Lead ExposureLEIPNCT07401251
Lead Exposure Intervention Program
A study testing Home visit with tailored messages and In-clinic lead risk reduction intervention in people with Lead Exposure and High Blood Lead Level, run by University of Washington at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Lead Exposure, High Blood Lead Level
- What is being tested?
- Home visit with tailored messages and In-clinic lead risk reduction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2027to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child age 12-72 months
- Parent or primary caregiver that is a biological relative is available to give informed consent for LEIP study
- Parent/caregiver is 18 years of age or older or is an emancipated minor
- Parent available for 9 months follow-up
Who cannot join
- -Parent unwilling to be contacted for the purposes of tracing and follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read more
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
- Conditions
- Lead Exposure, High Blood Lead Level
- Being tested
- Home visit with tailored messages, In-clinic lead risk reduction intervention
- Keywords
- lead, pediatric, Sub-Saharan Africa, lead risk reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visit with tailored messagesBehavioural
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.
In-clinic lead risk reduction interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Home visit with tailored messages; Behavioral: In-clinic lead risk reduction intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 3 and 9 months post clinic visit
Secondary outcomes (1)
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.
Measured: 3 and 9 months post clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lead ExposureStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Sarah Benki-Nugent, University of Washington
- Investigators
- Sarah Benki-Nugent, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401251
- Sponsor's protocol ID
- STUDY00022114
- Other IDs
- 1R01ES036010
- Acronym
- LEIP
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data other than patient direct or indirect identifiers will be shared.
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.
PubMed 42241430Onoh 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.
PubMed 42094172
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lead Exposure Intervention Program
- ClinicalTrials.gov ID
- NCT07401251
- Acronym / sponsor ID
- LEIP / STUDY00022114
- Conditions
- Lead Exposure, High Blood Lead Level
- Keywords
- lead, pediatric, Sub-Saharan Africa, lead risk reduction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate messages | Active comparator | Behavioral: In-clinic lead risk reduction interventionCaregivers 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. |
| Home visit | Experimental | Behavioral: Home visit with tailored messages, Behavioral: In-clinic lead risk reduction interventionCaregivers 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. |
Who may qualify
- Ages
- 12 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child age 12-72 months
- Parent or primary caregiver that is a biological relative is available to give informed consent for LEIP study
- Parent/caregiver is 18 years of age or older or is an emancipated minor
- Parent available for 9 months follow-up
Key exclusion criteria (1 listed)
- -Parent unwilling to be contacted for the purposes of tracing and follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home visit with tailored messagesThe 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. | Behavioural | Home visit |
| In-clinic lead risk reduction interventionFor 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. | Behavioural | Home visit, Immediate messages |
Primary outcome
Recall of survey risk factors
Time frame: 3 and 9 months post clinic visit
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).
Self report of risk-reduction behavior
Time frame: 3 and 9 months post clinic visit
Assess the proportion of caregivers self-reporting uptake of at least one of their risk reduction recommendations within arms and by BLL.
1 secondary outcome
Differences in outcomes between arms
Time frame: 3 and 9 months post clinic visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 42241430Onoh 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.
- Derived from this study: PubMed 42094172Onoh 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.
- Individual participant dataSharing planned: Yes. All data other than patient direct or indirect identifiers will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Benki-Nugent principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visit with tailored messages and In-clinic lead risk reduction intervention in people with Lead Exposure and High Blood Lead Level, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Jansen (206-685-6392, kjansen@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall of survey risk factors (time frame: 3 and 9 months post clinic visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07401251, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.