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.

Participatory Development and Assessment of Audio-Delivered Interventions and Written Material and Their Impact on the Perception, Knowledge, and Attitudes Toward Leprosy in Nigeria: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: In Nigeria, similar to many leprosy-endemic countries, leprosy is highly stigmatized. High levels of stigma among community members as well as internalized stigma among persons affected by leprosy often result in negative psychosocial consequences for those affected. To break this vicious cycle, it is important to conduct context-specific behavioral change activities. Although written material has been successful in improving knowledge and perception, it is not suitable for populations with low educational levels. Audio-delivered interventions are likely to be more suitable for people who are illiterate. This study proposes to assess the impact of an audio-delivered intervention on the perception (knowledge, attitudes, and beliefs) of community members with regard to leprosy in Nigeria. OBJECTIVE: This study aims to assess the impact of audio-delivered and written health education on the perception of leprosy. Specific objectives are to (1) investigate the perception (local beliefs, knowledge, and attitudes) of community members toward leprosy and persons affected by leprosy; (2) investigate whether there is a difference in impact on perception between participants who have received audio-delivered health education and those who have received written health education, with specific reference to gender differences and differences between rural and urban areas; and (3) assess the impact of the participatory development of the audio-delivered and written interventions on empowerment and internalized stigma of persons affected by leprosy who developed the interventions. Additionally, we will translate and cross-culturally validate 4 study instruments measuring outcomes in 2 major Nigerian languages. METHODS: We will use a mixed methods, cross-sectional study design for the intervention development and a 3-arm cluster randomized controlled trial for its implementation and evaluation, comprising (1) baseline assessments of knowledge, attitudes, perceptions, and fears of community members, to develop the audio-delivered content and written material, and the self-esteem and internalized stigma of persons affected by leprosy; and (2) participatory development of the audio-delivered content and written material by persons affected by leprosy and the pilot and implementation of the interventions. This will be done among different groups (selected using cluster randomization) that will be compared (control group, audio-intervention group, and written material group) to evaluate the intervention and the impact of developing the intervention on the persons affected. RESULTS: This study was funded in June 2022, and community member participant recruitment started in January 2023. Baseline data collection was completed by May 2023 (n=811). Participatory cocreation of the audio and written health education content began in July 2023, and the materials are currently under development. Study results are expected in September 2024. CONCLUSIONS: Study findings will contribute to developing evidence-based, context-specific behavioral change interventions, which are critical to addressing stigma in many leprosy-endemic communities where leprosy is highly stigmatized, and contribute toward global triple zero leprosy efforts. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR202205543939385; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23667. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53130.

The cross-cultural validation of the Beach Center Family Quality of Life Scale among persons affected by leprosy or podoconiosis in Northwest Ethiopia.

BACKGROUND: The Beach Center Family Quality of Life Scale has been developed and validated in different languages in different countries. However, this scale has not been validated in the Ethiopian Amharic language context. Therefore, this study aimed to investigate the cross-cultural validity of the Beach Center Family Quality of Life Scale, among Ethiopian families of persons affected by leprosy and podoconiosis. METHODOLOGY: We explored the semantic equivalence, internal consistency, reproducibility, floor and ceiling effects, and interpretability of the Beach Center Family Quality of Life Scale in Amharic. A cross-sectional study was conducted after the translation and back-translation of the instrument. A total of 302 adult persons affected by leprosy or podoconiosis was asked about their level of satisfaction with their family life, using the Beach Center Family Quality of Life Scale. In addition, 50 participants were re-interviewed two weeks after the initial assessment to test the reproducibility of the scale. Participants were recruited in the East Gojjam zone of Northwest Ethiopia. RESULTS: The findings of this study showed that the Beach Center Family Quality of Life Scale had high internal consistency (Cronbach's alpha of 0.913) and reproducibility (intra-class correlation coefficient of 0.857). The standard error of measurement was 3.01, which is 2.4% of the total score range. The smallest detectable change was 8.34. Confirmatory factor analysis showed adequate factor loadings and model fit indices like the original scale. The composite reliability and average variance extracted from the scale were acceptable. No floor and ceiling effects were found. CONCLUSIONS: Our findings indicate that the Amharic version of the Beach Center Family Quality of Life Scale has adequate cultural validity to assess the family quality of life in Ethiopian families of persons affected by leprosy and podoconiosis.

