NCT00146692

Brief Summary

Effective control strategies for malaria depend both on preventing disease and on treating those who become infected to prevent significant morbidity and mortality. There are many barriers to preventing access to prompt and effective treatment, some of which are amenable to intervention, others (such as distance to healthcare) less so. This study will concentrate on modifiable financial barriers to care. With the aim of increasing health service utilization and reducing morbidity and mortality among children under five, some governments are currently implementing policies aimed at reducing financial barriers to health care. There is at the same time an on-going debate concerning the relative importance of cost as a barrier to health care. Though theoretically the aim for reducing these barriers should be achieved, its actual impact has not been directly assessed or demonstrated by means of an intervention trial. This study aims to determine by means of a randomized trial the impact of reducing such barriers on morbidity due to severe malaria among children 6 months to five years and on outpatient utilization. An existing pre-payment scheme in the study area will be utilized to improve financial access for half of 2500 households who have not registered for either year I or II. The impact on severe anaemia, mean haemoglobin and anthropometric measurements will be assessed. Health service utilisation rates will be measured in both groups by active and passive surveillance. Patient perceptions and health-seeking behaviour will be compared. The study will contribute to the current debate on the relative importance of cost of care as a barrier to health care and the potential for the removal of this barrier as a strategy for malaria control, and on methods to optimise this.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

September 5, 2005

Last Update Submit

January 11, 2017

Conditions

Keywords

MalariaCostTreatmentDiagnosisAfricaGhana

Outcome Measures

Primary Outcomes (1)

  • Prevalence of severe anaemia among children under five years of age after peak malaria transmission season.

Secondary Outcomes (5)

  • • Mean haemoglobin count among the two groups at study end

  • • Number of admissions to hospital with malaria among children under five years of age in both groups

  • • Average number of visits to per child under five years to primary care facility among both groups

  • • Anthropometric measurements of children in the two groups

  • • All cause mortality in both groups, all ages

Interventions

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child in household aged between 6 months and 5 years
  • Informed consent from parents
  • Household to which child belongs resident in the Dodowa sub district and intending to remain resident until the end of the next two years

You may not qualify if:

  • Parents refuse to participate in the study
  • Household due to emigrate from study area within two years
  • Household currently enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dangme West District

Dodowa, Ghana

Location

Related Publications (1)

  • Ansah EK, Narh-Bana S, Asiamah S, Dzordzordzi V, Biantey K, Dickson K, Gyapong JO, Koram KA, Greenwood BM, Mills A, Whitty CJ. Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial. PLoS Med. 2009 Jan 6;6(1):e1000007. doi: 10.1371/journal.pmed.1000007.

MeSH Terms

Conditions

MalariaDisease

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Evelyn Ansah, MD

    Dangme West / LSHTM

    STUDY DIRECTOR
  • Christopher Whitty, FRCP

    London School of Hygiene and Tropical Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2005

First Posted

September 7, 2005

Study Start

April 1, 2004

Study Completion

February 1, 2005

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations