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

NCT00259142 | Terminated

• 1 other identifier: UGA.5.2RNA2005
• Study Type: interventional
• Target: 1,314
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever; Anaemia; Malaria

Keywords

home management of fever, malaria, Uganda

Outcome Measures

Primary Outcomes (1)

• See detailed description

Secondary Outcomes (1)

• See detailed description

Interventions

Chloroquine, sulphadoxine-pyrimethamine DRUG

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children 0-59 months with fever

Sponsors & Collaborators

• DBL -Institute for Health Research and Development: lead
• World Health Organization: collaborator
• Institute for Epidemiology and Social Medicine, Aarhus University, Denmark: collaborator

Study Sites (1)

Kayunga District

Kayunga, Uganda

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fever; Anemia; Malaria

Interventions

Chloroquine; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robinah Najjembe, MD, MPH

  Makerere University Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2005
• First Posted: November 29, 2005
• Study Start: November 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

UG (1)