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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6513 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

In Cameroon: Existing practice (with microscopy widely available)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

RDTs & Provider Training on Malaria Diagnosis and Treatment

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

RDTs & Provider Training on Malaria Diagnosis and Treatment

Intervention Type BEHAVIORAL

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

Extended provider training (Cameroon only)

Intervention Type BEHAVIORAL

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

School based malaria education (Nigeria only)

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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RDTs supplied: SD Bioline Training course provider training quality of care school based intervention teachers peer health educators

Eligibility Criteria

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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