An interventional study of Home visit with tailored messages and In-clinic lead risk reduction intervention in Lead Exposure and High Blood Lead Level, sponsored by University of Washington. Not yet recruiting at 1 site in Kenya. Open to participants aged 12 Months to 72 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by University of Washington · Not applicable, Interventional, and Health services research
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:
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:
Exclusion Criteria:
-Parent unwilling to be contacted for the purposes of tracing and follow-up
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
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: Home visit with tailored messages · Behavioral: In-clinic lead risk reduction intervention
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.
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.
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).
Time frame: 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.
Time frame: 3 and 9 months post clinic visit
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.
Time frame: 3 and 9 months post clinic visit
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.
Time frame: 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.
Time frame: 3 and 9 months post-initial clinic visit
Plan to share: Yes — All data other than patient direct or indirect identifiers will be shared.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Washington