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Lead Exposure Intervention Program

Lead Exposure Intervention Program

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07401251
Acronym
LEIP
Enrollment
500
Registered
2026-02-10
Start date
2026-04-01
Completion date
2030-04-01
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Blood Lead Levels, Lead Exposure

Keywords

lead, pediatric, Sub-Saharan Africa, lead risk reduction

Brief 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

Interventions

BEHAVIORALHome 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.

BEHAVIORALIn-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

University of Washington
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 72 Months
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Recall of survey risk factors3 and 9 months post clinic visitLead 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).
Self report of risk-reduction behavior3 and 9 months post clinic visitAssess the proportion of caregivers self-reporting uptake of at least one of their risk reduction recommendations within arms and by BLL.

Secondary

MeasureTime frameDescription
Differences in outcomes between arms3 and 9 months post clinic visitUsing risk survey responses and self-reported changes in risk reduction behavior, we will compare the participants of both arms to assess for differences.

Countries

Kenya

Contacts

CONTACTKaren Jansen
kjansen@uw.edu206-685-6392
PRINCIPAL_INVESTIGATORSarah Benki-Nugent

University of Washington

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026