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

24 janvier 2022 mis à jour par: Rila Ratovoson, Institut Pasteur de Madagascar

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

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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

1000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Madagascar
    • : Fianarantsoa, Vatovavy Fitovinany
      • Mananjary, : Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Andranomavo
    • Fianarantsoa, Vatovavy Fitovinany
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Ambakoana
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Ambalamanasa
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Ambalaromba
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Ambinany Namorona
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Amboditandroho
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Ambohimiarina II
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Ambohinihaonana
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Ambolotara
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Andranomiteka
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Anilavinany
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Ankazotokana
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Anosimparihy
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Kianjavato
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Mahavoky Sud
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Manotro
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Maroamboka
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Sahafotahina
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Sandravakoka
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Tanambao Sud
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Tanambaobe
      • Mananjary, Fianarantsoa, Vatovavy Fitovinany, Madagascar, 317
        • Fokontany Tsarahafatra

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

2 mois et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention fokontany
Comportemental: 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.
Aucune intervention: Control fokontany

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
Délai: 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
an average of 1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
percent of households visited every two weeks
Délai: 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
The event was assessed up to 30 weeks (15 biweekly visits).
percent of households gave consent
Délai: 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
The event was assessed up to 30 weeks (15 biweekly visits).
Fever incidence
Délai: The event was assessed up to 30 weeks (15 biweekly visits).
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
Délai: 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
The event was assessed up to 30 weeks (15 biweekly visits).
fever cases with RDT performed
Délai: The event was assessed up to 30 weeks (15 biweekly visits).
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
Délai: The event was assessed up to 30 weeks (15 biweekly visits).
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
Délai: 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
an average of 1 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Institut Pasteur de Madagascar

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Rila Ratovoson, MD, Institut Pasteur de Madagascar
  • Directeur d'études: Milijaona Randrianarivelojosia, PhD, Institut Pasteur de Madagascar

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 décembre 2016

Achèvement primaire (Réel)

12 décembre 2016

Achèvement de l'étude (Réel)

29 décembre 2018

Dates d'inscription aux études

Première soumission

10 janvier 2022

Première soumission répondant aux critères de contrôle qualité

24 janvier 2022

Première publication (Réel)

4 février 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 février 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2017-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

All IPD that underlie results in a publication

Délai de partage IPD

Some summary data are available from December 2021; and some data at the time of publication (2022)

Critères d'accès au partage IPD

IPD and any additional supporting information will be shared in supplementary files in publication and via Harvard Dataverse

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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