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Environmental ExposureEcolectivosNCT05130632

Plastic Waste and Human Health Effects in Guatemala

A study testing The community working group in people with Environmental Exposure, run by Emory University at 2 sites in Guatemala.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Environmental Exposure
What is being tested?
The community working group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
2 sitesGuatemala
Study dates
31 Jan 2022to 24 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)
Show all 22Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Guatemala2 sites

  • Universidad del Valle de Guatemala

    Guatemala City, Departamento de Guatemala

  • Project Office, Jalapa

    Jalapa, Jalapa

Other trials in Guatemala

About this study

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

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. 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.

Read the 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.

Being tested
The community working group
Keywords
Plastic Burning Practice, Plastic Waste Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The community working groupBehavioural

    Also called Intervention Group

    The intervention consists of educational working group (WG) sessions over 12 weeks. Eight core modules discussing essential elements (such as main problems of solid waste management, health effects of exposure to burning plastic, sustainable alternatives to plastic litter) and four 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 one task that can be attained in the next 9 months, with the guidance of community workers (promotoras), such as:

    • engaging in a community clean-up
    • 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, eliminating plastic packaging
    • creating materials out of plastic, like bottle planters
Study groups in NCT05130632
Study groupRoleWhat they receive
The community working groupExperimentalFemale 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.
Receives: Behavioral: The community working group
Control Group.No interventionParticipants in control villages will receive small trees for reforestation during the intervention activities in the intervention group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PM2.5 exposure

    Air pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal PM2.5 exposure among women participating in the two study arms.

    Measured: Baseline, 4-5 months, and 12 - 20 months

  2. Black carbon (BC) exposure

    Air pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal BC exposure among women participating in the two study arms.

    Measured: Baseline, 4-5 months, and 12 - 20 months

  3. Urinary bisphenols

    To assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in bisphenol concentrations among women participating in the two study arms.

    Measured: Baseline and 4-5 months

  4. Urinary phthalates

    To assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in phthalate concentrations among women participating in the two study arms.

    Measured: Baseline and 4-5 months

  5. Urinary polycyclic aromatic hydrocarbons (PAHs)

    To assess urinary biomarkers of exposure to combustion by-products, including plastic, this study will compare differences in PAH concentrations among women participating in the two study arms.

    Measured: Baseline and 4-5 months

Secondary outcomes (5)

  1. Reach of intervention using the RE-AIM implementation science framework

    Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, assess the reach of the intervention in the intervention arm, as measured by: 1) the number and proportion of total invited participants who attend working groups; 2) the number and proportion of participants' household members who engage in working group activities; and 3) the number of intervention village members who engage in working group activities.

    Measured: 4-5 months and 12 - 20 months

  2. Effectiveness of intervention using the RE-AIM implementation science framework

    Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, assess the effectiveness of the intervention by measuring the number of intervention group participants who report behavior changes. These changes are categorized as "high" or "low" behaviors based on factors such as working group attendance, engagement in activities, and reported reductions in plastic burning.

    Measured: 4-5 months and 12 - 20 months

  3. Enablers and barriers to the adoption of the intervention using the RE-AIM implementation science framework

    Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM implementation science framework, assess the enablers and barriers to the adoption of the intervention using qualitative data collected from focus groups and interviews with participants and environmental promotoras. This will help identify the factors influencing the uptake of the intervention at the village level. There are no units of measure.

    Measured: 20 months

  4. Adoption of the intervention by direct observation using the RE-AIM implementation science framework

    Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, assess the adoption of the intervention through direct observations of intervention activities, using qualitative data analysis to evaluate the extent of implementation at the community level. There are no units of measure.

    Measured: 20 months

  5. Maintenance of the intervention using the RE-AIM implementation science framework

    Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, assess the maintenance (sustainment of intervention strategies) at the participant, household, and village level, as measured by: 1) number and proportion of participants who report no longer burning plastic in household fires (a measure of de-adoption); 2) number and proportion of households who continue their involvement in intervention activities at the village level after the working groups are completed; and 3) number of community members and organizations who have independently maintained, or established, similar intervention activities in the communities after the working groups are completed in the intervention arm.

    Measured: After 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start31 Jan 2022
  3. Primary completion24 May 2026
  4. Study completion24 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05130632
Sponsor's protocol ID
STUDY00002412
Other IDs
R01ES032009, 1F31ES036126, 1P2CES033430-01, 2025P010326
Acronym
Ecolectivos
Status last verified
Sep 2026
First submitted
20 Oct 2021
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan to share the following information: Exposure data, laboratory data, questionnaire related to the outcome and intervention, and standard of operating procedures.

Publications

  • Thompson LM, Lovvorn AE, Raheel H, Hengstermann-Artiga M, Lopez MR, Ramirez A, Barr DB, Higgins M, McCracken JP, Saikawa E, Handley MA. A village-level cluster randomized controlled implementation trial to measure the effectiveness of a behavioral intervention aiming to reduce women's exposures to household plastic waste burning in rural Guatemala: study protocol for the Ecolectivos trial. Trials. 2025 Dec 13;27(1):49. doi: 10.1186/s13063-025-09338-z.

    PubMed 41390662

  • Thompson LM, Ferguson A, Raheel H, Lovvorn AE, Hengstermann-Artiga M, Lopez MR, Higgins M, Saikawa E, Handley MA. PRECIS-2 used as an implementation science tool for global environmental health: A cross-sectional evaluation of the Ecolectivos study protocol to reduce burning of household plastic waste in rural Guatemala. PLoS One. 2024 Dec 30;19(12):e0316161. doi: 10.1371/journal.pone.0316161. eCollection 2024.

    PubMed 39775435

Questions about this trial

What is this clinical trial studying?

A study testing The community working group in people with Environmental Exposure, run by Emory University at 2 sites in Guatemala.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PM2.5 exposure (time frame: Baseline, 4-5 months, and 12 - 20 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05130632, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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