Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial.

Background: Leprosy leads to nerve damage and slow-healing ulcers, which are treatable with routine therapy. There has been a recent resurgence of interest in the use of honey for the treatment of different kinds of wounds. Objective: The aim of this study, Honey Experiment on Leprosy Ulcer (HELP), is to evaluate the healing properties of raw, unadulterated African honey in comparison with normal saline dressing for the treatment leprosy ulcers. Methods: This is a multicenter, comparative, prospective, single-blinded, parallel-group, and 1:1 individually randomized controlled trial to be conducted at The Leprosy Referral Hospital, Chanchaga in Minna, Niger State, North Central Nigeria, and St. Benedict Tuberculosis and Leprosy Rehabilitation Hospital in Ogoja, Cross River State, South-South Nigeria. Raw, unadulterated honey will be used in the ulcer dressing of eligible, consenting participants in the intervention group, whereas those in the control group will be treated by dressing with normal saline. The main outcomes will be the proportion of complete healing and the rate of healing up to 84 days after randomization. Follow-up will be conducted 6 months after randomization. We aim to enroll 90-130 participants into the study. Blinded observers will examine photographs of ulcers to determine the outcomes. Results: The recruitment of trial participants began on March 14, 2022, and has been continuing for approximately 24 months. Conclusions: Our study will provide an unbiased estimate of the effect of honey on the healing of neuropathic ulcers.

An evaluation protocol of 'Replicability Model' project for detection and treatment of leprosy and related disability in Chhattisgarh, India.

INTRODUCTION: People affected by leprosy are at increased risk of impairments and deformities from peripheral nerve damage. This mostly occurs if diagnosis and treatment is delayed and contributes to continued transmission within the community. Champa district of Chhattisgarh state in India is an endemic area with the highest national annual case detection and disability rates for leprosy. The Replicability Model is a system strengthening intervention implemented by the Leprosy Mission Trust India in Champa that aims to promote early diagnosis and treatment of leprosy, improve on-going management of the effects of leprosy and improve welfare for the people affected by leprosy. This protocol presents a plan to describe the overall implementation of the Replicability Model and describe the barriers and facilitators encountered in the process. We will also quantify the effect of the program on one of its key aims- early leprosy diagnosis. METHODS: The replicability model will be implemented over four years, and the work described in this protocol will be conducted in the same timeframe. We have two Work Packages (WPs). In WP1, we will conduct a process evaluation. This will include three methods i) observations of replicability model implementation teams' monthly meetings ii) key informant interviews (n = 10) and interviews with stakeholders (n = 30) iii) observations of key actors (n = 15). Our purpose is to describe the implementation process and identify barriers and facilitators to successful implementation. WP2 will be a quantitative study to track existing and new cases of leprosy using routinely collected data. If the intervention is successful, we expect to see an increase in cases (with a higher proportion detected at an early clinical stage) followed by a decrease in total cases. CONCLUSION: This study will enable us to improve and disseminate the Replicability Model by identifying factors that promote success. It will also identify its effectiveness in fulfilling one of its aims: reducing the incidence of leprosy by finding and tracking cases at an earlier stage in the disease.

Investigating the sustainability of self-help programmes in the context of leprosy and the work of leprosy missions in Nigeria, Nepal and India: a qualitative study protocol.

INTRODUCTION: Leprosy occurs among very poor people who may be stigmatised and pushed further to the margins of society. Programmes to improve social integration and stimulate economic development have been implemented to help break the vicious cycle of poverty, reduced quality of life and ulcer recurrence. These involve forming groups of people, with a common concern, to provide mutual support and form saving syndicates-hence the term 'self-help groups' (SHGs). While there is literature on the existence and effectiveness of SHGs during the funded periods, little is known about their sustainability. We aim to explore the extent to which SHG programme activities have continued beyond the funding period and record evidence of sustained benefits. METHODS AND ANALYSIS: In India, Nepal and Nigeria, we identified programmes funded by international non-governmental organisations, primarily aimed at people affected by leprosy. In each case, financial and technical support was allocated for a predetermined period (up to 5 years).We will review documents, including project reports and meeting minutes, and conduct semistructured interviews with people involved in delivery of the SHG programme, potential beneficiaries and people in the wider environment who may have been familiar with the programme. These interviews will gauge participant and community perceptions of the programmes and barriers and facilitators to sustainability. Data will be analysed thematically and compared across four study sites. ETHICS AND DISSEMINATION: Approval was obtained from the University of Birmingham Biomedical and Scientific Research Ethics Committee. Local approval was obtained from: The Leprosy Mission Trust India Ethics Committee; Federal Capital Territory Health Research Ethics Committee in Nigeria and the Health Research Ethics Committee of Niger State Ministry of Health; University of Nigeria Teaching Hospital and the Nepal Health and Research Council. Results will be disseminated via peer-reviewed journals, conference presentations and community engagement events through the leprosy missions.

