Trial reportPloS one2026
Adapting, piloting, and evaluating a pediatric lead screening and risk-reduction intervention in Nairobi: A hybrid implementation-effectiveness trial protocol.
Trial report in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07401251 (Lead Exposure Intervention Program), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Lead Exposure Intervention Program
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13 authors.
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Abstract
backgroundChildhood lead exposure is prevalent worldwide including low- and middle-income countries (LMICs). Structured screening and prevention programs to address pediatric lead exposure are largely absent in these settings. Adapted interventions are needed to close this implementation gap in an urban African context. This paper describes the protocol for the Lead Exposure Intervention Program (LEIP), which aims to adapt, pilot, and evaluate a pediatric lead exposure screening and risk-reduction protocol in Nairobi, Kenya.
methodsLEIP is a multi-phase, hybrid type 3 implementation-effectiveness study. Phase 1 is a formative one-arm study leveraging an existing mother-child cohort and stakeholder-led tools adaptation to pilot a program comprising blood lead level (BLL) screening with a lead risk survey and tailored caregiver risk reduction messaging. Phase 2 is a randomized trial in public sector clinics. In this phase, approximately 1,500 children will be screened to identify 100 with elevated BLL (≥5 µg/dL) for enrollment, who will then be randomized 1:1 to receive either clinic-only risk-reduction messaging or the same clinic-based messaging plus a home visit for environmental assessment and additional tailored messaging. Follow-up at 3 and 9 months will assess caregiver recall of key messages and adoption of recommended exposure-reduction behaviors, as well as changes in child BLL. Phase 3 involves qualitative interviews with caregivers and key stakeholders to identify multi-level barriers and facilitators to intervention uptake. Quantitative and qualitative findings will be integrated to inform refinements for scale-up. DISCUSSION: This study represents a critical opportunity to develop and evaluate an adaptive, screening-based lead exposure intervention tailored to the urban LMIC context. By incorporating implementation science principles and stakeholder-driven design, LEIP is well-positioned to inform scalable national and regional approaches. The inclusion of both quantitative and qualitative components enhances the protocol's ability to capture multilevel dynamics of uptake, fidelity, and sustainability, and generate actionable insights for future large-scale implementations.
trial registrationClinicalTrials.gov NCT07401251.
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