Lead Exposure Intervention Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Recall of survey risk factors
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregivers with children ages 12-72 months attending routine care/vaccination visit at Nairobi clinical site.
排除标准
- •Children outside of age range, caregivers younger than 18; plan to leave study catchment within 9 months.
研究组 & 干预措施
Immediate messages
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.
干预措施: In-clinic lead risk reduction intervention (Behavioral)
Home visit
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.
干预措施: Home visit with tailored messages (Behavioral)
Home visit
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.
干预措施: In-clinic lead risk reduction intervention (Behavioral)
结局指标
主要结局
Recall of survey risk factors
时间窗: 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
时间窗: 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.
次要结局
- Differences in outcomes between arms(3 and 9 months post clinic visit)
研究者
Sarah Benki-Nugent
Associate Professor, Department of Global Health
University of Washington