MalariaREACT-2NCT05535465
Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities
A study testing Public health intervention in people with Malaria, run by Institut de Recherche pour le Developpement at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Public health intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- global population
Who cannot join
- absence of informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Burkina Faso1 site, 1 recruiting
- Recruiting
IRSS
Bobo-Dioulasso, Houet
Roch Dabiré, PhD, 0022670739069, dabireroch@gmail.com
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
IPR
Bouaké
Alphonsine Koffi, PhD, 002250707620886, koffi_alphonsine@yahoo.fr
About this study
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.
- Conditions
- Malaria
- Being tested
- Public health intervention
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public health interventionOther
additional trained mobile health workers are hired to support and supervise the activities of community health workers
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Heath system strengthening with additional trained mobile health care worker to help community health workers Receives: Other: Public health intervention |
| Standard of care | No intervention | National strategy to control malaria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 (cross-sectional survey)
Secondary outcomes (1)
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
Measured: Day 0 (cross-sectional survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Dec 2021
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster randomized - Step-wedged design
- Masking
- None (open label)
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, Institut Pierre Richet, Expertise France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535465
- Sponsor's protocol ID
- IRD-2-002
- Acronym
- REACT-2
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities
- ClinicalTrials.gov ID
- NCT05535465
- Acronym / sponsor ID
- REACT-2 / IRD-2-002
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, Institut Pierre Richet, Expertise France
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized - Step-wedged design
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Public health interventionHeath system strengthening with additional trained mobile health care worker to help community health workers |
| Standard of care | No intervention | –National strategy to control malaria |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- global population
Key exclusion criteria (1 listed)
- absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Public health interventionadditional trained mobile health workers are hired to support and supervise the activities of community health workers | Other | Intervention arm |
Primary outcome
Difference of malaria incidence between control and intervention arms
Time frame: Day 0 (cross-sectional survey)
Incidence will be calculated as the number of malaria cases detected during the cross-sectionnal surveys relative to the population size
1 secondary outcome
Difference of malaria prevalence between control and intervention arms
Time frame: Day 0 (cross-sectional survey)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Public health intervention in people with Malaria, run by Institut de Recherche pour le Developpement at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso, Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cédric Pennetier, PhD (0022656080455, cedric.pennetier@ird.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of malaria incidence between control and intervention arms (time frame: Day 0 (cross-sectional survey)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.