TLC Eligibility Screener

Form Approved

OMB No. 0920 – New

Expiration Date: XX/XX/XXXX

Evaluation of TransLife Center (TLC): A Locally-Developed Combination Prevention

Intervention for Transgender Women at High Risk of HIV Infection

Attachment 4a

TLC Eligibility Screener

Privacy Act Statement:

This information is collected under the authority of the Public Health Service Act, Section 301, "Research and Investigation," (42 U.S.C. 241); and Sections 304, 306 and 308(d) which discuss authority to maintain data and provide assurances of confidentiality for health research and related activities (42 U.S.C. 242 b, k, and m(d)).  This information is also being collected in conjunction with the provisions of the Government Paperwork Elimination Act and the Paperwork Reduction Act (PRA). This information will only be used by the Centers for Disease Control and Prevention (CDC) staff to evaluate TransLife Center (TLC) as an HIV prevention intervention for transgender women.

Public reporting burden of this collection of information is estimated to average 4 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)

Hi, My name is (name) and I’m one of the staff members working on the Trans Life Care study, also known as the TLC study, which is being conducted at Chicago House and Social Service Agency (Chicago House), in collaboration with Ann & Robert H. Lurie Children’s Hospital of Chicago (Lurie Children’s). The TLC offers supportive services to transgender women, such as help with housing, employment, legal and medical services. The purpose of this study is to see if the TLC helps prevent HIV and other infections in trans women. You will be compensated for your time and effort as part of this study. Are you interested in hearing more about it?

Response: If yes, continue. If no, thank them for their time and discontinue screening.

If you are eligible and decide to join this study, you will be in it for about 8 months. Participation will include access to the services at the TLC, testing for HIV and other STIs, and completion of evaluation questionnaires on a computer. The questionnaire asks about your experiences with sex, alcohol and drugs, health care and mental health, and your experience as a transgender woman. If you have taken a pill in the past few weeks to prevent HIV, (also called PrEP or pre-exposure prophylaxis), we will also ask for a small sample of your hair to test for the medicine in your body. We will ask you to come back in 4 months and then 8 months to do the HIV/STI testing again and to complete a follow up questionnaire.

You will receive $50 each time you complete the questionnaire at each of 3 study visits, for a total of up to $150 for completion of all questionnaires.

If you are eligible and decide to participate we will keep all information we collect from you private, and only the evaluation team will have access to this information. We will need to ask you for contact information so that we can invite you back for follow-up assessments, to complete the follow-up visits.

Please remember that participation in the study, including answering any of the screening questions, is completely voluntary. You can refuse to answer any of the questions or decide that you do not want to participate in the study at any time. You can also decide to participate in TLC services, but not the study component. If you have questions about this study, you can contact the Principal Investigator, Judy Perloff or the Coordinator of the TLC at Chicago House at 773-248-5200 or the Principal Investigator at Lurie Children’s, Lisa Kuhns at (773) 303-6055.

To find out if you’re eligible to participate in this study, I’ll need to take about 4 minutes to ask you some questions. Some of these questions are quite personal and sensitive; however, your answers to these questions will be kept private. One of the reasons we stress privacy is that we do ask some very personal questions, and it is very important that you be as honest and as accurate as you can be with your answers. It is only if you are eligible and interested in participating that I will ask for your name and contact information. Your contact information will be stored separately from your answers to this questionnaire and be linked only by an identification number.

Answering these questions is completely voluntary. You can choose not to screen for this study if you don’t want to. Whether you choose to screen for this study or not will not impact your relationship with Chicago House or Lurie Children’s or any staff of either organization. Are you willing to answer some questions to determine if you are eligible for the study?

Response: If yes, continue with Screening Questions. If no, ask for reasons why:

No interest . . . . . . . . . . . . . . . . . . . . 01

Worried about anonymity . . . . . . . . 02

Project takes too long . . . . . . . . . . . . 03

Afraid of evaluation/guinea-pig . . . . . 04

Rather not say . . . . . . . . . . . . . . . . . 05

Other . . . . . . . . . . . . . . . . . . . . . . . . 06

If other, specify __________________________________

Thank the participant for their time.

INSTRUCTIONS: Participant ID numbers will only be assigned (a) after the screening questions determine the volunteer to be eligible for this study and (b) after the participant signs the consent form. Regardless of whether or not the volunteer is eligible, record their responses to all questions.

