Site Newsletter 04/10/2017

Table of Contents
  
REPRIEVE Trial Status

  3129 participants are enrolled
  271 participants are in screening
 108 sites are open for enrollment
 25 sites have enrolled at least 1 participant in the past week
   34 sites have screened at least 1 participant in the past week 

Rankings!
Don't forget! Help us get to 50% of our target enrollment. Each site that enrolls 4 or more participants between March 6th and April 28th will receive a prize. Winners will be announced in the newsletter on May 8th. Many sites have attained this goal and many others are very close- your site still has time to be among the winners!!!

Thank You to All Sites Enrolling Participants Week of 04/3/2017!
UCSF HIV/AIDS CRS
Chapel Hill CRS
The Ponce de Leon Ctr. CRS
University of Colorado Hospital CRS
Weill Cornell Chelsea CRS
Family Clinical Research Unit
Wits Helen Joseph Hospital CRS (Wits HJH CRS)
Durban International CRS
Hospital Nossa Senhora da Conceicao CRS
SOWETO
Gaborone CRS
Denver Public Health
Whitman-Walker Health CRS
University of Cape Town Lung Institute
Thai Red Cross AIDS Research Center
Wake Forest University
VA West Los Angeles Medical Center
Los Angeles LGBT Center
Florida Department of Health Hillsborough County
Bluegrass Care Clinic/University of Kentucky Research FDN CRS
Toronto General Hospital
School of Medicine, Federal University of Minas Gerais CRS
Hospital Federal dos Servidores do Estado
Abbott Northwestern Hospital
HGNI HIV Family Care Clinic HHFCC
 
Timeline for REPRIEVE DSMB Meeting 
 
Tuesday, June 6th 2017
 
The timeline below lists important tasks and deadlines for the upcoming Data and Safety Monitoring Board (DSMB) review of the REPRIEVE trial. This timeline is posted under the Study Monitoring tab on the REPRIEVE (A5332) PSWP for future reference.
*Please make sure that you respond promptly to all queries and clarifications from the DCC regarding source documents submitted for adjudication. This will ensure the DCC is able to submit complete packets to TIMI for adjudication prior to the DSMB meeting.
Retention Tips
The last REPRIEVE Newsletter outlined the importance of retention in REPRIEVE. In the next several newsletters, we will offer strategies to help maintain high rates of retention.

Employ Routine Strategies to Achieve High Rates of Retention
#1: Create a Welcoming Environment
  • The first step in enhancing retention is to make the experience for participants as smooth and enjoyable as possible. One way to achieve this goal is to assure that staff are welcoming and respectful.
  • A nonjudgmental and accepting attitude is essential for our participants.
  • Make sure to conduct all study visits in a professional manner and in a location that assures privacy.
  • Remember, REPRIEVE participants are volunteers in this trial.
Does your site have an effective retention strategy?  
Please share it with other REPRIEVE sites during the next Monthly Site call on Tuesday, April 18th, 1:00 PM ET or email Katie Fitch, CCC Project Manager.
For ACTG/IMPAACT Sites
Q.  We are trying to enroll a participant who has an IMPAACT PID. May we use this IMPAACT PID for REPRIEVE enrollment?
FAQs
For current ACTG/IMPAACT sites, participants who previously enrolled into an ACTG/IMPAACT study can be enrolled into REPRIEVE with the same ACTG/IMPAACT PID.
Q. A potential participant was not eligible for REPRIEVE because of a report of chest pain of unknown etiology. The evaluation showed that the chest pain was non-cardiac in nature and it has since resolved. Can this person be screened again for REPRIEVE?

Chest pain of a non-cardiac nature is not exclusionary and the potential participant is eligible to screen. Exclusion 4.2.1 relates to the diagnosis of clinical ASCVD*, including stroke and TIA.

If the potential participant has been assessed by their medical doctor and the symptoms are not related to any of the ASCVD categories, then these symptoms are not exclusionary and you should screen them for the study.

*ASCVD=atherosclerotic cardiovascular disease
MOPS Reminder! 
Did you know, Section 11.2 of the REPRIEVE (A5332) MOPS has important tips about study medication adherence? 
 
Section 11.2 Study Medication Adherence

Using simple, everyday language, please review the following with participants at every visit post screen: 
  • Name of study medication.
  • Indication for pitavastatin and why it is being studied in REPRIEVE (use language from the consent form).
  • Dose, route, and frequency of study medication administration.
  • Remind participants that the study medication should be taken at the same time each day, with or without food.
  • Instruct participants to take ONE tablet per day and to complete one bottle before starting another.
  • Review potential side effects related to study medication.
  • What to do if a dose is missed (MOPS has instructions).
  • Non-adherence (MOPS has instructions)
A paragraph regarding the importance of adherence to the study medication is also included in the Participant Handout that is distributed annually and located in the Protocol -Specific Support Documents folder on the REPRIEVE (A5332) PSWP.
Meet the Team at Inova Juniper Program 


From left to right: Kathy Morgan-director of Cardiac Outpatient Research, Tenzin Dechen, RN Jane Lettmann, RN Chris deFilippi, MD, Hunfa Asghar, CRC Katherine Armstrong, CRC.

Site 31963 Inova Juniper Program is located in Richmond, Virginia. In the 24 weeks Inova has been activated, the team has enrolled 13 participants!

The Inova team has shared their recruitment plan, which is proving to be successful.

"One advantage we have at the Inova Juniper Program is REPRIEVE is the only study open to enrollment. Our patients are eager to participate!" -Jane Lettman, RN, Inova

Recruitment Plan:
  • Screen patients in EMR (Epic) prior to the visit, preferably one week in advance.
  • Flag hard charts of potential participants the morning of the appointment.
  • Give the provider a list of potential participants the morning of the appointment.
  • Talk to the patient if interested, and give them the ICF to review along with a REPRIEVE flyer.
  • Follow-up with a phone a call a couple of days later, and schedule a meeting with them on their next visit, or schedule a research visit.
For Staff New to REPRIEVE
 
We have put together a resource for new staff that includes instructions on how to obtain access to the various portals and trainings required for REPRIEVE.  

Click here to download

For future reference, this tool is located in the Protocol Training folder on the REPRIEVE (A5332) PSWP. 
Next REPRIEVE Monthly Site Call:  
Tuesday, April 18th 
1:
00 PM ET
 
The discussion will be focused on the importance of follow-up visits and evaluations.

If your team has an effective strategy, please be ready to share it with other REPRIEVE colleagues during this call.

An email announcement with the final agenda and slides will be distributed via email prior to the call.

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
Prohibited and Precautionary Medication List, dated 04/07/4017 (updated)
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 Non-ACTG Sites:
Version 3.0 dated 01/04/2017


These documents are on the A5332 PSWP

REPRIEVE Mechanistic Substudy (A5333s):  Are you up to date? 

For A5333s please use
Protocol: 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
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For future reference, all newsletters are available on the REPRIEVE Website

We welcome suggestions and ideas for upcoming newsletters. Please submit any comments or suggestions to the REPRIEVE News Team at reprieve.news@fstrf.org.
 
REPRIEVE Trial Clinical Coordinating Center
Massachusetts General Hospital
55 Fruit Street, LON 207
Boston, MA 02114

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