COMPLETED

Staph Intervention for Effective Local Defense

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Indigenous persons experience a high burden of Staphylococcus aureus (SA) invasive disease and skin and soft tissue infections. SA carriage on the skin is factor for development of SA infections. The goal of this clinical trial is to evaluate a community-informed approach to reduce carriage of SA. Participants will be assigned to education and household supplies for prevention of SA with and without a biomedical intervention. Researchers will compare SA carriage in the two groups.

Official Title

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

Quick Facts

Study Start:2024-04-01
Study Completion:2025-11-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06210594

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Native American adult living on or adjacent to the WMA Tribal lands
  2. * 18 years of age and older
  3. * Lab-confirmed SA carriage at time of enrollment
  4. * Ability to provide written informed consent
  5. * Ability to comply with follow-up activities
  6. * 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
  1. * Immediate family member of study staff
  2. * Allergy to citrus or any ingredient in Nozin, Hibiclens, or mupirocin
  3. * Without a permanent home (e.g., living in a group home, shelter, or is unhoused)
  4. * Use of antibiotics within 30 days prior to the first study visit (time-limited)
  5. * Current SA infection (time-limited)

Contacts and Locations

Principal Investigator

Laura Hammitt, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health

Study Locations (Sites)

Whiteriver Center for Indigenous Health
Whiteriver, Arizona, 85941
United States

Collaborators and Investigators

Sponsor: Johns Hopkins Bloomberg School of Public Health

  • Laura Hammitt, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

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 Registration Dates

Study Start Date2024-04-01
Study Completion Date2025-11-14

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-11-14

Terms related to this study

Keywords Provided by Researchers

  • Skin and soft tissue infections (SSTI)
  • Methicillin-resistant staphylococcus aureus (MRSA)
  • Carriage density
  • Biomedical intervention

Additional Relevant MeSH Terms

  • Staphylococcus Aureus Infection