Interview Participant Agreement - Category 1

Appendix 4a

Category 1

Interview Participant Agreement Form

(Name of Project)

Interview Participation Agreement Form

Purpose, Participation, and Procedures

This project is funded by the Centers for Disease Control and Prevention (CDC) to look at (1) how (Agency Name) refers clients to HIV prevention and support services and (2) your outcomes from the referrals you receive. The findings may help (Agency Name) improve the way they provide HIV prevention and support services to people in the community in the future.

To participate in this project, you must be: 1) living with HIV; 2) age 13 or older; and 3) in receipt of a referral to HIV medical care from (Agency Name) in the last 30 days.

As part of this project, you are expected to complete five interviews. The first interview will take place about 30 days after receiving a referral to HIV medical care and the remaining interviews will take place at 3, 6, 9 and 15 months after the first interview. During the interviews, you will be asked questions about yourself including drug and sex behaviors, experiences with HIV medical care, and other services you may or may not have used.

Risks and Discomfort

The questions asked during the interviews are personal. A staff member will ask you the questions and enter your answers into the computer. All of your responses will be kept private. Your participation in this project is voluntary. You do not have to answer any questions you do not want to answer and can stop the interview at any time.

Benefits

There is no direct benefit to you for being in the project, but what we learn from the project may help (Agency Name) improve the way they provide HIV prevention and support services to people in the community in the future.

Disclosure of Alternative Treatment

Your participation in this project is voluntary. If you do not want to participate in this project, you are still eligible to participate in HIV medical care and other HIV prevention and support services from (Agency Name).

Privacy

The information collected during the interviews is personal and sensitive in nature. The staff at (Agency Name) will:

• Implement strict CDC security requirements, including the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to ensure security of the data and all information.

• Work with CDC to maintain client privacy and security standards throughout the project.

• Keep paper copies of files in a locked filing cabinet inside a locked room. Project data will not contain any information that could identify you. In other words, your name will not be connected to your answers to any questions.

• Encrypt data before sending to CDC.

• Submit data to CDC via the Secure Data Network (SDN).

Once electronic data are received by CDC, they will be reviewed for completeness and errors and stored securely.

Tokens of Appreciation

Agency will need to insert information about their tokens of appreciation here.

Contact Information

Agency will need to insert contact information for project agency staff here.

Agreement Statement and Signature

Your participation in this project is voluntary. In other words, you decide if you want to participate in this project or not. If you agree to participate and later decide that you no longer want to, you can withdraw from the project at that time.

I agree to participate in this project. The staff explained the project, the time needed, and the tokens of appreciation that will be given to me in the project.

___________________________________________ ___________________

Project Participant Date

___________________________________________ ___________________

Project Staff Member Date

Medical Records Sharing Agreement Form

Purpose, Participation, and Procedures

As part of this project, we would like to look at your medical record to collect clinical information about your HIV infection and medical care. This information will include your viral load, CD4 counts, HIV medicines you have been prescribed, and the number of visits you have attended. The findings may help (Agency Name) improve the way they provide HIV prevention and support services to people in the community in the future.

We do not send any information to the CDC that could identify you or be traced back to you. Information from your medical records will be linked to your answers only by a code number.

Privacy

We protect your privacy. All information you give us will be kept private. We do not send any information to the CDC that could identify you or be traced back to you. Information from your medical records will be linked to your answers only by a code number

The staff at (Agency Name) will:

• Implement strict CDC security requirements, including the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to ensure security of the data and all information.

• Work with CDC to maintain client privacy and security standards throughout the project.

• Keep paper copies of files in a locked filing cabinet inside a locked room. Project data will not contain any information that could identify you. In other words, your name will not be connected to your answers to any questions.

• Encrypt data before sending to CDC.

• Submit data to CDC via the Secure Data Network (SDN).

Once electronic data are received by CDC, they will be reviewed for completeness and errors and stored securely.

Contact Information

Agency will need to insert contact information for project agency staff here.

Agreement Statement and Signature

Sharing medical records is voluntary. In other words, you decide if you want to continue to share your medical records or not. If you agree to share your medical records and later decide that you no longer want to, you can tell a staff member at any time.

I agree to share my medical records related to my HIV infection and medical care

___________________________________________ ___________________

Project Participant Date

___________________________________________ ___________________

Project Staff Member Date