Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria (REACT)
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| First Received Date ICMJE | May 9, 2011 | ||||||||||||
| Last Updated Date | January 9, 2012 | ||||||||||||
| Start Date ICMJE | May 2011 | ||||||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria [ Time Frame: As patients exit the health facility ] [ Designated as safety issue: No ] Recommended treatment is defined as
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01350752 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Health worker knowledge [ Time Frame: Two time points: (i) pre and post training evaluation and (ii) during the provider survey (3 months after implementation of interventions) ] [ Designated as safety issue: No ] Mean score (and standard deviation) in HW knowledge on malaria diagnosis and treatment |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria | ||||||||||||
| Official Title ICMJE | A Cost-effectiveness Analysis of Alternative Strategies for the Deployment of ACTs at the Community Level in Cameroon and Nigeria | ||||||||||||
| 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. |
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| 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:
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:
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Malaria | ||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Wiseman V, Ogochukwu E, Emmanuel N, Lindsay J M, Bonnie C, Jane E, Eloka U, Benjamin U, Obinna O. A cost-effectiveness analysis of provider and community interventions to improve the treatment of uncomplicated malaria in Nigeria: study protocol for a randomized controlled trial. Trials. 2012 Jun 9;13:81. doi: 10.1186/1745-6215-13-81. | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 8900 | ||||||||||||
| Estimated Completion Date | April 2012 | ||||||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 6 Months and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Cameroon, Nigeria | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01350752 | ||||||||||||
| Other Study ID Numbers ICMJE | REACT | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | London School of Hygiene and Tropical Medicine | ||||||||||||
| Study Sponsor ICMJE | London School of Hygiene and Tropical Medicine | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | London School of Hygiene and Tropical Medicine | ||||||||||||
| Verification Date | January 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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