Perceived quality of care and choice of healthcare provider in informal settlements.

When a person chooses a healthcare provider, they are trading off cost, convenience, and a latent third factor: "perceived quality". In urban areas of lower- and middle-income countries (LMICs), including slums, individuals have a wide range of choice in healthcare provider, and we hypothesised that people do not choose the nearest and cheapest provider. This would mean that people are willing to incur additional cost to visit a provider they would perceive to be offering better healthcare. In this article, we aim to develop a method towards quantifying this notion of "perceived quality" by using a generalised access cost calculation to combine monetary and time costs relating to a visit, and then using this calculated access cost to observe facilities that have been bypassed. The data to support this analysis comes from detailed survey data in four slums, where residents were questioned on their interactions with healthcare services, and providers were surveyed by our team. We find that people tend to bypass more informal local services to access more formal providers, especially public hospitals. This implies that public hospitals, which tend to incur higher access costs, have the highest perceived quality (i.e., people are more willing to trade cost and convenience to visit these services). Our findings therefore provide evidence that can support the 'crowding out' hypothesis first suggested in a 2016 Lancet Series on healthcare provision in LMICs.

Burn Admissions Across Low- and Middle-income Countries: A Repeated Cross-sectional Survey.

Burn injuries have decreased markedly in high-income countries while the incidence of burns remains high in Low- and Middle-Income Countries (LMICs) where more than 90% of burns are thought to occur. However, the cause of burns in LMIC is poorly documented. The aim was to document the causes of severe burns and the changes over time. A cross-sectional survey was completed for 2014 and 2019 in eight burn centers across Africa, Asia, and Latin America: Cairo, Nairobi, Ibadan, Johannesburg, Dhaka, Kathmandu, Sao Paulo, and Guadalajara. The information summarised included demographics of burn patients, location, cause, and outcomes of burns. In total, 15,344 patients were admitted across all centers, 37% of burns were women and 36% of burns were children. Burns occurred mostly in household settings (43-79%). In Dhaka and Kathmandu, occupational burns were also common (32 and 43%, respectively). Hot liquid and flame burns were most common while electric burns were also common in Dhaka and Sao Paulo. The type of flame burns varies by center and year, in Dhaka, 77% resulted from solid fuel in 2014 while 74% of burns resulted from Liquefied Petroleum Gas in 2019. In Nairobi, a large proportion (32%) of burns were intentional self-harm or assault. The average length of stay in hospitals decreased from 2014 to 2019. The percentage of deaths ranged from 5% to 24%. Our data provide important information on the causes of severe burns which can provide guidance in how to approach the development of burn injury prevention programs in LMIC.

Global prevalence and trends in hypertension and type 2 diabetes mellitus among slum residents: a systematic review and meta-analysis.

OBJECTIVE: First, to obtain regional estimates of prevalence of hypertension and type 2 diabetes in urban slums; and second, to compare these with those in urban and rural areas. DESIGN: Systematic review and meta-analysis. ELIGIBILITY CRITERIA: Studies that reported hypertension prevalence using the definition of blood pressure ≥140/90 mm Hg and/or prevalence of type 2 diabetes. INFORMATION SOURCES: Ovid MEDLINE, Cochrane CENTRAL and EMBASE from inception to December 2020. RISK OF BIAS: Two authors extracted relevant data and assessed risk of bias independently using the Strengthening the Reporting of Observational Studies in Epidemiology guideline. SYNTHESIS OF RESULTS: We used random-effects meta-analyses to pool prevalence estimates. We examined time trends in the prevalence estimates using meta-regression regression models with the prevalence estimates as the outcome variable and the calendar year of the publication as the predictor. RESULTS: A total of 62 studies involving 108 110 participants met the inclusion criteria. Prevalence of hypertension and type 2 diabetes in slum populations ranged from 4.2% to 52.5% and 0.9% to 25.0%, respectively. In six studies presenting comparator data, all from the Indian subcontinent, slum residents were 35% more likely to be hypertensive than those living in comparator rural areas and 30% less likely to be hypertensive than those from comparator non-slum urban areas. LIMITATIONS OF EVIDENCE: Of the included studies, only few studies from India compared the slum prevalence estimates with those living in non-slum urban and rural areas; this limits the generalisability of the finding. INTERPRETATION: The burden of hypertension and type 2 diabetes varied widely between countries and regions and, to some degree, also within countries. PROSPERO REGISTRATION NUMBER: CRD42017077381.

An individual randomised efficacy trial of autologous blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in leprosy in Nepal: the TABLE trial protocol.

BACKGROUND: Leprosy is curable with multidrug therapy and treatment in the early stages can prevent disability. However, local nerve damage can lead to injury and consequently recurring and disfiguring ulcers. The aim of this study is to evaluate the treatment of leprosy ulcers using an autologous blood product; leukocyte and platelet-rich fibrin (L-PRF) to promote healing. METHODS: This is a single-centre study in the Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal. Consenting patients (n=130) will be individually randomised in a single-blinded, controlled trial. Participants will be 18 years of age or older, admitted to the hospital with a clean, dry and infection-free chronic foot ulcer between 2 and 20 cm2 in size. If the ulcer is infected, it will be treated before enrolment into the study. The intervention involves the application of leukocyte and platelet-rich fibrin (L-PRF) matrix on the ulcer beds during twice-weekly dressing changes. Controls receive usual care in the form of saline dressings only during their twice-weekly dressing changes. Primary outcomes are the rate of healing assessed using standardised photographs by observers blind to allocated treatment, and time to complete re-epithelialization. Follow-up is at 6 months from randomisation. DISCUSSION: This research will provide valuable information on the clinical and cost-effectiveness of L-PRF in the treatment of leprosy ulcers. An additional benefit is the evaluation of the effects of treatment on quality of life for people living with leprosy ulcers. The results will improve our understanding of the scalability of this treatment across low-income countries for ulcer healing in leprosy and potentially other conditions such as diabetic ulcers. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN14933421 . Registered on 16 June 2020.

Evaluation of a self-help intervention to promote the health and wellbeing of marginalised people including those living with leprosy in Nepal: a prospective, observational, cluster-based, cohort study with controls.

BACKGROUND: People affected by leprosy are at increased risk of ulcers from peripheral nerve damage. This in turn can lead to visible impairments, stigmatisation and economic marginalisation. Health care providers suggest that patients should be empowered to self-manage their condition to improve outcomes and reduce reliance on services. Self-care involves carrying out personal care tasks with the aim of preventing disabilities or preventing further deterioration. Self-help, on the other hand, addresses the wider psychological, social and economic implications of leprosy and incorporates, for example, skills training and microfinance schemes. The aim of this study, known as SHERPA (Self-Help Evaluation for lepRosy and other conditions in NePAl) is to evaluate a service intervention called Integrated Mobilization of People for Active Community Transformation (IMPACT) designed to encourage both self-care and self-help in marginalised people including those affected by leprosy. METHODS: A mixed-method evaluation study in Province 5, Nepal comprising two parts. First, a prospective, cluster-based, non-randomised controlled study to evaluate the effectiveness of self-help groups on ulcer metrics (people affected by leprosy only) and on four generic outcome measures (all participants) - generic health status, wellbeing, social integration and household economic performance. Second, a qualitative study to examine the implementation and fidelity of the intervention. IMPACT: This research will provide information on the effectiveness of combined self-help and self-care groups, on quality of life, social integration and economic wellbeing for people living with leprosy, disability or who are socially and economically marginalised in low- and middle- income countries.

Comparing the use of direct observation, standardized patients and exit interviews in low- and middle-income countries: a systematic review of methods of assessing quality of primary care.

