Lead Exposure Intervention Program
NCT07401251 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2026-02-10
Summary
The goal of this clinical trial is to learn if BLL (blood lead level) screening and "healthy home" lead prevention program created in the US is adaptable to a Sub-Saharan African context. It will also work to address child lead exposure in Nairobi, Kenya. The main questions it aims to answer is:
* Can materials and protocols developed for a US audience be effective in a Sub-Saharan African one?
* Is there a difference in learning and action between groups that receive different degrees of intervention?
Researchers will compare the outcomes of a group that received lead risk reduction information only in the clinical setting to a group that also received a home visit and tailored risk reduction messages.
Participants will:
* Have their child's blood lead levels measured at several timepoints
* Take part in a questionnaire about lead risk
* Receive lead risk reduction messaging either only in the clinic setting or also in their homes
* Have their knowledge and risk reduction behaviors measured
Conditions
- Lead Exposure
- High Blood Lead Levels
Interventions
- BEHAVIORAL
-
Home visit with tailored messages
The home visit will be conducted within 2 weeks of initial screening. During the home visit, the lead exposure risk survey will be re-administered, for comparison to in-clinic self-report survey responses. In addition, an observational checklist of potential lead exposure risk factors will be conducted to identify and discuss residential features and items in the home environment that may be influencing their BLL. Tailored messages on lead exposure risk reduction will be provided. A random sample of caregivers will complete an in-depth interview to gather barriers, understandability, and acceptability of the lead risk reduction messages received.
- BEHAVIORAL
-
In-clinic lead risk reduction intervention
For children with BLL \< 5 ug/dL, the result will be provided to the caregiver, together with standard post-test messaging on reducing lead exposure. A job-aid, such as a poster, showing common sources of lead exposure in children, and important sources of iron rich foods will be used to guide messaging. For BLLs ≥ 5, tailored messaging on potential sources identified on the risk factor survey will be provided. A random sample of caregivers will complete an in-depth interview to gather barriers, understandability, and acceptability of the lead risk reduction messages received.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Institute of Environmental Health Sciences (NIEHS)
collaborator NIH - lead OTHER
Principal Investigators
-
Sarah Benki-Nugent · University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Months
- Max Age
- 72 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2029-04-30
- Completion
- 2030-04-30
Countries
- Kenya
Study Locations
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