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| ID | Type | Description | Link |
|---|---|---|---|
| R01ES032009 | U.S. NIH Grant/Contract | View source | |
| 1F31ES036126 | U.S. NIH Grant/Contract | View source | |
| 1P2CES033430-01 | U.S. NIH Grant/Contract | View source | |
| 2025P010326 | Other Identifier | Emory Insight Humans IRB |
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| Name | Class |
|---|---|
| Universidad del Valle, Guatemala | OTHER |
| University of California, San Francisco | OTHER |
| University of Georgia | OTHER |
| National Institute of Environmental Health Sciences (NIEHS) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The community working group | Experimental | 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. |
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| Control Group. | No Intervention | Participants in control villages will receive small trees for reforestation during the intervention activities in the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The community working group | Behavioral | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in 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. | Baseline, 4-5 months, and 12 - 20 months |
| Change in 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. | Baseline, 4-5 months, and 12 - 20 months |
| Change in 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. | Baseline, 4-5 months, and 12 - 20 months |
| Change in 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. | Baseline, 4-5 months, and 12 - 20 months |
| Change in 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. | Baseline, 4-5 months, and 12 - 20 months |
| Change in urinary volatile organic compounds (VOCs) | To assess urinary biomarkers of exposure to combustion by-products, including plastic, this study will compare differences in VOC concentrations among women participating in the two study arms. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health-related Quality of Life (HRQOL) Score | Using the HRQOL instrument, compare differences in quality of life among women participating in the two study arms. The HRQOL consists of 4 questions measuring: a) overall general health (5 items- excellent, very good, good, fair, or poor; used independently, ordinal outcome); b) number of days physical health was not good in the last 30 days; c) number of days mental health was not good in the last 30 days (b and c are summed together, not to exceed 30 days, continuous outcome); and d) number of days poor physical or mental health limited daily activities in the last 30 days (used independently, continuous outcome). Higher scores typically represent poorer health and quality of life, with individuals reporting more health-related problems and worse functioning in daily activities, mental well-being, and social interactions. Lower scores suggest better health status, with individuals reporting fewer limitations or challenges in their physical, emotional, or social well-being. |
Inclusion Criteria:
For attendees at community working groups:
For questionnaires administered to workshop attendees:
For the collection of urine and personal air pollution samples:
For promotoras:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eri Saikawa, PhD | Emory College of Arts and Sciences: Environmental Sciences | Principal Investigator |
| Lisa M Thompson, PhD, RN, FNP | Emory University - Nell Hodgson Woodruff School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad del Valle de Guatemala | Guatemala City | Departamento de Guatemala | Guatemala | |||
| Project Office, Jalapa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41390662 | Derived | 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. | |
| 39775435 |
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Plan to share the following information: Exposure data, laboratory data, questionnaire related to the outcome and intervention, and standard of operating procedures.
One year after the study ends or when submitting publication (at editor's or funder's request)
The research team will create a data request form where they will outline procedures for accessing de-identified data which will include the name and affiliation of researchers, outcomes, and variables being requested with an approved statistical analysis plan.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 21, 2024 | Jun 11, 2025 | ICF_000.pdf |
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| NIH |
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| Baseline, 4-5 months, and 12 - 20 months |
| 4-5 months and 12 - 20 months |
| 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. | 4-5 months and 12 - 20 months |
| 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. | 20 months |
| 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. | 20 months |
| 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. | After 20 months |
| Baseline, 4-5 months, and 12 - 20 months |
| Change in Household Decision Making | Using a 7-part instrument, compare differences in household decision-making (e.g., spending earned money, major and minor purchases, job decisions, cooking foods, visiting others) among women participating in the two study arms. The responses are coded on a 4-point scale (respondent's sole decision; husband's decision; joint decision between respondent and husband; other family member makes decision). Scores range from 7 to 28; the lower the score, the greater the woman's agency to make household decisions. | Baseline, 4-5 months, and 12 - 20 months |
| Change in New General Self-Efficacy Scale (NGSE) Score | Using the New General Self-Efficacy Scale (NGSE), an 8-part instrument, compare differences in self-efficacy (e.g., problem-solving, goal setting, confidence, resourcefulness) among women participating in the two study arms. Each item is rated on a 5-point scale (strongly disagree; disagree; neither agree nor disagree; agree; strongly agree). NGSE scores range from 5 to 40; the higher the score, the greater the individual's generalized self-efficacy belief. | Baseline, 4-5 months, and 12 - 20 months |
| Change in Short Social Capital Assessment Tool (SASCAT) Score | Using the 12-part Short Social Capital Assessment Tool, compare differences in group membership, citizenship, and cognitive social capital (trust) among women participating in the two study arms. Responses are Yes/No, and scoring ranges from 0-37. The responses are summed to calculate a total social capital score, with higher scores indicating higher levels of social capital, signifying more support, trust, and participation in community networks. | Baseline, 4-5 months, and 12 - 20 months |
| Change in Community Mobilization Scale Score | Using the Community Mobilization Scale, compare differences in the Critical Consciousness sub-scale (modified 9-item instrument) and the Collective Action sub-scale (modified 2-item instrument) among women participating in the two study arms. The Critical Consciousness sub-scale score is measured using a 3-point Likert scale (agree, somewhat agree, disagree; scores ranging from 9-27, measured continuously). The Collective Action sub-scale asks about the number of times the participant and community have worked on community problems in the last 3 months and is measured continuously. For both scales, higher scores indicate higher levels of mobilization. | Baseline, 4-5 months, and 12 - 20 months |
| Change in the quantification of emissions estimates of air pollutants from plastic incineration. | Using filter-based antimony (Sb) and 1,3,5-Triphenylbenzene (TPB) as tracers of plastic burning and collecting household plastic waste, apportion PM2.5 and quantify emissions estimates of air pollutants from plastic incineration and assess effects of potential emissions reduction on air quality with a chemical transport model. | Baseline, 4-5 months, and 12 - 20 months |
| Jalapa |
| Jalapa |
| Guatemala |
| 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. |