Reducing Staphylococcus aureus infections in Indigenous communities
SHIELD (Staph Intervention for Effective Local Defense): An Open-label Randomized Controlled Trial to Assess Efficacy of a Sustained Intervention (Topical Antibiotics and Skin Antisepsis) to Decrease Staphylococcus Aureus Carriage in Adults
This study is testing a new way to help Native American adults living near the White Mountain Apache Tribal lands reduce the presence of Staphylococcus aureus infections by providing education and supplies, along with some receiving a special treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 1 site (Whiteriver, Arizona) |
| Trial ID | NCT06210594 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a community-informed approach to reduce the carriage of Staphylococcus aureus (SA) among Native American adults living on or near the White Mountain Apache Tribal lands. Participants will receive education and household supplies for prevention, with some also receiving a biomedical intervention involving mupirocin, Nozin, and chlorhexidine gluconate. The study will compare the effectiveness of these interventions in reducing SA carriage, which is a significant factor in the development of infections. The trial addresses the high burden of SA and MRSA infections in this population, aiming to improve health outcomes through targeted interventions.
Who should consider this trial
Good fit: Ideal candidates are Native American adults aged 18 and older who have lab-confirmed SA carriage and risk factors for SA-associated infections.
Not a fit: Patients without a permanent home or those currently infected with Staphylococcus aureus may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of Staphylococcus aureus infections in Indigenous communities.
How similar studies have performed: While there have been various approaches to decolonization, this community-informed strategy is novel and specifically tailored to the needs of the White Mountain Apache community.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Native American adult living on or adjacent to the WMA Tribal lands * 18 years of age and older * Lab-confirmed SA carriage at time of enrollment * Ability to provide written informed consent * Ability to comply with follow-up activities * Risk factor for SA-associated infection: Diagnosed with diabetes OR body mass index ≥30 OR documented SSTI or SA infection in the past 3 years Exclusion Criteria: * Immediate family member of study staff * Allergy to citrus or any ingredient in Nozin, Hibiclens, or mupirocin * Without a permanent home (e.g., living in a group home, shelter, or is unhoused) * Use of antibiotics within 30 days prior to the first study visit (time-limited) * Current SA infection (time-limited)
Where this trial is running
Whiteriver, Arizona
- Whiteriver Center for Indigenous Health — Whiteriver, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Laura Hammitt, MD — Johns Hopkins Bloomberg School of Public Health
- Study coordinator: Monica Pilewskie, MSPH
- Email: mpilews1@jhu.edu
- Phone: 928-338-5215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.