Adapting, piloting, and evaluating a pediatric lead screening and risk-reduction intervention in Nairobi: A hybrid
Ikenna Onoh1, Cyrus Mugo2, Anne Riederer3
1Department of Global Health, School of Public Health, University of Washington, Seattle, Washington, United States of America.
Insights
This study pilots an adaptive intervention to screen and reduce childhood lead exposure in Kenya. The Lead Exposure Intervention Program (LEIP) aims to protect children in low-resource settings.
Area of Science:
- Implementation Science
- Pediatric Environmental Health
- Global Public Health
Background:
- Childhood lead exposure is a significant global health issue, particularly in low- and middle-income countries (LMICs).
- Structured screening and prevention programs for pediatric lead exposure are often lacking in LMIC settings.
- There is a need for adapted interventions to address lead exposure in urban African contexts.
Purpose of the Study:
- To describe the protocol for the Lead Exposure Intervention Program (LEIP).
- To adapt, pilot, and evaluate a pediatric lead exposure screening and risk-reduction protocol in Nairobi, Kenya.
- To inform scalable national and regional approaches for lead exposure interventions.
Main Methods:
- A multi-phase, hybrid type 3 implementation-effectiveness study (ClinicalTrials.gov NCT07401251).
- Phase 1: Formative study to pilot screening (blood lead level - BLL), risk survey, and caregiver messaging.
- Phase 2: Randomized trial (N=1500 screened, N=100 enrolled) comparing clinic-based messaging with/without home visits.
- Phase 3: Qualitative interviews to identify barriers and facilitators to intervention uptake.
Main Results:
- (Study ongoing; results not yet available) The study aims to assess caregiver recall, behavior adoption, and changes in child BLL at 3 and 9 months.
- The integrated findings will inform refinements for intervention scale-up.
Conclusions:
- The LEIP study will develop and evaluate an adaptive, screening-based lead exposure intervention for urban LMIC settings.
- Incorporating implementation science and stakeholder input is key to developing scalable interventions.
- Mixed-methods approach will capture multilevel dynamics for future large-scale implementations.
Background:
Childhood 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.
Methods:
LEIP 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 Registration:
ClinicalTrials.gov NCT07401251.
