Target product profiles: leprosy diagnostics.

The World Health Organization (WHO) aims to reduce new leprosy cases by 70% by 2030, necessitating advancements in leprosy diagnostics. Here we discuss the development of two WHO's target product profiles for such diagnostics. These profiles define criteria for product use, design, performance, configuration and distribution, with a focus on accessibility and affordability. The first target product profile outlines requirements for tests to confirm diagnosis of leprosy in individuals with clinical signs and symptoms, to guide multidrug treatment initiation. The second target product profile outlines requirements for tests to detect Mycobacterium leprae or M. lepromatosis infection among asymptomatic contacts of leprosy patients, aiding prophylactic interventions and prevention. Statistical modelling was used to assess sensitivity and specificity requirements for these diagnostic tests. The paper highlights challenges in achieving high specificity, given the varying endemicity of M. leprae, and identifying target analytes with robust performance across leprosy phenotypes. We conclude that diagnostics with appropriate product design and performance characteristics are crucial for early detection and preventive intervention, advocating for the transition from leprosy management to prevention.

L'Organisation mondiale de la Santé (OMS) vise à réduire le nombre de nouveaux cas de lèpre de 70% d'ici 2030, ce qui nécessite un meilleur diagnostic de la maladie. Dans le présent document, nous évoquons le développement de deux profils de produit cible établis par l'OMS à cette fin. Ces profils définissent des critères en matière d'utilisation, de conception, de performances, de configuration et de distribution du produit, en accordant une attention particulière à l'accessibilité et à l'abordabilité. Le premier profil de produit cible décrit les exigences pour les tests servant à confirmer le diagnostic de la lèpre chez les individus qui présentent des signes cliniques et des symptômes, afin d'orienter l'instauration d'un traitement à base de plusieurs médicaments. Le second profil de produit cible décrit les exigences pour les tests servant à détecter une infection à Mycobacterium leprae ou M. lepromatosis parmi les contacts asymptomatiques de patients lépreux, ce qui contribue à l'adoption de mesures prophylactiques et à la prévention. Nous avons eu recours à une modélisation statistique pour évaluer les exigences de sensibilité et de spécificité de ces tests diagnostiques. Cet article met en évidence les obstacles à l'atteinte d'un niveau élevé de spécificité en raison de l'endémicité variable de M. leprae, et à l'identification d'analytes cibles offrant de bons résultats chez les phénotypes lépreux. Nous concluons qu'un diagnostic reposant sur des caractéristiques de performance et de conception appropriées est essentiel pour détecter rapidement la maladie et intervenir en amont, et nous plaidons pour une prévention plutôt qu'une gestion de la lèpre.

La Organización Mundial de la Salud (OMS) pretende reducir los nuevos casos de lepra en un 70% para 2030, lo que requiere avances en el diagnóstico de la lepra. Aquí se analiza el desarrollo de dos perfiles de productos objetivo de la OMS para este tipo de diagnósticos. Estos perfiles definen los criterios de uso, diseño, rendimiento, configuración y distribución de los productos, centrándose en su accesibilidad y asequibilidad. El primer perfil de producto objetivo describe los requisitos de las pruebas para confirmar el diagnóstico de la lepra en personas con signos y síntomas clínicos, con el fin de orientar el inicio del tratamiento con múltiples fármacos. El segundo perfil de producto objetivo describe los requisitos de las pruebas para detectar la infección por Mycobacterium leprae o M. lepromatosis entre los contactos asintomáticos de los pacientes con lepra, para facilitar las intervenciones profilácticas y la prevención. Se utilizaron modelos estadísticos para evaluar los requisitos de sensibilidad y especificidad de estas pruebas diagnósticas. El artículo destaca las dificultades para lograr una alta especificidad, dada la diferente endemicidad de M. leprae, y para identificar analitos diana con un rendimiento sólido en todos los fenotipos de lepra. Concluimos que los diagnósticos con un diseño de producto y unas características de rendimiento adecuados son fundamentales para la detección precoz y la intervención preventiva, lo que favorece la transición del manejo de la lepra a la prevención.

The PEP++ study protocol: a cluster-randomised controlled trial on the effectiveness of an enhanced regimen of post-exposure prophylaxis for close contacts of persons affected by leprosy to prevent disease transmission.

