camps, located in peri-urban Mogadishu, Somalia. Within 10 IDP camps (henceforth clusters) selected using a humanitarian vulnerability assessment, all households were targeted for the CBI. Ten additional clusters located adjacent to the intervention clusters were selected as controls. The CBI comprised a monthly unconditional cash transfer of US$84.00 for 5 months, a once-only distribution of a non-food-items kit, and the provision of piped water free of charge. The cash transfers started in May 2016. Cash recipients were female household representatives. In March and September 2016, from a cohort of randomly selected households in the intervention (n = 111) and control (n = 117) arms (household cohort), we collected household and individual level data from children aged 6-59 months (155 in the intervention and 177 in the control arms) and their mothers/primary carers, to measure known malnutrition risk factors. In addition, between June and November 2016, data to assess acute malnutrition incidence were collected monthly from a cohort of children aged 6-59 months, exhaustively sampled from the intervention (n = 759) and control (n = 1,379) arms (child cohort). Primary outcomes were the mean Child Dietary Diversity Score in the household cohort and the incidence of first episode of acute malnutrition in the child cohort, defined by a mid-upper arm circumference < 12.5 cm and/or oedema. Analyses were by intention-to-treat. For the household cohort we assessed differences-in-differences, for the child cohort we used Cox proportional hazards ratios. In the household cohort, the CBI appeared to increase the Child Dietary Diversity Score by 0.53 (95% CI 0.01; 1.05). In the child cohort, the acute malnutrition incidence rate (cases/100 child-months) was 0.77 (95% CI 0.70; 1.21) and 0.92 (95% CI 0.53; 1.14) in intervention and control arms, respectively. The CBI did not appear to reduce the risk of acute malnutrition: unadjusted hazard ratio 0.83 (95% CI 0.48; 1.42) and hazard ratio adjusted for age and sex 0.94 (95% CI 0.51; 1.74). The CBI appeared to increase the monthly household expenditure by US$29.60 (95% CI 3.51; 55.68), increase the household Food Consumption Score by 14.8 (95% CI 4.83; 24.8), and decrease the Reduced Coping Strategies Index by 11.6 (95% CI 17.5; 5.96). The study limitations were as follows: the study was not randomised, insecurity in the field limited the household cohort sample size and collection of other anthropometric measurements in the child cohort, the humanitarian vulnerability assessment data used to allocate the intervention were not available for analysis, food market data were not available to aid results interpretation, and the malnutrition incidence observed was lower than expected.ConclusionsThe CBI appeared to improve beneficiaries' wealth and food security but did not appear to reduce acute malnutrition risk in IDP camp children. Further studies are needed to assess whether changing this intervention, e.g., including specific nutritious foods or social and behaviour change communication, would improve its nutritional impact.Trial registrationISRCTN Registy ISRCTN29521514.

Undernutrition during pregnancy leads to low birthweight, poor growth and inter-generational undernutrition. We did a non-blinded cluster-randomised controlled trial in the plains districts of Dhanusha and Mahottari, Nepal to assess the impact on birthweight and weight-for-age z-scores among children aged 0-16 months of community-based participatory learning and action (PLA) women's groups, with and without food or cash transfers to pregnant women.We randomly allocated 20 clusters per arm to four arms (average population/cluster = 6150). All consenting married women aged 10-49 years, who had not had tubal ligation and whose husbands had not had vasectomy, were monitored for missed menses. Between 29 Dec 2013 and 28 Feb 2015 we recruited 25,092 pregnant women to surveillance and interventions: PLA alone (n = 5626); PLA plus food (10 kg/month of fortified wheat-soya 'Super Cereal', n = 6884); PLA plus cash (NPR750≈US$7.5/month, n = 7272); control (existing government programmes, n = 5310). 539 PLA groups discussed and implemented strategies to improve low birthweight, nutrition in pregnancy and hand washing. Primary outcomes were birthweight within 72 hours of delivery and weight-for-age z-scores at endline (age 0-16 months). Only children born to permanent residents between 4 June 2014 and 20 June 2015 were eligible for intention to treat analyses (n = 10936), while in-migrating women and children born before interventions had been running for 16 weeks were excluded. Trial status: completed.In PLA plus food/cash arms, 94-97% of pregnant women attended groups and received a mean of four transfers over their pregnancies. In the PLA only arm, 49% of pregnant women attended groups. Due to unrest, the response rate for birthweight was low at 22% (n = 2087), but response rate for endline nutritional and dietary measures exceeded 83% (n = 9242). Compared to the control arm (n = 464), mean birthweight was significantly higher in the PLA plus food arm by 78·0 g (95% CI 13·9, 142·0; n = 626) and not significantly higher in PLA only and PLA plus cash arms by 28·9 g (95% CI -37·7, 95·4; n = 488) and 50·5 g (95% CI -15·0, 116·1; n = 509) respectively. Mean weight-for-age z-scores of children aged 0-16 months (average age 9 months) sampled cross-sectionally at endpoint, were not significantly different from those in the control arm (n = 2091). Differences in weight for-age z-score were as follows: PLA only -0·026 (95% CI -0·117, 0·065; n = 2095); PLA plus cash -0·045 (95% CI -0·133, 0·044; n = 2545); PLA plus food -0·033 (95% CI -0·121, 0·056; n = 2507). Amongst many secondary outcomes tested, compared with control, more institutional deliveries (OR: 1.46 95% CI 1.03, 2.06; n = 2651) and less colostrum discarding (OR:0.71 95% CI 0.54, 0.93; n = 2548) were found in the PLA plus food arm but not in PLA alone or in PLA plus cash arms.Food supplements in pregnancy with PLA women's groups increased birthweight more than PLA plus cash or PLA alone but differences were not sustained. Nutrition interventions throughout the thousand-day period are recommended.ISRCTN75964374.

