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

• ClinicalTrials.gov Identifier: NCT01292707
• Recruitment Status: Completed
• First Posted: February 9, 2011
• Last Update Posted: November 19, 2014
• Sponsor: London School of Hygiene and Tropical Medicine
• 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: January 28, 2011
• First Posted Date: February 9, 2011
• Last Update Posted Date: November 19, 2014
• Study Start Date: February 2011
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Cluster-randomised Trial of Interventions to Improve Antimalarial Prescribing With Malaria Tests
• 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Malaria

Intervention

• 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

• 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 *

• 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.
• Cundill 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.
• Chandler 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 8, 2011): 1152
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2012
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Tanzania

Administrative Information

• NCT Number: NCT01292707
• Other Study ID Numbers: ACTc TACT
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: London School of Hygiene and Tropical Medicine
• Study Sponsor: London School of Hygiene and Tropical Medicine

Collaborators

• Kilimanjaro Christian Medical Centre, Tanzania
• Ministry of Health, Tanzania

Investigators

• 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