Plastic Waste and Human Health Effects in Guatemala

Environmental Exposure Clinical Trial

Official title: Combustion of Plastic Waste and Human Health Effects in Guatemala

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Environmental Exposure

• NCT number: NCT05130632
• Study type: Interventional
• Source: Emory University
• Contact: Lisa M Thompson, PhD, RN, FNP
• Phone: 404-712-7350
• Email: lisa.thompson@emory.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Completion date: May 2026