Proactive Community Case Management (Pro-CCM) in Rural Madagascar (Pro-CCM)
Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar
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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
: Fianarantsoa, Vatovavy Fitovinany
-
Mananjary、: Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Andranomavo
-
-
Fianarantsoa, Vatovavy Fitovinany
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Ambakoana
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Ambalamanasa
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Ambalaromba
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Ambinany Namorona
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Amboditandroho
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Ambohimiarina II
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Ambohinihaonana
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Ambolotara
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Andranomiteka
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Anilavinany
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Ankazotokana
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Anosimparihy
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Kianjavato
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Mahavoky Sud
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Manotro
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Maroamboka
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Sahafotahina
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Sandravakoka
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Tanambao Sud
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Tanambaobe
-
Mananjary、Fianarantsoa, Vatovavy Fitovinany、马达加斯加、317
- Fokontany Tsarahafatra
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
Exclusion Criteria:
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention fokontany
|
CHWs in the intervention arm conducted door-to-door fever screening for all inhabitants of all consenting households in their catchment area every fortnight.
All individuals with temperature ≥ 37.5°C or history of self-reported fever in the previous two weeks were tested with an RDT; positive individuals who were not pregnant and did not have signs of severe disease were treated with artesunate-amodiaquine according to treatment guidelines.
Individuals identified as requiring a referral during Pro-CCM visits were assisted with transfer to the healthcare center, with transportation handled by the project staff.
|
|
无干预：Control fokontany
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
大体时间：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
|
an average of 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
percent of households visited every two weeks
大体时间：The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of households visited every two weeks out of the number of the households registered in initial census
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
percent of households gave consent
大体时间：The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of households that were visited every two weeks and gave consent for the screening during each visit
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
Fever incidence
大体时间：The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of fever cases out of all individuals screened during each visit
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
Malaria incidence
大体时间：The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of persons with positive RDT and fever cases out of all individuals screened during each visit
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
fever cases with RDT performed
大体时间：The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of fever cases with RDT performed
|
The event was assessed up to 30 weeks (15 biweekly visits).
|
|
RDT-positive persons treated with an ACT
大体时间：The event was assessed up to 30 weeks (15 biweekly visits).
|
percent of RDT-positive persons treated with an ACT during each visit
|
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
大体时间：an average of 1 year
|
Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of anemia in the 2 arms
|
an average of 1 year
|
合作者和调查者
合作者
调查人员
- 首席研究员：Rila Ratovoson, MD、Institut Pasteur de Madagascar
- 研究主任：Milijaona Randrianarivelojosia, PhD、Institut Pasteur de Madagascar
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.