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

NCT ID: NCT01130155

Last Updated: 2011-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 33900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-12-31

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.

Conditions

Malaria; Anaemia

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Mwanza Region

Households, and patients presenting at public health facilities in Mwanza Region

No interventions assigned to this group

Mbeya Region

Households, and patients presenting at public health facilities in Mbeya Region

No interventions assigned to this group

Mtwara Region

Households, and patients presenting at public health facilities in Mtwara Region

No interventions assigned to this group

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

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ifakara Health Institute

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

LSHTM

Principal Investigators

Catherine Goodman, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Patrick Kachur, MD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Salim Abdulla, PhD

Role: PRINCIPAL_INVESTIGATOR

Ifakara Health Institute

Locations

Ifakara Health Institute

Dar es Salaam, , Tanzania

Countries

Tanzania

Other Identifiers

PHGBVG04

Identifier Type: -

Identifier Source: org_study_id