NCT00884728

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,329

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
Last Updated

April 21, 2009

Status Verified

April 1, 2009

Enrollment Period

2.9 years

First QC Date

April 20, 2009

Last Update Submit

April 20, 2009

Conditions

ScabiesImpetigoPyodermaStreptococcal Infections

Keywords

ScabiesImpetigoPyodermaStreptococcal infections

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

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

    2 years

Study Arms (1)

Indigenous children aged <15 years

Indigenous children aged \<15 years within participating communities of the Northern Territory

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All children aged \<15 years in the participating communities

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menzies School of Health Research

Casuarina, Northern Territory, 0811, Australia

Location

Related Publications (1)

  • 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.

    PMID: 19936297DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

ScabiesImpetigoPyodermaStreptococcal Infections

Condition Hierarchy (Ancestors)

Mite InfestationsEctoparasitic InfestationsSkin Diseases, ParasiticParasitic DiseasesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesStaphylococcal Skin InfectionsStaphylococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSkin Diseases, Bacterial

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

September 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

April 21, 2009

Record last verified: 2009-04

Locations

AU(1)