BACKGROUND: Leprosy is an infectious disease with a slow decline in global annual caseload in the past two decades. Active case finding and post-exposure prophylaxis (PEP) with a single dose of rifampicin (SDR) are recommended by the World Health Organization as measures for leprosy elimination. However, more potent PEP regimens are needed to increase the effect in groups highest at risk (i.e., household members and blood relatives, especially of multibacillary patients). The PEP++ trial will assess the effectiveness of an enhanced preventive regimen against leprosy in high-endemic districts in India, Brazil, Bangladesh, and Nepal compared with SDR-PEP. METHODS: The PEP++ study is a cluster-randomised controlled trial in selected districts of India, Brazil, Bangladesh, and Nepal. Sub-districts will be allocated randomly to the intervention and control arms. Leprosy patients detected from 2015 - 22 living in the districts will be approached to list their close contacts for enrolment in the study. All consenting participants will be screened for signs and symptoms of leprosy and tuberculosis (TB). In the intervention arm, eligible contacts receive the enhanced PEP++ regimen with three doses of rifampicin (150 - 600 mg) and clarithromycin (150 - 500 mg) administered at four-weekly intervals, whereas those in the control arm receive SDR-PEP. Follow-up screening for leprosy will be done for each individual two years after the final dose is administered. Cox' proportion hazards analysis and Poisson regression will be used to compare the incidence rate ratios between the intervention and control areas as the primary study outcome. DISCUSSION: Past studies have shown that the level of SDR-PEP effectiveness is not uniform across contexts or in relation to leprosy patients. To address this, a number of recent trials are seeking to strengthen PEP regimens either through the use of new medications or by increasing the dosage of the existing ones. However, few studies focus on the impact of multiple doses of chemoprophylaxis using a combination of antibiotics. The PEP++ trial will investigate effectiveness of both an enhanced regimen and use geospatial analysis for PEP administration in the study communities. TRIAL REGISTRATION: NL7022 on the Dutch Trial Register on April 12, 2018. Protocol version 9.0 updated on 18 August 2022 https://www.onderzoekmetmensen.nl/en/trial/23060.

Out of the silos: identifying cross-cutting features of health-related stigma to advance measurement and intervention.

BACKGROUND: Many health conditions perceived to be contagious, dangerous or incurable, or resulting in clearly visible signs, share a common attribute - an association with stigma and discrimination. While the etiology of stigma may differ between conditions and, sometimes, cultural settings, the manifestations and psychosocial consequences of stigma and discrimination are remarkably similar. However, the vast majority of studies measuring stigma or addressing stigma through interventions employ a disease-specific approach. MAIN BODY: The current paper opposes this siloed approach and advocates a generic concept of 'health-related stigma' in both stigma measurement and stigma interventions. Employing a conceptual model adapted from Weiss, the current paper demonstrates the commonalities among several major stigmatized conditions by examining how several stigma measurement instruments, such as the Social Distance Scale, Explanatory Model Interview Catalogue, Internalized Stigma of Mental Illness, and Berger stigma scale, and stigma reduction interventions, such as information-based approaches, contact with affected persons, (peer) counselling, and skills building and empowerment, were used successfully across a variety of conditions to measure or address stigma. The results demonstrate that 'health-related stigma' is a viable concept with clearly identifiable characteristics that are similar across a variety of stigmatized health conditions in very diverse cultures. CONCLUSION: A more generic approach to the study of health-related stigma opens up important practical opportunities - cross-cutting measurement and intervention tools are resource saving and easier to use for personnel working with multiple conditions, allow for comparison between conditions, and recognize the intersectionality of many types of stigma. Further research is needed to build additional evidence demonstrating the advantages and effectiveness of cross-condition approaches to stigma measurement and interventions.

An enhanced regimen as post-exposure chemoprophylaxis for leprosy: PEP+.

The ongoing transmission of Mycobacterium (M.) leprae reflected in a very slow decline in leprosy incidence, forces us to be innovative and conduct cutting-edge research. Single dose rifampicin (SDR) as post-exposure prophylaxis (PEP) for contacts of leprosy patients, reduces their risk to develop leprosy by 60%. This is a promising new preventive measure that can be integrated into routine leprosy control programmes, as is being demonstrated in the Leprosy Post-Exposure Programme that is currently ongoing in eight countries.The limited (60%) effectiveness of SDR is likely due to the fact that some contacts have a preclinical infection beyond the early stages for which SDR is not sufficient to prevent the development of clinical signs and symptoms of leprosy. An enhanced regimen, more potent against a higher load of leprosy bacteria, would increase the effectiveness of this preventive measure significantly.The Netherlands Leprosy Relief (NLR) is developing a multi-country study aiming to show that breaking the chain of transmission of M. leprae is possible, evidenced by a dramatic reduction in incidence. In this study the assessment of the effectiveness of an enhanced prophylactic regimen for leprosy is an important component. To define the so called PEP++ regimen for this intervention study, NLR convened an Expert Meeting that was attended by clinical leprologists, public health experts, pharmacologists, dermatologists and microbiologists.The Expert Meeting advised on combinations of available drugs, with known efficacy against leprosy, as well as on the duration of the intake, aiming at a risk reduction of 80-90%. To come to a conclusion the Expert Meeting considered the bactericidal, sterilising and bacteriostatic activity of the potential drugs. The criteria used to determine an optimal enhanced regimen were: effectiveness, safety, acceptability, availability, affordability, feasibility and not inducing drug resistance.The Expert Meeting concluded that the enhanced regimen for the PEP++ study should comprise three standard doses of rifampicin 600 mg (weight adjusted when given to children) plus moxifloxacin 400 mg given at four-weekly intervals. For children and for adults with contraindications for moxifloxacin, moxifloxacin should be replaced by clarithromycin 300 mg (weight adjusted).

