S i t e N e w s l e t t e r 0 3 / 1 3 / 2 0 1 7...The hearts with limes denote participants that...

4/4/2017 REPRIEVE Newsletter 03/13/2017

http://us10.campaignarchive1.com/?u=e1847bb1ab55a7a34456394ea&id=459319db86 1/7

Site Newsletter 03/13/2017 Table of Contents

REPRIEVE Trial StatusUniv. of Colorado Tracks Hearty EnrollmentFAQMOPS Reminder!"Pathways to Healthy Hearts in HIV" WebinarLearn More about HIVrelated Cardiovascular DiseaseREPRIEVE (A5332): Are you up to date? REPRIEVE Mechanistic Substudy (A5333s): Are you up to date?

REPRIEVE Trial Status: March 13th 2950 participants are enrolled

240 participants are in screening107 sites are open for enrollment

29 sites have enrolled at least 1 participant in the past week 33 sites have screened at least 1 participant in the past week

REPRIEVE Announcements

As April approaches, don't forget our important goal ofreaching 50% of REPRIEVE's total enrollment. You may have heard, but just in case to help us reach ourenrollment milestone, we are starting another recruitmentchallenge: REPRIEVE’s Race to 50%! Each site that enrolls 4 or more participants between March

6th and April 28th will receive a prize (prizes may vary depending on the location of the site but



include a $100 gift card for a team lunch, REPRIEVE tshirts for your team, or a REPRIEVEbanner for your site; the REPRIEVE CCC would contact you to determine your team’spreference). We will provide race status updates in the REPRIEVE Site Newsletter and winners

will be announced in the newsletter on May 8th!

Welcome!!!A warm welcome to the newest site open for enrollment

Hospital Geral de Nova Iguacu (HGNI)

Thank You to All Sites Enrolling Participants Week of03/6/2017!

Brigham and Women's Hospital Therapeutics CRS UCSF HIV/AIDS CRSUniversity of Iowa

Washington University Therapeutics (WT) CRS Cincinnati CRS

Weill Cornell Chelsea CRS Family Clinical Research Unit

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRSColumbia Physicians and Surgeons CRS

UIC Project WISH CRSDenver Public Health

Houston AIDS Research Team CRS Chiang Mai University HIV Treatment CRS

University of Rochester Adult HIV Therapeuitc Network CRS Alabama CRS

Thai Red Cross AIDS Research Center AIDS Research Treatment Center of the Treasure Coast

Medical Universitry of South CarolinaUT Southwestern

Vancouver ID Research and Care Centre Society Bluegrass Care Clinic/University of Kentucky Research FDN CRS

Mount Sinai Downtown CRSMount Sinai St. Luke's CRS

Postive Health ClinicSchool of Medicine, Federal University of Minas Gerais CRS

Abbott Northwestern HospitalCapital Medical Associates

Universtiy of Toledo Medical Center Inova Heart and Vascular Institute

Univ. of Colorado Tracks Hearty Enrollment



The University of Colorado Team (Site 6101)has found a fun way to count their totalnumber of enrolled participants for the year.For the studies that they track, there isalways a theme and for counting REPRIEVEenrollees, they appropriately selected heartsto record each participant. The hearts with limes denote participants thatthey enrolled during a REPRIEVE enrollmentcompetition. This follows another theme withthe University of Colorado site they enjoyspending their hardearned competition giftcards on Taco Tuesday treats!

The University of Colorado Team. Left to right: Tom Campbell, Cathi Basler, GrahamRay, Josie Marshall, Pat Kittelson, Christine Griesmer, Suzanne Fiorillo Thank you to the University of Colorado team for sharing your successful enrollmenttracking technique! Does your site have a special way to track your team's successful enrollment that youwant to share? If so, send an email to Laura at [email protected].



FAQ *** More about participants who become prisoners while on study*** We are adding a note to our guidance on this topic in the MOPS to stress that no intervention orinteraction is allowed while the participant is incarcerated/involuntarily confined, such as studyprocedures or dispensation of study medication. Watch for this additional text in therevised REPRIEVE (A5332) MOPS, expected later this month.

Q. My participant did not start taking her study drug on time. How do I reportthis protocol deviation?

Delayed initiation of study drug is a departure from the protocol that the REPRIEVE teamis interested in tracking. The REPRIEVE MOPS section 17.0 offers guidance regardingnext steps for formally reporting this event to our team – specifically, the template inMOPS Appendix II should be filled out and sent to [email protected] and theREPRIEVE Key Deviations Log should be updated in Open Clinica. As per the MOPS,this documentation is in addition to and not in lieu of any reporting required by your localIRB or other regulatory entities.

Q. I would like to enroll participants coming off another study where they receivecolchicine, which is exclusionary for REPRIEVE. How long do the potentialparticipants have to be off colchicine before they are eligible for REPRIEVE? There is guidance about this in the REPRIEVE MOPS, section 5.1, Prohibited Medications:

Per Exclusion Criterion 4.2.10, current use of colchicine, erythromycin, or rifampin isexclusionary. We recommend a 30day washout before study entry; however, a minimumof 14 days is acceptable.

MOPS Reminder!Section 5.0 of the MOPS includes guidance on thefollowing:

Prohibited MedicationsPrecautionary MedicationsConcomitant MedicationsDocumentation of Permanent Discontinuation of Study

medicationGuidance Regarding Exclusion Criterion 4.2.9

Please refer to this section to answer questions you may have about these topics. If

mailto:[email protected]



you still have questions after reviewing this section please email the core team.

