Lead PoisoningNCT07632937
A Study to Assess the Efficacy of Public Health Campaigns in Reducing Lead Exposure
A study testing Intensive Public Health Campaign and Standard Information Dissemination in people with Lead Poisoning and Environmental Exposure, run by International Health Strategies LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning, Environmental Exposure
- What is being tested?
- Intensive Public Health Campaign and Standard Information Dissemination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Philadelphia City Center
Philadelphia, Pennsylvania, 19107
Brian Goldstein, MD MPH, 215-287-7688, brgold@sas.upenn.edu
About this study
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.
Read the detailed description
Lead exposure is a persistent environmental health issue, particularly in urban areas with older housing stock, deteriorating paint, and legacy industrial contamination. Chronic lead exposure, even at low levels, has been associated with neurodevelopmental deficits in children and cardiovascular, renal, and cognitive effects in adults. Despite regulatory progress, disparities in lead exposure persist, often affecting low-income and minority communities.
Traditional public health approaches have relied on passive dissemination of information via municipal websites, pamphlets, and occasional community events. However, evidence suggests that more intensive, community-engaged interventions may be necessary to change behaviors and reduce environmental risks. This study is designed to rigorously assess the efficacy of a comprehensive public health campaign compared to standard information dissemination in reducing lead exposure.
The trial will enroll households from urban neighborhoods identified through environmental surveillance as having elevated lead risks. Eligible participants will be randomized to either the intensive campaign arm or the standard information arm. The intensive campaign will include a series of interactive community workshops, distribution of tailored educational materials, provision of lead-safe cleaning kits, and access to home visits by trained health educators. The control group will receive the standard municipal information package currently in use.
Primary outcomes will include changes in blood lead levels among index participants at baseline and after 12 months. Secondary outcomes will assess changes in lead-related knowledge, adoption of lead-safe practices, and environmental lead measurements in the home. The study will also monitor the incidence of new cases of elevated blood lead and assess participant satisfaction with the interventions.
Data will be collected through home visits, validated questionnaires, and laboratory testing. The trial will use a parallel-group, randomized controlled design with community-level randomization to minimize contamination. Results will inform policymakers and public health practitioners regarding the value of intensive, community-based approaches for environmental hazard reduction.
- Conditions
- Lead Poisoning, Environmental Exposure
- Being tested
- Intensive Public Health Campaign, Standard Information Dissemination
- Keywords
- lead poisoning, lead
- Medical subject headings
- Lead Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Public Health CampaignBehavioural
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.
Standard Information DisseminationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Information Dissemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Lead Level
Mean change in venous blood lead concentration (μg/dL) among index household participants from baseline to 12 months.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Change in Lead-Related Knowledge
Change in scores on a validated questionnaire assessing knowledge of lead exposure risks and prevention strategies.
Measured: Through study completion, an average of 1 year
Adoption of Lead-Safe Practices
Proportion of households reporting regular use of lead-safe cleaning and food preparation practices, as assessed by structured survey.
Measured: Through study completion, an average of 1 year
Environmental Lead Levels in Home
Change in environmental lead concentrations (surface dust, tap water) measured in the home.
Measured: Through study completion, an average of 1 year
Incidence of New Elevated Blood Lead Cases
Number of new cases of blood lead ≥5 μg/dL among children and adults during the study period.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start31 Oct 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lead PoisoningStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment of neighborhoods to either intensive public health campaign or standard information dissemination.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Health Strategies LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Goldstein, MD MPH, Study director, International Health Strategies LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632937
- Sponsor's protocol ID
- InternationalHealth2026
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still deciding based on direction of the study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Efficacy of Public Health Campaigns in Reducing Lead Exposure
- ClinicalTrials.gov ID
- NCT07632937
- Acronym / sponsor ID
- InternationalHealth2026
- Conditions
- Lead Poisoning, Environmental Exposure
- Keywords
- lead poisoning, lead
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- International Health Strategies LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 8 Jun 2026 (actual)
- 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.
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.
Detailed description
Lead exposure is a persistent environmental health issue, particularly in urban areas with older housing stock, deteriorating paint, and legacy industrial contamination. Chronic lead exposure, even at low levels, has been associated with neurodevelopmental deficits in children and cardiovascular, renal, and cognitive effects in adults. Despite regulatory progress, disparities in lead exposure persist, often affecting low-income and minority communities.
Traditional public health approaches have relied on passive dissemination of information via municipal websites, pamphlets, and occasional community events. However, evidence suggests that more intensive, community-engaged interventions may be necessary to change behaviors and reduce environmental risks. This study is designed to rigorously assess the efficacy of a comprehensive public health campaign compared to standard information dissemination in reducing lead exposure.
The trial will enroll households from urban neighborhoods identified through environmental surveillance as having elevated lead risks. Eligible participants will be randomized to either the intensive campaign arm or the standard information arm. The intensive campaign will include a series of interactive community workshops, distribution of tailored educational materials, provision of lead-safe cleaning kits, and access to home visits by trained health educators. The control group will receive the standard municipal information package currently in use.
Primary outcomes will include changes in blood lead levels among index participants at baseline and after 12 months. Secondary outcomes will assess changes in lead-related knowledge, adoption of lead-safe practices, and environmental lead measurements in the home. The study will also monitor the incidence of new cases of elevated blood lead and assess participant satisfaction with the interventions.
Data will be collected through home visits, validated questionnaires, and laboratory testing. The trial will use a parallel-group, randomized controlled design with community-level randomization to minimize contamination. Results will inform policymakers and public health practitioners regarding the value of intensive, community-based approaches for environmental hazard reduction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment of neighborhoods to either intensive public health campaign or standard information dissemination.
| Arm | Type | Receives |
|---|---|---|
| Intensive Public Health Campaign | Experimental | Behavioral: Intensive Public Health CampaignParticipants receive an intensive, multi-modal public health campaign including workshops, educational materials, lead-safe cleaning kits, and home visits by health educators. |
| Standard Information Dissemination | Active comparator | Behavioral: Standard Information DisseminationParticipants receive the standard municipal information package on lead exposure prevention currently distributed by city health departments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Public Health CampaignA 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. | Behavioural | Intensive Public Health Campaign |
| Standard Information DisseminationProvision 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. | Behavioural | Standard Information Dissemination |
Primary outcome
Change in Blood Lead Level
Time frame: Through study completion, an average of 1 year
Mean change in venous blood lead concentration (μg/dL) among index household participants from baseline to 12 months.
4 secondary outcomes
Change in Lead-Related Knowledge
Time frame: Through study completion, an average of 1 year
Adoption of Lead-Safe Practices
Time frame: Through study completion, an average of 1 year
Environmental Lead Levels in Home
Time frame: Through study completion, an average of 1 year
Incidence of New Elevated Blood Lead Cases
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided. Still deciding based on direction of the study.
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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.
Brian Goldstein, MD MPH study director
International Health Strategies LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Public Health Campaign and Standard Information Dissemination in people with Lead Poisoning and Environmental Exposure, run by International Health Strategies LLC at 1 site in United States.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Goldstein, MD MPH (215-287-7688, Brian.Goldstein@intlhealthstrategies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Lead Level (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.