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

24 januari 2022 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

1000

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 månader och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention fokontany
Beteende: 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.
Inget ingripande: Control fokontany

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
percent of households visited every two weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Institut Pasteur de Madagascar

Samarbetspartners

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

Utredare

  • Huvudutredare: Rila Ratovoson, MD, Institut Pasteur de Madagascar
  • Studierektor: Milijaona Randrianarivelojosia, PhD, Institut Pasteur de Madagascar

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 december 2016

Primärt slutförande (Faktisk)

12 december 2016

Avslutad studie (Faktisk)

29 december 2018

Studieregistreringsdatum

Först inskickad

10 januari 2022

Först inskickad som uppfyllde QC-kriterierna

24 januari 2022

Första postat (Faktisk)

4 februari 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 februari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 januari 2022

Senast verifierad

1 januari 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2017-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

All IPD that underlie results in a publication

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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