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

Malaria Clinical Trial

— IMPACT2  

Official title:

IMPACT2: Monitoring Interventions to Improve ACT Access and Targeting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01130155
• Other study ID #: PHGBVG04
• Status: Active, not recruiting
• Phase: N/A
• First received: May 24, 2010
• Last updated: June 22, 2011
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2011
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: LSHTM Ethics CommitteeUnited States: Institutional Review Board, US Centers for Disease Control and PreventionTanzania: Institutional Review Board, Ifakara Health InstituteTanzania: National Institute for Medical Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33900
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months and older

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anaemia
• Malaria

Locations

Country	Name	City	State
Tanzania	Ifakara Health Institute	Dar es Salaam

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention, Ifakara Health Institute

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs			No
Primary	Percent of population reporting fever in last two weeks that got a finger/heel stick for a malaria diagnostic test within 24hrs/48hrs			No
Primary	Proportion of patients presenting to public health facilities with fever who receive a diagnostic test for malaria			No
Primary	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			No
Secondary	Percent of patients receiving an ACT that adhered to full dose with correct dose timing			No
Secondary	Mean and median household cost per febrile episode			No
Secondary	The accuracy of RDTs performed by health workers			No
Secondary	Adequacy of health facility resources for diagnosis and treatment of malaria			No

External Links

•   ACT Consortium