If you are a nonACTG site, please go to the A5332 PSWP anddownload the updated nonACTG Site Specific ShippingSchedule (dated 03/07/2017) located in the Lab Resources

folder. Or click here to download.

Miss the "Pathways to Healthy Hearts in HIV" Webinar, or want to share it?The video is embedded above and can also be found on our website.

Learn More about HIVrelated Cardiovascular DiseaseDr. Turner Overton, a REPRIEVE CoInvestigator, shared an educational activityoffered by Academy for Continued Healthcare Learning. It is designed for cardiologists,infectious disease specialists, primary care physicians, and other clinicians interestedin the management of patients with HIVrelated cardiovascular disease.

https://gallery.mailchimp.com/e1847bb1ab55a7a34456394ea/files/0e549625-e6fe-4ea5-a64d-8a23c7cd0af0/REPRIEVE_Non_ACTG_Site_Shipping_Schedule_03_07_2017.xlsxhttp://www.reprievetrial.org/pathways-webinar/https://youtu.be/Ac9dKcnS-h4



Click here to access this series which consists of 4 continuing educationeNewsletters to launch quarterly.

REPRIEVE (A5332): Are you up to date? For A5332 please use

Protocol: Version 3.0 dated 01/28/2016

Clarification Memo #1 dated 04/04/2016 Clarification Memo #2 dated 04/12/2016 (corrects an error in CM #1)

Clarification Memo #3 dated 12/27/2016 Letter of Amendment, Version 3.0 #1 dated 08/17/16

MOPS: Version 3.0, revision 1, dated 09/09/16, watch your email, an updated version will be distributed

to the field very soon!A5332 LPC for ACTG Sites: Version 3.0 dated 01/04/2017

A5332 LPC for NonACTG Sites:Version 3.0 dated 01/04/2017

These documents are on the A5332 PSWP

REPRIEVE Mechanistic Substudy (A5333s): Are you up todate?

For A5333s please useProtocol: Version 3.0 dated 01/28/2016 MOPS: Version 3.0 dated 09/02/2016

A5333s LPC : Version 3.0 dated 01/04/2017

These documents are on the A5333s PSWP

Share Tweet Forward

For future reference, all newsletters are available on the REPRIEVEWebsite

We welcome suggestions and ideas for upcoming newsletters. Please submit any comments orsuggestions to the REPRIEVE News Team at [email protected].

REPRIEVE Trial Clinical Coordinating Center Massachusetts General Hospital

55 Fruit Street, LON 207Boston, MA 02114

Want to change how you receive these emails?

Youcanupdate your preferences or unsubscribe from this list

http://www.freecme.com/courses/9/2016/HIV-related_Cardiovascular_Disease_ACHLhttps://member.actgnetwork.org/study/53278#profile=4https://member.actgnetwork.org/study/53279http://www.facebook.com/sharer/sharer.php?u=http%3A%2F%2Feepurl.com%2FcEkZjnhttp://www.facebook.com/sharer/sharer.php?u=http%3A%2F%2Feepurl.com%2FcEkZjnhttp://twitter.com/intent/tweet?text=REPRIEVE+Newsletter+03%2F13%2F2017:%20http%3A%2F%2Feepurl.com%2FcEkZjnhttp://twitter.com/intent/tweet?text=REPRIEVE+Newsletter+03%2F13%2F2017:%20http%3A%2F%2Feepurl.com%2FcEkZjnhttp://us10.forward-to-friend.com/forward?u=e1847bb1ab55a7a34456394ea&id=459319db86&e=[UNIQID]http://us10.forward-to-friend.com/forward?u=e1847bb1ab55a7a34456394ea&id=459319db86&e=[UNIQID]http://reprievetrial.org/collaborating-sites/reprieve-site-newsletters/mailto:[email protected]://reprievetrial.us10.list-manage.com/profile?u=e1847bb1ab55a7a34456394ea&id=e0d99a8ba3&e=[UNIQID]http://reprievetrial.us10.list-manage1.com/unsubscribe?u=e1847bb1ab55a7a34456394ea&id=e0d99a8ba3&e=[UNIQID]&c=459319db86



This email was sent to why did I get this? unsubscribe from this list update subscription preferences Massachusetts General Hospital · 5 Longfellow Place · Boston, MA 02214 · USA

mailto:http://reprievetrial.us10.list-manage.com/about?u=e1847bb1ab55a7a34456394ea&id=e0d99a8ba3&e=[UNIQID]&c=459319db86http://reprievetrial.us10.list-manage1.com/unsubscribe?u=e1847bb1ab55a7a34456394ea&id=e0d99a8ba3&e=[UNIQID]&c=459319db86http://reprievetrial.us10.list-manage.com/profile?u=e1847bb1ab55a7a34456394ea&id=e0d99a8ba3&e=[UNIQID]http://www.mailchimp.com/monkey-rewards/?utm_source=freemium_newsletter&utm_medium=email&utm_campaign=monkey_rewards&aid=e1847bb1ab55a7a34456394ea&afl=1

S i t e N e w s l e t t e r 0 3 / 1 3 / 2 0 1 7...The hearts with limes denote participants that...

Documents

Transcript of S i t e N e w s l e t t e r 0 3 / 1 3 / 2 0 1 7...The hearts with limes denote participants that...