Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

Sponsor

Muhimbili University of Health and Allied Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00687895

Collaborator

Karolinska Institutet (Other)

3,131

Enrollment

Location

Arms

Duration (Months)

390.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malaria	Procedure: Clinical algorithm and microscopy diagnosis of malaria	Phase 4

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:

below five years of age
fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
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 Design

Study Type:

Interventional

Actual Enrollment :

3131 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Mar 1, 2004

Actual Study Completion Date :

Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: 3 Control

Arm

Intervention/Treatment

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

No Intervention: 3

Control

Outcome Measures

Primary Outcome Measures

the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms [Day 0]

Secondary Outcome Measures

prescriptions of antibiotics, cost of drugs [Day 0]
health outcome of the patients [Day 1-6, day 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	dispensaries/health centers in Kibaha and Bagamoyo	Coast		Tanzania

Sponsors and Collaborators

Muhimbili University of Health and Allied Sciences
Karolinska Institutet

Investigators

Study Director: Anders Bjorkman, MD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00687895

Other Study ID Numbers:

HF2003

First Posted:

Jun 2, 2008

Last Update Posted:

Jun 2, 2008

Last Verified:

May 1, 2008

Keywords provided by , ,

malaria microscopy primary health care children

Additional relevant MeSH terms:

Malaria

Study Results

No Results Posted as of Jun 2, 2008