PEP4LEP - Chemoprophylaxis for leprosy: comparing the effectiveness and feasibility of a skin camp intervention to a health centre-based interventio

Not Applicable

Recruiting

• Conditions: leprosy, and other skin diseases including skin NTDs; Skin and Connective Tissue Diseases

• Registration Number: PACTR202303742093429
• Lead Sponsor: R

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

Index patients:
- Consent to participate in the PEP4LEP project
- Diagnosed with leprosy (preferred maximum of 6 months prior to inclusion)
- Residence in the PEP4LEP districts for a minimum of 3 months prior to the date of diagnosis
- Index patient has started MDT
- Community-based skin camp intervention: Leprosy patient gives permission for the set-up of a skin camp in his/her community (sharing their leprosy diagnosis with their contacts is not needed)
- Health center-based household screening intervention: Leprosy patient with household contacts, and who is willing to inform these contacts about PEP4LEP

Contacts:
- Consent to participate in the PEP4LEP project
- Community-based skin camp intervention: Community contact of the index patient for a minimum of 3 months
- Health center-based household screening intervention: Contact which is a household member of the index patient for a minimum of 3 months, visiting the screening health center =3 months after the index patient was included

The eligibility criterium for aditional stakeholders (community leaders, health workers, community health volunteers and health policy decision maker, contacts refusing SDR-PEP) taking part in the acceptability evaluation and the capacity assessment is providing consent to participate in the PEP4LEP project.

Exclusion Criteria

Index patients:
- Index patient or parents/legal guardians unable to understand the purpose and risks of participating in the PEP4LEP study

Contacts:
- Contact or parents/legal guardians unable to understand the purpose and risks of participating in the PEP4LEP study
- Age <2 years and/or <10 kg of weight*
- Pregnancy*
- Receiving or having received rifampicin for any reason in the last 2 years
- Known allergy to rifampicin
- History of liver or renal disorders
- Individuals with leprosy and those who have possible signs and/or symptoms of leprosy (e.g., leprosy-like skin lesions or nerve manifestations) until their disease status has been clarified**
- Individuals with possible signs and/or symptoms of TB (cough for more than two weeks or cough in known HIV/AIDS patients, night sweats, unexplained fever, weight loss) until their disease status has been clarified ***
- Individuals with possible signs and/or symptoms of COVID-19 (self-assessed temperature of 38°C or more, respiratory or cold-like symptoms, sudden loss of smell/taste) or possible contact with a COVID-19 patient in the past 14 days***

* A voucher will be given for repeated skin screening and SDR-PEP. This can be used in a PEP4LEP affiliated health center when this person becomes eligible (e.g., after giving birth)
** If referral was needed and no leprosy is detected, repeated skin screening and SDR-PEP can be provided in a PEP4LEP affiliated health center
*** Skin screening and SDR-PEP can only be provided in a PEP4LEP affiliated health center after the contact is tested negative for COVID-19/TB (according to national guidelines)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•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.<br>•To compare the feasibility of the two chemoprophylaxis interventions in terms of cost effectiveness and acceptability.

Secondary Outcome Measures

Name	Time	Method
•To assess the acceptability of a common skin diseases approach and the use of the NLR SkinApp, a phone application which supports health workers in detecting skin diseases<br>•To compare the capacity of health workers in diagnosing leprosy and other neglected tropical diseases (NTDs) that manifest with skin lesions before the start of the study with their capacity in the third year<br>