Clinical records in primary healthcare settings in low- and middle-income countries (LMIC) are often lacking or of too poor quality to accurately assess what happens during the patient consultation. We examined the most common methods for assessing healthcare workers' clinical behaviour: direct observation, standardized patients and patient/healthcare worker exit interview. The comparative feasibility, acceptability, reliability, validity and practicalities of using these methods in this setting are unclear. We systematically review and synthesize the evidence to compare and contrast the advantages and disadvantages of each method. We include studies in LMICs where methods have been directly compared and systematic and narrative reviews of each method. We searched several electronic databases and focused on real-life (not educational) primary healthcare encounters. The most recent update to the search for direct comparison studies was November 2019. We updated the search for systematic and narrative reviews on the standardized patient method in March 2020 and expanded it to all methods. Search strategies combined indexed terms and keywords. We searched reference lists of eligible articles and sourced additional references from relevant review articles. Titles and abstracts were independently screened by two reviewers and discrepancies resolved through discussion. Data were iteratively coded according to pre-defined categories and synthesized. We included 12 direct comparison studies and eight systematic and narrative reviews. We found that no method was clearly superior to the others-each has pros and cons and may assess different aspects of quality of care provision by healthcare workers. All methods require careful preparation, though the exact domain of quality assessed and ethics and selection and training of personnel are nuanced and the methods were subject to different biases. The differential strengths suggest that individual methods should be used strategically based on the research question or in combination for comprehensive global assessments of quality.

Impact of the societal response to COVID-19 on access to healthcare for non-COVID-19 health issues in slum communities of Bangladesh, Kenya, Nigeria and Pakistan: results of pre-COVID and COVID-19 lockdown stakeholder engagements.

INTRODUCTION: With COVID-19, there is urgency for policymakers to understand and respond to the health needs of slum communities. Lockdowns for pandemic control have health, social and economic consequences. We consider access to healthcare before and during COVID-19 with those working and living in slum communities. METHODS: In seven slums in Bangladesh, Kenya, Nigeria and Pakistan, we explored stakeholder perspectives and experiences of healthcare access for non-COVID-19 conditions in two periods: pre-COVID-19 and during COVID-19 lockdowns. RESULTS: Between March 2018 and May 2020, we engaged with 860 community leaders, residents, health workers and local authority representatives. Perceived common illnesses in all sites included respiratory, gastric, waterborne and mosquitoborne illnesses and hypertension. Pre-COVID, stakeholders described various preventive, diagnostic and treatment services, including well-used antenatal and immunisation programmes and some screening for hypertension, tuberculosis, HIV and vectorborne disease. In all sites, pharmacists and patent medicine vendors were key providers of treatment and advice for minor illnesses. Mental health services and those addressing gender-based violence were perceived to be limited or unavailable. With COVID-19, a reduction in access to healthcare services was reported in all sites, including preventive services. Cost of healthcare increased while household income reduced. Residents had difficulty reaching healthcare facilities. Fear of being diagnosed with COVID-19 discouraged healthcare seeking. Alleviators included provision of healthcare by phone, pharmacists/drug vendors extending credit and residents receiving philanthropic or government support; these were inconsistent and inadequate. CONCLUSION: Slum residents' ability to seek healthcare for non-COVID-19 conditions has been reduced during lockdowns. To encourage healthcare seeking, clear communication is needed about what is available and whether infection control is in place. Policymakers need to ensure that costs do not escalate and unfairly disadvantage slum communities. Remote consulting to reduce face-to-face contact and provision of mental health and gender-based violence services should be considered.

Mobile consulting (mConsulting) and its potential for providing access to quality healthcare for populations living in low-resource settings of low- and middle-income countries.

OBJECTIVE: The poorest populations of the world lack access to quality healthcare. We defined the key components of consulting via mobile technology (mConsulting), explored whether mConsulting can fill gaps in access to quality healthcare for poor and spatially marginalised populations (specifically rural and slum populations) of low- and middle-income countries, and considered the implications of its take-up. METHODS: We utilised realist methodology. First, we undertook a scoping review of mobile health literature and searched for examples of mConsulting. Second, we formed our programme theories and identified potential benefits and hazards for deployment of mConsulting for poor and spatially marginalised populations. Finally, we tested our programme theories against existing frameworks and identified published evidence on how and why these benefits/hazards are likely to accrue. RESULTS: We identified the components of mConsulting, including their characteristics and range. We discuss the implications of mConsulting for poor and spatially marginalised populations in terms of competent care, user experience, cost, workforce, technology, and the wider health system. CONCLUSIONS: For the many dimensions of mConsulting, how it is structured and deployed will make a difference to the benefits and hazards of its use. There is a lack of evidence of the impact of mConsulting in populations that are poor and spatially marginalised, as most research on mConsulting has been undertaken where quality healthcare exists. We suggest that mConsulting could improve access to quality healthcare for these populations and, with attention to how it is deployed, potential hazards for the populations and wider health system could be mitigated.

