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

Malaria Clinical Trial

— REACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350752
• Other study ID #: REACT
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: September 8, 2016
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: October 2013
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6513
• Est. completion date: January 2015
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Cameroon	Various health facilities	Bamenda	North West Region
Cameroon	Various health facilities	Yaounde	Central Region
Nigeria	Various health facilities	Enugu	Enugu State

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	University of Nigeria, Enugu Campus, University of Yaounde

Countries where clinical trial is conducted

Cameroon,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No

External Links

•   ACT Consortium