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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259142
Recruitment Status : Terminated (Study never started)
First Posted : November 29, 2005
Last Update Posted : May 13, 2015
World Health Organization
Institute for Epidemiology and Social Medicine, Aarhus University, Denmark
Information provided by:
DBL -Institute for Health Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Fever Anaemia Malaria Drug: Chloroquine, sulphadoxine-pyrimethamine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1314 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Malaria

Primary Outcome Measures :
  1. See detailed description

Secondary Outcome Measures :
  1. See detailed description

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • children 0-59 months with fever

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259142

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
Principal Investigator: Robinah Najjembe, MD, MPH Makerere University Institute of Public Health

Additional Information: Identifier: NCT00259142     History of Changes
Other Study ID Numbers: UGA.5.2RNA2005
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Body Temperature Changes
Signs and Symptoms
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents