Plastic Waste and Human Health Effects in Guatemala

Study Overview
=================
Brief Summary
-----------------
The goal of this cluster-randomized trial 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 as well as other community members from these villages will be enrolled in each group. The follow-up period is 12 months. A Community Advisory Board will be formed in order to provide input on study activities, evaluate working group intervention strategies, and discuss the potential to expand activities regionally. 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.

Detailed Description
-----------------
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. The aim of this study is to conduct a cluster-randomized trial to evaluate the uptake and sustainability of intervention strategies to reduce use, recycle, and repurpose plastic that will lead to reductions in household-level plastic burning in selected villages in rural Guatemala. The 200 intervention group participants, along with 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 outcomes include personal air pollution exposure, comparison of urinary biomarkers of exposure to plastic combustion, quantification of emissions estimated or air pollutants from plastic incineration, Health-related Quality of Life, self-efficacy and social cohesion, and implementation quality and fidelity of adherence. In the first year, formative research involving a rapid assessment, formation of a Community Advisory Board, working group refinement, and a working group pilot will occur. The implementation science Capabilities-Opportunities-Motivations-Behavior (COM-B) framework will guide the development of the behavioral intervention (community working groups) during the formative phase. In Years 2 - 4 (the main trial), data collection will include participant surveys (at baseline, 4 months, and 12 months), the community working groups (12 weeks), focus groups (month 12), biomarker (urine) collection (baseline, 4 months and 12 months), plastic waste collection (baseline and 4 months), and modeling activities around emissions scenarios and regional air quality. In Year 5, program evaluation will occur, and results will be disseminated to the participating intervention and control communities and to regional and national policymakers.

Official Title
-----------------
Combustion of Plastic Waste and Human Health Effects in Guatemala

Conditions
-----------------
Environmental Exposure

Intervention / Treatment
-----------------
* Behavioral: The community working group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For community working groups: There are no inclusion or exclusion criteria 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 Report that plastic is burned in household fires (in the cooking stove or outdoors) Exclusion Criteria: Inability to consent Cognitively impaired or individuals with impaired decision-making capacity Pregnant women. However, women who become pregnant during the course of the study may continue to participate. Women who report using tobacco products

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The community working group<br>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. | Behavioral: The community working group<br>* The intervention consists of educational working group (WG) sessions over a 12-week period. Eight core modules-the essential ingredients-and 4 periphery modules to help identify community-driven interventions to reduce plastic burning in household fires, consume less plastic, recycle, and repurpose plastic, will be held. Participants will prioritize 1 task that can be attained in the next 9 months, with the guidance of community workers (promotoras), such as: -starting an organic compost pile free of plastic waste -training on community recycling, focusing on plastics recycling -making organic soaps, to use for personal grooming or washing clothes, eliminate plastic packaging -creating materials out of plastic, like bottle planters, crocheted plastic bags, purses.<br>* Other names: Intervention Group;|
| No Intervention: Control Group.<br>No specific activities | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PM2.5 exposure | Air pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal PM2.5 within and between women. | Baseline, 4-5 months, and up to 13 months | 
| Change in BC exposure | Air pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal BC within and between women. | Baseline, 4-5 months, and up to 13 months | 
| Change in urinary bisphenol level | To assess urinary biomarkers of exposure to plastic combustion, bisphenol level in urine will be evaluated in 200 reproductive-age women participating in the community working groups. | Baseline, 4-5 months, and up to 13 months | 
| Change in urinary phthalate level | To assess urinary biomarkers of exposure to plastic combustion, phthalate level in urine will be evaluated in 200 reproductive-age women participating in the community working groups. | Baseline, 4-5 months, and up to 13 months | 
| Change in urinary polycyclic aromatic hydrocarbon level | To assess urinary biomarkers of exposure to plastic combustion, polycyclic aromatic hydrocarbon level in urine will be evaluated in 200 reproductive-age women participating in the community working groups. | Baseline, 4-5 months, and up to 13 months | 
| Change in urinary volatile organic compound level | To assess urinary biomarkers of exposure to plastic combustion, volatile organic compound level in urine will be evaluated in 200 reproductive-age women participating in the community working groups. | Baseline, 4-5 months, and up to 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health-related Quality of Life Score | Using the HRQOL instrument, the research team will compare differences in quality of life (e.g.: general health, physical and mental health, and daily activity level) within and between women. | Baseline, 4-5 months, and up to 13 months | 
| Change in Household Decision Making | Using a 7-part instrument, compare differences in household decision making (e.g., spending earned money, major and minor purchases, job decisions, visiting others) within and between women. | Baseline, 4-5 months, and up to 13 months | 
| Change in New General Self-Efficacy Scale (GSE) Score | Using the New General Self-Efficacy Scale (GSE) 8-part instrument, compare differences in self-efficacy (e.g., problem-solving, goal setting, confidence, resourcefulness) within and between women. | Baseline, 4-5 months, and up to 13 months | 
| Change in Short Social Capital Assessment Tool Score | Using the 9-part Short Social Capital Assessment Tool, compare differences in Group Membership, Citizenship, and Cognitive Social Capital within and between women. | Baseline, 4-5 months and up to 13 months | 
| Change in Community Mobilization Scale Score. | Using the Community Mobilization Scale Score 16-part instrument, compare differences in the Critical Consciousness Sub-scale and the Collective Action Sub-scale within and between women. | Baseline, 4-5 months and up to 13 months | 
| Change in the quantification of emissions estimates of air pollutants from plastic incineration. | Using filter-based antimony (Sb) and 1,3,5-Triphenylbenzene (TPB) as tracers of plastic burning and collecting household plastic waste, apportion PM2.5 and quantify emissions estimates of air pollutants from plastic incineration and assess effects of potential emissions reduction on air quality with a chemical transport model. | Baseline, 4-5 months and up to 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plastic Burning Practice, Plastic Waste Reduction