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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ifakara Health Institute
Bill and Melinda Gates Foundation
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01130155
First received: May 24, 2010
Last updated: June 22, 2011
Last verified: June 2011

May 24, 2010
June 22, 2011
May 2010
September 2012   (final data collection date for primary outcome measure)
  • Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs [ Designated as safety issue: No ]
  • Percent of population reporting fever in last two weeks that got a finger/heel stick for a malaria diagnostic test within 24hrs/48hrs [ Designated as safety issue: No ]
  • Proportion of patients presenting to public health facilities with fever who receive a diagnostic test for malaria [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01130155 on ClinicalTrials.gov Archive Site
  • Percent of patients receiving an ACT that adhered to full dose with correct dose timing [ Designated as safety issue: No ]
  • Mean and median household cost per febrile episode [ Designated as safety issue: No ]
  • The accuracy of RDTs performed by health workers [ Designated as safety issue: No ]
  • Adequacy of health facility resources for diagnosis and treatment of malaria [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
IMPACT2: Monitoring Interventions to Improve Artemisinin-based Combination Therapy (ACT) Access and Targeting
IMPACT2: Monitoring Interventions to Improve ACT Access and Targeting

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.

Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

For the household survey, all selected households in Mtwara, and Mwanza and Mbeya Regions in Tanzania.

For the health facility survey patients presenting to selected health facilities with fever or history of fever in the prior 24 hours.

  • Malaria
  • Anaemia
Not Provided
  • Mwanza Region
    Households, and patients presenting at public health facilities in Mwanza Region
  • Mbeya Region
    Households, and patients presenting at public health facilities in Mbeya Region
  • Mtwara Region
    Households, and patients presenting at public health facilities in Mtwara Region
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
33900
December 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
3 Months and older
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT01130155
PHGBVG04
Yes
Catherine Goodman, LSHTM
London School of Hygiene and Tropical Medicine
  • Ifakara Health Institute
  • Centers for Disease Control and Prevention
  • Bill and Melinda Gates Foundation
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
London School of Hygiene and Tropical Medicine
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP