Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,000

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach

1 country

22 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

December 12, 2016

Completed

Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2016

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2018

Completed

3 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed

25 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed

Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

Same day

First QC Date

January 10, 2022

Last Update Submit

January 24, 2022

Conditions

Malaria Case Management

Keywords

MalariaRural areaCommunity health workers

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

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).
+2 more secondary outcomes

Study Arms (2)

Intervention fokontany

EXPERIMENTAL

Behavioral: Proactive community case management

Control fokontany

NO INTERVENTION

Interventions

Proactive community case managementBEHAVIORAL

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.

Intervention fokontany

Eligibility Criteria

Age2 Months+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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
Resident in the relevant areas during the study period and consenting to participate

You may not qualify if:

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
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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Institut Pasteur de Madagascarlead
Peace Corpscollaborator
National Malaria Control Programme, Madagascarcollaborator
United States Agency for International Development (USAID)collaborator

Study Sites (22)

Fokontany Andranomavo

Mananjary, : Fianarantsoa, Vatovavy Fitovinany, 317, Madagascar

Location

Fokontany Ambakoana