Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory - Full Text View

Sponsor:	Menzies School of Health Research
Collaborators:	University of Melbourne Murdoch Childrens Research Institute Cooperative Research Centre for Aboriginal Health
Information provided by:	Menzies School of Health Research
ClinicalTrials.gov Identifier:	NCT00884728

Purpose

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

Condition
Scabies Impetigo Pyoderma Streptococcal Infections

Study Type:	Observational
Study Design:	Observational Model: Ecologic or Community Time Perspective: Prospective
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Coping with Chronic Illness Fever Impetigo Scabies Streptococcal Infections

U.S. FDA Resources

Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

throat swabs, pyoderma swabs and skin scrapings for tinea where individual consent was obtained within selected participating communities

Enrollment:	2329
Study Start Date:	September 2004
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
Indigenous children aged <15 years Indigenous children aged <15 years within participating communities of the Northern Territory

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.

Eligibility

Ages Eligible for Study:	up to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Residents aged <15 years of participating communities in a remote region of the Northern Territory

Criteria

Inclusion Criteria:

All children aged <15 years in the participating communities

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884728

Locations

Australia, Northern Territory
Menzies School of Health Research
Casuarina, Northern Territory, Australia, 0811

Sponsors and Collaborators

Menzies School of Health Research

University of Melbourne

Murdoch Childrens Research Institute

Cooperative Research Centre for Aboriginal Health

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

More Information

No publications provided by Menzies School of Health Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andrews RM, Kearns T, Connors C, Parker C, Carville K, Currie BJ, Carapetis JR. A regional initiative to reduce skin infections amongst aboriginal children living in remote communities of the Northern Territory, Australia. PLoS Negl Trop Dis. 2009 Nov 24;3(11):e554.

Responsible Party:	Professor Jonathan Carapetis, Menzies School of Health Research
ClinicalTrials.gov Identifier:	NCT00884728 History of Changes
Other Study ID Numbers:	41 17May2004
Study First Received:	April 20, 2009
Last Updated:	April 20, 2009
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Menzies School of Health Research:

Scabies
Impetigo
Pyoderma
Streptococcal infections

Additional relevant MeSH terms:

Impetigo
Pyoderma
Scabies
Streptococcal Infections
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases

ClinicalTrials.gov processed this record on February 09, 2012