Investigator Name: Quality of Life of HIV-infected Patients Study OptumInsight is seeking for additional investigators for a multicenter longitudinal observational study involving adult patients with HIV. The study is sponsored by Merck & Co., Inc. Investigator must be a MD, DO, FNP, or a PA and must be able to prescribe treatment and assess SAEs. Last patient first visit is scheduled for August 2013 and therefore, your site must complete all required start-up procedures and be activated by June 5 th, 2013. Please read the study summary and respond to the following questions via Fax: 888-881-7443 Email: MerckHIV@optum.com If you have any questions, please contact us by phone at 888-705-2440 or by email at MerckHIV@optum.com If you do not want to receive further faxes from OptumInsight, please let us know by calling 1-866-854-4108 or by faxing us at 1-973-241-9373. You must include the telephone number or numbers of the fax machines you want to exclude. We will honor your request within 30 days; our failure to do so is unlawful. Feasibility Questionnaire Page 1 of 9
Research Interest Questionnaire This multi-site longitudinal observational study will enroll adult patients diagnosed with Human Immunodeficiency Virus (HIV) during normal medical visits. The enrollment period is 6 months with an expected enrollment of at least 5 patients per investigator; however, sites will not be limited to this number. The primary objective of this study is to compare quality of life (QOL) among HIV patients initiating or switching antiretroviral therapies for the first time. The primary comparisons will be among patients initiating or switching to integrase inhibitor+2 NRTI regimens versus a) NNRTI+2 NRTI regimens and b) PI+2 NRTIs regimens. For this observational study, sites will be asked to complete an electronic case report form at the enrollment visit for each participant, and participants will be asked to complete a baseline and follow-up survey. First patient was enrolled in December 2012 and patient enrollment is scheduled to go through August 2013. Patient eligibility criteria include the following: Patient Inclusion Criteria Patient Exclusion Criteria Clinical diagnosis of HIV 18 years of age If treatment-experienced, switching from first-line antiretroviral therapy to NNRTI, PI or integrase inhibitor-containing regimens(s) for the first time at the enrollment visit Have signed an informed consent form indicating that they understand the purpose of the study, the required study procedures, and that they are willing to participate in the study, and Ability to complete questionnaire in English Currently pregnant Presence of currently active tuberculosis, Hepatitis B, and/or Hepatitis C, and receiving treatment for the condition(s) during the study period (e.g., at the time of the enrollment visit and/or during the follow-up period) Presence of currently active pneumonia or other signs of opportunistic infections at the time of the enrollment visit Currently participating in a clinical trial or other research study that may interfere with the results of this study The physician investigator will: 1) be required to complete or confirm completion of human subjects protection training; 2) identify and approach potentially eligible HIV patients during a regularly scheduled visit to initiate or switch antiretroviral medication(s); 3) maintain an enrollment log with basic information of eligible patients who decline study participation; 4) follow a standardized protocol-designated process to solicit patient interest in study participation; 5) provide enrolled patients with written study documentation that describes the goals of the study, data collection and informed consent process; 6) obtain informed consent from the patients prior to any study-related procedures being conducted; 7) facilitate self-administered patient surveys according to protocol; and 8) complete an Internet-based case report form. Feasibility Questionnaire Page 2 of 9
1. Are you interested in participating in this study? please review the Investigator Contact Information box below and complete pages 3-9. please mark reason(s) below in Question 2, provide a response to Investigator s consent on page 9, and fax this page back to us at 1-888-881-7443. 2. If you are not interested in participating, please indicate your reason. Please select all that apply. 1 Too busy to participate 2 Inadequate staffing/support to conduct research 3 Not interested in conducting research 4 Lack of appropriate patient population 5 Budget/financial reasons 6 Other (specify): 7 Please remove me from your mailing list 3. Investigator Contact Information: Please correct any information that is incomplete or incorrect. Investigator Name Clinic Name Address (1) Address (2) City/State/Zip Medical License Number Phone Contact Name Completed by (Name) Email: Fax: Contact Email: Date Completed: Position: Feasibility Questionnaire Page 3 of 9
Part 1: Staff and Facilities 4. The above-named investigator is a: 1 Physician (MD/DO) 2 Nurse Practitioner 3 Physician Assistant 4 Other (please specify below): 5. What is the primary specialty classification or area in which the above-named investigator works? 1 Family/General Practice 2 General Internal Medicine 3 Infectious Disease Specialist 4 Other (please specify below): 6. What is the primary practice setting of the abovenamed investigator? 1 Private practice 2 Group practice, single specialty 3 Group practice, multi-specialty 4 Employed by or affiliated with academic/university setting 5 Other (please specify below): 7. Is the investigator affiliated with a Research Organization or Site Management Organization (SMO)? 8. How many years has the above-named investigator been in practice? 9. What types of research studies has the above-named investigator participated in? (Check all that apply.) If Yes, please provide name of the Organization: 3 Do not know Years 1 Phase I 2 Phase II-III 3 Phase IV 4 Randomized clinical trials 5 Outcomes research 6 Survey research 7 Observational research 8 Focus groups 9 No research experience Feasibility Questionnaire Page 4 of 9
