Consent for Health Care Providers

Att 2b_ Informed Consents Health Care Providers 08112010.docx

Formative Research and Tool Development

Consent for Health Care Providers

OMB: 0920-0840

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Minority HIV/AIDS Research Initiative (MARI) Project:

Empowering Latinas to Lash Out Against AIDS (ELLAS)


Generic Information Collection Request under 0920-0840







Attachment 2b. Informed Consents for Health Care Provider Interviews and Materials Survey





Study Title: Empowering Latinas to Lash Out Against AIDS (ELLAS)


Sponsors: University of South Carolina, Arnold School of Public Health

Minority AIDS Research Initiative; Centers for Disease Control (CDC)


Principal Investigator: Dr. Myriam Torres, University of South Carolina


Flesch-Kincaid Grade Level Score: 10.8



INFORMED CONSENT FOR HEALTH CARE PROVIDERS INTERVIEWS


Purpose and Background: This research study is called the “Empowering Latinas to Lash Out Against AIDS (ELLAS) Project” and is funded by the Centers for Disease Control (CDC). Selected prenatal care providers at one of the ELLAS study sites located in Dillon, Lexington, Marion, Richland, and Williamsburg Counties, SC are being asked to participate. You have been identified as a potential participant for this project. You are being asked to take part in an interview to describe your prenatal care counseling practices and experiences with your pregnant Latina patients especially as it relates to HIV prevention education and testing.


What is asked of you:

You will be asked to fill out a short form describing yourself but you will not put your name on the form. Then you will take part in an interview that will take about 30-45 minutes. The interview will be recorded.


Confidentiality: Your opinions and that of other participants will be summarized as a group. Your name will not be recorded on the audio recording. Information about you and your responses will never be linked and will be kept strictly confidential as allowed by law. Your personal identity will not be revealed in any publications or release of results. We will use identification numbers rather than your name on all of the assessment forms.


Your rights: Taking part in this study is completely voluntary. Whether or not you decide to take part in this project and answer the questions will not affect your current or future relationship with the University of South Carolina, your patients, or any organizations in your area. You may ask questions about the study at any time. Your answers are important, but you can choose not to answer any question and to withdraw at any time.


Costs and Compensations: You will receive a $20 token of appreciation for your participation in the interview.

Potential risks or discomforts: Your responses will not be linked to your name. The questions we ask about the opt-out testing process, your counseling practices and experiences may make you feel uncomfortable. You may choose not to answer any question(s) at any time.


Potential benefits: This information will help identify prenatal care providers’ perceptions of the needs, problems, assets, and resources being provided to pregnant Latina patients. The information will be used to support the University's ELLAS Project in developing and implementing culturally appropriate projects and services to help prenatal care providers and Latinas reduce the risk of contracting or passing HIV during pregnancy.


If you agree to be in the study, fill out the form below. If you do NOT agree to be in the study, you can STOP now.


I have read this informed consent form and I have been given an opportunity to ask and have answered any questions. I understand the information above and I agree to complete the information sheet and to take part in the discussion. I have received a copy of this form.


Name:(print)_________________________________


Address:________________________________________________________________


_______________________________________________________________________


Signature:______________________________________________Date:____________


If you have any questions or concerns, please contact:

Dr. Myriam Torres, Director Ms. Edena Meetze

Consortium for Latino Immigration Studies Research Associate

University of South Carolina University of South Carolina

730 Devine Street 730 Devine Street

Columbia, SC 29208 Columbia, SC 29208

803 777-4253 803 777-0861



Study Title: Empowering Latinas to Lash Out Against AIDS (ELLAS)


Sponsors: University of South Carolina, Arnold School of Public Health

Minority AIDS Research Initiative; Centers for Disease Control (CDC)


Principal Investigator: Dr. Myriam Torres, University of South Carolina


Flesch-Kincaid Grade Level Score: 11.3


INFORMED CONSENT FOR PROVIDER MATERIALS SURVEY


Purpose and Background: This research study is called the “Empowering Latinas to Lash Out Against AIDS (ELLAS) Program” and is funded by the Centers for Disease Control and Prevention (CDC). Selected prenatal care providers from Eau Claire Cooperative Health Centers, Inc in Columbia, SC, are being asked to participate. You are being asked to take part in a brief survey to describe your thoughts and opinions in regards to the feasibility of using the perinatal HIV prevention and testing materials developed by ELLAS staff in your prenatal clinic(s).


What is asked of you:

You will be asked to fill out a short form describing yourself but you will not put your name on the form. Then you will be asked to review the HIV education and testing materials developed by ELLAS and CDC specifically for pregnant Latinas and then complete a brief survey about the feasibility of using these materials in your clinic(s). A university staff person will be available in person or via phone to answer any questions you may have in regards to the materials. You will have two weeks to review the materials and complete the survey. A self-addressed, stamped envelope will be provided to you so that you can mail the materials and completed survey back to ELLAS’ headquarters within two weeks. The review process should take no more than 30 minutes.


Confidentiality: No individual information will ever be reported and your responses will never be linked to you individually. Your name will not be included on any forms or reports.


Your rights: Whether or not you decide to take part in this project and answer the questions, will not affect your current or future relationship with the University of South Carolina or any organizations in your area. Your answers are important, but you can choose not to answer any question and to withdraw at any time.


Costs and Compensations: You will not be paid for participating in this study, but will be provided with a $20 token of appreciation for completing the survey.

Potential risks or discomforts: There are no risks to you. Your responses will not be linked to your name. You may choose not to answer any question(s) at any time.


Potential benefits: The information will be used to modify the materials developed by the University’s ELLAS Project so health care facilities such as yours can provide culturally appropriate prenatal care services to their Latina patients.

If you agree to be in the study, fill out the form below. If you do NOT agree to be in the study, you can STOP now.


I have read this informed consent form and I have been given an opportunity to ask and have answered any questions. I understand the information above and I agree to complete the information sheet and to take part in the discussion. I have received a copy of this form.


Name:(print)_________________________________


Address:________________________________________________________________


_______________________________________________________________________


Signature:______________________________________________Date:____________


If you have any questions or concerns, please contact:

Dr. Myriam Torres, Director Ms. Edena Meetze

Consortium for Latino Immigration Studies Research Associate

University of South Carolina University of South Carolina

730 Devine Street 730 Devine Street

Columbia, SC 29208 Columbia, SC 29208

803 777-4253 803 777-0861




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