A Cluster-randomised Trial of Interventions to Improve Antimalarial Prescribing With Malaria Tests - Full Text View

Purpose

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.

Condition	Intervention
Malaria	Behavioral: Control Behavioral: HW Behavioral: HWC


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
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

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:

The proportion of patients with a non-severe non-malarial illness prescribed a recommended antimalarial drug in a new consultation. [ Time Frame: 1year ] [ Designated as safety issue: No ]


Enrollment:	1152
Study Start Date:	February 2011
Study Completion Date:	April 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Control Prescribing staff in control facilities will receive the standard package of RDT training that is being provided by NMCP in Tanzania	Behavioral: Control Standard national training
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.	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
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.	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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292707

Locations


Tanzania
Joint Malaria Programme
Moshi, Kilimanjaro, Tanzania

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Kilimanjaro Christian Medical Centre, Tanzania

Ministry of Health, Tanzania

Investigators


Principal Investigator:	Hugh Reyburn, MD	London School of Hygiene and Tropical Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT01292707 History of Changes
Other Study ID Numbers:	ACTc TACT
Study First Received:	January 28, 2011
Last Updated:	November 18, 2014
Health Authority:	United Kingdom: Data Safety and Monitoring Board, Chairperson Professor Alison Grant, Department of Tropical and Infectious Disease, LSHTM, Keppel St, London WC1E7HT. Contact alison.grant@lshtm.ac.uk Tanzania: National Institute for Medical Research, contact: +255222121400; headquarters@nimr.or.tz

Keywords provided by London School of Hygiene and Tropical Medicine:


malaria rdt fever treatment

Additional relevant MeSH terms:


Malaria Protozoan Infections Parasitic Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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