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
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Cost-effectiveness Analysis of Alternative Strategies for the Deployment of ACTs at the Community Level in Cameroon and Nigeria

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 6513
Study Start Date: May 2011
Estimated Study Completion Date: April 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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)

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

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01350752

Locations
Cameroon
Various health facilities
Yaounde, Central Region, Cameroon
Various health facilities
Bamenda, North West Region, Cameroon
Nigeria
Various health facilities
Enugu, Enugu State, Nigeria
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Yaounde
University of Nigeria, Enugu Campus
Investigators
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
  More Information

Additional Information:
No publications provided by London School of Hygiene and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01350752     History of Changes
Other Study ID Numbers: REACT
Study First Received: May 9, 2011
Last Updated: October 10, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
cost effectiveness
provider knowledge
schools

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014