PACTR202303742093429招募中Unknown
PEP4LEP - Chemoprophylaxis 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
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- R
- 入组人数
- 30,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 Year(s) 至 5 Year(s)（—）
- 性别
- All
入选标准
- •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
- •- 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.
排除标准
- •Index patients:
- •- Index patient or parents/legal guardians unable to understand the purpose and risks of participating in the PEP4LEP study
- •- 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)
研究者
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