Lead Exposure Intervention Program (LEIP)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lead Exposure; High Blood Lead Levels
• Intervention / Treatment: Behavioral: In-clinic lead risk reduction intervention; Behavioral: Home visit with tailored messages

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Jansen; Phone Number: 206-685-6392; Email: kjansen@uw.edu

Study Locations

• Kenya
  • Nairobi, Kenya
    • Pumwani Hospital and Baba Ndogo Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Caregivers with children ages 12-72 months attending routine care/vaccination visit at Nairobi clinical site.

Exclusion Criteria: Children outside of age range, caregivers younger than 18; plan to leave study catchment within 9 months.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate messages; Caregivers of children with elevated blood lead levels will be provided with immediate messages about lead risk mitigation in the clinic setting. They will receive follow-up at 3 months and 9 months and will complete recall, behavior, and recheck questionnaires and their children will have BLL rechecks.	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.
Experimental: Home visit; Caregivers of children with elevated blood lead levels will be provided with immediate messages about lead risk mitigation in the clinic setting. They will also receive a home observation visit and have those risk reduction methods reiterated and tailored to their home situation. They will receive follow-up at 3 months and 9 months and will complete recall, behavior, and recheck questionnaires and their children will have BLL rechecks.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recall of survey risk factors	Lead risk surveys will be completed by participants during the clinic visit and at 3 and 9 months post home visit. Qualitative analysis of the lead risk survey will summarize themes on understandability and acceptability of survey items and messages. The rapid analysis will also explore facilitators and barriers to uptake of recommended exposure reduction measures, and individual level determinants associated with uptake (e.g., empowerment, self-efficacy).	3 and 9 months post clinic visit
Self report of risk-reduction behavior	Assess the proportion of caregivers self-reporting uptake of at least one of their risk reduction recommendations within arms and by BLL.	3 and 9 months post clinic visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in outcomes between arms	Using risk survey responses and self-reported changes in risk reduction behavior, we will compare the participants of both arms to assess for differences.	3 and 9 months post clinic visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of the BLL re-check	Return for a re-check visit is an indicator of caregiver awareness of importance of reducing lead exposure. We will summarize the proportions of caregivers returning for each BLL re-check visit for each arm.	3 and 9 months post-initial visit
Change in BLL	Change in BLL at re-checks. We do not anticipate observing a significant reduction in child BLL, given that caregivers might not have the ability to identify and/or modify a lead risk exposure.	3 and 9 months post-initial clinic visit

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institutes of Health (NIH); National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Sarah Benki-Nugent, University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; Sub-Saharan Africa; lead; lead risk reduction
• Additional Relevant MeSH Terms: Professional Practice; Organization and Administration; Health Services Administration; House Calls
• Other Study ID Numbers: STUDY00022114; 1R01ES036010 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data other than patient direct or indirect identifiers will be shared.
• IPD Sharing Access Criteria: Other researchers can contact the MPIs and complete an approved Data Sharing Agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No