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Attachment 4

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Fleisch-Kincaid Reading Level: 8.4

Aerosols from cyanobacterial blooms: exposures and health effects in highly exposed populations

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Do you spend much of your time on Lake Okeechobee?

HERE’S A CHANCE TO BE IN A RESEARCH STUDY

The National Center for Environmental Health, Centers for Disease Control and Prevention (CDC), and the Florida Department of Health are doing a research study.

You may have heard about cyanobacteria, also called blue-green algae. They are very tiny organisms that grow in water. Some types of cyanobacteria make chemicals, called cyanobacterial toxins, which can make people sick. For example, we know these chemicals can cause liver or kidney damage in people when they drink water with a lot cyanobacterial toxins in it.

The purpose of our study is to find out if the toxins made by these algae get into the air and then into people’s bodies. Similar studies have been done in Florida, Michigan, and California.

We hope you want to be in our study. To be in our study, you must be at least 18 years old; live or work near a canal or river; spend at least two hours outside on most days; understand English, Spanish, or Haitian Creole; spend at least 2 hours a day outside each day; be able to do a lung function test; and be willing to do all study activities listed below.

If you are interested in our study, we will ask you to complete a Screening/Baseline survey.

If you agree to participate, we will ask you to do the following during approximately 16 weeks:

• Read and sign a consent form

• Make 5 appointments with study staff to do study activities (study days 1, 2, 3, 4, and 5) NOTE: study days will not be consecutive but will occur across bloom season—one day at the beginning of the bloom, 3 during the bloom, and one at the end of the bloom.

• On study days 1, 3, and 5:

  • Provide a blood specimen for liver enzyme levels and creatinine levels in the morning

  • Receive training on how to collect a urine sample (one time only)

  • Do the following in the morning and evening:

    • Complete symptom survey

    • Provide urine specimen for cyanobacterial toxin and creatinine levels

    • Perform lung function test

    • Provide nasal swab for cyanobacterial toxin levels

  • Wear a personal air sampler during the day

  • Record time spent outdoors

  • Allow study staff to put air samplers (one for aerosols, one for gases and vapors (e.g., hydrogen sulfide) near your home or worksite

  • At the end of the day, allow study staff to collect air monitoring equipment

  • Provide a fish if you fish on the study day

• On study days 2 and 4:

  • Do all study activities you do on study days 1, 3, and 5, except that you will not need to give us a blood sample.

There is no cost to be in this study. We will give you tokens of appreciation for the data you provide.

We will give you the clinical results from the study, which include lung function test results, levels of creatinine and liver enzymes in your blood. Because this is a research study and we cannot be certain what the results mean, we will not give you the results of the analysis of cyanobacterial toxins in your urine.

Please be assured that CDC will take COVID-19 prevention measures at every step of our work in your community. The study will be conducted following all state, local, and CDC guidelines in place at the time the study is conducted. CDC team members will be monitored twice daily for fever and any COVID-19-related symptoms. Any team members with fever or COVID-19-related symptoms will not be allowed to collect data until they have quarantined for the recommended period, if appropriate, and have tested negative for COVID-19. There will be times when study staff will visit your home to collect information (study forms, urine specimens, personal air samples). If there is any face-to-face contact with study staff at that time, study team members will wear surgical masks and gloves and study participants will wear a face covering or mask. If you do not have a mask, one will be provided to you. If you are unable to wear a mask for medical reasons, you can let us know.

If you want to learn more about this research study, please call xxx-xxx-xxxx. Please leave a message with your name, phone number with area code, and best times to call you back. Thank you for your interest!