Intersilo ACASI-1 and ACASI-2 demo

intersilo acasi-1 and acasi-2 demo page

The questions below use ACASI-2 (Recorded sound files on your PC, and text from the Internet) ACASI-2 requires a download from the website. Click Here

Instructions for ACASI-1: you must change a setting in your browser, and run NT2000, XP or better.

On your browser, go to Tools, Internet options
Click the Security tab, click Custom level
Change "Initialize and script ActiveX objects not marked as Safe" to "Prompt"
(This action will not decrease your security; you will be prompted to allow the sound connection to happen)

The text below will be read by ACASI-1 (text from the Internet is converted to sound by means of Synthesis)

INFORMED CONSENT.

PURPOSE:	This study is designed to examine the effects of stress and stress management techniques (such as, relaxation and coping techniques) on your health, feelings, and behaviors.  This form requests your participation in the study.

PROCEDURE:	If you agree to participate in this study, you will be asked questions about feelings, behaviors, and how you handle different situations.  This will be done at five different times: before the program begins, at the end of the program, and six, twelve and twenty-four months later.  These questions will concern several aspects of your life including things that are happening in your life and how you deal with them, your friend and family relationships, how anxious or depressed you are, as well as if you have had thoughts about hurting yourself.  You also will be asked questions regarding physical activity, diet, sexual behaviors and your use of drugs and alcohol.  The first testing session will be divided into one  two-hour session and one  three-hour session. The other four testing sessions should take approximately  three hours each.  These interviews will be audio taped.  Over the course of the study, you will be asked to provide samples of blood, urine, and/or saliva. This will involve having blood drawn from a vein in your arm using a needle and blood tube (called venipuncture), providing a urine sample, and or sample of other bodily fluids. The purpose of collecting these specimens would be to keep track of your disease status and immune functioning throughout the length of this project. Also, urine samples will be tested at random (by chance) for drugs and alcohol.  However, prior to testing the urine, your name will be separated from the sample, or unlinked.  This will protect your confidentiality and anonymity.  No one will be able to link your urine sample to your name. We will provide information about your disease status and immune functioning to you and your physician upon your written request.

As part of this study you will be placed at random (by chance) either in a group that meets once a week for two and one-half hours for ten weeks or individual sessions once a week for ten weeks.  If you are placed in the stress management group you will be asked to meet with 6-10 other HIV+ women and two group leaders once a week for 10 weeks.  After the 10-week program, you will again be placed at random (by chance) either in a group that meets twice a month for three months or in individual sessions twice a month for three months. These sessions deal with taking your medication, diet, physical activity, safer sex, and what drugs and alcohol do to you (each of these sessions will last approximately two and a half hours each). During some of these sessions, you will also learn how to use sexual barrier methods, such as the male and female condoms. We would like for everyone to try these products.  If you choose not to have sex, you can still participate in the study. These products will be provided to you over a three-month period, during which you will be encouraged, but not required, to try them.  You will also be expected to receive permission from your physician to take nutritional products and participate in light physical activity. We will ask you to return to the clinic for assessments three more times; at six months, twelve months, and twenty-four months from the end of the 10-week sessions. A physician from the University of Miami School of Medicine will provide supervision of the clinical aspects of this study.

COSTS:	The procedures involved in this study include interviews, blood draw, urine testing, and program attendance.  Your participation in this study will involve no expense to you as a study participant.

RISKS:	The interviews include items of a personal nature such as questions about your mood and the way you handle situations.  There is the possibility that you may experience anxiety while answering these questions.  If at any time it is determined that you are in need of immediate medical or psychological assistance, an immediate referral for treatment will be made to your primary care physician and/or an appropriate emergency services provider.  When blood is drawn, you may experience discomfort during blood sampling.  The risks of blood sampling by venipuncture commonly include the occurrence of soreness or a bruise at the site of the puncture and, less commonly, fainting, infection or the formation of a small blood clot or swelling of the vein and surrounding tissue or bleeding at the needle puncture site. You should understand that at present, male latex condoms are considered to be the best available protection against all sexually transmitted infections.  Complete confidentiality cannot be guaranteed when one participates in a group discussion.  There is a risk that a group member may violate the rules of group confidentiality and share information with others about the group.

