Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 44
- 主要终点
- The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
研究概览
简要总结
The trial took place in a rural area hyper endemic for malaria, the hypothesis of which was that active detection and treatment of malaria in the population (all ages combined) in the event of a positive test could reduce the prevalence of malaria in the region. zoned. It was a two-armed, randomized, cluster-based community intervention trial:
- one arm with home treatment of malaria for the duration of the study for patients with a positive result in the rapid diagnostic test for malaria.
- a control arm with the usual malaria management procedures (ie consultation with community workers or the nearest health centers in the event of fever or suspected signs of malaria).
Before the start of monitoring, an initial survey (Baseline) was carried out in the "fokontany" (villages / cluster) included in the 2 arms, in order to determine the prevalence of malaria. Then, in the intervention arm, screening for malaria by RDT every 2 weeks in subjects with a suspected malaria case (fever or notion of fever in the 2 days preceding the visit) and treatment with Artesunate-amodiaquine (ACT) for patients with a positive RDT. At the end of the follow-up period, a final survey (Endline), based on the same questionnaires as during the Baseline, was carried out in the 2 villages of the 2 arms.
As a secondary objective, a study on anemia in women aged between 15 and 49 years was also carried out during the baseline and endline periods in order to compare the prevalence between the 2 periods
详细描述
This study aims to compare the prevalence of malaria in the rural community of Mananjary after the Malaria Home Care Program (PECADOM Plus).
The study will take place in fokontany rural communes of the district of Mananjary.
This district was chosen for the following reasons:
- High prevalence of malaria in this area (31% in subjects with fever and attending medical consultation in the CSB included in the sentinel IPM fever site)
- presence of Peace Corps Volunteers (PCV) in this district. Mananjary District is situated in southeastern Madagascar, located in the central part of the Vatovavy Fitovinany Region, in the province of Fianarantsoa. It is located at 21°13'52" South and 48°20'31" East. The district is composed of one urban commune and 28 rural communes. After obtaining the agreement of the ethics committee for the realization of the study, the coordinator or the assistant coordinator of the project will make courtesy visits to all administrative and health officials in the Vatovavy Fitovinany and Mananjary District (Regional Directorate, District Chief ...).A random draw of fokontany meeting the inclusion criteria will be carried out later, to identify the distribution of fokontany in the intervention arm and control arm in the project. In addition to the 22 fokontany required, a draw of 8 reserve fokontany will be made (4 for each arm).
A courtesy visit will be conducted in the fokontany raffled. The coordinator will check the number of inhabitants in these fokontany with the information gathered at the time of the preparation of the protocol (projection of the population according to the data of INSTAT, information from the Medical Inspector of Mananjary). If the fokontany will not be eligible, the reserve fokontany will replace them in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria in community:
- •Fokontany in rural communes of Mananjary district (fokontany level of safety, accessibility by the study teams, and phone network availability was assessed).
- •Agreement of the chief of Fokontany for the participation of his fokontany in the study
- •Fokontany with at least 1,000 inhabitants
- •Individual inclusion criteria:
- •Resident in the relevant areas during the study period and consenting to participate
排除标准
- •Exclusion criteria in community:
- •Fokontany with a total population of less than 1000 inhabitants
- •Fokontany in an urban commune
- •Fokontany in an area whose access is risky and perilous
- •Individual exclusion criteria:
- •None (Non-resident present at the time of passage were tested in the study if they have suggestive signs of malaria but they were considered as visitors)
结局指标
主要结局
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
时间窗: an average of 1 year
Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of malaria RDT positivity in the 2 arms
次要结局
- percent of households visited every two weeks(The event was assessed up to 30 weeks (15 biweekly visits).)
- percent of households gave consent(The event was assessed up to 30 weeks (15 biweekly visits).)
- Fever incidence(The event was assessed up to 30 weeks (15 biweekly visits).)
- Malaria incidence(The event was assessed up to 30 weeks (15 biweekly visits).)
- fever cases with RDT performed(The event was assessed up to 30 weeks (15 biweekly visits).)
- RDT-positive persons treated with an ACT(The event was assessed up to 30 weeks (15 biweekly visits).)
- The change in the prevalence of anemia in women aged between 15 and 49 years old in the intervention versus control fokontany(an average of 1 year)
研究者
Rila Ratovoson
Researcher
Institut Pasteur de Madagascar