0920-1266 ChiCAS Eligibility Screener - English JUN2021

Form Approved

OMB No: 0920-1266

Exp. Date: XX/XX/XXXX

HIV prevention among Latina transgender women who have sex with men:

Evaluation of a locally developed intervention

Attachment 4a

ChiCAS Screener English

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 privacy 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 the efficacy of the locally developed ChiCAS HIV prevention intervention for Hispanic/Latina 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)

Form Approved

OMB No: 0920-1266

Exp. Date: XX/XX/XXXX

Over the phone screening

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 privacy 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 the efficacy of the locally developed ChiCAS HIV prevention intervention for Hispanic/Latina 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! I’m ______________ [The recruiter provides his/her full name]. I am with Triad Health Project.

We are recruiting for a research study. The purpose of this study is to implement and evaluate ChiCAS Creando Acceso a la Salud (Girls Creating Access to Health), a small-group program designed to reduce HIV and increase safe use of hormone therapy. You have seen the flier.

Are you interested in seeing whether you are eligible to participate in the ChiCAS study for Latina transgender women?

[If the person says that she is not interested in being part of the research study, the recruiter should thank her for her time.]

Good, before I take too much of your time explaining the study and scheduling a time to thoroughly discuss the study, let me ask you a few questions to make sure you are eligible. Some of these questions may be sensitive, but your answers will be kept private and your name will be separated from your answers here.

[The recruiter asks the following questions and documents the answers provided. Read only the questions outlined in Column A and denote potential participant’s response in Column B. Follow instructions in Column C to determine whether the potential participant is eligible for that criterion and select the correct response in Column D.]

A	B	C	D
Inclusion criteria	Answer	Instructions	Eligible?
			No	Yes
1) Which of the following best describes your ethnicity?	1 Hispanic or Latino 0 Not Hispanic or Latino	[If “Hispanic or Latino”, select “Yes” in the following Column… Otherwise, select “No”.]	0 No	1 Yes
2) How old are you?	__________ years old	[If ≥18 years old, select “Yes” in the following Column… Otherwise, select “No”.]	0 No	1 Yes
3) In which language would you consider yourself to be fluent?	1 Only Spanish 2 More Spanish than English 3 Both equally 4 More English than Spanish 5 Only English	[If “Only Spanish”, “More Spanish than English”, or “Both equally”, then select “Yes” in the following Column… Otherwise, select “No”.]	0 No	1 Yes
4) What sex was on your original birth certificate?	0 Male 1 Female 2 Refused 3 Don’t know	[If “Male”, then select “Yes” in the following Column… Otherwise, select “No”.]	0 No	1 Yes
5) Do you currently describe yourself as male, female or transgender?	0 Male 1 Female 2 Transgender 3 none of these	[If “Female” or “Transgender”, then select “Yes” in the following Column… Otherwise, select “No”.]	0 No	1 Yes
6) What was the result of your recent HIV test?	0 Positive 1 Negative 2 I don’t know 3 Indeterminate 4 Never tested	[If “Positive”, select “No” in the following Column…Otherwise, select “Yes”.]	0 No	1 Yes
7) In the past 6 months, have you had sex with a man at least once?	0 No 1 Yes	[If “Yes”, then select “Yes” in the following Column… Otherwise, select “No”.]	0 No	1 Yes
8) In the past 12 months have you participated in any HIV prevention intervention such as ChiCAS, HOLA en Grupos, or HOLA?	0 No 1 Yes	[If “Yes”, then select “No” in the following Column… Otherwise, select “Yes”.]	0 No	1 Yes

[Now there are 2 options:]

1. [If there is a “NO” for any question in Column D, the recruiter says:]

Thanks for your help. I really appreciate your interest in this study but the information that you have shared with us indicates that you are not eligible.

[The recruiter and the person say good-bye.]

2. [If there are zero “NO” answers and 8 “YES” answers in Column D, the recruiter says:]

It looks like you are eligible to participate in the study. You will need to get tested for HIV to confirm your eligibility. ChiCAS is a study that includes answering questions about your health and sexual behavior two times over a 6-7 month period. It also includes participating in 2 educational sessions virtually through WebEx or Zoom. We will help you learn how to use web-conferencing platforms. The sessions will provide you with information about PrEP, which is an HIV prevention method in which people take a pill daily to reduce the chances that they will get HIV from an infected sex partner; how to access transition-related healthcare services (such as hormone therapy); and how to use a condom correctly. Since PrEP is an HIV prevention method, participants need to be HIV negative to be part of the study, which is the reason why an HIV test will be conducted. You will receive $30.00 for answering questions by telephone the first time and $40.00 for answering questions by telephone the second time. You also will receive $40.00 for each of the 2 educational sessions you attend.

I would like to schedule a time so that you can take the test for HIV to confirm your negative status so that I can tell you more about the study, and to obtain your consent to participate. After that, we will give you a questionnaire to fill out.

[The recruiter and potential participant set up a time and place that offers privacy and is convenient for the potential participant to receive an HIV test, and review the consent form and complete the baseline assessment if the potential participant chooses to participate.]

Also, could you please give me your name and number? I will give you my number as well in case you need to change appointment time and place.

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NOTE TO STAFF: Please detach this page from the rest of the screening form and store in a separate lock box when completed.

Date of recruitment:
Time of recruitment:
Name of potential participant:
Telephone number of potential participant:
Can we leave a message at this number?	Voice message: 0 No 1 Yes Text message: 0 No 1 Yes
Date of appointment:
Time of appointment:
Place of appointment:
How did you hear about this study?