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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01ES036010 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home visit with tailored messages | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in outcomes between arms | Using risk survey responses and self-reported changes in risk reduction behavior, we will compare the participants of both arms to assess for differences. | 3 and 9 months post clinic visit |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of the BLL re-check | Return for a re-check visit is an indicator of caregiver awareness of importance of reducing lead exposure. We will summarize the proportions of caregivers returning for each BLL re-check visit for each arm. | 3 and 9 months post-initial visit |
| Change in BLL |
Inclusion Criteria:
Exclusion Criteria: Children outside of age range, caregivers younger than 18; plan to leave study catchment within 9 months.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Jansen | Contact | 206-685-6392 | kjansen@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Benki-Nugent | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pumwani Hospital and Baba Ndogo Health Centre | Nairobi | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42241430 | Derived | 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. | |
| 42094172 | Derived | 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. |
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All data other than patient direct or indirect identifiers will be shared.
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Other researchers can contact the MPIs and complete an approved Data Sharing Agreement
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| ID | Term |
|---|---|
| D006792 | House Calls |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| In-clinic lead risk reduction intervention | Behavioral | 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. |
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Change in BLL at re-checks. We do not anticipate observing a significant reduction in child BLL, given that caregivers might not have the ability to identify and/or modify a lead risk exposure. |
| 3 and 9 months post-initial clinic visit |