Overview

This trial is active, not recruiting.

Conditions malaria, anaemia
Sponsor London School of Hygiene and Tropical Medicine
Collaborator Ifakara Health Institute
Start date May 2010
End date September 2012
Trial size 33900 participants
Trial identifier NCT01130155, PHGBVG04

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective cross-sectional
Arm
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

Primary Outcomes

Measure
Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs
time frame:
Percent of population reporting fever in last two weeks that got a finger/heel stick for a malaria diagnostic test within 24hrs/48hrs
time frame:
Proportion of patients presenting to public health facilities with fever who receive a diagnostic test for malaria
time frame:
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
time frame:

Secondary Outcomes

Measure
Percent of patients receiving an ACT that adhered to full dose with correct dose timing
time frame:
Mean and median household cost per febrile episode
time frame:
The accuracy of RDTs performed by health workers
time frame:
Adequacy of health facility resources for diagnosis and treatment of malaria
time frame:

Eligibility Criteria

Male or female participants at least 3 months old.

Inclusion Criteria: - Household survey - All consenting and assenting residents available in selected households - Health facility survey - patients presenting to selected health facilities with fever or history of fever in the prior 24 hours; Age >= 3 months, or Weight ≥ 5 kg; First visit to this health facility for this illness episode Exclusion Criteria: - Household survey - Children less than 3 months of age will be excluded from providing a blood sample - Health facility survey - Signs of severe illness

Additional Information

Official title IMPACT2: Monitoring Interventions to Improve ACT Access and Targeting
Principal investigator Catherine Goodman, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine.