Plastic Waste and Human Health Effects in Guatemala (Ecolectivos)

Emory University

Status: Suspended

Conditions: Environmental Exposure

Treatments: Behavioral: The community working group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05130632

1P2CES033430-01 (U.S. NIH Grant/Contract)

1F31ES036126 (U.S. NIH Grant/Contract)

STUDY00002412

R01ES032009 (U.S. NIH Grant/Contract)

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 and other community members from these villages will be enrolled in each group. The follow-up period is 12 months. 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.

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.

Enrollment: 400 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For attendees at 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
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 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:

Participants in control villages will receive small trees for reforestation during the intervention activities in the intervention group.