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A Cluster-randomised Trial of Interventions to Improve Antimalarial Prescribing With Malaria Tests (TACT)

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ClinicalTrials.gov Identifier: NCT01292707
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : November 19, 2014
Sponsor:
Collaborators:
Kilimanjaro Christian Medical Centre, Tanzania
Ministry of Health, Tanzania
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE January 28, 2011
First Posted Date  ICMJE February 9, 2011
Last Update Posted Date November 19, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
The proportion of patients with a non-severe non-malarial illness prescribed a recommended antimalarial drug in a new consultation. [ Time Frame: 1year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Cluster-randomised Trial of Interventions to Improve Antimalarial Prescribing With Malaria Tests
Official Title  ICMJE A Cluster-randomised Trial of Health Worker and Community Interventions to Improve Adherence to National Guidelines for the Use of ACTs in Tanzania
Brief 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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Malaria
Intervention  ICMJE
  • Behavioral: Control
    Standard national training
  • Behavioral: HW
    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
  • Behavioral: HWC
    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 Arms  ICMJE
  • Active Comparator: Control
    Prescribing staff in control facilities will receive the standard package of RDT training that is being provided by NMCP in Tanzania
    Intervention: Behavioral: Control
  • Active Comparator: HW
    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.
    Intervention: Behavioral: HW
  • Active Comparator: HWC
    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.
    Intervention: Behavioral: HWC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2011)
1152
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01292707
Other Study ID Numbers  ICMJE ACTc TACT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Kilimanjaro Christian Medical Centre, Tanzania
  • Ministry of Health, Tanzania
Investigators  ICMJE
Principal Investigator: Hugh Reyburn, MD London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP