IMPACT2: Monitoring Interventions to Improve Artemisinin-based Combination Therapy (ACT) Access and Targeting (IMPACT2)
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|ClinicalTrials.gov Identifier: NCT01130155|
Recruitment Status : Unknown
Verified June 2011 by London School of Hygiene and Tropical Medicine.
Recruitment status was: Active, not recruiting
First Posted : May 25, 2010
Last Update Posted : June 23, 2011
It is generally agreed that artemisinin-based combination therapy (ACT) is the malaria therapy of choice but there is much less agreement about the best ACT-deployment strategies. Countries are now beginning to adopt policies to enhance ACT deployment that aim to address 2 key goals: (i) making ACTs more readily and speedily accessible to patients: or (ii) targeting ACTs to patients shown to have malaria parasitaemia.
The Tanzanian Government has secured funding to address both ACT access and targeting on a national scale. Access is to be improved through the distribution of subsidised ACTs through private facilities and retail drug shops under the Affordable Medicines Facility-malaria (AMFm). Targeting is to be addressed through enhancing microscopy and introducing rapid diagnostic tests (RDTs) in health facilities at every level of the system.
This study will evaluate these two interventions in 3 rural regions of Tanzania which are all expected to receive both interventions during the study period. The investigators will assess the effectiveness of the interventions in terms of coverage, equity, quality, adherence, and public health impact using a pre-post plausibility design based on before and after household, health facility and outlet surveys. The null hypothesis is that the interventions will have no impact on the coverage of prompt effective treatment for fever and malarial. In addition, the investigators will estimate the cost and cost-effectiveness of implementation from a health system and household perspective. Finally the investigators will explore the socio-cultural context and other factors that influence the implementation and outcome of the interventions.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||33900 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||IMPACT2: Monitoring Interventions to Improve ACT Access and Targeting|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||December 2012|
Households, and patients presenting at public health facilities in Mwanza Region
Households, and patients presenting at public health facilities in Mbeya Region
Households, and patients presenting at public health facilities in Mtwara Region
- Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs
- Percent of population reporting fever in last two weeks that got a finger/heel stick for a malaria diagnostic test within 24hrs/48hrs
- Proportion of patients presenting to public health facilities with fever who receive a diagnostic test for malaria
- Proportion of patients presenting to public health facilities with fever who receive rapid diagnostic test (RDT) for malaria and are appropriately treated according to RDT results
- Percent of patients receiving an ACT that adhered to full dose with correct dose timing
- Mean and median household cost per febrile episode
- The accuracy of RDTs performed by health workers
- Adequacy of health facility resources for diagnosis and treatment of malaria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130155
|Ifakara Health Institute|
|Dar es Salaam, Tanzania|
|Principal Investigator:||Catherine Goodman, PhD||LSHTM|
|Principal Investigator:||Patrick Kachur, MD||Centers for Disease Control and Prevention|
|Principal Investigator:||Salim Abdulla, PhD||Ifakara Health Institute|