Plastic Waste and Human Health Effects in Guatemala

Emory University

Status: Enrolling

Conditions: Environmental Exposure

Treatments: Behavioral: The community working group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05130632

R01ES032009-01A1 (U.S. NIH Grant/Contract)

STUDY00002412

Details and patient eligibility

About

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 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.

Full 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 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 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.

Enrollment: 2,370 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,370 participants in 2 patient groups

The community working group

Experimental group

Description:

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.

Treatment:

Behavioral: The community working group

Control Group.

No Intervention group

Description:

No specific activities