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| Name | Class |
|---|---|
| Peace Corps | OTHER |
| National Malaria Control Programme, Madagascar | OTHER_GOV |
| United States Agency for International Development (USAID) | FED |
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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:
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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention fokontany | Experimental |
| |
| Control fokontany | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive community case management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| percent of households visited every two weeks | 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 |
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Inclusion Criteria:
Inclusion criteria in community:
Individual inclusion criteria:
Exclusion Criteria:
Exclusion criteria in community:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Rila Ratovoson, MD | Institut Pasteur de Madagascar | Principal Investigator |
| Milijaona Randrianarivelojosia, PhD | Institut Pasteur de Madagascar | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fokontany Andranomavo | Mananjary | : Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar | ||
| Fokontany Ambakoana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36192774 | Derived | Ratovoson R, Garchitorena A, Kassie D, Ravelonarivo JA, Andrianaranjaka V, Razanatsiorimalala S, Razafimandimby A, Rakotomanana F, Ohlstein L, Mangahasimbola R, Randrianirisoa SAN, Razafindrakoto J, Dentinger CM, Williamson J, Kapesa L, Piola P, Randrianarivelojosia M, Thwing J, Steinhardt LC, Baril L. Proactive community case management decreased malaria prevalence in rural Madagascar: results from a cluster randomized trial. BMC Med. 2022 Oct 4;20(1):322. doi: 10.1186/s12916-022-02530-x. |
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All IPD that underlie results in a publication
Some summary data are available from December 2021; and some data at the time of publication (2022)
IPD and any additional supporting information will be shared in supplementary files in publication and via Harvard Dataverse
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The study was a two-arm cluster randomized community intervention trial, with 11 fokontany in the intervention arm implementing malaria pro-CCM and 11 in the control arm. In both arms, CHWs provided passive integrative community case management (iCCM) among children under five per usual standard of care, including diagnosis with RDT for febrile illness, treatment with artesunate-amodiaquine according to RDT results, along with diagnosis and management of acute respiratory infections and diarrhea, and referral to a higher level of care if indicated. Oral rehydration salts, antibiotics were distributed to CHWs in the intervention arm to reinforce the iCCM activities already implemented.
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|
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 | 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 | 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 | 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 | 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 | 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 |
| Mananjary |
| Fianarantsoa, Vatovavy Fitovinany |
| 317 |
| Madagascar |
| Fokontany Ambalamanasa | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Ambalaromba | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Ambinany Namorona | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Amboditandroho | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Ambohimiarina II | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Ambohinihaonana | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Ambolotara | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Andranomiteka | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Anilavinany | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Ankazotokana | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Anosimparihy | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Kianjavato | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Mahavoky Sud | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Manotro | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Maroamboka | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Sahafotahina | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Sandravakoka | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Tanambao Sud | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Tanambaobe | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| Fokontany Tsarahafatra | Mananjary | Fianarantsoa, Vatovavy Fitovinany | 317 | Madagascar |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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