MalariaPhase 4GhanaCommRDTNCT01907672
The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level
A Phase 4 study testing Rapid Diagnostic Test in people with Malaria, run by Ghana Health Services at 1 site in Ghana.
Trial summary
This study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria
- What is being tested?
- Rapid Diagnostic Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,748 participants
- Where
- 1 siteGhana
- Study dates
- Aug 2011to Apr 2013
- Phase
- Phase 4
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients reporting to chemical seller with complaint of fever or who request for an anti-malarial drug
Who cannot join
- Clients providing a prescription from a health facility
- Clients with signs of severe disease who will be referred onward
Trial locations and contacts
1 site in 1 country.
Ghana1 site
Dodowa Health Research Centre, Ghana Health Service
Dodowa, Greater Accra Region, Box DD1
About this study
Official title: The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial
This study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level.
Read the detailed description
In many settings the majority of people with malaria particularly the poorest do not access formal care but access anti-malarials at the informal community level. ACTs were previously unaffordable to this group but this should change with the introduction of the AMFm. To avoid missing alternative causes of illness, reduce costs and delay the spread of resistance to ACTs, they need to be targeted at those who really need them. Studies in formal healthcare settings in Ghana have shown that where microscopy is not available, the impact of Rapid Diagnostic Tests (RDTs) can be substantial. RDTs are relatively simple to use, requiring fairly minimal training to master the mechanics of test preparation and interpretation Whether to deploy RDTs as part of AMFm is unclear at this time.Even in the absence of AMFm the question about how best to target antimalarials in the community is an important one, and will get more so as malaria incidence in many countries decreases, making presumptive treatment of all febrile illness as malaria increasingly ineffective. Locally chemical sellers are the closest equivalent as they provide the majority of treatments, especially for the poorest.
It is difficult to predict whether RDTs would make chemical sellers more commonly accessed (because patients prefer a diagnosis) , or less accessed (patients do not like having choice restricted/do not want a blood test etc). Studies in other settings suggest interventions to improve diagnosis by shop-keepers can be effective and cost-effective .
- Conditions
- Malaria
- Being tested
- Rapid Diagnostic Test
- Keywords
- Malaria, Rapid Diagnostic Tests for Malaria, Chemical Shops, Drug Shops, Diagnostics, Testing for Malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Diagnostic TestProcedure or surgery
Also called mRDT, RDT for malaria, RDT
Rapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests
| Study group | Role | What they receive |
|---|---|---|
| Rapid Diagnostic Test | Experimental | Rapid Diagnostic Test for malaria to direct antimalarial dispensing decisions in Chemical Shops Receives: Procedure: Rapid Diagnostic Test |
| No RDT | No intervention | Chemical sellers dispense antimalarials as per their own decisions without the benefit of test results |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms
Out of all clients who test negative when their blood slides are read by two independent expert microscopists, how many received an antimalarial treatment from the Licensed Chemical Seller
Measured: Until the estimated sample size is obtained or up to 2 yrs whichever comes first
Secondary outcomes (4)
Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm
Out of all clients who test negative by RDT, number who receive an antimalarial
Measured: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients tested using a Rapid Diagnostic Test
The number of clients who agree to be tested with an RDT Out of all clients who meet inclusion criteria
Measured: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients in each arm receiving an antibiotic
The number of clients in the intervention and control arms who receive an antibiotic out of the total number of clients recruited into each arm
Measured: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are
The number of clients who receive additional or alternative treatments in the intervention and control arms out of the total number recruited into both arms
Measured: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghana Health Services
- Sponsor type
- Other government
- Collaborators
- London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Evelyn K. Ansah, Ghana Health Services
- Investigators
- Evelyn K Ansah, MD,MPH,PhD, Principal investigator, Ghana Health ServicesChristopher C Whitty, BSc,MSc,PhD, Principal investigator, London School of Hygiene and Tropical MedicineMargaret Gyapong, BSc,MSc,PhD, Principal investigator, Ghana Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907672
- Sponsor's protocol ID
- ITDCVT68
- Other IDs
- MCDC_SF_02
- Acronym
- GhanaCommRDT
- Status last verified
- Jul 2013
- First submitted
- 2 Sep 2012
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ansah EK, Narh-Bana S, Affran-Bonful H, Bart-Plange C, Cundill B, Gyapong M, Whitty CJ. The impact of providing rapid diagnostic malaria tests on fever management in the private retail sector in Ghana: a cluster randomized trial. BMJ. 2015 Mar 4;350:h1019. doi: 10.1136/bmj.h1019.
