NCT07632937

Brief Summary

This clinical trial aims to evaluate the effectiveness of targeted public health campaigns in reducing lead exposure among adults living in urban communities with known environmental lead hazards. Lead exposure remains a significant public health concern, particularly in older urban neighborhoods with aging infrastructure and legacy contamination. Despite existing regulations and remediation efforts, many communities continue to experience elevated blood lead levels, especially among vulnerable populations. The study will compare the impact of an intensive, multi-modal public health campaign-featuring community workshops, educational materials, and home intervention resources-against standard municipal information dissemination. By assessing changes in blood lead levels and lead-related knowledge, attitudes, and behaviors over a 12-month period, the trial seeks to determine whether enhanced public health outreach can more effectively reduce lead exposure and promote safer practices. The findings will inform future strategies for community-based environmental health interventions.

Trial Health

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Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 31, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

May 27, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

lead poisoninglead

Outcome Measures

Primary Outcomes (1)

  • Change in Blood Lead Level

    Mean change in venous blood lead concentration (μg/dL) among index household participants from baseline to 12 months.

    Through study completion, an average of 1 year

Secondary Outcomes (4)

  • Change in Lead-Related Knowledge

    Through study completion, an average of 1 year

  • Adoption of Lead-Safe Practices

    Through study completion, an average of 1 year

  • Environmental Lead Levels in Home

    Through study completion, an average of 1 year

  • Incidence of New Elevated Blood Lead Cases

    Through study completion, an average of 1 year

Study Arms (2)

Intensive Public Health Campaign

EXPERIMENTAL

Participants receive an intensive, multi-modal public health campaign including workshops, educational materials, lead-safe cleaning kits, and home visits by health educators.

Behavioral: Intensive Public Health Campaign

Standard Information Dissemination

ACTIVE COMPARATOR

Participants receive the standard municipal information package on lead exposure prevention currently distributed by city health departments.

Behavioral: Standard Information Dissemination

Interventions

A comprehensive intervention including: (1) three interactive community workshops on lead risks and prevention, (2) distribution of tailored educational materials, (3) provision of lead-safe cleaning kits (HEPA vacuums, cleaning supplies), and (4) two home visits by trained health educators to reinforce messages and assess household practices. Delivered over a 12-month period.

Intensive Public Health Campaign

Provision of standard municipal information on lead exposure prevention, including pamphlets and website links, as currently distributed by public health authorities. No additional workshops or home visits provided.

Standard Information Dissemination

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resident of selected urban neighborhoods with documented environmental lead risk
  • Household includes at least one adult aged 18-75 years willing to participate
  • Willing to provide informed consent
  • Willing to allow home visits and blood sampling
  • Able to understand study procedures and interventions

You may not qualify if:

  • Planning to relocate from the area within the next 12 months
  • Household member with a known diagnosis of severe anemia or bleeding disorder
  • Participation in another intervention study targeting lead exposure in the past 12 months
  • Inability or unwillingness to comply with study procedures
  • Household with known ongoing lead remediation efforts during the study period
  • Pregnant women (due to additional ethical considerations for blood sampling)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia City Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Lead Poisoning

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Brian Goldstein, MD MPH

    International Health Strategies LLC

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open-label due to the nature of behavioral and educational interventions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel assignment of neighborhoods to either intensive public health campaign or standard information dissemination.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 8, 2026

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations