Cx3 Study - Patient Recruitment

Form Approved

OMB No. 0920-xxxx

Exp. xx/xx/xxxx

CDC Cervical Cancer (Cx3) Study

PATIENT RECRUITMENT SCRIPT

Hello, [patient name]. You are here today for your woman’s wellness visit with [Dr. or Ms. name of provider], is that right?

IF YES:

Our clinic was one of 18 clinics in Illinois that were selected to take part in a cervical cancer screening study for the Centers for Disease Control and Prevention. I’ve looked at your medical record and you may be eligible for the research study. I would like to ask you some questions to see if you do meet the study requirements.

[READ LIST OF QUESTIONS AND COMPARE ANSWERS TO THE STUDY ELIGIBILITY CRITERIA]

How old are you? [35 – 60]

Are you pregnant at this time? [NO]

Have you had a hysterectomy? [NO]

Have you ever had cervical cancer? [NO]

Was your last Pap test normal? [YES]

AFTER ASKING ALL QUESTIONS, IF THE PATIENT GAVE ANY ANSWER(S) THAT DO NOT MEET STUDY ELIGIBILITY:

Thank you very much but you are not eligible to participate in this study. Please be seated and [Dr. or Ms. name of provider] will see you as soon as possible.

IF THE PATIENT MEETS ALL OF THE STUDY ELIGIBILITY CRITERIA:

You are eligible for the study, which involves receiving an HPV test, along with your Pap test today. If you think that you might be interested in participating in the study, I would like you to read the patient consent form. The consent form will tell you what the study involves and will explain all about this additional screening test. [GIVE PATIENT THE CONSENT FORM (ENGLISH OR SPANISH VERSION, AS APPROPRIATE) AND ANSWER ANY QUESTIONS ABOUT THE STUDY.]

Public reporting burden of this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS E-11, Atlanta, Georgia 30333; ATTN: PRA (0920-XXXX)

AFTER THE PATIENT HAS AGREED TO PARTICIPATE IN THE STUDY AND SIGNED THE CONSENT FORM, COMPLETE THE PATIENT ENROLLMENT. FOR THOSE PATIENTS WHO WILL BE ASKED TO COMPLETE THE PATIENT SURVEY, COMPLETE THE BOTTOM OF THE PATIENT ENROLLMENT FORM TO RECORD CONTACT INFORMATION FOR THE FOLLOW-UP SURVEYS.

IF THE PATIENT HAS BEEN SELECTED FOR THE PATIENT SURVEY:

You have been selected as one of the patients for the patient survey. As explained in the consent form that you just signed, you will be asked to complete a survey in the office today before you see [Dr. or Ms. name of provider]. This is the survey that we would like you to fill out today. Here is a pencil. HAND PATIENT SURVEY, ENVELOPE, AND PENCIL. When you have finished the survey, please put it in this envelope. Seal the envelope so that nobody but the researchers will see your answers. Then return the sealed envelope to me and I will give you $5 for taking the time to fill out the survey. You will also receive two surveys by mail—one in about 18 months and another in about 40 months—with $5 in each of those surveys.

WHEN THE PATIENT HAS RETURNED THE SURVEY:

Thank you very much. Here is the $5 to thank you for completing the survey. Please be seated and [Dr. or Ms. name of provider] will see you as soon as possible.

Attachment E1a. Patient recruitment script 2