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

Study Overview
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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.

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.

Official Title
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A Cost-effectiveness Analysis of Alternative Strategies for the Deployment of ACTs at the Community Level in Cameroon and Nigeria

Conditions
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Malaria

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


Participation Criteria
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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 Exclusion Criteria: the patient is pregnant the patient is <6 months old the patient has signs or symptoms of severe malaria

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>In Cameroon: Existing practice (with microscopy widely available) In Nigeria: Expected practice (RDTs will be provided with basic instructions) | |
| Active Comparator: Provider Intervention<br>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<br>* 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<br>* Other names: Training course;|
| Active Comparator: Extended intervention<br>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<br>* 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<br>* Other names: Training course;Behavioral: Extended provider training (Cameroon only)<br>* 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<br>* Other names: quality of care;Behavioral: School based malaria education (Nigeria only)<br>* 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<br>* Other names: peer health educators;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cost effectiveness, provider knowledge, schools