No registrations found.
Source
Brief title
Health condition
Leprosy
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
o Rate ratio of the case detection rate among close contacts treated with PEP++ over the case detection rate among close contacts treated with SDR-PEP
o Percentage decline in case detection rate in the study districts over 2023 compared to 2019
Secondary outcome
o Acceptability of the PEP++ regimen as post-exposure prophylaxis
o Improvement in knowledge about leprosy in the study areas
o Reduction in leprosy-related stigma in the study areas
o Understanding the transmission in high-endemic 'hotspots' areas
Background summary
The PEP++ study uses a cluster-randomised controlled trial design to test the efficacy of an enhanced chemoprophylaxis regimen against leprosy. In addition, an enhanced package of leprosy control measures, that includes chemoprophylaxis, will be implemented in both intervention and control areas. Clusters of persons affected by leprosy will be identified by GIS mapping to target blanket campaigns where chemoprophylaxis will be provided to around 100 close contacts per leprosy patient. In the intervention areas, twenty close contacts of leprosy patients will receive enhanced chemoprophylaxis (i.e. PEP++ regimen) and an additional eighty contacts will receive SDR-PEP. In the control areas, all contacts will receive SDR-PEP. Outside the cluster areas, twenty close contacts will receive the PEP++ regimen in the intervention areas and SDR-PEP in control areas. The SIMCOLEP mathematical model predicts that this combination of interventions will result in a 50% reduction in new case detection rate in a 5-year period. The PEP++ project targets India, Brazil and Indonesia because 81% of all the new leprosy cases globally are detected in these three countries.
Study objective
It is possible to interrupt transmission of M. leprae in an endemic community by rigorous application of contact screening and chemoprophylaxis to both close contacts and a wider circle of contacts around each index patient.
Post-exposure prophylaxis (PEP) with 3 doses of clarithromycin and rifampicin (PEP++) is more effective in preventing leprosy in close contacts than PEP with single-dose rifampicin (SDR PEP). With culture-sensitive and contextualized messages and other interventions, it is possible to improve attitudes and behaviour towards persons affected by leprosy.
Study design
Start enrolment: Jan 2020
Last enrolment: Dec 2021
Follow-up contacts after 24 months
Intervention
The PEP++ regimen comprises 3 doses of rifampicin 600 mg and clarithromycin 500 mg given at 4 weekly intervals to twenty close contacts of leprosy patients registered from 2014 onwards in the intervention areas. The control group will receive single-dose rifampicin (SDR) 600 mg, which is the current standard for chemoprophylaxis given to contacts of new leprosy patients.
An enhanced ‘package’ of leprosy control measures will be implemented in all study areas. This will comprise: 1) awareness-raising of leprosy through context-sensitive public education materials using a variety of media; 2) involvement of persons affected by leprosy, community members, traditional healers and religious leaders in case detection and stigma reduction; 3) improved coverage of contact screening and intensified follow-up to enhance early case detection; 4) capacity strengthening and refresher training of health staff and volunteers involved in leprosy control; and 5) a one-time blanket campaign with post-exposure prophylaxis in high-endemic clusters.
Inclusion criteria
o Patients having a confirmed diagnosis of leprosy and who give consent for approaching their contacts for the trial
o For contacts:
o A person according to the definition of a ‘close contact’ as written in the research protocol
o Consent to participate in the PEP++ project
o Age ≥ 2 years (with parental or guardian consent up to 18 years)
Exclusion criteria
o Patients who have no contacts
For contacts:
o Pregnant women (PEP can be given after delivery)
o People receiving or having received rifampicin for any reason in the last two years (e.g. for tuberculosis [TB] or leprosy treatment, or as a contact from another leprosy index case)
o People with a history of liver disorders (e.g. jaundice) or renal disorders or neurological disorders (e.g. seizures)
o People with leprosy disease or people who have possible signs and/or symptoms of leprosy, until their status has been clarified (these individuals should be referred for confirmation of diagnosis)
o People who have possible signs and/or symptoms of TB (patients having any of the following symptoms should be screened for TB: a cough for more than two weeks, night sweats, unexplained fever, weight loss), (these individuals should be referred for confirmation of diagnosis)
o Known allergy to rifampicin or clarithromycin
o People who are using any other medication on a regular basis
Design
Recruitment
IPD sharing statement
Plan description
o <i>Personal data security is mandatory<i> –NLR International Office (IO) must comply with the European Union’s General Data Protection Regulation (EU GDPR) which indicates which kind of personal data may be stored and used. At the same time, all three countries seek to protect their study subjects’ privacy and ensure local ownership. So, this is a main consideration for the national data management committees; <br>
<br>
o <i>Platform data security is of critical importance <i> – PEP++ will collect a massive amount of data and needs to be able to show the outcomes of all study subjects. We cannot afford any lost data due to safety breaches or human error, therefore are committed to the highest level of data security at all levels of the project - at point of collection, uploading to the database server and storage on the cloud server. Strict user roles and permissions that define levels of hierarchy and access to the data will be agreed upon with the Principal Investigators and project teams of each country involved; <br>
<br>
o <i>There are no increased risks of disease disclosure from the system<i> – Names and personally identifiable data are protected using barcodes and unique identification codes to ensure that any persons affected or their close contacts are stigmatised or harmed in any way by the study;<br>
<br>
o <i>National collection and ownership of data<i> – As mentioned above, all data will be collected and directly uploaded to national servers to ensure that primary ownership rests with the national team;<br>
<br>
o <i>Full sharing of encrypted, non-identifiable data<i> – While national data ownership and protection is a key principle of the study; it is essential to have a merged multi-centre database for joint analysis by NLR IO, Erasmus Medical Center and the PhD students. Any personal data fields (such as name, address and GPS coordinates) will be excluded from any international data transfer.<br>
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7022 |
NTR-old | NTR7221 |
Other | Health Research Ethics Committee, Dr Soetomo Hospital, Airlangga, Indonesia : 1369/KEPK/VIII/2019 |
Summary results
<br>
van 't Noordende, A. T., Hinders, D. C., Tiwari, A., Richardus, J. H., & van Brakel, W. (2019). A leprosy elimination investment case: proceedings of an expert consultation. Leprosy Review, 90(1), 124-127.<br>
<br>
van ‘t Noordende, A. T., Korfage, I., Lisam, S., Arif, M. A., Kumar, A., & van Brakel, W. H. (2019). The role of perceptions and knowledge of leprosy in the elimination of leprosy: A baseline study in Fatehpur district, northern India. PLoS neglected tropical diseases, 13(4), e0007302.<br>