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Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities (REACT-2)

Primary Purpose

Malaria

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Public health intervention
Sponsored by
Institut de Recherche pour le Developpement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Malaria

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • global population

Exclusion Criteria:

  • absence of informed consent

Sites / Locations

  • IRSSRecruiting
  • IPRRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Standard of care

Arm Description

Heath system strengthening with additional trained mobile health care worker to help community health workers

National strategy to control malaria

Outcomes

Primary Outcome Measures

Difference of malaria incidence between control and intervention arms
Incidence will be calculated as the number of malaria cases detected during the cross-sectionnal surveys relative to the population size

Secondary Outcome Measures

Difference of malaria prevalence between control and intervention arms
Prevalence will be calculated as the proportion of participants with malaria infection (i.e. positive blood smears) detected during the cross-sectionnal surveys

Full Information

First Posted
August 24, 2022
Last Updated
September 6, 2022
Sponsor
Institut de Recherche pour le Developpement
Collaborators
Institut de Recherche en Sciences de la Sante, Burkina Faso, Institut Pierre Richet, Expertise France
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1. Study Identification

Unique Protocol Identification Number
NCT05535465
Brief Title
Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities
Acronym
REACT-2
Official Title
Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherche pour le Developpement
Collaborators
Institut de Recherche en Sciences de la Sante, Burkina Faso, Institut Pierre Richet, Expertise France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the REACT 2 project, a consortium proposes to study in Burkina Faso and Côte d'Ivoire, the impact of a public health intervention in rural communities in order to improve access to malaria therapeutic and preventive arsenal for vulnerable populations (i.e. children, adolescents and pregnant women). The intervention relies on the implementation of mobile health workers to support community health workers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cluster randomized - Step-wedged design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Heath system strengthening with additional trained mobile health care worker to help community health workers
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
National strategy to control malaria
Intervention Type
Other
Intervention Name(s)
Public health intervention
Intervention Description
additional trained mobile health workers are hired to support and supervise the activities of community health workers
Primary Outcome Measure Information:
Title
Difference of malaria incidence between control and intervention arms
Description
Incidence will be calculated as the number of malaria cases detected during the cross-sectionnal surveys relative to the population size
Time Frame
Day 0 (cross-sectional survey)
Secondary Outcome Measure Information:
Title
Difference of malaria prevalence between control and intervention arms
Description
Prevalence will be calculated as the proportion of participants with malaria infection (i.e. positive blood smears) detected during the cross-sectionnal surveys
Time Frame
Day 0 (cross-sectional survey)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: global population Exclusion Criteria: absence of informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cédric Pennetier, PhD
Phone
0022656080455
Email
cedric.pennetier@ird.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence Fournet, PhD
Phone
0033787232208
Email
florence.fournet@ird.fr
Facility Information:
Facility Name
IRSS
City
Bobo-Dioulasso
State/Province
Houet
Country
Burkina Faso
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roch Dabiré, PhD
Phone
0022670739069
Email
dabireroch@gmail.com
Facility Name
IPR
City
Bouaké
Country
Côte D'Ivoire
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alphonsine Koffi, PhD
Phone
002250707620886
Email
koffi_alphonsine@yahoo.fr

12. IPD Sharing Statement

Learn more about this trial

Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities

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