Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria (REACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Yaounde
University of Nigeria, Enugu Campus
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01350752
First received: May 9, 2011
Last updated: October 10, 2013
Last verified: October 2013

May 9, 2011
October 10, 2013
May 2011
September 2012   (final data collection date for primary outcome measure)
Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria [ Time Frame: As patients exit the health facility ] [ Designated as safety issue: No ]

Recommended treatment is defined as

  • Febrile patients should be tested for malaria, either using microscopy or using a RDT
  • Artemisinin-based Combination Therapy (ACT) should be provided if the patient has a positive malaria test result
  • No antimalarial should be provided if patient has a negative test result.
Same as current
Complete list of historical versions of study NCT01350752 on ClinicalTrials.gov Archive Site
Health worker knowledge [ Time Frame: Two time points: (i) pre and post training evaluation and (ii) during the provider survey (3 months after implementation of interventions) ] [ Designated as safety issue: No ]
Mean score (and standard deviation) in HW knowledge on malaria diagnosis and treatment
Same as current
Not Provided
Not Provided
 
Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria
A Cost-effectiveness Analysis of Alternative Strategies for the Deployment of ACTs at the Community Level in Cameroon and Nigeria

The objective of the REACT project is to evaluate the effectiveness and cost-effectiveness implications of interventions designed to improve health worker practice in providing treatment for uncomplicated malaria to febrile patients attending health facilities in Cameroon and Nigeria.

NIGERIA

Two interventions will be evaluated: (i) provider intervention including introducing RDTs with detailed instructions, one-off training, job aides and on-the-site supportive supervisory visits and (ii) combined provider intervention [as under (i)]and community-based intervention (using primary and secondary schools as focal points)including school malaria events with drama, peer-health education, distribution of health education materials. Types of facilities include: public primary health facilities, private pharmacies and private Patent Medicine Dealers (PMDs)in Enugu State. The two sites in Enugu State are: Enugu urban (comprising of Enugu East, Enugu South and Enugu North Local government areas (LGA) and Udi LGA. The impact of the interventions will be evaluated using a 3-arm stratified, cluster randomized trial with a cluster defined as a geographical community and the two study sites as the strata. The three arms of the trial are:

  • Intervention - Provider intervention
  • Intervention - Provider plus school-based malaria activities
  • Control - Expected practice (once RDTs have been introduced)

CAMEROON

Two interventions will be evaluated: (i) the introduction of rapid diagnostic tests (RDTs) with basic provider training on malaria diagnosis and treatment; and (ii) the basic provider training [as under (i)] plus enhanced provider training to improve the quality of care that includes aspects of interactive self awareness, communication modules between health workers and also between health workers and patients. Types of facilities include: public district hospitals, public health centres (including integrated health centres), mission hospitals and mission health centres (including integrated health centres)in Yaoundé and Bamenda Health Districts. A stratified, cluster randomized trial will be used in which health facilities are the cluster and the two study sites are the strata. The three arms of the trial are:

  • Intervention - RDTs with basic provider training;
  • Intervention - RDTs with basic plus enhanced provider training;
  • Control - which represents current practice and neither intervention will be implemented.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Malaria
  • Behavioral: RDTs & Provider Training on Malaria Diagnosis and Treatment
    In Cameroon and Nigeria, malaria RDTs will be made available in health facilities and health care providers will receive training and job aids on malaria diagnosis and treatment. The training course covers the following topics: clinical and parasitological diagnosis of malaria, how to use a rapid diagnostic test, algorithm based on malaria test result, recommended treatment for confirmed malaria cases (including dosage and regimen for artemisinin-based combination therapies), advice for treatment of test-negative patients
    Other Names:
    • RDTs supplied: SD Bioline
    • Training course
  • Behavioral: Extended provider training (Cameroon only)
    2-day training course which supplements basic provider training on malaria diagnosis and treatment, which focuses on understanding change in malaria treatment guidelines, professionalism, and communication skills
    Other Names:
    • provider training
    • quality of care
  • Behavioral: School based malaria education (Nigeria only)
    Schools will be invited to undertake activities to raise awareness about malaria RDTs and treatment among children and community members. The intervention includes training teachers on peer health education, malaria awareness activities and providing support to hold a malaria educational event
    Other Names:
    • school based intervention
    • teachers
    • peer health educators
  • No Intervention: Control

    In Cameroon: Existing practice (with microscopy widely available)

    In Nigeria: Expected practice (RDTs will be provided with basic instructions)

  • Active Comparator: Provider Intervention

    Cameroon: Introduce malaria RDTs with basic provider training and job aids on malaria diagnosis and treatment

    Nigeria: Introduce malaria RDTs with provider training and job aids on malaria diagnosis and treatment

    Intervention: Behavioral: RDTs & Provider Training on Malaria Diagnosis and Treatment
  • Active Comparator: Extended intervention

    Cameroon: Introduce malaria RDTs with basic provider training and job aids on malaria diagnosis and treatment AND enhanced provider training on improving quality of care

    Nigeria: Introduce malaria RDTs with provider training and job aids on malaria diagnosis and treatment AND School-based malaria education intervention (with drama, peer-health education and distribution of health education materials)

    Interventions:
    • Behavioral: RDTs & Provider Training on Malaria Diagnosis and Treatment
    • Behavioral: Extended provider training (Cameroon only)
    • Behavioral: School based malaria education (Nigeria only)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6513
April 2014
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • the patient (or their caregiver) reports that the patient is suffering from a fever or has a history of fever in this illness episode
  • the patient is present at the health facility

Exclusion Criteria:

  • the patient is pregnant
  • the patient is <6 months old
  • the patient has signs or symptoms of severe malaria
Both
6 Months and older
No
Contact information is only displayed when the study is recruiting subjects
Cameroon,   Nigeria
 
NCT01350752
REACT
No
London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • University of Yaounde
  • University of Nigeria, Enugu Campus
Principal Investigator: Virginia Wiseman London School of Hygiene and Tropical Medicine
Principal Investigator: Wilfred Mbacham University of Yaounde I
Principal Investigator: Obinna Onwujekwe University of Nigeria
London School of Hygiene and Tropical Medicine
October 2013

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