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

24 gennaio 2022 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

2 mesi e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention fokontany
Comportamentale: 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.
Nessun intervento: Control fokontany

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
percent of households visited every two weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Institut Pasteur de Madagascar

Collaboratori

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

Investigatori

  • Investigatore principale: Rila Ratovoson, MD, Institut Pasteur de Madagascar
  • Direttore dello studio: Milijaona Randrianarivelojosia, PhD, Institut Pasteur de Madagascar

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 dicembre 2016

Completamento primario (Effettivo)

12 dicembre 2016

Completamento dello studio (Effettivo)

29 dicembre 2018

Date di iscrizione allo studio

Primo inviato

10 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

24 gennaio 2022

Primo Inserito (Effettivo)

4 febbraio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 febbraio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 gennaio 2022

Ultimo verificato

1 gennaio 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2017-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

All IPD that underlie results in a publication

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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