Meaningful Engagement of Persons Affected by Leprosy in Research: An Exploration of Its Interpretation, Barriers, and Opportunities.

Despite the growing interest in public and patient involvement in research, best practices in the leprosy context have yet to be explored. This mixed-method study aimed to explore the interpretation, barriers and opportunities of meaningful engagement of persons affected by leprosy in research through: (i) an exploratory phase consisting of key informant interviews with experts in public and patient involvement (n = 2) and experts-by-experience (i.e., persons affected by leprosy; n = 4), and (ii) an in-depth phase among leprosy researchers consisting of an online survey (n = 21) and key informant interviews (n = 7). Qualitative data were thematically analyzed. Basic descriptive statistics were used to summarize the survey data. Key informant interviewees unanimously agreed to the importance of engagement in research. Survey results indicated that the level of engagement differed across research stages. Identified barriers included a lack of skills for or awareness of engagement among both experts-by-experience and researchers, stigma and limited time and resources. Opportunities included capacity strengthening, creating a shared understanding, building rapport, and establishing a safe environment. In conclusion, this exploratory study emphasized the importance of engagement of experts-by-experience in leprosy research and identified ways forward that include, but are not limited to, the acknowledgement of its value and creating a shared understanding.

Changing perception and improving knowledge of leprosy: An intervention study in Uttar Pradesh, India.

INTRODUCTION: Since ancient times leprosy has had a negative perception, resulting in stigmatization. To improve the lives of persons affected by leprosy, these negative perceptions need to change. The aim of this study is to evaluate interventions to change perceptions and improve knowledge of leprosy. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a pre-post intervention study in Fatehpur and Chandauli districts, Uttar Pradesh, India. Based on six steps of quality intervention development (6SQuID) two interventions were designed: (1) posters that provided information about leprosy and challenged misconceptions, and (2) meetings with persons affected by leprosy, community members and influential people in the community. The effect of the interventions was evaluated in a mixed-methods design; in-depth interviews, focus group discussions, and questionnaires containing a knowledge measure (KAP), two perception measures (EMIC-CSS, SDS) and an intervention evaluation tool. 1067 participants were included in Survey 1 and 843 in Survey 2. The interventions were effective in increasing knowledge of all participant groups, and in changing community and personal attitudes of close contacts and community members (changes of 19%, 24% and 13% on the maximum KAP, EMIC-CSS and SDS scores respectively, p<0.05). In Survey 1, 13% of participants had adequate knowledge of leprosy versus 53% in Survey 2. Responses showed stigmatizing community attitudes in 86% (Survey 1) and 61% (Survey 2) of participants and negative personal attitudes in 37% (Survey 1) and 19% (Survey 2). The number of posters seen was associated with KAP, EMIC-CSS and SDS scores in Survey 2 (p<0.001). In addition, during eight post-intervention focus group discussions and 48 interviews many participants indicated that the perception of leprosy in the community had changed. CONCLUSIONS/SIGNIFICANCE: Contextualized posters and community meetings were effective in changing the perception of leprosy and in increasing leprosy-related knowledge. We recommend studying the long-term effect of the interventions, also on behavior.

Strengthening individual and family resilience against leprosy-related discrimination: A pilot intervention study.

BACKGROUND: Leprosy and leprosy-related stigma can have a major impact on psychosocial wellbeing of persons affected and their family members. Resilience is a process that incorporates many of the core skills and abilities which may enable people to address stigma and discrimination. The current study aimed to develop and pilot an intervention to strengthen individual and family resilience against leprosy-related discrimination. METHODOLOGY: We used a quasi-experimental, before-after study design with a mixed methods approach. The 10-week family-based intervention was designed to strengthen the resilience of individuals and families by enhancing their protective abilities and capacity to overcome adversity. The study was conducted in two sites, urban areas in Telangana state, and in rural areas in Odisha state, India. Persons affected and their family members were included using purposive sampling. Two questionnaires were used pre-and post-intervention: the Connor-Davidson Resilience Scale (CD-RISC, maximum score 100, with high scores reflecting greater resilience) and the WHOQOL-BREF (maximum score of 130, with higher scores reflecting higher quality of life). In addition, semi-structured interviews were conducted post-intervention. Data were collected at baseline, a few weeks after completion of the intervention, and in the Odisha cohort again at six months after completion. Paired t-tests measured differences pre- and post- intervention. Qualitative data were thematically analysed. FINDINGS: Eighty participants across 20 families were included in the study (23 persons affected and 57 family members). We found a significant increase in CD-RISC scores for persons affected and family members from Odisha state (baseline 46.5, first follow-up 77.0, second follow-up 70.0), this improvement was maintained at six-month follow-up. There was no increase in CD-RISC scores post-intervention among participants from Telangana state. WHOQOL-BREF scores were significantly higher at follow-up for persons affected in both states, and for family members in Odisha state. No families dropped out of the study. In the qualitative feedback, all participants described drawing benefit from the programme. Participants especially appreciated the social dimensions of the intervention. CONCLUSION: This pilot study showed that the 10-week family-based intervention to strengthen resilience among persons affected by leprosy and their family members was feasible, and has the potential to improve resilience and quality of life. A large-scale efficacy trial is necessary to determine the effectiveness and long-term sustainability of the intervention.

A family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis in Ethiopia: A proof of concept study.

A key issue for persons with leprosy-, lymphatic filariasis- and podoconiosis-related disabilities is the life-long need to practice self-management routines. This is difficult to sustain without regular encouragement and support of others. Family-based support may be a sustainable and feasible strategy to practice self-management routines. This proof of concept study aimed to develop and pilot a family-based intervention to support prevention and self-management of leprosy, lymphatic filariasis and podoconiosis-related disabilities in Ethiopia. We used a quasi-experimental pre/post intervention study design with a mixed methods approach. The study population included persons affected by leprosy, lymphatic filariasis and podoconiosis and their family members. All persons affected had visible impairments due to their condition. We collected physical impairment outcomes, data on activity limitations, stigma and family quality of life using the SALSA scale (range 0-80), the SARI stigma scale (range 0-63) and the Beach Centre Family Quality of Life scale (range 0-125) and conducted in-depth interviews and focus group discussions. Quantitative data were analysed using paired t-tests, unequal variances t-tests, linear regression and binary logistic regression. Qualitative data were coded using open, inductive coding and content analysis. The family-based intervention consisted of self-management of disabilities, awareness raising and socio-economic empowerment. The intervention was delivered over several monthly group meetings over the course of several months. A total of 275 (100%) persons affected attended at least one session with a family member, and 215 (78%) attended at least three sessions. There was no significant improvement in eye and hand problems after the intervention. However, foot and leg impairments, number of acute attacks, lymphedema and shoe wearing all significantly improved at follow-up. In addition, family quality of life significantly improved from 67.4 at baseline to 89.9 at follow-up for family members and from 76.9 to 84.1 for persons affected (p<0.001). Stigma levels significantly decreased from 24.0 at baseline to 16.7 at follow-up (p<0.001). Activity levels improved, but not significantly. This proof of concept study showed that the family-based intervention had a positive effect on impairments and self-management of disabilities, family quality of life and stigma. We recommend a large-scale efficacy trial, using a randomised controlled trial and validated measurement tools, to determine its effectiveness and long-term sustainability.

Key sources of strength and resilience for persons receiving services for Hansen's disease (leprosy) in Porto Velho, Brazil: What can we learn for service development?

BACKGROUND: Individuals affected by Hansen's disease (leprosy) often experience stigma and discrimination. Greater psychosocial resilience may enable people to deal with such discrimination. This study aimed to explore sources of strength and resilience for individuals affected by Hansen's disease in Brazil. METHODS: We used a cross-sectional study design with a qualitative approach. Semistructured focus groups were conducted. Analysis comprised thematic categorisation of transcripts. RESULTS: Thirty-one participants were included: 23 individuals affected by Hansen's disease and 8 healthcare providers. We found that while a few individuals affected were provided with formal psychological support in the early phases of their treatment, many noted the importance of providing such support at this time. Most participants described relationships with and social support from family members, friends and with others affected by Hansen's disease as their primary source of resilience. A key context for building resilience was through the peer-level sharing and engagement experienced in self-care and support groups. Participants also emphasised the importance of providing appropriate information about Hansen's disease and the importance of beliefs and spirituality. CONCLUSIONS: Hansen's disease services should seek to build resilience in early treatment through counselling and during treatment and beyond by having people affected getting together. Across both settings supporting family and social relationships, providing accurate information and acknowledging spiritual beliefs are important.

An exploration of family quality of life in persons with leprosy-, lymphatic filariasis- and podoconiosis-related disabilities and their family members in Ethiopia.

BACKGROUND: Leprosy, podoconiosis and lymphatic filariasis (LF) may adversely affect the social, economic and psychological well-being of persons affected and their families. The objectives of this study were to assess and compare family quality of life of persons affected and their family members, explore the relationship between family quality of life and perceived stigma and activity limitations and explore what factors influence family quality of life. METHODS: A cross-sectional quantitative study was conducted in the Awi zone in Ethiopia. Persons affected and their family members were selected using purposive sampling. Three questionnaires were used: the Beach Center Family Quality of Life (FQOL) scale (range 25-125, with higher scores denoting higher family quality of life), the SARI Stigma Scale (range 0-63, with higher scores denoting higher levels of stigma) and the Screening of Activity Limitation and Safety Awareness (SALSA) scale (range 0-80, with higher scores denoting more activity limitations). Data analysis consisted of simple descriptive analysis and regression analysis. RESULTS: A total of 95 persons affected and 117 family members were included. The overall mean of the family quality of life score was 71.7. Persons affected had significantly higher mean family quality of life scores than family members on all domains. Female gender, a smaller family size and occupation were associated with lower family quality of life. We found a mean SARI Stigma score of 22.3 and a mean SALSA score of 37.6. There was no association between the FQOL and SARI scores or between the FQOL and SALSA scores. CONCLUSIONS: Family quality of life is an important area to address because neglected tropical diseases often affect the whole family. It is therefore important in order to provide appropriate support for persons affected and their family members. Efforts to improve the quality of life of families in which a family member is affected by leprosy, podoconiosis or LF should give priority to women and families with a smaller family size.

The impact of leprosy, podoconiosis and lymphatic filariasis on family quality of life: A qualitative study in Northwest Ethiopia.

BACKGROUND: Several studies have shown that leprosy, podoconiosis and lymphatic filariasis impact individual quality of life. In contrast, family quality of life has not received as much attention despite evidence that families are also affected. This is especially relevant given the crucial role of the family in most societies around the world. This study looks at the impact of leprosy, podoconiosis and lymphatic filariasis on family quality of life. METHODOLOGY: The study used a cross-sectional design with a qualitative approach. Both semi-structured interviews and focus group discussions were conducted. Participants, persons affected and their family members, were selected by purposive sampling. Data were collected between August and November 2017 in Awi zone, Northwest Ethiopia and analysed by three independent researchers using open, inductive coding and content analysis. RESULTS: A total of 86 participants were included in this study: 56 participants in the in-depth interviews and 30 participants in the focus group discussions. We found that participation restrictions, reduced productivity and marginalisation were common. In addition, discrimination in the communities occurred often, often extending to family members of persons affected. Divorce and difficulties in finding a spouse were common for persons affected and their family members. Many persons affected reported mental health problems. While most people got social and physical support from their families, there were a few exceptions. In particular, persons with younger children seemed to lack social support. Having to provide for their affected family member sometimes caused stress, school dropouts and an additional workload. Financial problems and loss of livelihood were reported by almost all participants. CONCLUSION: This study revealed that leprosy, lymphatic filariasis and podoconiosis have an effect on several dimensions of family quality of life. Many problems reported related to stigma and poverty.

