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NCT Number: NCT07401251

Lead Exposure Intervention Program

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

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Key information

Conditions

Lead Exposure High Blood Lead Levels

Age range

12 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pumwani Hospital and Baba Ndogo Health Centre

Nairobi, Kenya

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Home visit with tailored messages

Behavioral

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.

In-clinic lead risk reduction intervention

Behavioral

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.

Primary outcomes

  1. Recall of survey risk factors

    Time frame: 3 and 9 months post clinic visit

    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).

  2. Self report of risk-reduction behavior

    Time frame: 3 and 9 months post clinic visit

    Assess the proportion of caregivers self-reporting uptake of at least one of their risk reduction recommendations within arms and by BLL.

Secondary outcomes

  1. Differences in outcomes between arms

    Time frame: 3 and 9 months post clinic visit

    Using risk survey responses and self-reported changes in risk reduction behavior, we will compare the participants of both arms to assess for differences.

Other outcomes

  1. Uptake of the BLL re-check

    Time frame: 3 and 9 months post-initial visit

    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.

  2. Change in BLL

    Time frame: 3 and 9 months post-initial clinic visit

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Jansen

CONTACT

[email protected]

206-685-6392

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)
  • National Institutes of Health (NIH)

Registry information

Acronym: LEIP

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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