Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

Phase 4

Completed

• Conditions: Malaria
• Interventions: Procedure: Clinical algorithm and microscopy diagnosis of malaria

• Registration Number: NCT00687895
• Lead Sponsor: Muhimbili University of Health and Allied Sciences

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

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 Timeline

• Study Start: 2003-07
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Status Verified: 2008-05
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-28
• Last Update Submitted: 2008-05-28
• Study First Posted: 2008-06-02
• Last Update Posted: 2008-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3131

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Clinical algorithm and microscopy diagnosis of malaria	training in clinical algorithm plus microscopy
2	Clinical algorithm and microscopy diagnosis of malaria	clinical algorithm

Primary Outcome Measures

Name	Time	Method
the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms	Day 0

Secondary Outcome Measures

Name	Time	Method
prescriptions of antibiotics, cost of drugs	Day 0
health outcome of the patients	Day 1-6, day 7

Trial Locations

Locations (1)

dispensaries/health centers in Kibaha and Bagamoyo; 🇹🇿 Coast, Tanzania