ScabiesEAHSPNCT00884728
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory
An observational study of Scabies and Impetigo, run by Menzies School of Health Research at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages Up to 15 years
- How many people
- 2,329 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2004to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Residents aged <15 years of participating communities in a remote region of the Northern Territory
Who may be able to join
- All children aged <15 years in the participating communities
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Australia1 site
Menzies School of Health Research
Casuarina, Northern Territory, 0811
About this study
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
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
Read the 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.
- Conditions
- Scabies, Impetigo, Pyoderma, Streptococcal Infections
- Keywords
- Scabies, Impetigo, Pyoderma, Streptococcal infections
- Medical subject headings
- Scabies, Impetigo, Pyoderma, Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Indigenous children aged <15 years | Indigenous children aged <15 years within participating communities of the Northern Territory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startSep 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, Murdoch Childrens Research Institute, Cooperative Research Centre for Aboriginal Health
- Investigators
- Ross M Andrews, PhD, Principal investigator, Menzies School of Health ResearchJonathan R Carapetis, PhD, MBBS, Principal investigator, Menzies School of Health ResearchBart Currie, MBBS, DTM&H, Principal investigator, Menzies School of Health ResearchChristine Connors, MBBS, Principal investigator, Northern Territory Govermnent Department of Health and FamiliesShelley Walton, PhD, Principal investigator, Menzies School of Health ResearchColin J Parker, MBBS, Principal investigator, Australasian College of Dermatologists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884728
- Sponsor's protocol ID
- 41 17May2004
- Acronym
- EAHSP
- Status last verified
- Apr 2009
- First submitted
- 20 Apr 2009
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1371/journal.pntd.0000554.
PubMed 19936297
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00884728
- Acronym / sponsor ID
- EAHSP / 41 17May2004
- Conditions
- Scabies, Impetigo, Pyoderma, Streptococcal Infections
- Keywords
- Scabies, Impetigo, Pyoderma, Streptococcal infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,329 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- University of Melbourne, Murdoch Childrens Research Institute, Cooperative Research Centre for Aboriginal Health
- Study start
- Sep 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indigenous children aged <15 years | – | –Indigenous children aged <15 years within participating communities of the Northern Territory |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Residents aged <15 years of participating communities in a remote region of the Northern Territory
Key inclusion criteria (1 listed)
- All children aged <15 years in the participating communities
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2009.
- Derived from this study: PubMed 19936297Andrews 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. doi: 10.1371/journal.pntd.0000554.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross M Andrews, PhD principal investigator
Menzies School of Health Research
Jonathan R Carapetis, PhD, MBBS principal investigator
Menzies School of Health Research
Bart Currie, MBBS, DTM&H principal investigator
Menzies School of Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scabies and Impetigo, run by Menzies School of Health Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00884728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2009.