Leprosy Post-Exposure Prophylaxis (LPEP) Programme : study protocol for evaluating the feasibility and impact on case detection rates of contact tracing and single dose rifampicin

Introduction: The reported number of new leprosy patients has barely changed in recent years. Thus, additional approaches or modifications to the current standard of passive case detection are needed to interrupt leprosy transmission. Large-scale clinical trials with single dose rifampicin (SDR) given as post-exposure prophylaxis (PEP) to contacts of newly diagnosed patients with leprosy have shown a 50–60% reduction of the risk of developing leprosy over the following 2 years. To accelerate the uptake of this evidence and introduction of PEP into national leprosy programmes, data on the effectiveness, impact and feasibility of contact tracing and PEP for leprosy are required. The leprosy post-exposure prophylaxis (LPEP) programme was designed to obtain those data. Methods and analysis: The LPEP programme evaluates feasibility, effectiveness and impact of PEP with SDR in pilot areas situated in several leprosy endemic countries: India, Indonesia, Myanmar, Nepal, Sri Lanka and Tanzania. Complementary sites are located in Brazil and Cambodia. From 2015 to 2018, contact persons of patients with leprosy are traced, screened for symptoms and assessed for eligibility to receive SDR. The intervention is implemented by the national leprosy programmes, tailored to local conditions and capacities, and relying on available human and material resources. It is coordinated on the ground with the help of the in-country partners of the International Federation of Anti-Leprosy Associations (ILEP). A robust data collection and reporting system is established in the pilot areas with regular monitoring and quality control, contributing to the strengthening of the national surveillance systems to become more action-oriented. Ethics and dissemination: Ethical approval has been obtained from the relevant ethics committees in the countries. Results and lessons learnt from the LPEP programme will be published in peer-reviewed journals and should provide important evidence and guidance for national and global policymakers to strengthen current leprosy elimination strategies

Leprosy Post-Exposure Prophylaxis (LPEP) programme: Study protocol for evaluating the feasibility and impact on case detection rates of contact tracing and single dose rifampicin

Introduction: The reported number of new leprosy patients has barely changed in recent years. Thus, additional approaches or modifications to the current standard of passive case detection are needed to interrupt leprosy transmission. Large-scale clinical trials with single dose rifampicin (SDR) given as post-exposure prophylaxis (PEP) to contacts of newly diagnosed patients with leprosy have shown a 50-60% reduction of the risk of developing leprosy over the following 2 years. To accelerate the uptake of this evidence and introduction of PEP into national leprosy programmes, data on the effectiveness, impact and feasibility of contact tracing and PE

Minimal essential data to document contact tracing and single dose rifampicin (SDR) for leprosy control in routine settings

In leprosy control there is a renewed interest in active case finding, which is increasingly being combined with chemoprophylactic interventions to try and reduce M. leprae transmission. The Leprosy Post-Exposure Prophylaxis (LPEP) programme, currently ongoing in eight endemic countries, pilots the provision of single-dose rifampicin (SDR) to eligible contacts of leprosy patients. LPEP has developed a surveillance system including data collection, reporting and regular monitoring for every participating country. This system is still largely programmespecific to LPEP. To facilitate continuity after completion of the project phase and start-up in other interested countries, we aim at identifying the minimal set of data required to appropriately document contact tracing activities and SDR administration for leprosy control in a routine setting. We describe four indicators for the index case (plus four already routinely collected) and seven indicators for household/neighbour screening, and community surveys. We propose two generic forms to capture all relevant information required at field and district level to follow-up on individuals or data if needed, provide gu

Leprosy post-exposure prophylaxis with single-dose rifampicin

_Objective:_ Leprosy post-exposure prophylaxis with single-dose rifampicin (SDRPEP) has proven effective and feasible, and is recommended by WHO since 2018. This SDR-PEP toolkit was developed through the experience of the leprosy postexposure prophylaxis (LPEP) programme. It has been designed to facilitate and standardise the implementation of contact tracing and SDR-PEP administration in regions and countries that start the intervention. _Results:_ Four tools were developed, incorporating the current evidence for SDRPEP and the methods and learnings from the LPEP project in eight countries. (1) th

