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

Scabies Clinical Trial

— EAHSP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884728
• Other study ID #: 41 17May2004
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: April 20, 2009
• Start date: September 2004
• Est. completion date: August 2007

Study information

• Verified date: April 2009
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2329
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

• All children aged <15 years in the participating communities

Exclusion Criteria:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Impetigo
• Pyoderma
• Scabies
• Streptococcal Infections

Locations

Country	Name	City	State
Australia	Menzies School of Health Research	Casuarina	Northern Territory

Sponsors (4)

Lead Sponsor	Collaborator
Menzies School of Health Research	Cooperative Research Centre for Aboriginal Health, Murdoch Childrens Research Institute, University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years	No
Primary	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		2 years	No
Secondary	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		2 years	No