Clinical trial NCT05130632: Plastic Waste and Human Health Effects in Guatemala
Official title: Combustion of Plastic Waste and Human Health Effects in Guatemala
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Environmental Exposure
Keywords: Plastic Burning Practice
Plastic Waste Reduction
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Universidad del Valle, Guatemala
name: University of California, San Francisco
name: University of Georgia
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2021-11-23
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in PM2.5 exposure
timeFrame: Baseline, 4-5 months, and up to 13 months
measure: Change in black carbon (BC) exposure
timeFrame: Baseline, 4-5 months, and up to 13 months
measure: Change in urinary bisphenols
timeFrame: Baseline, 4-5 months, and up to 13 months
measure: Change in urinary phthalates
timeFrame: Baseline, 4-5 months, and up to 13 months
measure: Change in urinary polycyclic aromatic hydrocarbons (PAHs)
timeFrame: Baseline, 4-5 months, and up to 13 months
measure: Change in urinary volatile organic compounds (VOCs)
timeFrame: Baseline, 4-5 months, and up to 13 months
Secondary outcomes:
measure: Reach of intervention using the RE-AIM implementation science framework
timeFrame: 4-5 months and up to 13 months
measure: Effectiveness of intervention using the RE-AIM implementation science framework
timeFrame: 4-5 months and up to 13 months
measure: Enablers and barriers to the adoption of the intervention using the RE-AIM implementation science framework
timeFrame: 13 months
measure: Adoption of the intervention by direct observation using the RE-AIM implementation science framework
timeFrame: 13 months
measure: Maintenance of the intervention using the RE-AIM implementation science framework
timeFrame: After 13 months
Other outcomes:
measure: Change in Health-related Quality of Life (HRQOL) Score
timeFrame: Baseline, 4-5 months, and up to 13 months
measure: Change in Household Decision Making
timeFrame: Baseline, 4-5 months, and up to 13 months
measure: Change in New General Self-Efficacy Scale (NGSE) Score
timeFrame: Baseline, 4-5 months, and up to 13 months
measure: Change in Short Social Capital Assessment Tool (SASCAT) Score
timeFrame: Baseline, 4-5 months and up to 13 months
measure: Change in Community Mobilization Scale Score
timeFrame: Baseline, 4-5 months and up to 13 months
measure: Change in the quantification of emissions estimates of air pollutants from plastic incineration.
timeFrame: Baseline, 4-5 months and up to 13 months
Locations:
city: Guatemala
country: Guatemala
facility: Universidad del Valle de Guatemala
city: Jalapa
country: Guatemala
facility: Project Office, Jalapa
Study officials:
affiliation: Emory University-School of Nursing
name: Lisa M Thompson, PhD, RN, FNP
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory College of Arts and Sciences: Environmental Sciences
name: Eri Saikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References: