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

NCT01130155 | Unknown DMC

• 1 other identifier: PHGBVG04
• Study Type: observational
• Target: 33,900
• Locations: 1 country
• Sites: 1

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

Keywords

Antimalarials; Diagnosis; Access to treatment; Quality of care

Outcome Measures

Primary Outcomes (4)

• Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs

• Percent of population reporting fever in last two weeks that got a finger/heel stick for a malaria diagnostic test within 24hrs/48hrs

• Proportion of patients presenting to public health facilities with fever who receive a diagnostic test for malaria

• 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 (4)

• Percent of patients receiving an ACT that adhered to full dose with correct dose timing

• Mean and median household cost per febrile episode

• The accuracy of RDTs performed by health workers

• Adequacy of health facility resources for diagnosis and treatment of malaria

Study Arms (3)

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 Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Household survey - Children less than 3 months of age will be excluded from providing a blood sample
• Health facility survey - Signs of severe illness

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Ifakara Health Institute: collaborator
• Centers for Disease Control and Prevention: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Ifakara Health Institute

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

Malaria; Anemia; Disease

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Goodman, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Patrick Kachur, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Salim Abdulla, PhD

  Ifakara Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 25, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

TA (1)