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

BACKGROUND: With the introduction of new interventions to prevent leprosy, such as post-exposure prophylaxis (PEP) given to contacts of leprosy patients, it is necessary to update our understanding of knowledge and perception of leprosy among the populations where these interventions will be introduced, in order to tailor communication optimally to the current situation. This study is a baseline study of the PEP++ project and aimed to assess the knowledge, attitudes and practices regarding leprosy in Fatehpur, India. METHODOLOGY: The study used a community-based cross-sectional design with a mixed-methods approach. We assessed knowledge, attitudes, and practices with the KAP measure, and stigma with the Explanatory Model Interview Catalogue community stigma scale (EMIC-CSS) and the Social Distance Scale (SDS). In addition, semi-structured interviews and focus group discussions were conducted with all participant groups. The quantitative data were analysed using stepwise multivariate regression. The qualitative data were analysed using open, inductive coding and content analysis. FINDINGS: A total of 446 participants were included in the study: 100 persons affected by leprosy, 111 close contacts, 185 community members and 50 health care workers. In addition, 24 in-depth interviews were conducted and 35 people were included in focus group discussions. 12.5% of the participants had adequate knowledge of leprosy, while 22% had poor knowledge. Knowledge on cause (answered correctly by 10% of the participants), mode of transmission (5%) and symptoms of leprosy (16%) was especially poor. The mean EMIC-CSS score was 15.3 (95%CI 14.6-16.0) and mean SDS score 7.2 (95%CI 6.6-7.8). Better knowledge of leprosy was associated with lower levels of social distance towards persons affected by leprosy. CONCLUSION: This study revealed poor knowledge regarding leprosy and high levels of stigma and fear and desire to keep social distance towards persons affected by leprosy. Community education that takes cultural beliefs, knowledge gaps and fears into consideration could improve knowledge, reduce misconceptions and positively influence the perception of leprosy.

The Impact of Leprosy on Marital Relationships and Sexual Health among Married Women in Eastern Nepal.

Background. Leprosy is one of the most stigmatized diseases known today. The stigma surrounding leprosy can be a major burden and affects many dimensions of a person's life, including intimate relationships. We aimed to investigate the experiences of women affected by leprosy regarding marital life and sexuality, comparing these to the experiences of women with other physical disabilities and to those of able-bodied women in South-East Nepal. Methods. This study used a qualitative approach and a cross-sectional, nonrandom survey design. Thirty women underwent in-depth interviews about their marital and sexual relationship by means of a semi-structured interview guide. These thirty women included ten women affected by leprosy, ten women with other physical disabilities, and ten able-bodied women living in South-East Nepal. Results. We found that many women faced violence and abuse in their marriages. However, women affected by leprosy appeared to face more problems with regard to their marital and sexual relationships than women with physical disabilities and able-bodied women. Some of these related to the fear of leprosy. Conclusions. Further research is recommended to investigate the extent of this problem and ways to ameliorate the situation of the affected women. Education and counselling at diagnosis may help prevent many of the problems reported.

Towards a toolkit for cross-neglected tropical disease morbidity and disability assessment.

BACKGROUND: Neglected tropical diseases (NTDs) are a group of often chronic and disabling infectious conditions, closely related to poverty and inequities. While it is estimated that millions of people are affected, accurate and internationally comparable data about NTD-related morbidity and disability are lacking. Therefore we aimed to develop and pilot a toolkit to assess and monitor morbidity and disability across NTDs. METHODS: A cross-sectional, non-random survey design with a mixed methods approach was used. We conducted a literature review on existing tools to assess and monitor disability, followed by a Delphi study with NTD experts to compile a prototype toolkit. A first-phase validation study was conducted in Northeast Brazil among people with Chagas disease, leishmaniasis, leprosy and schistosomiasis. RESULTS: Instruments included were the clinical profile, WHODAS, P-scale, SRQ, WHOQOL-BREF and WHOQOL-DIS. Most questions in the various instruments were readily understood with the exception of the WHOQOL-BREF, where additional explanations and examples were often needed. The respondents were very appreciative of the instruments and found it valuable to have the opportunity to talk about these aspects of their condition. CONCLUSIONS: Our findings support the acceptability and relevance of five of the six instruments tested and the concept of a cross-NTD toolkit.