PubMed 25739769
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01907672
- Acronym / sponsor ID
- GhanaCommRDT / ITDCVT68
- Conditions
- Malaria
- Keywords
- Malaria, Rapid Diagnostic Tests for Malaria, Chemical Shops, Drug Shops, Diagnostics, Testing for Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,748 participants (actual)
- Lead sponsor
- Ghana Health ServicesOther government
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Jul 2013 (estimated)
- 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.
This study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level.
Detailed description
In many settings the majority of people with malaria particularly the poorest do not access formal care but access anti-malarials at the informal community level. ACTs were previously unaffordable to this group but this should change with the introduction of the AMFm. To avoid missing alternative causes of illness, reduce costs and delay the spread of resistance to ACTs, they need to be targeted at those who really need them. Studies in formal healthcare settings in Ghana have shown that where microscopy is not available, the impact of Rapid Diagnostic Tests (RDTs) can be substantial. RDTs are relatively simple to use, requiring fairly minimal training to master the mechanics of test preparation and interpretation Whether to deploy RDTs as part of AMFm is unclear at this time.Even in the absence of AMFm the question about how best to target antimalarials in the community is an important one, and will get more so as malaria incidence in many countries decreases, making presumptive treatment of all febrile illness as malaria increasingly ineffective. Locally chemical sellers are the closest equivalent as they provide the majority of treatments, especially for the poorest.
It is difficult to predict whether RDTs would make chemical sellers more commonly accessed (because patients prefer a diagnosis) , or less accessed (patients do not like having choice restricted/do not want a blood test etc). Studies in other settings suggest interventions to improve diagnosis by shop-keepers can be effective and cost-effective .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid Diagnostic Test | Experimental | Procedure: Rapid Diagnostic TestRapid Diagnostic Test for malaria to direct antimalarial dispensing decisions in Chemical Shops |
| No RDT | No intervention | –Chemical sellers dispense antimalarials as per their own decisions without the benefit of test results |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients reporting to chemical seller with complaint of fever or who request for an anti-malarial drug
Key exclusion criteria (2 listed)
- Clients providing a prescription from a health facility
- Clients with signs of severe disease who will be referred onward
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 |
|---|---|---|
| Rapid Diagnostic TestAlso: mRDT, RDT for malaria, RDTRapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests | Procedure or surgery | Rapid Diagnostic Test |
Primary outcome
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms
Time frame: Until the estimated sample size is obtained or up to 2 yrs whichever comes first
Out of all clients who test negative when their blood slides are read by two independent expert microscopists, how many received an antimalarial treatment from the Licensed Chemical Seller
4 secondary outcomes
Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm
Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients tested using a Rapid Diagnostic Test
Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients in each arm receiving an antibiotic
Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are
Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- Derived from this study: PubMed 25739769Ansah EK, Narh-Bana S, Affran-Bonful H, Bart-Plange C, Cundill B, Gyapong M, Whitty CJ. The impact of providing rapid diagnostic malaria tests on fever management in the private retail sector in Ghana: a cluster randomized trial. BMJ. 2015 Mar 4;350:h1019. doi: 10.1136/bmj.h1019.
- Malaria Capacity Development ConsortiumLink provided by the sponsor.
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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.
Evelyn K Ansah, MD,MPH,PhD principal investigator
Ghana Health Services
Christopher C Whitty, BSc,MSc,PhD principal investigator
London School of Hygiene and Tropical Medicine
Margaret Gyapong, BSc,MSc,PhD principal investigator
Ghana Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapid Diagnostic Test in people with Malaria, run by Ghana Health Services at 1 site in Ghana.
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 2 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: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms (time frame: Until the estimated sample size is obtained or up to 2 yrs whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01907672, which also lists 1 linked publication.
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 25 Jul 2013.