Combustion of Plastic Waste and Human Health Effects in Guatemala
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- PM2.5 exposure
研究概览
简要总结
Ecolectivos is a type-1 hybrid-effectiveness-implementation study that uses a village-level cluster randomized controlled trial design. The goal of this study in rural Guatemala is to assess intervention strategies to reduce plastic burning in 8 intervention villages compared to 8 control villages. The intervention group participants will participate in 12 weekly behavioral working group sessions; the control group will not receive any specific activities. Two hundred women of reproductive age and other community members from these villages will be enrolled in each group. Data will be collected via interviews, focus groups, air pollution sampling, plastic waste collection, urinary biomarker assessments, and ambient air sampling. Program evaluation and results dissemination will occur in the last year of the project.
详细描述
Household air pollution from solid fuel combustion (e.g., wood) is a major environmental risk factor in low- and middle-income countries, accounting for an estimated 2.6 million deaths annually (World Health Organization, 2018). The contribution of plastic waste incineration in household fires has not been quantified. This is problematic for countries like Guatemala, where 71% of households burn waste as a primary means of disposal (Government of the Republic of Guatemala 2019). Plastic waste incineration is a critical, but understudied, public health and environmental hazard, as communities are inundated with cheap plastic without the means of safely disposing of plastic waste.
This study aims to conduct a type 1 hybrid-effectiveness-implementation study that uses a village-level cluster-randomized controlled trial design to evaluate the uptake and sustainability of intervention strategies to reduce the use, recycling, and repurposing of plastic that will lead to reductions in household-level plastic burning in selected villages in rural Guatemala. The 200 intervention group participants and other interested community members will participate in 12 weekly behavioral working group sessions. Each intervention community will commit to alternatives to burning plastic and drive initiatives they can achieve over the next 9 months. The 200 control group participants will not receive any specific activities until year 5, when dissemination of results will include control villages. Primary endpoints include personal exposure to air pollution, including particulate matter, black carbon, and other compounds produced while burning solid fuels and plastic waste. Secondary endpoints are assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For attendees at community working groups:
- •There are no inclusion or
排除标准
- •as the whole community will be invited
- •For questionnaires administered to workshop attendees:
- •Over the age of 15
- •For the collection of urine and personal air pollution samples:
- •Women of reproductive age (15 - <44 years, verified by official document)
- •Willingness to attend 12-week working groups
- •Willingness to participate in biomonitoring
- •Willingness to wear a silicone wristband for 1 week at baseline and 4-5 months
- •Household uses biomass as the primary fuel for cooking
- •Reports daily participation in household cooking
- •Reports that plastic is burned in household fires at least once a week (in the cooking stove or outdoors)
- •Plans to live in the household for the next 12 months
- •For promotoras:
- •Over the age of 18
- •Ability to read and write
- •Women who participate in biomonitoring in the intervention group
- •Willingness to make monthly household visits to study participants
- •Willingness to make weekly calls to study participants
- •Willingness to encourage participation in the activity selected by the village
- •Willingness to communicate weekly with the research team
- •Willingness to support community meetings to scale up the intervention in intervention and control villages
- •Exclusion Criteria:
- •Inability to consent
- •Cognitively impaired or individuals with impaired decision-making capacity
- •Pregnant women. However, women who become pregnant during the study may continue to participate.
- •Women who report using tobacco products
研究组 & 干预措施
The community working group
Female participants over the age of 15 randomized to the intervention group will participate in working group sessions over 12 weeks' time that addresses plastic waste and introduce strategies to reduce use, recycle, and repurpose plastic. Community members of participants in the intervention group will also be invited to participate in the working groups.
干预措施: The community working group (Behavioral)
Control Group.
Participants in control villages will receive small trees for reforestation during the intervention activities in the intervention group.
结局指标
主要结局
PM2.5 exposure
时间窗: Baseline, 4-5 months, and 12 - 20 months
Air pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal PM2.5 exposure among women participating in the two study arms.
Black carbon (BC) exposure
时间窗: Baseline, 4-5 months, and 12 - 20 months
Air pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal BC exposure among women participating in the two study arms.
Urinary bisphenols
时间窗: Baseline and 4-5 months
To assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in bisphenol concentrations among women participating in the two study arms.
Urinary phthalates
时间窗: Baseline and 4-5 months
To assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in phthalate concentrations among women participating in the two study arms.
Urinary polycyclic aromatic hydrocarbons (PAHs)
时间窗: Baseline and 4-5 months
To assess urinary biomarkers of exposure to combustion by-products, including plastic, this study will compare differences in PAH concentrations among women participating in the two study arms.
Change in PM2.5 exposure
时间窗: Baseline, 4-5 months, and 12 - 20 months
Air pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal PM2.5 exposure among women participating in the two study arms.
Change in black carbon (BC) exposure
时间窗: Baseline, 4-5 months, and 12 - 20 months
Air pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal BC exposure among women participating in the two study arms.
Change in urinary bisphenols
时间窗: Baseline, 4-5 months, and 12 - 20 months
To assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in bisphenol concentrations among women participating in the two study arms.
Change in urinary phthalates
时间窗: Baseline, 4-5 months, and 12 - 20 months
To assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in phthalate concentrations among women participating in the two study arms.
Change in urinary polycyclic aromatic hydrocarbons (PAHs)
时间窗: Baseline, 4-5 months, and 12 - 20 months
To assess urinary biomarkers of exposure to combustion by-products, including plastic, this study will compare differences in PAH concentrations among women participating in the two study arms.
Change in urinary volatile organic compounds (VOCs)
时间窗: Baseline, 4-5 months, and 12 - 20 months
To assess urinary biomarkers of exposure to combustion by-products, including plastic, this study will compare differences in VOC concentrations among women participating in the two study arms.
次要结局
- Reach of intervention using the RE-AIM implementation science framework(4-5 months and 12 - 20 months)
- Effectiveness of intervention using the RE-AIM implementation science framework(4-5 months and 12 - 20 months)
- Enablers and barriers to the adoption of the intervention using the RE-AIM implementation science framework(20 months)
- Adoption of the intervention by direct observation using the RE-AIM implementation science framework(20 months)
- Maintenance of the intervention using the RE-AIM implementation science framework(After 20 months)