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

April 20, 2009 updated by: Menzies School of Health Research

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

Completed

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

Observational

Enrollment (Actual)

2329

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • All children aged <15 years in the participating communities

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Indigenous children aged <15 years
Indigenous children aged <15 years within participating communities of the Northern Territory

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
2 years
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 20, 2009

First Posted (Estimate)

April 21, 2009

Study Record Updates

Last Update Posted (Estimate)

April 21, 2009

Last Update Submitted That Met QC Criteria

April 20, 2009

Last Verified

April 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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