Cultural validation of a new instrument to measure leprosy-related stigma: the SARI Stigma Scale.

Background: There is a need for comprehensive, valid and reliable instruments to assess leprosy-related stigma. This paper presents the process of the cross-cultural validation of an instrument in Cirebon District, Indonesia initiated by the Stigma Assessment and Reduction of Impact (SARI) project. Methods: The Berger Scale was initially developed to assess HIV/AIDS-related stigma. This study explores the conceptual, item, semantic, operational and measurement equivalence of this scale for leprosy. The process included a qualitative study, translation and back-translation, training of interviewers, a pilot and the main data collection. We aimed for a sample of 154 people affected by leprosy with 60 repeat interviews. They were selected through convenience sampling. Results: The original scale showed acceptable conceptual equivalence, but insufficient item, semantic and operational equivalences. For instance, there were irrelevant HIV-related items and the respondents found it difficult to indicate their level of agreement with the given statements. Major adjustments were necessary, leading to a new version of the scale. The measurement properties of the new version showed good internal consistency (Cronbach's alpha 0·88); no floor or ceiling effects; and a good reliability (intra-class correlation coefficient 0·75).

Impact of socio-economic development, contact and peer counselling on stigma against persons affected by leprosy in Cirebon, Indonesia ­a randomised controlled trial.

Objectives: People affected by leprosy are often stigmatised, but stigma is rarely quantified and the effectiveness of interventions is often not evaluated. The SARI Project aimed to test and evaluate three interventions: counselling (involving peer counsellors), socio-economic development (SED) and contact between community members and affected people. Results: This study used a controlled trial design in which pairs of the stigma-reduction interventions were randomly allocated to sub-districts in Cirebon District,Indonesia. The study sample consisted of one cohort of people affected by leprosy (on treatment or treated) and two independent samples of community members. The latter were selected through purposive sampling. Three scales (e.g. SARI Stigma Scale, Participation scale) were applied among leprosy-affected people and two scales (e.g. Social Distance Scale) were used among community members pre- and post-intervention. Among affected people (n=237), significant differences in reduction of stigma and participation restrictions were found in all intervention areas and an improvement in quality of life in some intervention areas. Social distance and social stigma significantly reduced among community members (n=213 and 375) in the two intervention areas where the contact intervention was implemented. Two of the five instruments indicated changes in the control area, but the changes in the intervention areas were much larger. Conclusion: The SARI Project has demonstrated that a measurable reduction in leprosy-related stigma can be achieved, both at community level and among people affected by leprosy, using reproducible interventions that can be adapted to different settings and target groups.

Comparing the perception of community members towards leprosy and tuberculosis stigmatization.

BACKGROUND: Health professionals at all levels gradually recognise the impact of stigma on case detection and treatment of various health conditions such as leprosy and tuberculosis. These diseases are identified as chronic diseases which are prone to stigmatisation. PURPOSE: To assess the perception of community members towards stigma related to leprosy and tuberculosis, in order to verify and compare the existence of stigma towards these two diseases in the community, and to provide baseline data for the evaluation of future de-stigmatising interventions. METHODS: This study was done in four sub-districts of Chaiyaphum province. Community members were interviewed using the EMIC stigma scale. Frequency was used to identify the percentage of community members who perceived stigma. A T-test was applied to compare the mean EMIC scores of community members between leprosy and tuberculosis. A P-value of < 0.05 was considered indicative of a statistically significant difference or association. RESULTS: It was found that community members perceived that people affected by leprosy or tuberculosis were stigmatised by the community. However, community members perceived more stigma towards leprosy than towards tuberculosis, particularly in terms of shame, embarrassment, and problems in getting married. The difference was highly significant (P = 0.001, paired t-test). CONCLUSION: The community's perceived stigma against people affected by either leprosy or tuberculosis may affect many aspects of their lives. The authors recommend use of strategically targeted de-stigmatising interventions that take local attitudes and perceptions into consideration.

