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’Chemoprophylaxis for leprosy: comparing the effectiveness and feasibility of a skin camp intervention to a health centre-based intervention’


- candidate number29516
- NTR NumberNTR7503
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2018
- Secondary IDsNLR2019PEP4LEP 
- Public Title’Chemoprophylaxis for leprosy: comparing the effectiveness and feasibility of a skin camp intervention to a health centre-based intervention’
- Scientific TitleChemoprophylaxis for leprosy: comparing the effectiveness and feasibility of a skin camp intervention to a health centre based intervention. An implementation trial in Mozambique, Ethiopia and Tanzania.
- ACRONYMPEP4LEP
- hypothesisImplementation of chemoprophylaxis can contribute to reducing the transmission by reducing the risk of developing the disease and by the early identification of new patients.The aim of the study is to contribute to interrupting the transmission of M. leprae by identifying the most effective and feasible method of screening people at risk of developing leprosy and administering chemoprophylaxis in Ethiopia, Mozambique and Tanzania.
- Healt Condition(s) or Problem(s) studiedLeprosy, Skin diseases, Dermatological diseases, Hansen's disease
- Inclusion criteriaInclusion criteria for household contacts:
o A household contact of a leprosy index case; or, a leprosy case with household contacts and willingness to inform those contacts about PEP4LEP;
o Consent to participation in the PEP4LEP project;
o Age ¡Ý 2 years (with parental or guardian consent up to 18 years).

Inclusion criteria for +/- 100 community members:
o A person living in the community of a leprosy index case; or, a leprosy case patient who gives permission for the set-up of a skin camp in his/her community;
o Consent to participation in the PEP4LEP project;
o Age ¡Ý 2 years (with parental or guardian consent up to 18 years).
- Exclusion criteriaExclusion criteria for PEP4LEP:
o Refusal to participate in the PEP4LEP project;
o Pregnant women;
o People with a history of liver disorders (e.g. jaundice) or renal disorders;
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);
o People who have possible signs and/or symptoms of TB (these individuals should be referred for confirmation of diagnosis);
o For contacts who should receive SDR: People with known allergy to rifampicin and people receiving or having received rifampicin for any reason in the last two years (e.g. for tuberculosis or leprosy treatment, or as a contact from another leprosy index case);
o For contacts who should receive PEP4LEP: People who have received the PEP4LEP medicines in the past two years (people who have only received PEP can be included) and people with known cardiac disease or known seizures.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2019
- planned closingdate31-jan-2022
- Target number of participants30000
- InterventionsOne intervention will be community based, using skin camps to screen around 100 contacts of leprosy patients and provide them with SDR when eligible. The other intervention will be health centre-based, inviting household contacts to be screened and given SDR when eligible. Both interventions will use a common skin diseases approach; other skin diseases, such as common skin diseases and neglected infectious diseases (NIDs) manifesting skin lesions, will also be diagnosed and treated. In this way, the project will contribute to health system strengthening in the area of diagnosis and treatment of dermatological conditions.
- Primary outcome• To compare the effectiveness of a skin camp prophylaxis intervention to a health centre-based prophylaxis intervention in terms of the rate of leprosy patients detected and delay in case detection
• To compare the feasibility of the two chemoprophylaxis interventions (screening household contacts or screening contact via skincamp) in terms of cost effectiveness and acceptability
- Secondary outcome• To assess the acceptability of a common skin diseases approach and the use of the SkinApp
• To compare the capacity of health workers in diagnosing leprosy and other NIDs that manifest with skin lesions before the start of the study with their capacity in the third year
- TimepointsThe project will run for 52 months from the date of the formal launch. The study targets are all newly detected leprosy patients diagnosed between January 2019 and January 2022 (index patients) and their contacts (household contacts and their local communities).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Anne Schoenmakers
- CONTACT for SCIENTIFIC QUERIES Anne Schoenmakers
- Sponsor/Initiator Nederlandse Stichting voor Leprabestrijding (NLR), Erasmus University Medical Center, DEUTSCHE LEPRA- UND TUBERKULOSEHILFE E. V. (DAHW), UNITED REPUBLIC OF TANZANIA CATHOLIC UNIVERSITY OF HEALTH AND ALLIED SCIENCES (CUHAS), ETHIOPIA ARMAUER HANSEN RESEARCH INSTITUTE (AHRI), FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA MINISTRY OF HEALTH (FMOH), ETHIOPIA, UNIVERSIDADE LÚRIO, MOZAMBIQUE, MINISTERIO DE SAÚDE ¨C MOZAMBIQUE, MOZAMBIQUE, MINISTRY OF HEALTH, COMMUNITY DEVELOPMENT, GENDER, ELDERLY AND CHILDREN - TANZANIA, UNITED REPUBLIC OF TANZANIA
- Funding
(Source(s) of Monetary or Material Support)
EDCTP (incl. EU), NLR
- Publicationsopen access papers expected during/after finalizing the project
- Brief summaryThe project PEP4LEP - ¡¯Chemoprophylaxis for leprosy: comparing the effectiveness and feasibility of a skin camp intervention to a health centre-based intervention¡¯, will perform an implementation trial in Mozambique, Ethiopia and Tanzania. The aim of the trial is to contribute to interrupting the transmission of M. leprae by identifying the most effective and feasible method of screening people at risk of developing leprosy and administering chemoprophylaxis in Ethiopia, Mozambique and Tanzania.

The primary objectives are:
• To compare the effectiveness of a skin camp prophylaxis intervention to a health centre-based prophylaxis intervention in terms of the rate of leprosy patients detected and delay in case detection
• To compare the feasibility of the two chemoprophylaxis interventions in terms of cost effectiveness and acceptability

The secondary objectives are:
• To assess the acceptability of a common skin diseases approach and the use of the SkinApp
• To compare the capacity of health workers in diagnosing leprosy and other NIDs that manifest with skin lesions before the start of the study with their capacity in the third year

The objectives will be achieved using a two-arm, clustered-randomized implementation trial design, comparing two interventions for screening of contacts of leprosy patients and distribution of single-dose rifampicin (SDR) as chemoprophylaxis. Both interventions are based on the evidence that contacts of leprosy patients, household contacts as well as neighbours, have a higher risk of developing leprosy. SDR has been proven to reduce the risk of developing leprosy with 60% when given to contacts of leprosy patients.

One intervention will be community based, using skin camps to screen around 100 contacts of leprosy patients and provide them with SDR when eligible. The other intervention will be health centre-based, inviting household contacts to be screened and given SDR when eligible. Both interventions will use a common skin diseases approach; other skin diseases, such as common skin diseases and neglected infectious diseases (NIDs) manifesting skin lesions, will also be diagnosed and treated. In this way, the project will contribute to health system strengthening in the area of diagnosis and treatment of dermatological conditions.

Both interventions will be compared against a baseline. They will be compared in terms of effectiveness by looking at the rate of leprosy patients detected and the delay in case detection. The feasibility of the two interventions will be evaluated by assessing the acceptability of the two interventions and by comparing cost-effectiveness.

This study will translate a medical intervention of proven efficacy (SDR) into routine care. Because of the feasibility component and the development of guidelines as part of the study, the results can be presented for uptake in national and international policies. Upscaling chemoprophylaxis for leprosy will have a major impact because it will contribute to interrupting the transmission of M. leprae.
- Main changes (audit trail)
- RECORD10-sep-2018 - 7-okt-2018


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