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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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: Fianarantsoa, Vatovavy Fitovinany
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Mananjary、: Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Andranomavo
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Fianarantsoa, Vatovavy Fitovinany
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Ambakoana
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Ambalamanasa
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Ambalaromba
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Ambinany Namorona
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Amboditandroho
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Ambohimiarina II
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Ambohinihaonana
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Ambolotara
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Andranomiteka
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Anilavinany
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Ankazotokana
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Anosimparihy
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Kianjavato
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Mahavoky Sud
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Manotro
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Maroamboka
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Sahafotahina
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Sandravakoka
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Tanambao Sud
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Tanambaobe
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Mananjary、Fianarantsoa, Vatovavy Fitovinany、マダガスカル、317
- Fokontany Tsarahafatra
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intervention fokontany
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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.
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介入なし：Control fokontany
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
時間枠：an average of 1 year
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Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of malaria RDT positivity in the 2 arms
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an average of 1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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percent of households visited every two weeks
時間枠：The event was assessed up to 30 weeks (15 biweekly visits).
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percent of households visited every two weeks out of the number of the households registered in initial census
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The event was assessed up to 30 weeks (15 biweekly visits).
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percent of households gave consent
時間枠：The event was assessed up to 30 weeks (15 biweekly visits).
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percent of households that were visited every two weeks and gave consent for the screening during each visit
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The event was assessed up to 30 weeks (15 biweekly visits).
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Fever incidence
時間枠：The event was assessed up to 30 weeks (15 biweekly visits).
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percent of fever cases out of all individuals screened during each visit
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The event was assessed up to 30 weeks (15 biweekly visits).
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Malaria incidence
時間枠：The event was assessed up to 30 weeks (15 biweekly visits).
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percent of persons with positive RDT and fever cases out of all individuals screened during each visit
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The event was assessed up to 30 weeks (15 biweekly visits).
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fever cases with RDT performed
時間枠：The event was assessed up to 30 weeks (15 biweekly visits).
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percent of fever cases with RDT performed
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The event was assessed up to 30 weeks (15 biweekly visits).
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RDT-positive persons treated with an ACT
時間枠：The event was assessed up to 30 weeks (15 biweekly visits).
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percent of RDT-positive persons treated with an ACT during each visit
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The event was assessed up to 30 weeks (15 biweekly visits).
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The change in the prevalence of anemia in women aged between 15 and 49 years old in the intervention versus control fokontany
時間枠：an average of 1 year
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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
|
協力者と研究者
協力者
捜査官
- 主任研究者：Rila Ratovoson, MD、Institut Pasteur de Madagascar
- スタディディレクター：Milijaona Randrianarivelojosia, PhD、Institut Pasteur de Madagascar
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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