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.

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.

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.].

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.

Leprosy perceptions and knowledge in endemic districts in India and Indonesia: Differences and commonalities.

BACKGROUND: Understanding how knowledge, attitudes and practices regarding leprosy differ in endemic countries can help us develop targeted educational and behavioural change interventions. This study aimed to examine the differences and commonalities in and determinants of knowledge, attitudes, practices and fears regarding leprosy in endemic districts in India and Indonesia. PRINCIPLE FINDINGS: A cross-sectional mixed-methods design was used. Persons affected by leprosy, their close contacts, community members and health workers were included. Through interview-administered questionnaires we assessed knowledge, attitudes, practices and fears with the KAP measure, EMIC-CSS and SDS. In addition, semi-structured interviews and focus group discussions were conducted. The quantitative data were analysed using stepwise multivariate regression. Determinants of knowledge and stigma that were examined included age, gender, participant type, education, occupation, knowing someone affected by leprosy and district. The qualitative data were analysed using open, inductive coding and content analysis. We administered questionnaires to 2344 participants (46% from India, 54% from Indonesia) as an interview. In addition, 110 participants were interviewed in-depth and 60 participants were included in focus group discussions. Knowledge levels were low in both countries: 88% of the participants in India and 90% of the participants in Indonesia had inadequate knowledge of leprosy. In both countries, cause, mode of transmission, early symptoms and contagiousness of leprosy was least known, and treatment and treatability of leprosy was best known. In both countries, health workers had the highest leprosy knowledge levels and community members the highest stigma levels (a mean score of up to 17.4 on the EMIC-CSS and 9.1 on the SDS). Data from the interviews indicated that people were afraid of being infected by leprosy. Local beliefs and misconceptions differed, for instance that leprosy is in the family for seven generations (Indonesia) or that leprosy is a result of karma (India). The determinants of leprosy knowledge and stigma explained 10-29% of the variability in level of knowledge and 3-10% of the variability in level of stigma. CONCLUSION: Our findings show the importance of investigating the perceptions regarding leprosy prior to educational interventions in communities: even though knowledge levels were similar, local beliefs and misconceptions differed per setting. The potential determinants we included in our study explained very little of the variability in level of knowledge and stigma and should be explored further. Detailed knowledge of local knowledge gaps, beliefs and fears can help tailor health education to local circumstances.

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.

Strategies for attraction and retention of health workers in remote and difficult-to-access areas of Chhattisgarh, India: Do they work?

BACKGROUND: To address the acute shortages of health workers in underserved, remote, and difficult-to-access areas, the Government of Chhattisgarh and the National Rural Health Mission (NRHM) launched the Chhattisgarh Rural Medical Corps (CRMC) in 2009. CRMC has enabled provisions such as financial incentives, residential accommodation, life insurance, and extra marks during admission at the postgraduate (PG) level to eligible doctors for the attraction and retention of health workers, i.e., doctors, staff nurses, auxiliary nurse midwives (ANMs), and rural medical assistants (RMAs) in underserved areas. OBJECTIVES: This study aims to understand the CRMC scheme in terms of implementation, challenges, gaps, and outcome in achieving the attraction and retention of health workers in the remote and difficult-to-access areas of Chhattisgarh. MATERIALS AND METHODS: The study adopts a mix of both qualitative and quantitative research methods. The purposive sampling method was used for the selection of three districts having normal, difficult, and inaccessible areas. Data were collected through key informant (KI) interviews with beneficiaries and non-beneficiaries of CRMC or district and state government officials, and reviews of document were analyzed using a thematic analysis approach. RESULTS: CRMC has made positive outcome as 1319 health workers, including doctors, have joined the service in 2010-11, reducing the vacancy of doctors from 90% to 45%. The scope of CRMC was primarily limited to payment of monthly financial incentives. The fund utilization rate of CRMC has increased (from 27% in 2009-10 to 98% in 2011-12), though there are delays in payment of incentives. The majority of staff lack awareness about CRMC during job applications. The payment of incentives based on facility performance has demotivated staff. CONCLUSIONS: Establishment of a performance management system, activating the CRMC cell to make it functional, and wide publicity of CRMC benefits are likely to improve attraction and retention of staff.

Minimum initial service package (MISP) for sexual and reproductive health in disasters.

BACKGROUND: This paper is based on a presentation given at the Evidence Aid Symposium, on 20 September 2014, at Hyderabad, India. The paper provides background about how the sexual and reproductive health (SRH) got conceived as a humanitarian health response that adopts human right approach, based on core principles driven by needs of adolescent girls and women, and having respect for their values, ethics and morals. METHODOLOGY: Good practices across nations documented by Inter-Agency Working Groups (IAWGs) on Reproductive Health in Humanitarian Crisis has supported the provision of essential SRH care services to adolescent girls and women in humanitarian crisis and in disasters. Secondary desk review is used to document the lessons learnt and good practices followed and documents for SRH. OBJECTIVE: These essential SRH care services are to be provided as "Minimum Initial Service Package (MISP)" for implementation at the outset of disaster. The Sphere Humanitarian Charter and Minimum Standards in Disaster Response incorporated the MISP for SRH as a minimum standard of care in disaster response with a goal to reduce mortality, morbidity and disability among populations affected by crises, particularly women and girls. Disaster prone countries are expected to roll out MISP to improve humanitarian response and emergency preparedness systems. RESULT: The East Europe and Central Asia (EECA) region including India have rolled out MISP starting from 2011 (EECA) and from 2013-2014 onwards in India across cities such as Chennai, Patna, Bhubaneshwar, Kolkata, Faridabad and Calcutta. Across India, through these national and state level trainings, nearly 600 people from NGOs, institutions, and government agencies were developed as national level trainers and resource persons for MISP who could advocate for RH in emergencies, apply core techniques provided in the MISP, apply coordination skills for the implementation of MISP and develop an action plan to integrate RH and Gender Based Violence (GBV) into Disaster Management Plans of respective agencies. CONCLUSION: The way forward includes focusing on MISP distance learning module, integration of MISP in Health action plans, and integration into national disaster preparedness and contingency planning of respective agencies and departments and building capacity at various levels.