Introductory Script

ATTACHMENT 3

ZODIAC Recruitment Procedure and Introductory Script

Recruitment Procedure

ZODIAC staff will contact families of children included in the initial case-control investigation by phone and/or in-person and invite the child and his/her primary caregiver to participate in a follow-up assessment. Staff will also enroll other children who meet the eligibility criteria from other investigations, including clinical cohorts in participating sites.

Staff will recruit participants in stages. If the family does not have a phone or cannot be contacted after three phone calls, outreach workers will make one effort to visit the home in person. If all contact attempts prove unsuccessful, the interview team will record “contact unsuccessful” in the participant recruitment and tracking log.

During the recruitment process (either by phone or in person), a project staff member will introduce himself/herself to the primary caregiver of each eligible child and provide a brief overview of the investigation. The primary caregiver will be asked if the family is interested in knowing more about the investigation and if they would like to participate. If they are interested, investigation staff will provide additional information. They will also ask if the primary caregiver is available to accompany the child to 2 and possibly up to 3 visits to a participating health facility when the child is between 12-24 months of age. If the primary caregiver is not available for participation in the investigation, the child will not be eligible for enrollment. If after reading the introductory script, the family is not interested in hearing more about the investigation, they will be thanked for their time and offered information about preventing mosquito-borne diseases, and other health information. The data collection team will record “refused” in the participant tracking log.

If the primary caregiver of an eligible child cannot be contacted after three phone calls, one final effort will be made through an in-person visit. If no contact is made after the final attempt, the data collection team will record “contact unsuccessful” in the participant tracking log.

Introductory Script

Below is an example of a recruitment call:

(Z=ZODIAC Staff Member)

Z: Hello, may I speak with [name]? Are you the [child’s name] primary caregiver most of the time? Confirm: You are the [child’s name’s] parent? If parent not available, ask for person who takes care of [child’s name] most of the time.

Z: My name is [name] and I am working with the state health secretariat and the University of Brasilia. I am calling

because [name of child] participated in a recent study about Zika (if a case-control study participant) or

because your doctor has indicated you and your family may be eligible for a study about Zika .

We’d like to invite you and [child’s name] to participate in an investigation to learn how Zika virus is affecting children as they develop and their families. This investigation is being conducted by the Brazilian Ministry of Health, the University of Brasilia, and the US Centers for Disease Control and Prevention. If you agree to participate, you would be helping us understand what medical and other services children and families affected by Zika need.

Z: Participation is expected to take 2 – 4 hours over 2 or 3 visits to a local health clinic. A doctor will assess [name of child] health, you will be asked questions, and we will review your child’s medical records (baby book). All of the information we collect will be kept private to the extent allowed by law. We will not ask you any questions or examine [child’s name] or look at the baby book without your permission.

Z: Are you interested learning more about this investigation?

If NO, read statement below and end phone call.

Z: Thank you for your time. If you would like, I can share information with you about preventing mosquito-borne diseases and other important health information. Is there an email address or mailing address where I can send this information?

If YES, read statement below and continue with following questions.

Z: Thank you for your interest. I am happy to share more information with you and answer your questions. First, can you please confirm whether you will be available to make 2 or 3 visits to [name of health facility] with [name of child] before [name of child]’s second birthday?

If NO, read statement below and end phone call.

Z: I appreciate your interest in learning more about the investigation. To participate in the investigation, you must be available to come with [name of child] 2 – 3 times before [name of child] is 24 months old. Although you are not available to participate, I can share information with you about preventing mosquito-borne diseases and other important health information. Is there an email address or mailing address where I can send this information?

If YES, read statement below and establish follow-up plan.

Z: Great. I would like to invite you to meet me at [name of health care facility] to review the details of the investigation. If you agree to participate, I will ask you to sign consent forms for you and your child. After the consent forms are signed, we can begin some of the assessments, depending on your availability. The appointment may take up to 3 hours. I can provide transportation to and from [name of health care facility]. How does this sound?

• If they are able to meet in person, ZODIAC staff member schedules appointment, gives the potential participant a chance to ask questions, and also gives the potential participant their contact information so that they can get in touch as needed.

Z: [if they are not able to meet in person]: If you would prefer, I can send you the information in the mail or through email, and I will call you back in one week to ask you if you’ve decided to participate and if so, schedule your first appointment.