MalariaTACTNCT01292707
A Cluster-randomised Trial of Interventions to Improve Antimalarial Prescribing With Malaria Tests
A study testing HW and HWC in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial summary
Background. Overdiagnosis of malaria is widespread in health facilities throughout Africa, a situation that is unsustainable given the relatively high cost of artemisinin combination therapy (ACTs) compared to older antimalarials. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- What is being tested?
- HW and HWC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,152 participants
- Where
- 1 siteTanzania
- Study dates
- Feb 2011to Apr 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Health Facility Inclusion criteria:
- Located in lowland Muheza, adjoining wards of Handeni, or any area of Moshi Rural Districts
- Health facilities that are registered with the District Health Authority
- Receives Government supplies of ALu and qualifies for RDT supply
- Agrees to exclusive use of RDT for routine diagnosis of first consultations for possible malaria
- Accessible by 4-wd vehicle throughout the year.
- Availability of data on proportion of consultations diagnosed with malaria in 2008 (or earliest available year)
Health Facility Exclusion:
- Presence of other research in the immediate area where study procedures could bias outcomes in either study.
- Fewer than 500 cases per year were reported in 2005 or 2006.
Patient Inclusion:
- All patients with non-severe illness in first consultations.
- Patient Exclusion
- Patients who have been referred to the next level of care
- Patient refuses consent to exit survey
- Follow-up consultations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster-randomised Trial of Health Worker and Community Interventions to Improve Adherence to National Guidelines for the Use of ACTs in Tanzania
Background.
Overdiagnosis of malaria is widespread in health facilities throughout Africa, a situation that is unsustainable given the relatively high cost of artemisinin combination therapy (ACTs) compared to older antimalarials. In addition it often denies patients treatment for their actual illness and generates unreliable data for health planners. For these reasons the National Malaria Control Programme introduced revised guidelines for malaria diagnosis and treatment in 2006 restricting the recommendation for antimalarial treatment in patients over the age of 5 years to those with a positive blood slide or malaria rapid diagnostic tests (RDTs) result. To support this, RDTs will be introduced into primary care health facilities in Tanzania starting in 2009.
Read more
The high accuracy of current rapid diagnostic tests (RDTs) provides the potential for a cost-effective solution to the problem of malaria overdiagnosis. However, RDTs with revised guidelines to restrict malaria diagnoses to RDT-positive patients have been unsuccessful unless accompanied by unsustainable levels of supervision and training.
Primary objective.
To conduct a trial of interventions directed at prescribers or prescribers and communities compared to control groups to improve adherence to national guidelines for prescription of antimalarial treatment when supported by RDTs in primary health care facilities in NE Tanzania.
Methods
All 60 participating health facilities will receive RDTs and basic training in their use and a copy of current NMCP/MOH guidelines for each prescribing staff member. A health worker intervention arm will, in addition, receive workplace-based interactive training and messages from senior staff A health worker-community arm will receive the same training as the health worker arm and in addition leaflets will be provided to RDT-tested patients providing information on the test and the treatment given. All training materials will be approved by NMCP in Tanzania as being consistent with current national guidelines but with the addition that prescribers will be asked to follow RDT results in prescribing for patients of any age This policy is in line with the most recent revision to WHO guidelines and is supported by NMCP in Tanzania.
Study outcomes will be recorded through a 40% (2 days per week) exit survey of patients. Anthropological and economics studies will assess the costs and acceptability of interventions.