Leprosy post-exposure prophylaxis with single-dose rifampicin (LPEP): an international feasibility programme

Background Innovative approaches are required for leprosy control to reduce cases and curb transmission of Mycobacterium leprae. Early case detection, contact screening, and chemoprophylaxis are the most promising tools. We aimed to generate evidence on the feasibility of integrating contact tracing and administration of single-dose rifampicin (SDR) into routine leprosy control activities. Methods The leprosy post-exposure prophylaxis (LPEP) programme was an international, multicentre feasibility study implemented within the leprosy control programmes of Brazil, India, Indonesia, Myanmar, Nepal, Sri Lanka, and Tanzania. LPEP explored the feasibility of combining three key interventions: systematically tracing contacts of individuals newly diagnosed with leprosy; screening the traced contacts for leprosy; and administering SDR to eligible contacts. Outcomes were assessed in terms of number of contacts traced, screened, and SDR administration rates. Findings Between Jan 1, 2015, and Aug 1, 2019, LPEP enrolled 9170 index patients and listed 179 769 contacts, of whom 174782 (97·2%) were successfully traced and screened. Of those screened, 22 854 (13·1%) were excluded from SDR mainly because of health reasons and age. Among those excluded, 810 were confirmed as new patients (46 per 10 000 contacts screened). Among the eligible screened contacts, 1182 (0·7%) refused prophylactic treatment with SDR. Overall, SDR was administered to 151 928 (86·9%) screened contacts. No serious adverse events were reported. Interpretation Post-exposure prophylaxis with SDR is safe; can be integrated into different leprosy control programmes with minimal additional efforts once contact tracing has been established; and is generally well accepted by index patients, their contacts, and health-care workers. The programme has also invigorated local leprosy control through the availability of a prophylactic intervention; therefore,

Leishmaniasis in Europe and Central Asia: epidemiology, impact of habitat and lifestyle changes, HIV coinfection

Visceral leishmaniasis (VL) and cutaneous leishmaniasis (CL) are endemic to the European region. Mainly the Mediterranean basin, southern Cauca sus, and Central Asia have a long history of outbreaks and burden. Control activities targeting the sand fly vectors or known reservoir hosts such as stray dogs have successfully reduced the incidence. If these efforts are discontinued, as seen in the former Soviet Union, leishmaniasis may reappear. Further, human activities and lifestyle changes are creating new habitats for sand flies and animal reservoir hosts, which has resulted in various recent outbreaks. A major challenge in the control of VL is the coinfection with HIV, which is considered responsible for the re-emergence of VL in southern Europe in the 1990s. Further challenges arise through an increased relocation of infected hosts, dogs in particular, and through the expansion of sand fly habitats due to climate change. For these reasons, we recommend the surveillance of Leishmania spp. and Phlebotomus spp. to be reinforced, not only in the South but also in central European countries that have so far not been affected by autochthonous human leishmaniasis

Minimal essential data to document contact tracing and single dose rifampicin (SDR) for leprosy control in routine settings

In leprosy control there is a renewed interest in active case finding, which is increasingly being combined with chemoprophylactic interventions to try and reduce M. leprae transmission. The Leprosy Post-Exposure Prophylaxis (LPEP) programme, currently ongoing in eight endemic countries, pilots the provision of single-dose rifampicin (SDR) to eligible contacts of leprosy patients. LPEP has developed a surveillance system including data collection, reporting and regular monitoring for every participating country. This system is still largely programme- specific to LPEP. To facilitate continuity after completion of the project phase and start-up in other interested countries, we aim at identifying the minimal set of data required to appropriately document contact tracing activities and SDR administration for leprosy control in a routine setting. We describe four indicators for the index case (plus four already routinely collected) and seven indicators for household/neighbour screening, and community surveys. We propose two generic forms to capture all relevant information required at field and district level to follow-up on individuals or data if needed, provide guidance on the sequence of tasks, provide quality control by listing key questions to assess SDR eligibility, and facilitate reporting. These generic forms have to be adapted to local requirements in terms of layout, language, and additional operational indicators