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

NCT01130155 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 33900

Last updated 2011-06-23

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER
  • Centers for Disease Control and Prevention

    collaborator FED
  • Bill and Melinda Gates Foundation

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Catherine Goodman, PhD · London School of Hygiene and Tropical Medicine

  • Patrick Kachur, MD · Centers for Disease Control and Prevention

  • Salim Abdulla, PhD · Ifakara Health Institute

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • Tanzania

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01130155 on ClinicalTrials.gov