IMPACT2: Monitoring Interventions to Improve Artemisinin-based Combination Therapy (ACT) Access and Targeting

• Conditions: Malaria; Anaemia

• Registration Number: NCT01130155
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-25
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ifakara Health Institute; 🇹🇿 Dar es Salaam, Tanzania