- Conditions
- Malaria
- Being tested
- Control, HW, HWC
- Keywords
- malaria, rdt, fever, treatment
- Medical subject headings
- Malaria, Rhabdoid Tumor, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Standard national training
HWBehavioural
Prescribing staff in the intervention facilities will receive the same package of nationally-approved training in RDT use as will be provided to prescribers in control facilities. Following this, prescribers in the intervention facilities will be invited to participate in 3 small group training modules delivered in an interactive style lasting approximately 11/2 hours, with one session repeated between the 6th and 7th month of the trial
HWCBehavioural
The health worker-community arm will receive the same intervention as the health workers arm but with the addition of an intervention aimed at patients. This will consist of community sensitisation, clinic posters and providing a leaflet to each RDT-tested patient or caretaker giving details of the test and the corresponding treatment provided.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Prescribing staff in control facilities will receive the standard package of RDT training that is being provided by NMCP in Tanzania Receives: Behavioral: Control |
| HW | Active comparator | Prescribing staff in the intervention facilities will receive the same package of nationally-approved training in RDT use as will be provided to prescribers in control facilities. Following this, prescribers in the intervention facilities will be invited to participate in 3 small group training modules delivered in an interactive style lasting approximately 11/2 hours, with one session repeated between the 6th and 7th month of the trial. Receives: Behavioral: HW |
| HWC | Active comparator | The health worker-community arm will receive the same intervention as the health workers arm but with the addition of an intervention aimed at patients. This will consist of community sensitisation, clinic posters and providing a leaflet to each RDT-tested patient or caretaker giving details of the test and the corresponding treatment provided. Receives: Behavioral: HWC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a non-severe non-malarial illness prescribed a recommended antimalarial drug in a new consultation.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,152 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, Ministry of Health, Tanzania
- Responsible party
- Sponsor
- Investigators
- Hugh Reyburn, MD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292707
- Sponsor's protocol ID
- ACTc TACT
- Acronym
- TACT
- Status last verified
- Nov 2014
- First submitted
- 28 Jan 2011
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leurent B, Reyburn H, Muro F, Mbakilwa H, Schellenberg D. Monitoring patient care through health facility exit interviews: an assessment of the Hawthorne effect in a trial of adherence to malaria treatment guidelines in Tanzania. BMC Infect Dis. 2016 Feb 3;16:59. doi: 10.1186/s12879-016-1362-0.
PubMed 26842751Cundill B, Mbakilwa H, Chandler CI, Mtove G, Mtei F, Willetts A, Foster E, Muro F, Mwinyishehe R, Mandike R, Olomi R, Whitty CJ, Reyburn H. Prescriber and patient-oriented behavioural interventions to improve use of malaria rapid diagnostic tests in Tanzania: facility-based cluster randomised trial. BMC Med. 2015 May 15;13:118. doi: 10.1186/s12916-015-0346-z.
PubMed 25980737Chandler CI, Meta J, Ponzo C, Nasuwa F, Kessy J, Mbakilwa H, Haaland A, Reyburn H. The development of effective behaviour change interventions to support the use of malaria rapid diagnostic tests by Tanzanian clinicians. Implement Sci. 2014 Jun 26;9:83. doi: 10.1186/1748-5908-9-83.
PubMed 24969367
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomised Trial of Health Worker and Community Interventions to Improve Adherence to National Guidelines for the Use of ACTs in Tanzania
- ClinicalTrials.gov ID
- NCT01292707
- Acronym / sponsor ID
- TACT / ACTc TACT
- Conditions
- Malaria
- Keywords
- malaria, rdt, fever, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,152 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, Ministry of Health, Tanzania
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Feb 2011 (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.
Background.
Overdiagnosis of malaria is widespread in health facilities throughout Africa, a situation that is unsustainable given the relatively high cost of artemisinin combination therapy (ACTs) compared to older antimalarials. In addition it often denies patients treatment for their actual illness and generates unreliable data for health planners. For these reasons the National Malaria Control Programme introduced revised guidelines for malaria diagnosis and treatment in 2006 restricting the recommendation for antimalarial treatment in patients over the age of 5 years to those with a positive blood slide or malaria rapid diagnostic tests (RDTs) result. To support this, RDTs will be introduced into primary care health facilities in Tanzania starting in 2009.
The high accuracy of current rapid diagnostic tests (RDTs) provides the potential for a cost-effective solution to the problem of malaria overdiagnosis. However, RDTs with revised guidelines to restrict malaria diagnoses to RDT-positive patients have been unsuccessful unless accompanied by unsustainable levels of supervision and training.
Primary objective.
To conduct a trial of interventions directed at prescribers or prescribers and communities compared to control groups to improve adherence to national guidelines for prescription of antimalarial treatment when supported by RDTs in primary health care facilities in NE Tanzania.
Methods
All 60 participating health facilities will receive RDTs and basic training in their use and a copy of current NMCP/MOH guidelines for each prescribing staff member. A health worker intervention arm will, in addition, receive workplace-based interactive training and messages from senior staff A health worker-community arm will receive the same training as the health worker arm and in addition leaflets will be provided to RDT-tested patients providing information on the test and the treatment given. All training materials will be approved by NMCP in Tanzania as being consistent with current national guidelines but with the addition that prescribers will be asked to follow RDT results in prescribing for patients of any age This policy is in line with the most recent revision to WHO guidelines and is supported by NMCP in Tanzania.
Study outcomes will be recorded through a 40% (2 days per week) exit survey of patients. Anthropological and economics studies will assess the costs and acceptability of interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlPrescribing staff in control facilities will receive the standard package of RDT training that is being provided by NMCP in Tanzania |
| HW | Active comparator | Behavioral: HWPrescribing staff in the intervention facilities will receive the same package of nationally-approved training in RDT use as will be provided to prescribers in control facilities. Following this, prescribers in the intervention facilities will be invited to participate in 3 small group training modules delivered in an interactive style lasting approximately 11/2 hours, with one session repeated between the 6th and 7th month of the trial. |
| HWC | Active comparator | Behavioral: HWCThe health worker-community arm will receive the same intervention as the health workers arm but with the addition of an intervention aimed at patients. This will consist of community sensitisation, clinic posters and providing a leaflet to each RDT-tested patient or caretaker giving details of the test and the corresponding treatment provided. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| ControlStandard national training | Behavioural | Control |
| HWPrescribing staff in the intervention facilities will receive the same package of nationally-approved training in RDT use as will be provided to prescribers in control facilities. Following this, prescribers in the intervention facilities will be invited to participate in 3 small group training modules delivered in an interactive style lasting approximately 11/2 hours, with one session repeated between the 6th and 7th month of the trial | Behavioural | HW |
| HWCThe health worker-community arm will receive the same intervention as the health workers arm but with the addition of an intervention aimed at patients. This will consist of community sensitisation, clinic posters and providing a leaflet to each RDT-tested patient or caretaker giving details of the test and the corresponding treatment provided. | Behavioural | HWC |
Primary outcome
The proportion of patients with a non-severe non-malarial illness prescribed a recommended antimalarial drug in a new consultation.
Time frame: 1year
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 19 Nov 2014.
- Derived from this study: PubMed 26842751Leurent B, Reyburn H, Muro F, Mbakilwa H, Schellenberg D. Monitoring patient care through health facility exit interviews: an assessment of the Hawthorne effect in a trial of adherence to malaria treatment guidelines in Tanzania. BMC Infect Dis. 2016 Feb 3;16:59. doi: 10.1186/s12879-016-1362-0.
- Derived from this study: PubMed 25980737Cundill B, Mbakilwa H, Chandler CI, Mtove G, Mtei F, Willetts A, Foster E, Muro F, Mwinyishehe R, Mandike R, Olomi R, Whitty CJ, Reyburn H. Prescriber and patient-oriented behavioural interventions to improve use of malaria rapid diagnostic tests in Tanzania: facility-based cluster randomised trial. BMC Med. 2015 May 15;13:118. doi: 10.1186/s12916-015-0346-z.
- Derived from this study: PubMed 24969367Chandler CI, Meta J, Ponzo C, Nasuwa F, Kessy J, Mbakilwa H, Haaland A, Reyburn H. The development of effective behaviour change interventions to support the use of malaria rapid diagnostic tests by Tanzanian clinicians. Implement Sci. 2014 Jun 26;9:83. doi: 10.1186/1748-5908-9-83.
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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.
Hugh Reyburn, MD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HW and HWC in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2014. 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 Tanzania. 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?
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 patients with a non-severe non-malarial illness prescribed a recommended antimalarial drug in a new consultation. (time frame: 1year). 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 NCT01292707, which also lists 3 linked publications.
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 19 Nov 2014.