A5272 Version 2.0, 5/19/11: Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy CONSENT TO PARTICIPATE IN A RESEARCH STUDY AND RESEARCH SUBJECT HIPAA AUTHORIZATION Your contacts for this study at the Hospital of the University of Pennsylvania [HUP] are: Principal Investigator: Pablo Tebas, MD (215) 349-8092 Coordinator: Joseph Quinn, RN (215) 349-8092 Study Nurses: Kathryn Maffei, RN (215) 349-8092 Aleshia Thomas, RN (215) 349-8092 Wayne Wagner, RN (215) 349-8092 Carol DiGiorgio, RN (215) 349-8092 24 Hour Emergency Number (215) 662-6059 Ask for the Immunodeficiency Program Doctor on call Introduction: You are being asked to take part in this research study because you are infected with human immunodeficiency virus (HIV), the virus that causes AIDS, and are about to start anti-hiv drugs as part of an ACTG or non-actg antiretroviral therapy (ART) study or as standard of care. This study is sponsored by the National Institutes of Health (NIH)/ AIDS Clinical Trials Group (ACTG). The doctor in charge of this study at this site is Dr. Pablo Tebas. Before you decide if you want to be a part of this study, we want you to know about the study. This is a consent form. It gives you information about this study. The study staff will talk with you about this information. You are free to ask questions about this study at any time. If you agree to take part in this study, you will be asked to sign this consent form. You will get a copy to keep. Why Is This Study Being Done? The purpose of this study is to evaluate the presence of human papillamovirus (HPV) after anti-hiv drug initiation. We do not know if you have been infected with HPV, but will monitor your saliva for the presence of HPV and will examine your mouth for oral warts over the course of the study after you start taking the anti-hiv drugs as part of an ACTG or non-actg ART study or as standard of care. What Do I Have To Do If I Am In This Study? Screening If you would like to take part in this study and plan to enroll in an ACTG or a non-actg ART study, the screening evaluations to determine eligibility and pre-entry into A5272 can occur at the same time during the screening or pre-entry visit. If it is not possible to have the evaluations at the same visit, some of the evaluations may occur between the screening and entry visits. If you are not coenrolling in an ART study, the A5272 screening/pre-entry visit must occur on a separate day before the entry visit and within 30 days before ART is started. You should not eat, chew gum, mints or candy, brush/floss teeth, or smoke for 90 minutes before the saliva/throat wash collections. The visit for A5272 will take about 30-40 minutes and will include: A throat wash collection by rinsing with a salt water solution for one minute and spitting the contents in a tube. Some throat wash will be stored for future HPV testing. Page 1 of 11
A saliva collection by spitting in a tube for 5-10 minutes to obtain 5 ml (one teaspoon) of saliva. Some saliva will be stored for future HPV testing. About 40 ml (8 teaspoons) of your blood will be collected and stored for future studies to look at your body s ability to fight HPV infection. If you are not coenrolling in an ACTG study, at this visit you will also have the following: Measurement of your HIV viral load (how much HIV is in your blood), and some routine blood tests for safety. You will be asked questions about your medical and medication history. Results of routine blood tests and CD4+ cell counts (cells that fight infections) and viral load (measure of HIV in the blood) evaluations will be given to you as soon as they are available Entry If you are eligible for this study and are coenrolling in an ACTG or non-actg ART study, entry evaluations should occur on the same day of the coenrolled study entry visit when possible, before study medication or ART is started. The entry visit for this study should last about 30 minutes and will include: Oral examination. Throat wash and saliva collection. Completion of a behavioral questionnaire. If you are not coenrolling in any ART study, the entry visit must occur on a separate day after the screening/pre-entry visit but before ART is started. ART must be started within 1 week of the A5272 study entry visit. This visit will take about 40 minutes and include all entry evaluations listed above. If you are not enrolling in an ACTG ART study, at this visit you will also have the following done at this visit: Blood drawn for routine safety tests, HIV viral load, and CD4+ and CD8+ cell counts. Any findings from the oral examination (e.g., presence of oral warts or other oral soft tissue abnormality) will be reported to you with a referral for follow-up care. All other test results (e.g., oral HPV DNA shedding) will be performed for research purposes only and will not be reported to you, since the clinical meaning of oral HPV shedding is not yet known. Post-Entry Evaluations You will have a study visit sometime between 12-18 weeks after the entry visit in addition to weeks 24 and 48. These visits should last about 1 hour or less, and most visits will include the following: Oral examination. Throat wash and saliva collection. At the 24-week visit, about 40 ml (8 teaspoons) of your blood will be collected and stored for future studies to look at your body s ability to fight HPV infection. Completion of a behavioral questionnaire at weeks 24 and 48 only. Note: If you are coenrolling in an ACTG ART study, CD4+ cell count and HIV viral load are collected as part of these studies. The results will be obtained from the study teams after the ART study s Page 2 of 9
completion. If you are starting ART as part of routine clinical care or a non-actg ART study, CD4+ cell count and HIV viral load will be obtained at these visits listed above, as well as at week 4. Premature Discontinuation Evaluation If you are coenrolled in an ART study and prematurely discontinue from that study BEFORE week 24, you will be asked to return to the clinic to have the week 24 evaluations performed before being taken off study A5272. These evaluations will take about 40 minutes and include: Oral examination Throat wash Whole saliva collection Blood will be collected and stored for future tests Completion of a behavioral questionnaire Blood for safety test will be collected in participants who are enrolled in a non-actg ART study. If you discontinue AFTER week 24, you will have the following evaluations which should take about 40 minutes: Current medications/changes Oral Examination Blood collected for CD4 + cell count Completion of a behavioral questionnaire If you are a standard clinic care participant and discontinue this study, you will be asked to return to the clinic for a premature discontinuation evaluation. This evaluation will take about 40 minutes and will include evaluations as stated above and be based upon whether you discontinue before week 24 or after week 24. Note: If you are coenrolled in an ART study and discontinue or change to non-study treatment but remain on study for follow-up, you will have the option to remain enrolled in A5272. However, if you discontinue the study completely, you will be withdrawn from A5272. Other If you agree, any remaining blood, saliva, and throat wash (that was not used for study-related testing) will be stored with usual protectors of identity and may be used for future ACTG-approved HIV-related research. You may participate in this study even if you do not agree to have any remaining blood, saliva, and throat wash stored. These samples may be held for an indefinite length of time. We cannot ensure that you will be told the results of the research done on these samples. YES, I agree to have any remaining blood, saliva, and throat wash samples stored for future ACTG-approved research. NO, I DO NOT agree to have any remaining blood, saliva, and throat wash samples stored for future ACTG-approved research. Page 3 of 9
You can withdraw your consent to having your samples stored for future testing at any time. To withdraw your consent, please contact the study staff at your site. How Many People Will Take Part in This Study? About 500 people from U.S. sites will take part in this study. About 30-40 people are expected to participate at the University of Pennsylvania. How Long Will I Be In This Study? You will be in this study for about 48 weeks. Why Would The Doctor Take Me Off This Study Early? The study doctor may need to take you off the study early without your permission if: The study is cancelled by the ACTG, the National Institutes of Health (NIH), Office for Human Research Protection (OHRP), or the University of Pennsylvania s Institutional Review Board (IRB). (An IRB is a committee that watches over the safety and rights of research participants.) You are not able to attend the study visits as required by the study. S/he thinks the study is no longer in your best interest. What Are The Risks Of The Study? Risk associated with having your blood drawn include: Discomfort associated with the needle piercing your skin Dizziness/feeling lightheaded, and/or fainting Bleeding or bruising at the spot where the needle enters your body Infection at site of puncture Risks associated with an examination of the mouth include: Discomfort Minor gagging Are There Risks Related To Pregnancy? There are no risks to unborn babies. Are There Benefits to Taking Part in This Study? If you take part in this study, there may be a direct benefit to you, but no guarantee can be made. It is also possible that you may receive no benefit from being in this study. Information learned from this study may help others who have HIV. What About Confidentiality? We will do everything we can to protect your privacy. In addition to the efforts of the study staff to help keep your personal information private, we have obtained a Certificate of Confidentiality from the U.S. Federal Government. This certificate means that researchers cannot be forced to tell people who are not connected with this study, such as the court system, about your participation. Also, any publication of this study will not use your name or identify you personally. Page 4 of 9
