Acceptability and Cost Effectiveness of Home Based Management of Fever: Different Strategies

This study has been terminated.
(Study never started)
Sponsor:
Collaborators:
World Health Organization
Institute for Epidemiology and Social Medicine, Aarhus University, Denmark
Information provided by:
DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT00259142
First received: November 25, 2005
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

Malaria remains a major cause of morbidity and mortality particularly among children < 5 years in Uganda. Due to inaccessibility many children die before they reach the health facility. The Home Based Management of Fever (HBMF) strategy was adopted in Uganda as a mean to improve access to early and appropriate treatment of fever at community level. Pre-packed chloroquine with sulphadoxine-pyrimethamine (HOMAPAK) is provided through Community Drug Distributors(CDDs). Initial evaluation showed underutilization of the CDDs (15%). This cast doubt on community acceptability, accessibility as well as its feasibility and cost effectiveness. This 3-year project intends to compare community acceptability and cost effectiveness of two HOMAPAK distribution methods. The current CDD-based HOMAPAK distribution versus home-based HOMAPAK distribution. The study hypothesis is that "home-based HOMAPAK distribution is more acceptable to the community and more cost effective than the CDD based HOMAPAK A non randomised community study will be conducted in two sub-counties of Mukono district. In the control arm, HOMAPAKs will be distributed through the CDDs while in the intervention arm, HOMAPAKs will be directly distributed to the caretakers in the homes. The study population are caretakers and their children < 5 years. At baseline a survey (Phase 1) with a sample size 657 in each study area will assess the common drugs stocked at home to treat malaria and the health seeking behaviour for malaria for children < 5 years and to determine the prevalence of malaria parasitaemia and anaemia among children < 5 years. Phase 2 includes the intervention. The villages will be assigned to either the control or intervention arm. Anaemia and malaria parasitaemia among children with fever will be assessed through active case finding. The impact of either distribution system on accessibility, acceptability, sustainability, compliance, cost effectiveness and malaria morbidity will be assessed during the evaluation phase. Health education messages on malaria prevention and treatment will be given to both communities. Drug misuse will be limited by distributing HOMAPAKs according to the number of children <5years in each household. HOMAPAK will only be replenished after the caretaker returns a used packet to the CDD.


Condition Intervention
Fever
Anaemia
Malaria
Drug: Chloroquine, sulphadoxine-pyrimethamine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Community Acceptability and Cost-effectiveness of Two Drug Distribution Methods for Home Based Management of Fevr in Kayunga District, Uganda

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

Primary Outcome Measures:
  • See detailed description

Secondary Outcome Measures:
  • See detailed description

Estimated Enrollment: 1314
Study Start Date: November 2005
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children 0-59 months with fever
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00259142

Locations
Uganda
Kayunga District
Kayunga, Uganda
Sponsors and Collaborators
DBL -Institute for Health Research and Development
World Health Organization
Institute for Epidemiology and Social Medicine, Aarhus University, Denmark
Investigators
Principal Investigator: Robinah Najjembe, MD, MPH Makerere University Institute of Public Health
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00259142     History of Changes
Other Study ID Numbers: UGA.5.2RNA2005
Study First Received: November 25, 2005
Last Updated: January 11, 2010
Health Authority: Uganda: Research Ethics Committee

Keywords provided by DBL -Institute for Health Research and Development:
home management of fever, malaria, Uganda

Additional relevant MeSH terms:
Fever
Malaria
Body Temperature Changes
Parasitic Diseases
Protozoan Infections
Signs and Symptoms
Fanasil, pyrimethamine drug combination
Pyrimethamine
Sulfadoxine
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014