Lay and peer counsellors to reduce leprosy-related stigma--lessons learnt in Cirebon, Indonesia.

OBJECTIVE: Counselling has been identified as a promising strategy to reduce stigma. Lay and peer counsellors have provided counselling in various fields, but this has not yet been studied in the field of leprosy. The Stigma Assessment and Reduction of Impact (SARI) project in Cirebon District, Indonesia took up this endeavour. This paper describes the initial experiences based on the perspectives of the lay and peer counsellors and aims to provide lessons learnt for future initiatives. METHODS: The selection of lay and peer counsellors was based upon pre-defined criteria such as completed junior high school and level of confidence. This study draws on the notes of seven monitoring and evaluation meetings and 21 group discussions the main researcher facilitated with the lay and peer counsellors and the notes written by the lay and peer counsellors on the sessions with their clients. RESULTS: In total, 198 people affected by leprosy were offered counselling by the 11 lay and 12 peer counsellors; 145 accepted this offer. The other 53 either did not need counselling or did not want to participate for example due to worries about disclosure. Effective communication skills such as listening and asking effective questions were important, but also difficult to acquire for the lay and peer counsellors. Sharing personal experiences was highly appreciated by clients and stimulated a deepened reflection. CONCLUSION: Challenges related to concealment and effective skills exist, but some people affected by leprosy and others can become effective counsellors making it at the outset a challenging but nevertheless promising intervention.

Serological responses to prednisolone treatment in leprosy reactions: study of TNF-α, antibodies to phenolic glycolipid-1, lipoarabinomanan, ceramide and S100-B.

BACKGROUND: Corticosteroids have been extensively used in the treatment of immunological reactions and neuritis in leprosy. The present study evaluates the serological response to steroid treatment in leprosy reactions and neuritis. METHODS: Seven serological markers [TNF-α, antibodies to Phenolic glycolipid-1 (PGL-1 IgM and IgG), Lipoarabinomannan (LAM IgG1 and IgG3), C2-Ceramide and S100 B] were analyzed longitudinally in 72 leprosy patients before, during and after the reaction. At the onset of reaction these patients received a standard course of prednisolone. The levels of the above markers were measured by Enzyme linked immunosorbent assay (ELISA) and compared with the individuals own value in the month prior to the reaction and presented as percentage increase. RESULTS: One month before the reaction individuals showed a varying increase in the level of different markers such as TNF-α (53%) and antibodies to Ceramide (53%), followed by to PGL-1 (51%), S100B (50%) and LAM (26%). The increase was significantly associated with clinical finding of nerve pain, tenderness and new nerve function impairment. After one month prednisolone therapy, there was a fall in the levels [TNF-α (60%), C2-Ceramide (54%), S100B (67%), PGL-1(47%) and LAM (52%)] with each marker responding differently to steroid. CONCLUSION: Reactions in leprosy are inflammatory processes wherein a rise in set of serological markers can be detected a month before the clinical onset of reaction, some of which remain elevated during their action and steroid treatment induces a variable fall in the levels, and this forms the basis for a variable individual response to steroid therapy.

Stigma in leprosy: concepts, causes and determinants.

BACKGROUND: Leprosy is a chronic infectious disease that has stigmatised people affected since ancient times until now. This has resulted in difficulties in the lives of those affected. PURPOSE: This literature review was conducted to understand the concept, causes, and determinants of stigma in leprosy. METHOD: Electronic searches were undertaken using PubMed (Medline), CINAHL and PsycInfo databases. The internet was searched through Google Scholar for papers not found in these databases. The main inclusion criteria were papers related to stigma or leprosy written in Thai or English. RESULTS: After searching the databases, 84 papers were identified, 3 were removed because of duplication and parallel publication, and 20 were removed on abstract screening. After reading 61 full papers, 7 were excluded. Finally, 54 were included in this review. It was found that the concept of stigma involves not only characteristics considered undesirable, but also the social context of the individual or group. Reported causes and determinants of stigma related to leprosy are the external manifestations of the disease, cultural and religious beliefs, fear of transmission, association with people considered inferior and public health-related interventions. CONCLUSION: Stigma is a complex phenomenon that has multiple causes, often linked to the cultural context in which it occurs. Despite this, many similarities were found in leprosy-related stigma across countries and cultures, which would facilitate the development of interventions.

How to reduce stigma in leprosy--a systematic literature review.

BACKGROUND: Interventions to reduce leprosy-related stigma reduce the manifestations of stigma that cause so much suffering to individuals and their families. PURPOSE: This systematic review aims to identify interventions that have been used to reduce such stigma and to summarise what is known about their efficacy. METHOD: Electronic searches were undertaken using PubMed (Medline), CINAHL and PsycInfo databases. The internet was searched using Google Scholar for papers not published in these databases. All relevant papers written in Thai or English were included. RESULTS: After reading 55 papers, three duplications and parallel literatures were removed, 18 were removed on abstract screening and nine after reading the full papers; eventually, 25 were included in this review. Interventions with some evidence of effectiveness in terms of stigma reduction comprise the integration of leprosy programmes into general health care; Information Education and Communication (IEC) programmes; and socio-economic rehabilitation. CONCLUSION: More evaluations are needed of the effect of the integration of leprosy programmes into general health services. The design and implementation of IEC interventions need to be preceded by careful study of the target area and population and should be undertaken in combination with other activities.

Cross-cultural validation of two scales to assess mental wellbeing in persons affected by leprosy in Province 1 and 7, Nepal.

To assess mental wellbeing among persons affected by leprosy, this study aimed to validate the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and the Patient Health Questionnaire (PHQ-9, depression tool) in Province 1 and 7, Nepal. Using purposive and convenience sampling, cross-cultural equivalences were assessed through semi-structured interviews with persons affected by leprosy (>18 years). Data were transcribed, translated, analysed and discussed with experts before revising the tools. Psychometric properties of the scales were assessed using an interviewer-administered questionnaire with cases affected by leprosy and controls not affected by leprosy (>18 years). Statistical analysis included internal consistency, construct validity, floor and ceiling effects, and interpretability. The qualitative study included 20 respondents of whom eleven were female. The statements in the original tools were rephrased to questions as participants had difficulties understanding the statements. Six additional changes were made to ensure items were understood well. The quantitative study included 90 cases (46% female) and 50 controls (54% female). The WEMWBS and PHQ-9 had adequate psychometric properties. Cronbach's alphas were 0.85 and 0.76, respectively, indicating good internal consistency, 75% of hypotheses for construct validity were confirmed, no floor and ceiling effects were found, and data to help users interpret results are presented. Our study provides evidence that the adapted versions of the WEMWBS and PHQ-9 have good cultural validity to measure mental wellbeing and depression among persons affected by leprosy in Province 1 and 7, Nepal.

Combining peer-led self-care interventions for people affected by leprosy or diabetes in leprosy-endemic countries. What do health care professionals think?

INTRODUCTION: Leprosy is slowly decreasing in incidence whereas diabetes is a growing health concern. Despite differences in aetiology, both diseases may lead to peripheral neuropathy and subsequent injuries and permanent impairments. There are also indications of similarities in psychosocial consequences. Prevention of Disability (POD) and self-management are often recommended for both diseases. This led to the idea of exploring the feasibility of combined peer-led self-care interventions for people with these disorders. OBJECTIVE: To explore the opinions of health care professionals about combining peer-led self-care interventions for people affected by leprosy or diabetes in leprosy-endemic countries. METHOD: An exploratory study was conducted to collect quantitative data by means of an e-questionnaire and qualitative data through in-depth semi-structured interviews with key informants. RESULTS: In total, 227 respondents answered the e-questionnaire and 22 in-depth interviews were conducted. Resemblances in physical complications between leprosy and diabetes were confirmed by the respondents. Psychosocial similarities included limitations in daily activity and in social participation, but stigma in leprosy was thought to be an important difference. Considerable overlap in current practices was found, mainly in patient education in POD, skin assessment and skin care, and the recommendation to use protective footwear. Knowledge exchange between leprosy and diabetes specialists is limited, although combined interventions were reported. The majority of respondents think that combined interventions are 'possible' (33.3%) or 'possible and promising' (30.8%). Professionals working with both diseases are more positive than those working with leprosy or diabetes only. The greatest barriers for combined interventions are perceived to be leprosy-related stigma, differences in underlying socio-economic status, attitudes of health care professionals and the current organization of health care systems. CONCLUSIONS: Responses indicate perspectives for combined interventions for the prevention of disabilities. For this, it is essential to intensify knowledge exchange between leprosy and diabetes professionals, to overcome barriers and to secure government policy support. Opportunities should be assessed in a situation-specific way.