Women's groups practicing participatory learning and action (PLA) in rural areas have been shown to improve maternal and newborn survival in low-income countries, but the pathways from intervention to impact remain unclear. We assessed the long-term impact of a PLA intervention in rural Nepal on women's agency in the household. In 2014, we conducted a follow-up study to a cluster randomised controlled trial on the impact of PLA women's groups from 2001-2003. Agency was measured using the Relative Autonomy Index (RAI) and its subdomains. Multi-level regression analyses were performed adjusting for baseline socio-demographic characteristics. We additionally adjusted for potential exposure to subsequent PLA groups based on women's pregnancy status and conduct of PLA groups in areas of residence. Sensitivity analyses were performed using two alternative measures of agency. We analysed outcomes for 4030 mothers (66% of the cohort) who survived and were recruited to follow-up at mean age 39.6 years. Across a wide range of model specifications, we found no association between exposure to the original PLA intervention with women's agency in the household approximately 11.5 years later. Subsequent exposure to PLA groups was not associated with greater agency in the household at follow-up, but some specifications found evidence for reduced agency. Household agency may be a prerequisite for actualising the benefits of PLA groups rather than a consequence.

Globally, there is a shortage of health workers in rural areas. Effective health systems depend on having sufficient, accessible health workers with the right skills. In countries like Nepal, highly skilled health workers often prefer to work overseas or in urban centres, and therefore, in the short term, it may be pragmatic to focus on ensuring support and skills development of mid level or paramedical health workers. Information technology has the potential to support these health workers. We describe a pilot intervention undertaken in Gulmi District, whereby all mid level health workers in the district have been provided with a free phone number to call three General Practitioner Doctors (GPs) in the District Hospital. The intervention aims to increase appropriate referral, and increase connectivity between the District centre and peripheral health facilities. We hope that our intervention will provide support to rural health workers, and, if implemented as part of a package of interventions, may increase retention. We present some initial findings from discussions with health workers and analysis of call-log data, and describe our next phase evaluation and possible scale-up. _______________________________________________________________________________________ Keywords: human resources; mobile phone; mhealth; Nepal; retention; rural.

Sepsis accounts for up to 15% of an estimated 3.3 million annual neonatal deaths globally. We used data collected from the control arms of three previously conducted cluster-randomised controlled trials in rural Bangladesh, India, and Nepal to examine the association between clean delivery kit use or clean delivery practices and neonatal mortality among home births.Hierarchical, logistic regression models were used to explore the association between neonatal mortality and clean delivery kit use or clean delivery practices in 19,754 home births, controlling for confounders common to all study sites. We tested the association between kit use and neonatal mortality using a pooled dataset from all three sites and separately for each site. We then examined the association between individual clean delivery practices addressed in the contents of the kit (boiled blade and thread, plastic sheet, gloves, hand washing, and appropriate cord care) and neonatal mortality. Finally, we examined the combined association between mortality and four specific clean delivery practices (boiled blade and thread, hand washing, and plastic sheet). Using the pooled dataset, we found that kit use was associated with a relative reduction in neonatal mortality (adjusted odds ratio 0.52, 95% CI 0.39-0.68). While use of a clean delivery kit was not always accompanied by clean delivery practices, using a plastic sheet during delivery, a boiled blade to cut the cord, a boiled thread to tie the cord, and antiseptic to clean the umbilicus were each significantly associated with relative reductions in mortality, independently of kit use. Each additional clean delivery practice used was associated with a 16% relative reduction in neonatal mortality (odds ratio 0.84, 95% CI 0.77-0.92).The appropriate use of a clean delivery kit or clean delivery practices is associated with relative reductions in neonatal mortality among home births in underserved, rural populations.