NCT07401251

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
48mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Apr 2030

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 3, 2026

Last Update Submit

February 3, 2026

Conditions

Lead ExposureHigh Blood Lead Levels

Keywords

leadpediatricSub-Saharan Africalead risk reduction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Differences in outcomes between arms

    3 and 9 months post clinic visit

Other Outcomes (2)

  • Uptake of the BLL re-check

    3 and 9 months post-initial visit

  • Change in BLL

    3 and 9 months post-initial clinic visit

Study Arms (2)

Immediate messages

ACTIVE COMPARATOR

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

Home visit

EXPERIMENTAL

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 messagesBehavioral: In-clinic lead risk reduction intervention

Interventions

Home visit with tailored messagesBEHAVIORAL

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.

Home visit
In-clinic lead risk reduction interventionBEHAVIORAL

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.

Home visitImmediate messages

Eligibility Criteria

Age12 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pumwani Hospital and Baba Ndogo Health Centre

Nairobi, Kenya

Location

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Sarah Benki-Nugent

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Jansen

CONTACT

206-685-6392kjansen@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Global Health

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2030

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All data other than patient direct or indirect identifiers will be shared.

Access Criteria
Other researchers can contact the MPIs and complete an approved Data Sharing Agreement

Locations

KE(1)