Leprosy
Conditions
Interventions
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 interven
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.
Sponsors
NLR; Erasmus Medical Center, Department of Public Health
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactDuane C. Hinders
NLR
Outcome results
None listed