Impact of basic psychological support on stigma and the mental well-being of people with disabilities due to leprosy and lymphatic filariasis: a postintervention evaluation study.

BACKGROUND: A peer support intervention, called basic psychological support for people affected by neglected tropical diseases (BPS-N), was piloted in India to improve mental well-being and social participation and to reduce stigma among people with disabilities due to leprosy or lymphatic filariasis. Preintervention and postintervention assessments showed improvements in mental well-being and reductions in depression and stigma. This study aimed to further evaluate this intervention at approximately 2 mo after its completion. METHODS: Scales were administered to 62 clients to measure stigma, depression, mental well-being and participation levels. Interviews with 13 clients and six peer supporters were conducted. RESULTS: Stigma scores were significantly reduced at 2 mo postintervention compared with preintervention and postintervention. The improvement in mental well-being detected at immediate postintervention had not changed significantly 2 mo later. Depression levels were higher than at postintervention, but lower than at preintervention levels. No significant differences were found in median participation scores, but the number of clients with moderate and severe participation restrictions reduced significantly from postintervention to 2 mo follow-up. Qualitative results showed that clients received information about their condition and treatment, and that some experienced positive effects on their emotions and self-esteem. CONCLUSIONS: This study provides additional evidence on the proof of concept of BPS-N. CONTEXTE: Une intervention de soutien par les pairs, appelée Soutien psychologique de base pour les personnes atteintes de maladies tropicales négligées (BPS-N), a été pilotée en Inde afin d'améliorer le bien-être mental et la participation sociale, et de réduire la stigmatisation, chez les personnes souffrant d'incapacités dues à la lèpre ou à la filariose lymphatique. Les évaluations avant et après l'intervention ont montré une amélioration du bien-être mental et une réduction de la dépression et de la stigmatisation chez ces personnes. Cette étude avait pour but d'évaluer cette intervention environ 2 mois après son achèvement. MÉTHODES: Des échelles ont été administrées à 62 clients pour mesurer la stigmatisation, la dépression, le bien-être mental et les niveaux de participation. Des entretiens ont été menés avec 13 clients et 6 pairs aidants. RÉSULTATS: Les scores de stigmatisation ont été significativement réduits deux mois après l'intervention par rapport à la situation avant et après l'intervention. L'amélioration du bien-être mental détectée immédiatement après l'intervention n'a pas changé de manière significative deux mois plus tard. Les niveaux de dépression étaient plus élevés qu'après l'intervention, mais plus bas qu'avant l'intervention. Aucune différence significative n'a été constatée dans les scores médians de participation, mais le nombre de clients ayant des restrictions de participation modérées et sévères a diminué de manière significative entre la période post-intervention et les deux mois de suivi. Les résultats qualitatifs ont montré que les clients ont reçu des informations sur leur état et leur traitement, et que certains ont ressenti des effets positifs sur leurs émotions et leur estime de soi. CONCLUSIONS: Cette étude a fourni des preuves supplémentaires de l'efficacité de la BPS-N. INTRODUCCIÓN: Una intervención de apoyo entre iguales, denominada Apoyo Psicológico Básico para personas afectadas por enfermedades tropicales desatendidas (BPS-N), se puso a prueba en la India para mejorar el bienestar mental y la participación social y reducir el estigma entre las personas con discapacidades debidas a la lepra o la filariasis linfática. Las evaluaciones previas y posteriores a la intervención mostraron mejoras en el bienestar mental y reducciones en la depresión y el estigma. El objetivo de este estudio era seguir evaluando esta intervención ∼2 meses después de su finalización. MÉTODOS: Se administraron escalas a 62 clientes para medir el estigma, la depresión, el bienestar mental y los niveles de participación. Se realizaron entrevistas con 13 clientes y 6 compañeros de apoyo. RESULTADOS: Las puntuaciones de estigma se redujeron significativamente a los 2 meses de la intervención, en comparación con antes y después de la misma. La mejora del bienestar mental detectada inmediatamente después de la intervención no había cambiado significativamente 2 meses después. Los niveles de depresión eran más altos que en el postintervención, pero más bajos que en el preintervención. No se encontraron diferencias significativas en las puntuaciones medias de participación, pero el número de clientes con restricciones de participación moderadas y graves se redujo significativamente entre el periodo posterior a la intervención y los 2 meses de seguimiento. Los resultados cualitativos mostraron que los clientes recibieron información sobre su enfermedad y tratamiento, y que algunos experimentaron efectos positivos en sus emociones y autoestima. CONCLUSIONES: Este estudio aportó pruebas adicionales sobre la prueba de concepto de la BPS-N.