People who may review your records include the ACTG, Office for Human Research Protections (OHRP), University of Pennsylvania IRB, OHRP, National Institutes of Health (NIH), study staff, and study monitors. Having a Certificate of Confidentiality does not prevent you from releasing information about yourself and your participation in the study. Even with the Certificate of Confidentiality, if the study staff learns of possible child abuse and/or neglect or a risk of harm to yourself or others, we will be required to tell the proper authorities. HIPAA AUTHORIZATION The authorization part of the consent gives more detailed information about how your personal health information may be used and disclosed by the University of Pennsylvania Health System (UPHS), the School of Medicine and the individual Principal Investigator, subject to University of Pennsylvania procedures. What personal health information is collected and used in this study and might also be disclosed? The following personal health information will be collected, used for research, and may be disclosed during your involvement with this research study: Name, address, telephone number, date of birth Personal and family medical history Current and past medications or therapies Information from questionnaires administered in the study Results of tests and procedures you will undergo during this research study Why is your personal contact and health information being used? Your personal contact information is important for the research team to contact you during the study. Your personal health information and results of tests and procedures are being collected as part of this research study. In some situations, your personal health information might be used to help guide your medical treatment. Which of our personnel may use or disclose your personal health information? The following individuals may use or disclose your personal health information for this research study: The Principal Investigator and the Investigator s study team Authorized members of the workforce of the UPHS and the School of Medicine, and University of Pennsylvania support offices, who may need to access your information in the performance of their duties (for example: for research oversight and monitoring, to provide treatment, to manage accounting or billing matters, etc.). Who, outside of UPHS and the School of Medicine, might receive your personal health information? As part of the study, the Principal Investigator, the study team and others listed above, may disclose your personal health information, including the results of the research study tests and procedures. This information may be disclosed to those listed below: Individuals or organizations responsible for administering the study: - AACTG Data Coordinating Center, Frontier Science Technology Research Foundation (FSTRF): Data for this study will be recorded on case report forms, keyed into a central database and Page 5 of 9
electronically submitted to the Data Coordinating Center. The data will be cleaned and stored at this facility until it is ready to be analyzed. - Statistical Data Analysis Center (SDAC): Approved data will be downloaded from FSTRF to the statistical data center for the AACTG at the Harvard School of Public Health. Specific study reports will be periodically provided to the study team and data safety review board to monitor if the trial is safe. - Contract Research Organization (PPD, Inc): Monitors from PPD will visit the AACTG on a quarterly basis to review data and correct mistakes before the data are sent to SDAC for analysis. - Government Agencies: Data from this study will be made available to the Food and Drug Administration and to the National Institutes of Health/Division of AIDS (DAIDS)/National Institute for Allergy and Infectious Disease (NIAID), for them to evaluate the safety and efficacy of the treatments being used in this study. Regulatory and safety oversight organizations The Food and Drug Administration The Office of Human Research Protections The Study Monitoring Committee Once your personal health information is disclosed to others outside of UPHS or the School of Medicine, it may no longer be covered by federal privacy protection regulations. Data are reported to the sponsor on Case Report Forms that identify you by your unique study number and not your name, date of birth or medical record number. Information regarding your health, such as side effects of the study vaccine you experience will be reported only by code number. All samples collected for analysis will be labeled with your study number, visit number and date of your visit. The Principal Investigator or study staff will inform you if there are any additions to the list above during your active participation in the trial. Any additions will be subject to University of Pennsylvania procedures developed to protect your privacy. How long may UPHS and the School of Medicine be able to use or disclose your personal health information? Your authorization for use of your personal health information for this specific study does not expire. Your information may be held in a research repository (database). However, UPHS and the School of Medicine may not re-use or re-disclose information collected in this study for a purpose other than this study unless: You have given written authorization to do so The University of Pennsylvania s Institutional Review Board grants permission after ensuring that appropriate privacy safeguards are in place As permitted by law Will you be able to access your records? During your participation in this study, you might not be able to access some or all of your medical records. For example, access to portions of your medical records may be denied in studies where Page 6 of 9