10. In the past 3 years, how many total studies has the investigator participated in? 11. Does the investigator have research experience conducting studies involving patients with HIV? 12. Please complete the table for 2 of the most recent HIV studies investigator has participated in, if applicable. Please include both the stop & start dates of the study (or if they are currently ongoing). total number of studies Study 1: Dates of study Did you meet the study enrollment goals? 3 Not applicable Study 2: Dates of study Did you meet the study enrollment goals? 3 Not applicable 13. Is the investigator currently conducting competing studies that would hinder your center s ability to participate in this study? 14. Is there a study coordinator available at this site to assist with this study? Site Study Coordinator Information If yes, please list brief study description(s) & dates: 1 Full-time 2 Part-time Name Phone Fax Email Years of experience Feasibility Questionnaire Page 5 of 9
Site Contract Specialist Information Not applicable Same as Study Coordinator Name Phone Fax Email 15. Does the investigator utilize a central IRB, a local IRB, or both? 16. If the investigator must utilize a local IRB, how often does the IRB meet? 17. If the investigator utilizes a local IRB, what is the average timeline from IRB submission to IRB approval? 18. If the investigator utilizes a local IRB, does the IRB allow for expedited review of non-interventional studies like this one? 19. How long does the contracting process take at your site on average? Feasibility Questionnaire Page 6 of 9 1 Central IRB 2 Local IRB 3 Central and Local IRB 4 Do not know 1 Weekly 2 Bi-Weekly 3 Monthly 4 >Monthly 5 Not applicable (use only Central IRB) 6 Do not know 1 <1 week 2 1-2 weeks 3 2-4 weeks 4 4-6 weeks 5 >6 weeks 6 Not applicable (use only a Central IRB) 7 Do not know 8 What are your suggestions to accelerate the IRB approval process? 3 Do not know 1 <2 weeks 2 2-4 weeks 3 4-6 weeks 4 >6 weeks 5 Do not know 6 What are your suggestions to accelerate the contracting process?
20. Does your site have experience in Electronic Data Capture/ Remote Data Entry for clinical studies and access to a computer with internet access for data entry? 21. Does your site have available space for patients to complete patient questionnaires? 22. How many patients with HIV does the investigator see per month at your institution? Part 2: Patient Population patients per month 23. Of the patients with HIV that the investigator sees each month at your institution, approximately what percent are a) Newly/initially diagnosed with HIV? b) Previously diagnosed with HIV? % newly/initially diagnosed patients % previously diagnosed patients 24. Please query your database to specifically answer this question. How many 18 year old treatment-naïve HIV patients were first prescribed an antiretroviral therapy by the investigator during the past 12 months? 25. Please query your database to specifically answer this question. How many 18 year old HIV patients currently on first-line antiretroviral therapy does the investigator have listed in his/her own practice in the last 12 months? 26. Please query your database to specifically answer this question. How many 18 year old treatment experienced HIV patients were switched from first-line antiretroviral therapy to another therapy by the investigator during the past 12 months? patients in past 12 months patients in past 12 months patients in past 12 months Feasibility Questionnaire Page 7 of 9
27. How many total patients with HIV who are initiating or switching therapy do you estimate your site can consent and enroll in 6 months (taking into consideration study eligibility criteria, competing trials, resource capabilities at your site, and patients willingness to participate)? 28. Please specify the languages spoken by your patients and percentage of patient population. estimated total number of patients who can be enrolled Of those patients: estimated total number of patients initiating therapies who can be enrolled estimated total number of patients switching therapies who can be enrolled 1 English 2 US Spanish 3 Other, please specify: 29. Based on the current study design, do you anticipate any specific challenges that may make patient enrollment difficult? Part 3: Physician Referral 30. Are you aware of any other physicians who may be interested in participating in this study? (see below) If yes, please provide the physician s name and contact information: Investigator Name Specialty Clinic Name Address City/State/Zip Email Fax Phone Primary Contact Name Feasibility Questionnaire Page 8 of 9
Investigator s Consent (To Be Completed Regardless of Your Response to Question 1 Above) By checking the box marked yes below, I unambiguously and expressly consent to: 1.) the processing (including the collection, use, disclosure and transfer) of my personal data which is submitted or confirmed by me to OptumInsight, pursuant to any current or future study, or otherwise, inside and outside of the country in which I live and the member states of the European Union; 2.) the inclusion of my personal data (i.e., contact details and professional information) in the OptumInsight Global Investigator Database; 3.) being contacted by mail, facsimile, or by electronic mail or other electronic means about possible participation in current and future studies; In each case, for the purposes of the possible participation in current or future research projects and studies and any other purpose set out in the OptumInsight Global Privacy Policy*. Yes No, I wish for all personal information about me (other than that which is expressly or impliedly permitted or required by local law to be retained) to be removed from the OptumInsight Global Investigator Database. I do not wish to be contacted in the future, and I consent to allow OptumInsight to retain a minimal amount of my personal information for the limited purpose of complying with my request not to be contacted. *Please fax 1-973-241-9373 in writing to request a copy of the OptumInsight Global Privacy Policy, to amend any details in respect to your personal data, or to request removal from the OptumInsight Global Investigator Database. Investigator Date Please submit your completed questionnaire to Fax: 888-881-7443 Email: MerckHIV@optum.com Thank you for your time and interest. We look forward to working with you! Feasibility Questionnaire Page 9 of 9