COMPENSATION FOR INJURY:  You may be exposed to risk of injury from participation in this study. If injury occurs, treatment in most cases will be available. If you have insurance, your insurance company may or may not pay for these costs. If you do not have insurance, or if your insurance company refuses to pay, you will be expected to pay. Funds to compensate for pain, expenses, lost wages and other damages are not routinely available.

BENEFITS:	Participation in this study will hopefully help you deal more effectively with your life situation.  However, you may not experience any direct benefit.  The major benefit resulting from your cooperation in this research is to help doctors understand the relationship between stress, stress management, health-protective behaviors, psychological factors and health for women living with HIV.

ALTERNATE TREATMENTS:	You may choose not to participate in this study and you will still be able to receive standard medical treatment and your decision will in no way affect the quality of your care.

COMPENSATION: You will be paid  $20 for each intervention session to compensate you for your time, effort, and transportation expenses.  A study completion bonus of up to $100 will be paid on the last treatment visit (session # 16).  You will receive $25 for your first assessment visit; $50 for your second, the post-intervention and sixth month visits; $60 for the twelve month visit, and $70 for the twenty-four month visit.  Compensation for childcare will be provided. Refreshments will be served after each session.

CONFIDENTIALITY:  It is particularly important for you to know that we have gotten a Certificate of Confidentiality from the Federal Government for this study to make sure we can best protect your privacy.  This certificate means that the researchers cannot be forced to tell people who are not connected with the study about your participation without you giving your permission in writing.	This includes courts and the police.  However, if we feel that keeping information private would immediately put you in danger, or put in danger someone else, we may talk to you about what to do, if possible.  Or we might release information in order to seek some other help to protect you or another person. Your consent to participate in this study includes consent for the investigators and their assistants to review all your medical records as necessary for the purposes of this study.  Your answers to the interview questions will be identified by code number only. The code will be kept in a locked file in the office of the principal investigator.  Your records and results will not be identified with you in any publication; results will be published using only group averages.  Information that you provide, including the audiotapes of your interviews, will be destroyed when the study is complete. Complete confidentiality cannot be guaranteed when one participates in a group. In an effort to protect your privacy and the privacy of other participants, you agree to keep confidential any and all information regarding other study participants you will meet at the SMART/EST Women's Project (e.g. names, HIV/AIDS status, etc.). Violation of this agreement could result in being terminated from the study.

WITHDRAWAL FROM THE STUDY:	Participation in this study is voluntary.  If you choose not to participate, you will not be denied any benefit to which you would otherwise be entitled.  You may refuse to participate or withdraw from the study at any time, and if you do so, you will not suffer any penalty.

QUESTIONS:	You are encouraged to ask any and all questions which come to your mind concerning this study.  The staff of the research program will be happy to discuss any questions with you.  At the completion of the study a staff member will discuss with you whatever results are available with respect to your participation in the study.  Any new information developed during the course of the study that may affect your participation in this study will be provided to you.  You will be provided with a copy of your signed consent form.  If you have any questions about your rights as a research subject you may contact Maria Arnold at the University of Miami at (305) 243-3195.  Any questions that you have about this study will be answered by one of the following investigators:

Dr. Stephen Weiss, Principal Investigator			Dr. Mary Ishii, Project Director

SMART/EST Women's Project:
     (305) 243-2103

__________________________			____________________
Signature of Subject					Date

__________________________			____________________
Signature of Witness					Date

Please read each sentence below and think about your choice.  After reading each sentence, place your initials next to the "yes" or "no".  Remember, no matter what you decide to do about these questions, you may still take part in the study.

By initialing this form, you agree that:

My left over blood and urine samples that are stored in a freezer may be used in future research studies.

__________YES					_____________NO

I would like for the results of my tests to be sent to my primary care physician or other designated provider.

__________YES					_____________NO