Plastic Waste and Human Health Effects in Guatemala (NCT05130632) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Plastic Waste and Human Health Effects in Guatemala
Guatemala400 participantsStarted 2022-01-31
Plain-language 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.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pregna…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PM2.5 exposure
Timeframe: Baseline, 4-5 months, and 12 - 20 months
2
Change in black carbon (BC) exposure
Timeframe: Baseline, 4-5 months, and 12 - 20 months
3
Change in urinary bisphenols
Timeframe: Baseline, 4-5 months, and 12 - 20 months
4
Change in urinary phthalates
Timeframe: Baseline, 4-5 months, and 12 - 20 months
5
Change in urinary polycyclic aromatic hydrocarbons (PAHs)
Timeframe: Baseline, 4-5 months, and 12 - 20 months
6
Change in urinary volatile organic compounds (VOCs)
Timeframe: Baseline, 4-5 months, and 12 - 20 months