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

Not Applicable

Completed

• Conditions: Malaria

• Registration Number: NCT01350752
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

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

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Primary Completion: 2012-09
• Status Verified: 2013-10
• Study Completion: 2015-01
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6513

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria	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.

Secondary Outcome Measures

Name	Time	Method
Health worker knowledge	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

Trial Locations

Locations (1)

Various health facilities; 🇳🇬 Enugu, Enugu State, Nigeria