Impact of basic psychological support on stigma and mental well-being of people with disabilities due to leprosy and lymphatic filariasis: a proof-of-concept study.

BACKGROUND: People with leprosy and lymphatic filariasis (LF)-related disabilities experience higher levels of poor mental well-being compared with the general community. Mental health services are often not available. This study was conducted to provide proof of concept that basic psychological support for people affected by neglected tropical diseases (BPS-N) can be given by peer supporters to reduce stigma, improve mental well-being and participation among clients. METHODS: The BPS-N approach was tested in a quasi-experimental design using mixed methods. To provide psychological support using the BPS-N, peer supporters were selected and trained. They supported people with leprosy- and LF-related disabilities. Preintervention and postintervention, stigma, mental well-being, depression and participation were measured through standard scales within 4 wk of the intervention; differences were tested using standard tests of significance. RESULTS: After 3 mo of intervention, the mean level of stigma had decreased (30.3 to 24, p<0.001); high mental well-being increased (0% to 13.3%, p<0.001); and moderate to severe depression decreased (88% to 47%, p<0.001). No significant change occurred in participation restrictions (87% to 92%, p=0.497). CONCLUSIONS: Psychological peer support using the BPS-N guideline appears effective in reducing stigma and improving mental well-being and can be operationalised. However, this should be confirmed through a randomised controlled trial. CONTEXTE: Les personnes atteintes de lèpre et de handicaps liés à la filariose lymphatique (FL) souffrent davantage d'un manque de bien-être mental que le reste de la population. Les services de santé mentale ne sont souvent pas disponibles hors des zones urbaines. Cette étude a été menée pour démontrer que le soutien psychologique de base pour les personnes atteintes de MTN (BPS-N) peut être dispensé par des pairs (dans une logique de transfert de tâches) afin de réduire la stigmatisation et d'améliorer le bien-être mental et la participation des clients. MÉTHODES: L'approche du BPS-N a été testée dans le cadre d'un modèle quasi-expérimental utilisant des méthodes mixtes. Pour fournir un soutien psychologique à l'aide du BPS-N, des pairs ont été sélectionnés et formés. Ils sont venus en aide aux personnes atteintes de lèpre et de déficiences liées à la FL. Avant et après l'intervention, les éléments suivants ont été mesurés à l'aide d'échelles standardisées: niveau de stigmatisation, bien-être mental, symptômes dépressifs, et enfin, la participation sociale. Les différences ont été testées à l'aide de tests de signification standardisés. RÉSULTATS: Après 3 mois d'intervention, le niveau moyen de stigmatisation a diminué (30,3 à 24, p<0 001) ; le niveau de bien-être mental a augmenté (0% à 13,3%, p<0 001) et la dépression modérée à sévère a diminué (88% à 47%, p<0 001). Aucun changement significatif n'a été observé en ce qui concerne les restrictions de participation (87% contre 92%, p=0 497). CONCLUSIONS: Le soutien psychologique par les pairs utilisant la ligne directrice BPS-N semble efficace pour réduire la stigmatisation et améliorer le bien-être mental. Toutefois, cette efficacité doit être confirmée par un essai contrôlé randomisé. ANTECEDENTES: Las personas con lepra y discapacidades relacionadas con la filariasis linfática (FL) sufren niveles más altos de malestar mental en comparación con la comunidad en general. Los servicios de salud mental no suelen estar disponibles a nivel periférico. Este estudio se llevó a cabo para proporcionar una prueba de concepto de que el Apoyo Psicológico Básico para personas afectadas por NTDs (BPS-N) puede ser dado por compañeros de apoyo (rotación de tareas) para reducir el estigma, mejorar el bienestar mental y la participación entre los clientes. MÉTODOS: El enfoque BPS-N se probó en un diseño cuasi-experimental utilizando métodos mixtos. Para proporcionar apoyo psicológico con el BPS-N, se seleccionaron y formaron compañeros de apoyo. Apoyaron a personas con lepra y discapacidades relacionadas con la FL. El estigma, el bienestar mental, la depresión y la participación se midieron antes y después de la intervención, mediante escalas estándar; las diferencias se comprobaron mediante pruebas estándar de significación. RESULTADOS: Después de 3 meses de intervención, el nivel medio de estigma disminuyó (30,3 a 24, p<0 001); el bienestar mental alto aumentó (0% a 13,3%, p<0 001) y la depresión moderada a grave disminuyó (88% a 47%, p<0 001). No se produjeron cambios significativos en las restricciones de participación (87% frente a 92%, p=0 497)). CONCLUSIONES: El apoyo psicológico entre iguales, utilizando la guía BPS-N, parece eficaz para reducir el estigma y mejorar el bienestar mental. Sin embargo, esto debe confirmarse mediante un ensayo controlado aleatorizado.

