Clinical trial NCT01130155: IMPACT2: Monitoring Interventions to Improve Artemisinin-based Combination Therapy (ACT) Access and Targeting
Official title: IMPACT2: Monitoring Interventions to Improve ACT Access and Targeting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malaria
Anaemia
Keywords: Antimalarials
Diagnosis
Access to treatment
Quality of care
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Ifakara Health Institute
name: Centers for Disease Control and Prevention
name: Bill and Melinda Gates Foundation
First posted: 2010-05-25
Enrollment: 33900
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs
measure: Percent of population reporting fever in last two weeks that got a finger/heel stick for a malaria diagnostic test within 24hrs/48hrs
measure: Proportion of patients presenting to public health facilities with fever who receive a diagnostic test for malaria
measure: 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 outcomes:
measure: Percent of patients receiving an ACT that adhered to full dose with correct dose timing
measure: Mean and median household cost per febrile episode
measure: The accuracy of RDTs performed by health workers
measure: Adequacy of health facility resources for diagnosis and treatment of malaria
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Ifakara Health Institute
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Catherine Goodman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Patrick Kachur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Institute
name: Salim Abdulla, PhD
role: PRINCIPAL_INVESTIGATOR
References: