Lead Exposure Intervention Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home visit with tailored messages, In-clinic lead risk reduction intervention.
- Who it may be relevant to
- Registry conditions: Lead Exposure, High Blood Lead Levels. Basic parameters: 12 months — 72 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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 samp - 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
Primary outcome measures
- Recall of survey risk factors [Time frame: 3 and 9 months post clinic visit]
- Self report of risk-reduction behavior [Time frame: 3 and 9 months post clinic visit]
Secondary outcome measures (1)
- Differences in outcomes between arms [Time frame: 3 and 9 months post clinic visit]
Eligibility criteria
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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Kenya · 1 center
- Pumwani Hospital and Baba Ndogo Health Centre — Nairobi
Publications
- Onoh I, Mugo C, Riederer A, Maleche-Obimbo E, Were FH, Loftus C, Mukumbang F, Lumumba E, Richardson B, Edemba PW, Mutai BC, Karr C, Benki-Nugent S. Adapting, piloting, and evaluating a pediatric lead screening and risk-reduction intervention in Nairobi: A hybrid implementation-effectiveness trial protocol. PLoS One. 2026 Jun 4;21(6):e0349153. doi: 10.1371/journal.pone.0349153. eCollection 2026. PMID 42241430
- Onoh I, Mugo C, Riederer A, Maleche-Obimbo E, Were FH, Loftus C, Mukumbang F, Lumumba E, Richardson B, Edemba PW, Mutai BC, Karr C, Benki-Nugent S. Adapting, piloting, and evaluating a pediatric lead screening and risk-reduction intervention in Nairobi: A hybrid implementation-effectiveness trial protocol. medRxiv [Preprint]. 2026 Apr 30:2026.04.28.26351918. doi: 10.64898/2026.04.28.26351918. PMID 42094172
Identifiers
NCT: NCT07401251 · STUDY00022114 · 1R01ES036010