- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00884728
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory (EAHSP)
East Arnhem Healthy Skin Project: A Regional Collaboration to Reduce Scabies, Skin Sores and Associated Chronic Diseases, Including Rheumatic Fever and Renal Disease, Among Australian Aboriginal Communities
The purpose of this study is to determine whether a coordinated regional approach to healthy skin programs in six remote Aboriginal communities can demonstrate, not only a reduction in the burden of scabies and streptococcal skin sores, but also broad health benefits, including primary prevention of some chronic diseases that occur at particularly high rates in Australian Aboriginal communities.
The primary objectives of the Program are:
- Demonstrate a reduction in scabies and skin sores on a regional basis
- Demonstrate the broader public health effects of Healthy Skin Programs, particularly those relating to chronic diseases such as rheumatic fever and renal diseases
- Build on the existing Indigenous capacity by assisting in the development of new knowledge and skills to improve the health and well being of Indigenous communities
- Establish the feasibility of incorporating Healthy Skin Programs into existing health service delivery
Study Overview
Status
Conditions
Detailed Description
There are standard government recommendations for the conduct of healthy skin programs within the Northern Territory (NT), where the key component involves a single mass treatment for scabies of all residents in the region followed by regular monitoring of skin infections with treatment of individuals as new cases arise. The key features of the guidelines include:
- Community planning and collaborative effort;
- Development of local educational resources;
- Single whole community treatment day for scabies with permethrin (5%);
- Community "clean up" involving house cleaning, linen and rubbish collection;
- Emphasis on housing functionality and "washing kids" to maintain low rates of skin sores; and
- Regular monitoring of scabies and skin sores, usually in a target group such as children
Previous programs have been successful in controlling scabies and related skin infections in the NT but have been limited to single communities with varying levels of success. In collaboration with communities in the East Arnhem Region, we propose to conduct a coordinated Healthy Skin Program. By concentrating on one region, the project has an increased likelihood of success because reinfection due to mobility between communities will be minimised, and because the project will be recognised as a collaboration between multiple communities.
The program is structured into three distinct components:
- Implementation of the program within the participating communities;
- Evaluation of the program against specific outcomes; and
- Integration of the program into routine service delivery.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Northern Territory
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Casuarina, Northern Territory, Australia, 0811
- Menzies School of Health Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All children aged <15 years in the participating communities
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Indigenous children aged <15 years
Indigenous children aged <15 years within participating communities of the Northern Territory
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduced prevalence of scabies among children in the participating communities from 30% (expected prevalence pre-program) to <10% at least 2 years following the introduction of the program
Time Frame: 2 years
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2 years
|
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Reduced prevalence of skin sores among children in the participating communities from 50% (expected prevalence pre-program) to <25% at least 2 years following the introduction of the program
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduced severity of skin sores among children in the participating communities from 40% classified as moderate/severe (expected pre-program) to <15% classified as moderate/severe at least two years following the introduction of the program
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ross M Andrews, PhD, Menzies School of Health Research
- Principal Investigator: Jonathan R Carapetis, PhD, MBBS, Menzies School of Health Research
- Principal Investigator: Bart Currie, MBBS, DTM&H, Menzies School of Health Research
- Principal Investigator: Christine Connors, MBBS, Northern Territory Govermnent Department of Health and Families
- Principal Investigator: Shelley Walton, PhD, Menzies School of Health Research
- Principal Investigator: Colin J Parker, MBBS, Australasian College of Dermatologists
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Parasitic Diseases
- Ectoparasitic Infestations
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Staphylococcal Infections
- Skin Diseases, Bacterial
- Mite Infestations
- Staphylococcal Skin Infections
- Scabies
- Streptococcal Infections
- Pyoderma
- Impetigo
Other Study ID Numbers
- 41 17May2004
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