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

24 januari 2022 bijgewerkt door: 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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1000

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • 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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 maanden en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention fokontany
Gedragsmatig: 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.
Geen tussenkomst: Control fokontany

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
percent of households visited every two weeks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Institut Pasteur de Madagascar

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Rila Ratovoson, MD, Institut Pasteur de Madagascar
  • Studie directeur: Milijaona Randrianarivelojosia, PhD, Institut Pasteur de Madagascar

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 december 2016

Primaire voltooiing (Werkelijk)

12 december 2016

Studie voltooiing (Werkelijk)

29 december 2018

Studieregistratiedata

Eerst ingediend

10 januari 2022

Eerst ingediend dat voldeed aan de QC-criteria

24 januari 2022

Eerst geplaatst (Werkelijk)

4 februari 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 februari 2022

Laatste update ingediend die voldeed aan QC-criteria

24 januari 2022

Laatst geverifieerd

1 januari 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2017-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

All IPD that underlie results in a publication

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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