0920- Model Consent (English)

Form Approved

OMB No. 0920-New

Expiration Date: XX/XX/XXXX

Surveillance of HIV-related service barriers among Individuals with Early or Late HIV Diagnoses (SHIELD)

Attachment 5a

Model Consent (English)

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 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)

SHIELD Model Consent

INTRO.9	Language ability:
LANGUAG	Thank you for taking part in this interview. Would you prefer to continue in English or Spanish?
	English	1
	Spanish	2

Skip Pattern to use either Spanish or English version of the survey.

Skip Pattern to use the Consent form from the corresponding Project area

If INTRO.7= ‘1’ [Florida] then GO to Consent_FL

ELSE if INTRO.7 = ‘2’ [Louisiana] then GO to Consent_LA

ELSE if INTRO.7 = ‘3’ [Michigan] then GO to Consent_MI

ELSE if INTRO.7 = ‘4’ [Houston, TX] then GO to Consent_HTX

******Model Consent Form*******

Statement of Informed Consent [for computer assisted telephone interview]

[Interviewer Note: The following statement must be read to all potential participants]:

You were chosen for this interview because of your recent lived experiences related to HIV testing and diagnosis. Taking part in this interview is up to you. You can choose to participate or not to participate. You do not have to take part in the interview if you do not want to. If you decide to take part, you may leave the interview at any time. There are no penalties if you choose not to take part or to leave the interview early. If you are currently incarcerated, taking part in this interview will not affect your parole or release.

Why we are doing this project

HIV is the virus that causes AIDS. Your health department and the Centers for Disease Control and Prevention (CDC) are doing this project to learn more about people living with HIV, including the services they use and need. We intend to use this information to help improve programs that keep people healthy and get them the help they need.

What we will need from you

If you choose to take part in this interview, I will ask you some personal questions.

Answering the questions will take about 50 minutes. You do not have to answer any question you do not want to answer.

The questions ask about your

• medical past

• use of medical and social services

• sex practices

• use of drugs and alcohol

• ability to work and take care of yourself and your family

We send the answers to CDC, but we don’t send them your name. Instead, we will assign a code number to your answers. We do not send CDC any information that identifies you or could be traced back to you. Your answers are confidential. All project materials are kept in a locked cabinet or secure computer.

A small number of interviews may be observed by supervisors to provide feedback to project staff on their work.

What you can expect from us

Privacy

We protect your privacy. All information you give us will be private and confidential.

Your records will be confidential as much as the law allows. Your answers will be grouped together with answers from other participants so that no one will know which answers are yours. We will send information from this project to CDC, but we will not send any information that could identify you. Federal law protects the confidentiality of information kept at CDC.

Token of appreciation

You will receive a token of appreciation in the amount of $50 for taking part in the interview. If you choose to leave the interview early, you may keep the token of appreciation.

Things to consider

• There is no cost to you (other than your time and effort) for taking part in this interview.

• If you like, we can give you information about how to avoid giving HIV to someone else.

• If you like, we can give you information about where to get medical and social services.

• There are no direct benefits from taking part in this interview. However, the information you give us can help us improve services available to other people living with HIV.

• Some of the questions may make you feel uncomfortable or may be too personal. Remember: You do not have to answer any questions you do not wish to answer.

If you have any questions about this project or the token of appreciation, you can ask me and I will do my best to answer. If there is a question I am not able to answer, you can directly contact the person you talked to at the health department about this survey, using the contact information they gave you. If you no longer have this contact information, you can reach your health department at

[Programming note: project-area specific information]

(phone number provided by health department)

If you have any questions about your rights and how the project works across the country, please contact

• (If applicable) The institutional review board (IRB) at (State/Local Health Department) at (phone number).

• (If applicable) (Local IRB contact) at (phone number).

Now I will read you a consent statement and you can choose to provide your consent or not consent:

I agree to take part in the project described here. I have been read the statement, understand the statement, and all my questions have been answered, or I have been given contact information to get my questions answered by others. I understand that my participation is completely voluntary.

Statement of Informed Consent [for web-based survey]

You were chosen for this survey because of your recent lived experiences related to HIV testing and diagnosis. Taking part in this survey is up to you. You can choose to participate or not to participate. You do not have to do this survey if you do not want to. If you decide to take part, you may end the survey at any time. There are no penalties if you choose not to take part or not to finish the survey. If you are currently incarcerated, taking part in this survey will not affect your parole or release.

Why we are doing this project

HIV is the virus that causes AIDS. Your health department and the Centers for Disease Control and Prevention (CDC) are doing this survey to learn more about people living with HIV, including the services they use and need. We intend to use this information to help improve programs that keep people healthy and get them the help they need.

What we will need from you

If you choose to take part in this survey, we will ask you some personal questions.

Answering the questions will take about 50 minutes. You do not have to answer any question you do not want to answer.

The questions ask about your

• medical past

• use of medical and social services

• sex practices

• use of drugs and alcohol

• ability to work and take care of yourself and your family

We send the answers to CDC, but we don’t send them your name. Instead, we will assign a code number to your answers. We do not send CDC any information that identifies you or could be traced back to you. Your answers are confidential. All project materials are kept in a locked cabinet or secure computer.

What you can expect from us

Privacy

We protect your privacy. All information you give us will be private and confidential.

Your records will be confidential as much as the law allows. Your answers will be grouped together with answers from other participants so that no one will know which answers are yours. We will send information from this project to CDC, but we will not send any information that could identify you. Federal law protects the confidentiality of information kept at CDC.

Token of appreciation

You will receive a token of appreciation in the amount of $50 for completing this survey. If you choose to leave the interview early, you may keep the token of appreciation.

Things to consider

• There is no cost to you (other than your time and effort) for taking part in this survey.

• Depending on how you answer the questions, you may receive information about where to get medical or social services or how to avoid giving HIV to someone else.

• There are no direct benefits from taking part in this survey. However, the information you give us can help us improve services available to other people living with HIV.

• Some of the questions may make you feel uncomfortable or may be too personal. Remember: You do not have to answer any questions you do not wish to answer.

If you have any questions about this project or the token of appreciation, you can directly contact the person you talked to at the health department about this survey, using the contact information they gave you. If you no longer have this contact information, you can reach your health department at

[Programming note: project-area specific information]

(phone number provided by health department)

If you have any questions about your rights and how the project works across the country, please contact

• (If applicable) The institutional review board (IRB) at (State/Local Health Department) at (phone number).

• (If applicable) (Local IRB contact) at (phone number).

I agree to take part in the survey described here. I have read the statement, understand the statement, and all my questions have been answered, or I have been given contact information to get my questions answered by others. I understand that my participation is completely voluntary.

CN1.
CONSENT	Do you agree to take part in the survey?
	No	0
	Yes	1

Skip Pattern

If Respondent does not consent (CN1 = 0[‘No’]), this survey will STOP immediately. GO TO END.1 to thank participant for their time and offer any referrals. Else, GO to INTRO.NOTE