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

NCT00259142 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1314

Last updated 2015-05-13

No results posted yet for this study

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

Interventions

DRUG

Chloroquine, sulphadoxine-pyrimethamine

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER
  • Institute for Epidemiology and Social Medicine, Aarhus University, Denmark

    collaborator OTHER
  • DBL -Institute for Health Research and Development

    lead OTHER

Principal Investigators

  • Robinah Najjembe, MD, MPH · Makerere University Institute of Public Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • Uganda

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00259142 on ClinicalTrials.gov