Clinical trial NCT05223933: Proactive Community Case Management (Pro-CCM) in Rural Madagascar
Official title: Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Case Management
Keywords: Malaria
Rural area
Community health workers
Lead sponsor: Institut Pasteur de Madagascar
Sponsor class: OTHER
Collaborators: name: Peace Corps
name: National Malaria Control Programme, Madagascar
name: United States Agency for International Development (USAID)
First posted: 2022-02-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
timeFrame: an average of 1 year
Secondary outcomes:
measure: percent of households visited every two weeks
timeFrame: The event was assessed up to 30 weeks (15 biweekly visits).
measure: percent of households gave consent
timeFrame: The event was assessed up to 30 weeks (15 biweekly visits).
measure: Fever incidence
timeFrame: The event was assessed up to 30 weeks (15 biweekly visits).
measure: Malaria incidence
timeFrame: The event was assessed up to 30 weeks (15 biweekly visits).
measure: fever cases with RDT performed
timeFrame: The event was assessed up to 30 weeks (15 biweekly visits).
measure: RDT-positive persons treated with an ACT
timeFrame: The event was assessed up to 30 weeks (15 biweekly visits).
measure: The change in the prevalence of anemia in women aged between 15 and 49 years old in the intervention versus control fokontany
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Mananjary
country: Madagascar
facility: Fokontany Andranomavo
state: : Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Ambakoana
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Ambalamanasa
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Ambalaromba
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Ambinany Namorona
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Amboditandroho
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Ambohimiarina II
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Ambohinihaonana
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Ambolotara
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Andranomiteka
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Anilavinany
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Ankazotokana
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Anosimparihy
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Kianjavato
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Mahavoky Sud
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Manotro
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Maroamboka
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Sahafotahina
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Sandravakoka
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Tanambao Sud
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Tanambaobe
state: Fianarantsoa, Vatovavy Fitovinany
city: Mananjary
country: Madagascar
facility: Fokontany Tsarahafatra
state: Fianarantsoa, Vatovavy Fitovinany
Study officials:
affiliation: Institut Pasteur de Madagascar
name: Rila Ratovoson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Pasteur de Madagascar
name: Milijaona Randrianarivelojosia, PhD
role: STUDY_DIRECTOR
References:
citation: 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.