NCT05535465

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

2.2 years

First QC Date

August 24, 2022

Last Update Submit

September 6, 2022

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 0 (cross-sectional survey)

Secondary Outcomes (1)

  • Difference of malaria prevalence between control and intervention arms

    Day 0 (cross-sectional survey)

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Other: Public health intervention

Standard of care

NO INTERVENTION

National strategy to control malaria

Interventions

Public health interventionOTHER

additional trained mobile health workers are hired to support and supervise the activities of community health workers

Intervention arm

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • global population

You may not qualify if:

  • absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRSS

Bobo-Dioulasso, Houet, Burkina Faso

RECRUITING

IPR

Bouaké, Côte d’Ivoire

RECRUITING

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Central Study Contacts

Cédric Pennetier, PhD

CONTACT

0022656080455cedric.pennetier@ird.fr

Florence Fournet, PhD

CONTACT

0033787232208florence.fournet@ird.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Cluster randomized - Step-wedged design
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2022

First Posted

September 10, 2022

Study Start

December 1, 2021

Primary Completion

February 1, 2024

Study Completion

September 1, 2024

Last Updated

September 10, 2022

Record last verified: 2022-09

Locations

CÔ(1)BU(1)