1. First, how did you find out about this project?

Brochure/flyer/sign: _____________________

Recruited by project staff: _____________________

Community event (parade, street fair, etc.): ___________________

Counseling and testing program: _____________________

Community based organization/agency: ______________________

Friend/family: __________________________

Other, specify: _________________________

2. How old were you at your last birthday?

|_____|_____| years (If not at least 18 years old, check ineligible and continue) Ineligible

3. What sex were you assigned at birth, on your original birth certificate*?

Male

Female

Refused

Don’t know

* Very nearly everyone is assigned a sex at birth – including persons with Disorders of Sex Development (DSDs) who are sometimes called Intersex. If a respondent mentions this, ask them again what their birth certificate says. If they are unclear or unsure, they are ineligible.

4. Do you currently describe yourself as male, female, or transgender?

Male

Female

Transgender

None of these

5. Just to confirm, you were assigned [FILL from #3] at birth, and now describe yourself as [FILL from #4]. Is that correct?

Yes

No

Refused

Don’t know

Assess combination of response to 3, 4 and 5, eligible participants must self-identify as transgender with a birth sex of male. Talking through these responses is expected, as many women who are eligible may respond to both 3 & 4 as Female. Remind participants that this project is for trans women.

If participant does not meet sex/gender identity requirements,

check ineligible and continue Ineligible

5. Have you had sex with a man in the past 4 months?

Yes

No

Don’t know/refused

If “No” or “Don’t know/refused” check ineligible and continue Ineligible

6. What was the result of your most recent HIV test?

Never tested

Positive

Negative

Indeterminate

Don’t know/refused

If “Positive,” check ineligible and continue Ineligible

7. Are you able to speak and understand English?

Yes

No (Check ineligible and continue) Ineligible

7. Have you received services through the TLC in the past 4 months?

Yes (Check ineligible and continue) Ineligible

No

7. Do you plan on staying in the Chicago area for the next 8 months?

Yes

No (Check ineligible and continue) Ineligible

Questions 10-13 are for the interviewer only.

DO NOT ASK THESE QUESTIONS OF THE VOLUNTEERS.

7. Does the volunteer seem cognitively functioning and able to understand the assent/consent process?

Yes

No (Check ineligible and continue) Ineligible (If ineligible based on this criterion, refer to supervisor to conduct ineligible script and provide referral.)

7. Does the volunteer seem distraught or emotionally unstable (i.e. suicidal, manic, exhibiting violent behavior)?

Yes (Check ineligible and continue)

No Ineligible (If ineligible based on this criterion, refer to supervisor to conduct ineligible script and provide referral.)

7. Does the volunteer seem intoxicated or under the influence of psychoactive agents?

Yes (Check ineligible)

No Ineligible (If ineligible based on this criterion, refer to supervisor to conduct ineligible script and provide referral.)

7. Aside from eligibility criteria, does the volunteer appear to be a good fit for the study?

Yes

No (Check ineligible and briefly explain below) Ineligible (If ineligible based on this criterion, refer to supervisor to conduct ineligible script and provide referral.)

INSTRUCTIONS: If any of the above ineligible boxes are checked, read the INELIGIBLE script. If none of the ineligible boxes are checked, read the ELIGIBLE script below.

SCRIPT For INELIGIBLE volunteers:

Participants in this study are selected based on the questions you were just asked. Based on your answers, it turns out you’re not eligible to participate in the study. Would you be interested in being contacted for other programs or research studies that you may be eligible for or if the eligibility criteria for this study changes in the future?

No (Thank volunteer and end interview)

Yes (Fill out contact information)

Script for ELIGIBLE volunteers:

Thank you very much for the information you provided. Based on your answers to these questions, you are eligible to participate in this study. Do you think you might be interested in taking part in this study?

Response: If “NO”, thank them for their time. If “YES”:

Great! Before we go any further, I need to get your name and then schedule an appointment with you to complete the initial appointment.

THE INFORMATION BELOW INCLUDES IDENTIFYING INFORMATION, STORE SEPERATELY FROM SCREENING DATA.

Preferred name (name you go by): ______________________

Preferred pronoun (she/her, he/him, etc): _____________

What’s a good time for you to come in? |_____|_____|--|_____|_____| at ____ ____:____ ____ AM / PM

And if we miss you at that time, what’s a good way to contact you to follow up?

Phone: _________________________ Ok to LVM?

1. What name should we use to ask for you at this number? _____________________

2. What pronoun should we use to ask for you at this number? _________________

Email: Ok to email?

Facebook: Ok to message?

_____ Initials of person completing this screening form

Entered into screening database

_____ Initials of person entering information into screening database

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