Proactive Community Case Management (Pro-CCM) in Rural Madagascar

Sponsor

Institut Pasteur de Madagascar (Other)

Overall Status

Completed

CT.gov ID

NCT05223933

Collaborator

Peace Corps (Other), National Malaria Control Programme, Madagascar (Other), United States Agency for International Development (USAID) (U.S. Fed)

1,000

Enrollment

Locations

Arms

24.5

Actual Duration (Months)

45.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Malaria Case Management	Behavioral: Proactive community case management	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar

Actual Study Start Date :

Dec 12, 2016

Actual Primary Completion Date :

Dec 12, 2016

Actual Study Completion Date :

Dec 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention fokontany	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.
No Intervention: Control fokontany

Arm

Intervention/Treatment

Experimental: Intervention fokontany

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.

No Intervention: Control fokontany

Outcome Measures

Primary Outcome Measures

The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany. [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

Secondary Outcome Measures

percent of households visited every two weeks [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
percent of households gave consent [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
Fever incidence [The event was assessed up to 30 weeks (15 biweekly visits).]
percent of fever cases out of all individuals screened during each visit
Malaria incidence [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
fever cases with RDT performed [The event was assessed up to 30 weeks (15 biweekly visits).]
percent of fever cases with RDT performed
RDT-positive persons treated with an ACT [The event was assessed up to 30 weeks (15 biweekly visits).]
percent of RDT-positive persons treated with an ACT during each visit
The change in the prevalence of anemia in women aged between 15 and 49 years old in the intervention versus control fokontany [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fokontany Andranomavo	Mananjary	: Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
2	Fokontany Ambakoana	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
3	Fokontany Ambalamanasa	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
4	Fokontany Ambalaromba	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
5	Fokontany Ambinany Namorona	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
6	Fokontany Amboditandroho	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
7	Fokontany Ambohimiarina II	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
8	Fokontany Ambohinihaonana	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
9	Fokontany Ambolotara	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
10	Fokontany Andranomiteka	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
11	Fokontany Anilavinany	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
12	Fokontany Ankazotokana	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
13	Fokontany Anosimparihy	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
14	Fokontany Kianjavato	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
15	Fokontany Mahavoky Sud	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
16	Fokontany Manotro	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
17	Fokontany Maroamboka	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
18	Fokontany Sahafotahina	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
19	Fokontany Sandravakoka	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
20	Fokontany Tanambao Sud	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
21	Fokontany Tanambaobe	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317
22	Fokontany Tsarahafatra	Mananjary	Fianarantsoa, Vatovavy Fitovinany	Madagascar	317

Sponsors and Collaborators

Institut Pasteur de Madagascar
Peace Corps
National Malaria Control Programme, Madagascar
United States Agency for International Development (USAID)

Investigators

Principal Investigator: Rila Ratovoson, MD, Institut Pasteur de Madagascar
Study Director: Milijaona Randrianarivelojosia, PhD, Institut Pasteur de Madagascar

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rila Ratovoson, Researcher, Institut Pasteur de Madagascar

ClinicalTrials.gov Identifier:

NCT05223933

Other Study ID Numbers:

2017-01

First Posted:

Feb 4, 2022

Last Update Posted:

Feb 4, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rila Ratovoson, Researcher, Institut Pasteur de Madagascar

Malaria

Rural area

Community health workers

Additional relevant MeSH terms:

Malaria

Study Results

No Results Posted as of Feb 4, 2022