Eligibility Screener

Form Approved

OMB No: 0920-1091

Exp. Date: 12/31/2018

Attachment 3a: Eligibility Screener Transgender Women

Eligibility Screener

Please remember that participants must speak and understand English, as the interview will be in English and there will not be a translator. Complete via phone or in-person with potential participants.

Begin by reading the consent statement below to participants to obtain verbal consent to participate in the eligibility screener.

CONSENT TO PARTICIPATE IN ELIGIBILITY SCREENER

Before we begin the screener, I need to make sure you understand the steps we will take to screen you and how this information will be used. As part of the screener we will ask you personal questions about: gender identity, sexual history in the previous year, HIV status and HIV testing.

Your participation is completely voluntary. You can stop at any time. You can also skip any question you do not want to answer. If you choose to not be in this study, it will not change the services that you receive with [ADD CBO name], or with your current healthcare provider.

These questions will be asked to see if you are eligible to participate in the study. If you are eligible to participate in the study, and if you are interested, we will schedule a separate appointment to conduct the interview.

The information you provide today on the screener will only include your first name and last initial. If we schedule an interview, your first name and last initial will be used on the schedule. Both documents will be kept in separate, locked cabinets that can only be accessed by authorized study staff. Although we have taken these steps to protect your privacy, there is the possibility that these documents could be linked. After the interview, your first name and initial will be removed from the screener and the paper form securely shredded. If you are ineligible for the study, your screener will be taken back to our offices and securely shredded within two-weeks.

Statement of Agreement to Participate in the Eligibility Screener

Do you agree with the conditions described to voluntarily participate in the screening process for this study?

_________ (participant will verbally answer yes/no)

Screener’s Name (Printed)

Screener’s Signature Date Time

DEMOGRAPHIC INFORMATION

1. What is your age? ______________

2. What is your sex or gender? (Check ALL that apply)

Male	1
Female	2
Transgender Male/Transman	3
Transgender Female/Transwoman	4
Genderqueer	5
Additional Sex or Gender, Please specify:_______________________________________	6
Refused to answer	7

3. What sex were you assigned at birth? (Check one)

   Male	1
   Female	2

4. When was the last time you had sex? (Check one)

In the past 90 days	1
In the past 6 months	2
Between 6 months and a year ago	3
More than 1 year ago	4

5. During that time have you had (Check all that apply):

Vaginal sex	1
Oral sex	2
Anal sex	3

HIV TESTING

6. Have you ever been tested for HIV?

No	0
Yes	1
Don’t know	2

IF POTENTIAL PARTICIPANT HAS NOT HAD AN HIV TEST OR DOES NOT KNOW IF THEY’VE HAD AN HIV TEST, SKIP TO Q10

7. What was the result of your last HIV test?

HIV negative	0
HIV positive	1
Don’t know	2

IF NEGATIVE, SKIP TO Q9

HIV-POSITIVE POTENTIAL PARTICIPANTS

8. How long have you known of your positive HIV diagnosis? ________________

SKIP TO INTERVIEW SCHEDULING SECTION

HIV-NEGATIVE POTENTIAL PARTICIPANTS

9. What was the date of your last HIV test? ________________________

1. Since you tested negative at [the CBO] within the last 3 months, we have the appropriate documentation on file.

CBO representative’s initials to verify date of last HIV-negative test result:__________

2. Since you tested negative at another HIV testing location within the last 3 months, we will need to verify documents or record of last HIV-negative test.

For the interview, can you please bring in documentation from the last 3 months that shows your HIV status? Y/N

If yes:

CBO representative’s initials to verify date of last HIV-negative test result:__________

[NOTE: If yes, the CBO must store eligibility form in locked cabinet until the potential participant brings in documentation of HIV-negative test result. The CBO study staff will not keep a copy of the potential participant’s proof of HIV-negative status on file. Simply review the documentation and initial once verified.]

If no:

Would you like to take another HIV test on-site for verification of HIV status? _____________

If you do not want to take an HIV test at this time, I’m sorry but you will not be able to participate in the study at this time. I thank you for your interest.

If you do want to take an HIV test at this time, we will arrange for you to do so at our office.

[NOTE: If yes, the CBO must store eligibility form in locked cabinet until the potential participant receives HIV-negative test result.]

Updated HIV testing date: _______________________

CBO representative’s initials to verify date of last HIV-negative test result:__________

[NOTE: Potential participants who test HIV-positive are linked to care and are ineligible for study.]

POTENTIAL PARTICIPANTS WHO HAVE NOT TAKEN AN HIV-TEST

You stated that you have not had an HIV test within the last 3 months. To meet the goals of our study, the team is seeking participants who have been tested more recently.

10. Would you be interested in taking an HIV test?

1. If you do not want to take an HIV test at this time, I’m sorry but you will not be able to participate in the study at this time. I thank you for your interest.

2. If you do want to take an HIV test at this time, we will arrange for you to do so at our office.

[NOTE: The CBO must store eligibility form in locked cabinet until the potential participant receives HIV test result.]

Updated HIV testing date: _______________________

CBO representative’s initials to verify date of last HIV-negative test result:__________

[NOTE: Potential participants who test HIV-positive are linked to care and are ineligible for study because participants living with HIV are required to have known their status for at least 12 months to answer some of the research questions regarding HIV care and treatment.]

INTERVIEW SCHEDULING

Potential participant may be scheduled for an interview if the potential participant:

• Aged 18 or older

• Chose the bolded response options in questions 2 -7 above

• For HIV-negative status, has had a negative test result in the last 3 months that has been verified by testing staff or with official documentation

• For HIV-positive status, has been aware of status for the past 12 months

Eligible:

Yes	1
No	2

If yes:

11. Date and time of Interview? _____________________________________________

11. Notified study team of scheduled interview? Yes/No

11. Was this participant recruited from within the CBO facility or through outreach recruitment?

Within CBO facility	1
Outreach recruitment	2

ATLAS/ABT VERIFICATION OF HIV-NEGATIVE STATUS

[After the Atlas/Abt Team has verified the first name and last initial of the participant] Can you please show us the results from your HIV test from the last 3 months so that we can verify the result of last HIV-negative test?

Atlas/Abt representative’s initials to verify date of last HIV-negative test result:__________

1