An interventional study of Proactive community case management in Malaria and Case Management, sponsored by Institut Pasteur de Madagascar. Completed at 22 sites in Madagascar. Open to participants aged 2 Months and older. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by Institut Pasteur de Madagascar · Not applicable, Interventional, and Health services research
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.
1,315 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 1,000 is above the median of 220 across 1,041 interventional studies indexed under Malaria.
Browse Malaria studies →Institut Pasteur de Madagascar is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Inclusion criteria in community:
Individual inclusion criteria:
Exclusion Criteria:
Exclusion criteria in community:
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)
Behavioral: Proactive community case management
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.
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
Time frame: an average of 1 year
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
Time frame: The event was assessed up to 30 weeks (15 biweekly visits).
percent of households gave consent
percent of households that were visited every two weeks and gave consent for the screening during each visit
Time frame: 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
Time frame: 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
Time frame: The event was assessed up to 30 weeks (15 biweekly visits).
fever cases with RDT performed
percent of fever cases with RDT performed
Time frame: 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
Time frame: 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
Time frame: an average of 1 year
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Some summary data are available from December 2021; and some data at the time of publication (2022)
Access criteria: IPD and any additional supporting information will be shared in supplementary files in publication and via Harvard Dataverse
Data sharing details ↗ · dataverse.harvard.edu
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Institut Pasteur de Madagascar