Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

Quality Malaria Case Management In Under- Fives In Primary Health Care (Phc) Institutions In Bagamoyo And Kibaha Districts Of Coastal Tanzania:a Multicomponent Controlled Intervention Study

General objective: To improve the quality of fever case management in children in government health facilities in Tanzania Hypothesis:The training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while reducing the amount and costs of drugs

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Procedure: Clinical algorithm and microscopy diagnosis of malaria

Detailed Description

PHC facilities were eligible for the study if they were rural government owned; accessible by road during rainy season; and within 3 hours by car from Muhimbili University College of Health Sciences (MUCHS), Dar es Salaam

All children attending the 16 PHC facilities under the study during daytime were enrolled if they fulfilled the following criteria:

1. below five years of age
2. fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
4. the mother/guardian or caretaker consented to participate.

Patients with severe disease and/or general danger signs requiring inpatient care according to the IMCI guidelines were admitted or referred to the health centers or the district hospitals

• Study Type: Interventional
• Enrollment (Actual): 3131
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tanzania
  • Coast, Tanzania
    • dispensaries/health centers in Kibaha and Bagamoyo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. below five years of age
2. fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
4. the mother/guardian or caretaker consented to participate

Exclusion Criteria:

a) N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 3; Control
Experimental: 1; training in clinical algorithm plus microscopy	Procedure: Clinical algorithm and microscopy diagnosis of malaria; Clinical alogarithm The content of the package included; description of signs and symptoms of malaria disease; history taking relevant to malaria and physical examination; identification of danger signs and severe illness for referral; appropriate treatment; counseling patients on the use of drugs. Malaria microscopy. contents; make thick blood smears from patients with fever and stain with Giemsa; identify and count malaria parasites; maintain the microscope and store blood slides.
Experimental: 2; clinical algorithm	Procedure: Clinical algorithm and microscopy diagnosis of malaria; Clinical alogarithm The content of the package included; description of signs and symptoms of malaria disease; history taking relevant to malaria and physical examination; identification of danger signs and severe illness for referral; appropriate treatment; counseling patients on the use of drugs. Malaria microscopy. contents; make thick blood smears from patients with fever and stain with Giemsa; identify and count malaria parasites; maintain the microscope and store blood slides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
prescriptions of antibiotics, cost of drugs	Day 0
health outcome of the patients	Day 1-6, day 7

Collaborators and Investigators

• Sponsor: Muhimbili University of Health and Allied Sciences
• Collaborators: Karolinska Institutet
• Investigators: Study Director: Anders Bjorkman, MD, Karolinska Institutet

Publications and helpful links

General Publications

• Bates I, Bekoe V, Asamoa-Adu A. Improving the accuracy of malaria-related laboratory tests in Ghana. Malar J. 2004 Nov 1;3:38. doi: 10.1186/1475-2875-3-38.
• Ngasala B, Mubi M, Warsame M, Petzold MG, Massele AY, Gustafsson LL, Tomson G, Premji Z, Bjorkman A. Impact of training in clinical and microscopy diagnosis of childhood malaria on antimalarial drug prescription and health outcome at primary health care level in Tanzania: a randomized controlled trial. Malar J. 2008 Oct 2;7:199. doi: 10.1186/1475-2875-7-199.

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): March 1, 2004
• Study Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: May 28, 2008
• First Submitted That Met QC Criteria: May 28, 2008
• First Posted (Estimate): June 2, 2008

Study Record Updates

• Last Update Posted (Estimate): June 2, 2008
• Last Update Submitted That Met QC Criteria: May 28, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: malaria microscopy primary health care children
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: HF2003