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

London School of Hygiene and Tropical Medicine

Status: Completed

Conditions: Malaria

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01350752

REACT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,513 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,513 participants in 3 patient groups

Control

No Intervention group

Description:

In Cameroon: Existing practice (with microscopy widely available) In Nigeria: Expected practice (RDTs will be provided with basic instructions)

Provider Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: RDTs & Provider Training on Malaria Diagnosis and Treatment

Extended intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Extended provider training (Cameroon only)

Behavioral: School based malaria education (Nigeria only)

Behavioral: RDTs & Provider Training on Malaria Diagnosis and Treatment