your knowledge of study results included in such records could affect the reliability of the study. You will have access to your medical record information when the study is over or earlier, if possible. The Principal Investigator is not required to release research information to you that is not part of your medical record. Can you change your mind? Yes, at any time you may withdraw your approval to allow the use and disclosure of your personal health information as described here. You must do so in writing to the Principal Investigator at the address on the first page. Even if you withdraw your permission, your personal health information that was collected before we received your written request may still be used and disclosed, as necessary for the study. If you withdraw your permission to use your personal health information, you will also be withdrawn from the research study. If you withdraw your permission to use any blood or tissue obtained for the study, the Principal Investigator will ensure that these specimens are destroyed or will ensure that any information that could identify you is removed from these specimens. You will be given a copy of this Research Subject HIPAA Authorization describing your confidentiality and privacy rights for this study. You will also be given the UPHS and School of Medicine s Notice of Privacy Practices that contains more information about the privacy of your personal health information. What Are the Costs To Me? Taking part in this study may lead to added costs to you and your insurance company if you are diagnosed with a condition that would require referral for treatment. No treatment of any oral diseases will be performed as part of, or paid by this study, but you will be referred to the appropriate specialist should you require any treatment. In some cases, it is possible that your insurance company will not pay for these costs because you are taking part in a research study. Will I Receive Any Payment? You will be compensated $25 for each of the study required visits (screening, entry, weeks 12-18, 24, and 48) for a maximum of $125 compensation for this study. There is no other form of compensation available such as reimbursements for parking, tokens or child care available. Please note that if you receive more than $600.00 compensation in one year for participation in research studies at the University of Pennsylvania, you must provide a Individual Tax Identification number or Social Security Number for tax purposes. What Happens If I Am Injured? If you have a medical emergency during the study you may contact the Principal Investigator or Emergency contact listed on page one of this form. You may also contact your own doctor, or seek treatment outside of the University of Pennsylvania. Be sure to tell the doctor or his/her staff that you are in a research study being conducted at the University of Pennsylvania. Ask them to call the telephone numbers on the first page of this consent form for further instructions or information about your care. Page 7 of 9
In the event of any physical injury resulting from research procedures, medical treatment will be provided without cost to you. There is no program for compensation either through the University of Pennsylvania or the National Institutes of Health. If you have an illness or injury during this research trial that is not directly related to your participation in this study, you and/or your insurance will be responsible for the cost of the medical care of that illness or injury. You do not give up your legal rights by signing this form. What Are My Rights As a Research Subject? Taking part in this study is completely voluntary. You may choose not to take part in this study or leave this study at any time. Your healthcare provider will treat you the same no matter what you decide. We will tell you about new information from this or other studies that may affect your health, welfare, or willingness to stay in this study. If you want the results of the study, let the study staff know. What Do I Do If I Have Questions Or Problems? For questions about this study or a research-related injury, contact: Pablo Tebas, MD (215-349-8092) Clinical Trials Unit (215 349-8092) For questions about your rights as a research subject, contact: Director of Regulatory Affairs at the University of Pennsylvania by phoning (215) 898-2614 CONSENT When you sign this form, you are agreeing to take part in this research study. This means that you have read the consent form, your questions have been answered, and you have decided to volunteer. Your signature also means that you are permitting the University of Pennsylvania Health System and the School of Medicine to use your personal health information collected about you for research purposes within our institution. You are also allowing the University of Pennsylvania Health System and the School of Medicine to disclose that personal health information to outside organizations or people involved with the operations of this study. A copy of this consent form will be given to you. You will also be given the University of Pennsylvania Health System and School of Medicine s Notice of Privacy Practices that contains more information about the privacy of your health information. Name of Subject (Please Print) Signature of Subject Date Name of Person Obtaining Signature Date Consent (Please Print) Page 8 of 9
For subjects unable to give authorization, the authorization is given by the following authorized subject representative: Authorized subject Authorized subject Date representative [print] representative Signature Provide a brief description of above person authority to serve as the subject s authorized representative. Page 9 of 9