Full-screening

Form Approved:

OMB No. 0920-xxxx

Expiration Date: xx/xx/xxxx

Critical Thinking and Cultural Affirmation (CTCA): Evaluation of a Locally Developed HIV Prevention Intervention

Attachment 4

Full-Screening Form

Public reporting burden of this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the 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 D-74, Atlanta, Georgia 30333; Attn: OMB-PRA (0920-New)

Full Screening Script Form

Potential Participant: I’d like to get more information about this study I heard about.

Study Staff: Great, thanks for calling/coming in. Let me tell you a little bit about the study to see if it’s something you might be interested in, then I’ll ask you a few questions to see if you are eligible to participate. You can stop me at any point if you have questions.

This study is called Critical Thinking and Cultural Affirmation: HIV Prevention Intervention for African American Men who have Sex with Men. The purpose of the study is to evaluate how effective the Critical Thinking and Cultural Affirmation group HIV prevention program is at getting men to think about their sexual behavior and make important decisions about their sexual health. Participants in the program will explore their gender, sexuality, culture, and health with other members of the group. Does that sound like something you are interested in?

If Potential Participant says No:

Study Staff: Okay, thanks for your time. Call/come back if you have any questions.

Potential Participant: Yes.

Study Staff: Great. Let me ask you a few questions about whether you fit the requirements for participation.

Question	Qualifying Answer
Are you between the ages of 18 and 55?	Yes.
What do you consider to be your primary race/ethnicity?	Black, African American, etc.
What is your gender?	Male
Are you a resident of the Chicago area? If yes, do you have a specific plan to move away from the area within the next 6 months?	Yes. No.
How many times have you had unprotected anal or vaginal sex with a man or a woman in the past 30 days?	>0
How many times have you had anal sex with a man in the past year?	>0
Of those times you had anal sex with a man, how many times did you use a condom? Never, Sometimes, Often, All of the time?	Never, Sometimes, Often
Have you ever participated in CTCA?	No.
Have you participated in any HIV prevention intervention in the past 6 months?	No.
When was the last time you saw your doctor?	Any; this is a distracter question.

If Potential Participant does not meet preliminary eligibility criteria:

Study Staff: Unfortunately, at this time, you do not meet the eligibility criteria to be in the study but thank you for your interest.

If Potential Participant meets preliminary eligibility criteria:

Study Staff: Okay, you meet the basic criteria. Let me tell you a little more about the study to see if it is something you are interested in being part of.

If you decide to participate, you will be asked to come to the study office to give written informed consent to be in the study. Then you will give us some contact information so that we can contact you about the study. Then you will complete a survey on a computer that will ask you some questions about yourself, including questions about your views about your racial identity and sexuality, your sexual behaviors, HIV testing, and other things about you. Then you will be assigned into either the treatment group or the control group. This visit will take approximately 2 hours and you will be given a token of appreciation for your travel and your time with a CTA Transit Pass and a $25 gift card. If you are assigned to the treatment group, you will be asked to participate in the group level intervention at a later date, and if you are assigned to the control group, you will not receive the intervention. No matter which group you are assigned to, you will receive basic men’s health and wellness messages twice per month. (9) Would you be willing to do this?

If Respondent says Yes:

If Respondent says Yes:

If you are randomly assigned to the treatment group, you will be asked to participate in and complete the group level intervention over the course of the scheduled weekend. The first day would take about three hours on a Friday night, about 8 hours on Saturday, and about 9 hours on Sunday. You would not be staying overnight at the retreat facility. If you are assigned to the control group, you will not receive the intervention. No matter which group you are assigned to, you will receive basic men’s health and wellness messages twice per month. (10) Are you willing to be available for a weekend-long program?

If Respondent says Yes:

Everyone will be asked to come back in about 3 months to fill out another survey on a computer that will ask the same kinds of things that the first survey did. This will take about an hour, and you will be given a token of appreciation for your travel and your time with a CTA Transit Pass and a $25 gift card. After completing this survey, responding to the health and wellness messages will automatically enter you in a raffle to win one of 3 prizes: an e-reader (like the Kindle), a $50 gift card, or a $25 gift card. (12) Are you willing to do this?

If Respondent says Yes:

Next, you will be asked to come back to the office one more time, about 6 months after you do the survey the first time or after you complete the CTCA program to fill out one more survey, and you will be given a token of appreciation for your travel and your time with a CTA Transit Pass and a $50 gift card.

(13) Do you have any questions? Does that still sound like something you want to do?

If Respondent says Yes:

Great. Let me set you up with an appointment to come in for the first visit to give your consent to participate and take the first survey. [Set up consenting & baseline visit.]

If Respondent says No to any of the above:

Study Staff: Okay, thanks for your time. Please contact us at [office phone number] if you have any questions.