Effectiveness, Feasibility, and Acceptability of Targeted Antimalarial Interventions for Seasonal Migrant Populations in Metema District, Amhara Region, Ethiopia
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,350
- 试验地点
- 1
- 主要终点
- Feasibility of TDA
研究概览
简要总结
The purpose of the study is to assess the effectiveness, feasibility, and acceptability of targeted drug administration for seasonal migrant populations in Metema District, Amhara Region, Ethiopia
详细描述
A cluster randomized controlled trial will be used to evaluate the effectiveness, feasibility, and acceptability of targeted antimalarial drug administration (TDA) for seasonal migrant farmworkers in the Delello farm sites in Metema district, Amhara Region. Individual farm sites will be randomized 1:1:1 to either of two intervention options or control, where all farmworkers at intervention sites will receive either two or three rounds of dihydro artemisinin piperaquine over the primary farming season.
All study farm-sites will receive enhanced case management conducted by mobile health teams throughout the study period.
Cross-sectional surveys will be conducted in all arms at baseline and 4 to 6 weeks following the third round of TDA to assess the effectiveness of the intervention for reducing parasite prevalence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At the time of the study, be a seasonal farm worker at one of the selected farm sites in Metema district
- •Available and willingness to participate in the study and provide consent (or parental/guardian consent and asset in the case of minors)
排除标准
- •Severe illness (will be referred for care)
- •Inability to provide informed consent
- •Age 14-17 years old and not having a parent/guardian at the farm who can provide consent
- •Age <14 years old
- •Additional exclusion criteria for the intervention group:
- •Having received an antimalarial drug within the last 2 weeks
- •Having any of the contraindications to receiving DP:
- •History of cardiac rhythm disturbances, bradycardia, or heart failure
- •Concomitant treatment with drugs that prolong the QT interval (fluconazole, fluoroquinolones, hydroxyzine, macrolides, ondansetron, etc.) or drugs containing any of the following: flecainide, metoprolol, imipramine, amitriptyline, clomipramine
- •Known allergic reactions to DP or other artemisinin derivatives
- •Pregnancy
研究组 & 干预措施
Intervention with 2 TDA rounds
TDA with DP will be administered two times with a 4 - 6 week interval between rounds to all workers in the selected farm sites
干预措施: Dihydroartemisinin-piperaquine (Drug)
Intervention with 3 TDA rounds
TDA with DP will be administered three times with a 4 - 6 week interval between rounds to all workers in the selected farm sites
干预措施: Dihydroartemisinin-piperaquine (Drug)
结局指标
主要结局
Feasibility of TDA
时间窗: Up to 6 months
Feasibility of TDA measured through intervention coverage (% of participants treated among the total farm population) and cost effectiveness
Plasmodium falciparum (Pf) parasite prevalence
时间窗: Up to 6 months
Prevalence of Pf as determined by PCR at the end of the study
Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities
时间窗: Up to 6 months
Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities measured through drug adherence (% of participants completing the drugs as prescribed, as reported in the endline survey), survey response (self-reported values provided during endline survey), and qualitative interview data
次要结局
- Feasibility and acceptability of enhanced case management through mobile clinics based on endline survey responses(Up to 6 months)
- Feasibility of enhanced case management through mobile clinics based on cost per case detected(Up to 6 months)
- Feasibility and acceptability of enhanced case management through mobile clinics based on qualitative interview data(Up to 6 months)
- Pf parasite prevalence in a subset of migrant farmworkers(Up to 2 months)
- Safety and tolerability of TDA(Up to 6 months)