Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,462
- 试验地点
- 1
- 主要终点
- Change from baseline prevalence of Lymphatic Filariasis at 24 months
研究概览
简要总结
The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6 rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping under insecticidal nets have significantly accelerated transmission interruption in some settings of high transmission intensity. Thus, it is evident that new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the LF elimination process. This study therefore seeks to test the hypothesis that biannual treatment of LF endemic communities will accelerate interruption of LF transmission.
Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB; (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residency in the disease endemic community for at least 12 months
- •Willingness to provide informed consent/assent
- •Willingness to donate blood (per the protocol)
排除标准
- •Recent residents (<12 months)
- •Inability to give informed consent
- •Pregnant and lactating women
- •Children below the age of 5.
研究组 & 干预措施
Control group
400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years
干预措施: 400 μg/kg Ivermectin + 400 mg Albendazole (Drug)
Expanded frequency group
400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years
干预措施: 400 μg/kg Ivermectin + 400 mg Albendazole (Drug)
结局指标
主要结局
Change from baseline prevalence of Lymphatic Filariasis at 24 months
时间窗: 0 and 24 months
The primary outcome, the prevalence of LF infection, will be measured through cross-sectional parasitological surveys conducted at baseline and at 24 months. The timing of the final follow-up survey will take into account differences in time since treatment of the annual and biannual treatment groups at 24 months
次要结局
- Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions(24 months)
- Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment(0, 12, 24, 30 months)
- Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions(24 months)