Because space matters: conceptual framework to help distinguish slum from non-slum urban areas.

Despite an estimated one billion people around the world living in slums, most surveys of health and well-being do not distinguish between slum and non-slum urban residents. Identifying people who live in slums is important for research purposes and also to enable policymakers, programme managers, donors and non-governmental organisations to better target investments and services to areas of greatest deprivation. However, there is no consensus on what a slum is let alone how slums can be distinguished from non-slum urban precincts. Nor has attention been given to a more fine-grained classification of urban spaces that might go beyond a simple slum/non-slum dichotomy. The purpose of this paper is to provide a conceptual framework to help tackle the related issues of slum definition and classification of the urban landscape. We discuss:The concept of space as an epidemiological variable that results in 'neighbourhood effects'.The problems of slum area definition when there is no 'gold standard'.A long-list of variables from which a selection must be made in defining or classifying urban slum spaces.Methods to combine any set of identified variables in an operational slum area definition.Two basic approaches to spatial slum area definitions-top-down (starting with a predefined area which is then classified according to features present in that area) and bottom-up (defining the areal unit based on its features).Different requirements of a slum area definition according to its intended use.Implications for research and future development.

Formative evaluation of a training intervention for community health workers in South Africa: A before and after study.

BACKGROUND: Community Health Workers (CHWs) have a crucial role in improving health in their communities and their role is being expanded in many parts of the world. However, the effectiveness of CHWs is limited by poor training and the education of CHWs has received little scientific attention. METHODS: Our study was carried out in two districts of KwaZulu-Natal, South Africa. We developed and piloted an inexpensive (two day) training intervention covering national government priorities: HIV/AIDS, sexually transmitted disease and Tuberculosis; and Women's Sexual and Reproductive Health and Rights. Sixty-four CHWs consented to participate in the main study which measured knowledge gains using a modified Solomon design of four different testing schedules to distinguish between the effects of the intervention, testing and any interaction between intervention and testing. We also measured confidence, satisfaction and costs. RESULTS: Following the training intervention, improvements in knowledge scores were seen across topics and across districts. These changes in knowledge were statistically significant (p<0.001) and of large magnitude (over 45 percentage points or four standard deviations). However, the CHWs assigned to the test-test-train schedule in one district showed high gains in knowledge prior to receiving the training. All CHWs reported high levels of satisfaction with the training and marked improvements in their confidence in advising clients. The training cost around US$48 per CHW per day and has the potential to be cost-effective if the large gains in knowledge are translated into improved field-based performance and thus health outcomes. CONCLUSION: Training CHWs can result in large improvements in knowledge with a short intervention. However, improvements seen in other studies could be due to test 'reactivity'. Further work is needed to measure the generalisability of our results, retention of knowledge and the extent to which improved knowledge is translated into improved practice.

Improving the health and welfare of people who live in slums.

In the first paper in this Series we assessed theoretical and empirical evidence and concluded that the health of people living in slums is a function not only of poverty but of intimately shared physical and social environments. In this paper we extend the theory of so-called neighbourhood effects. Slums offer high returns on investment because beneficial effects are shared across many people in densely populated neighbourhoods. Neighbourhood effects also help explain how and why the benefits of interventions vary between slum and non-slum spaces and between slums. We build on this spatial concept of slums to argue that, in all low-income and-middle-income countries, census tracts should henceforth be designated slum or non-slum both to inform local policy and as the basis for research surveys that build on censuses. We argue that slum health should be promoted as a topic of enquiry alongside poverty and health.

The history, geography, and sociology of slums and the health problems of people who live in slums.

Massive slums have become major features of cities in many low-income and middle-income countries. Here, in the first in a Series of two papers, we discuss why slums are unhealthy places with especially high risks of infection and injury. We show that children are especially vulnerable, and that the combination of malnutrition and recurrent diarrhoea leads to stunted growth and longer-term effects on cognitive development. We find that the scientific literature on slum health is underdeveloped in comparison to urban health, and poverty and health. This shortcoming is important because health is affected by factors arising from the shared physical and social environment, which have effects beyond those of poverty alone. In the second paper we will consider what can be done to improve health and make recommendations for the development of slum health as a field of study.