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

September 8, 2016 updated by: London School of Hygiene and Tropical Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6513

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
    • Central Region
      • Yaounde, Central Region, Cameroon
        • Various health facilities
    • North West Region
      • Bamenda, North West Region, Cameroon
        • Various health facilities
  • Nigeria
    • Enugu State
      • Enugu, Enugu State, Nigeria
        • Various health facilities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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. This involved 1-day training on: 1) Malaria Diagnosis; 2) Rapid Diagnostic Testing; 3) Malaria Treatment. These modules explain that all febrile patients should be tested for malaria; procedures for using an RDT; that confirmed cases of uncomplicated malaria should be treated with an ACT; and test-negative patients should not be given an antimalarial.

Nigeria: Introduce malaria RDTs with provider training and job aids on malaria diagnosis and treatment. This involved a 2-day training workshop and support visits. The training covered the following topics: causes and symptoms of malaria; demonstration on how to use an RDT; updated malaria guidelines; and communications skills. The training used a combination of seminars and facilitated small-group work, such as a treatment algorithm game, problem-solving exercises, self-developed participatory drama and role-playing.
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. Clinicians received 3-days of training: the first day was identical to the basic intervention, while the remainder of the course covered three additional modules targeting improvements in quality of care: 4) Adapting to Change; 5) Professionalism; 6) Communicating Effectively.

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). In addition, teachers and Peer Health Educators were offered support to hold malaria events in which parents, guardians, and other community members could participate in the same types of activities.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria
Time Frame: As patients exit the health facility

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.
As patients exit the health facility

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Mean score (and standard deviation) in HW knowledge on malaria diagnosis and treatment
Two time points: (i) pre and post training evaluation and (ii) during the provider survey (3 months after implementation of interventions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REACT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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