A global call for action to tackle skin-related neglected tropical diseases (skin NTDs) through integration: An ambitious step change.

On 8 June 2022, the World Health Organization (WHO) released pivotal guidance, "Ending the neglect to attain the Sustainable Development Goals: A strategic framework for integrated control and management of skin-related neglected tropical diseases." Skin-related neglected tropical diseases, or skin NTDs, comprise a group of NTDs that produce signs and symptoms on the skin and include at least 9 diseases or disease groups. Moving away from disease-specific approaches, it is anticipated that synergies will be identified and integrated building on this shared feature, where possible, to achieve a greater health impact. This paper intends to draw attention to the prospects created by this scheme. The framework is a key basis for a proposal produced by WHO dedicated to skin NTD integration and describes the practical opportunities for this evolving strategy. It underlines the wider health benefits that will follow, thus working towards Universal Health Coverage and skin health for all.

Empowerment assessment tools in people with disabilities in developing countries. A systematic literature review.

INTRODUCTION: Many initiatives are undertaken to improve the empowerment of people with disabilities in developing countries. However, an overview of adequate measurement tools to evaluate such activities is not available to date. This systematic literature review aims to describe and assess the available tools to measure empowerment in people with disability, suitable for use in developing countries. METHODS: A systematic literature review was conducted. Articles were eligible when they described the development, validation, translation or the use of an instrument measuring empowerment in the context of disability. The instruments were assessed on their psychometric properties and on equivalence properties when they were translated. RESULTS: Thirty-six articles were found in which 17 questionnaires were developed, validated, translated or used. The questionnaires varied in the construct of empowerment, the target population and the psychometric properties. None of the questionnaires were developed or validated in a developing country. The psychometric properties and equivalence criteria were not adequately described and measured in any article. The Empowerment Scale (ES) of Rogers was the most often validated, translated and used questionnaire, receiving the highest number of positive ratings for the psychometric properties. DISCUSSION/CONCLUSION: The ES is the tool most widely used to measure empowerment, but adequate validation in a developing country context is still lacking. Cultural validity should be assessed in any culture before it is used. Further research is needed to develop empowerment instruments for developing countries and to assess the equivalence criteria, including psychometric properties of such questionnaires.

Correction: The role of perceptions and knowledge of leprosy in the elimination of leprosy: A baseline study in Fatehpur district, northern India.

[This corrects the article DOI: 10.1371/journal.pntd.0007302.].

Identifying clusters of leprosy patients in India: A comparison of methods.

BACKGROUND: Preventive interventions with post-exposure prophylaxis (PEP) are needed in leprosy high-endemic areas to interrupt the transmission of Mycobacterium leprae. Program managers intend to use Geographic Information Systems (GIS) to target preventive interventions considering efficient use of public health resources. Statistical GIS analyses are commonly used to identify clusters of disease without accounting for the local context. Therefore, we propose a contextualized spatial approach that includes expert consultation to identify clusters and compare it with a standard statistical approach. METHODOLOGY/PRINCIPAL FINDINGS: We included all leprosy patients registered from 2014 to 2020 at the Health Centers in Fatehpur and Chandauli districts, Uttar Pradesh State, India (n = 3,855). Our contextualized spatial approach included expert consultation determining criteria and definition for the identification of clusters using Density Based Spatial Clustering Algorithm with Noise, followed by creating cluster maps considering natural boundaries and the local context. We compared this approach with the commonly used Anselin Local Moran's I statistic to identify high-risk villages. In the contextualized approach, 374 clusters were identified in Chandauli and 512 in Fatehpur. In total, 75% and 57% of all cases were captured by the identified clusters in Chandauli and Fatehpur, respectively. If 100 individuals per case were targeted for PEP, 33% and 11% of the total cluster population would receive PEP, respectively. In the statistical approach, more clusters in Chandauli and fewer clusters in Fatehpur (508 and 193) and lower proportions of cases in clusters (66% and 43%) were identified, and lower proportions of population targeted for PEP was calculated compared to the contextualized approach (11% and 11%). CONCLUSION: A contextualized spatial approach could identify clusters in high-endemic districts more precisely than a standard statistical approach. Therefore, it can be a useful alternative to detect preventive intervention targets in high-endemic areas.