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
  Purpose

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.


Condition
Malaria
Anaemia

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: IMPACT2: Monitoring Interventions to Improve ACT Access and Targeting

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 33900
Study Start Date: May 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130155

Locations
Tanzania
Ifakara Health Institute
Dar es Salaam, Tanzania
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Ifakara Health Institute
Bill and Melinda Gates Foundation
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Catherine Goodman, LSHTM
ClinicalTrials.gov Identifier: NCT01130155     History of Changes
Other Study ID Numbers: PHGBVG04
Study First Received: May 24, 2010
Last Updated: June 22, 2011
Health Authority: United Kingdom: LSHTM Ethics Committee
United States: Institutional Review Board, US Centers for Disease Control and Prevention
Tanzania: Institutional Review Board, Ifakara Health Institute
Tanzania: National Institute for Medical Research

Keywords provided by London School of Hygiene and Tropical Medicine:
Antimalarials
Diagnosis
Access to treatment
Quality of care

Additional relevant MeSH terms:
Anemia
Malaria
Hematologic Diseases
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 18, 2014