Site Newsletter 6/22/2015

Table of Contents

Trial Updates Week of 6/15/2015


Congratulations to Sites That Enrolled Participants Week of 6/15/15
Cincinnati
Chapel Hill
Massachusetts General Hospital
UCSD Antiviral Research Center
Puerto Rico AIDS CTU
Northwestern University
Houston AIDS Research Team
University of Colorado
Cooper University 
Miriam Hospital
Weill Cornell Uptown
Help us to Make REPRIEVE a Success: 
Enroll at Least 1 Participant per Week!

Recording Adverse Events for REPRIEVE (A5332)


Record the following on the REPRIEVE (A5332) AE log at post entry visits:
  • Any of the primary and/or secondary endpoints.
  • All signs and symptoms that led to a change in treatment (pitavastatin or placebo for pitavastatin) regardless of grade.
  • Any adverse event classified as a Serious Adverse Event (SAE)
  • Signs and symptoms, including any laboratory values with a severity of Grade 3 or higher.
If signs and symptoms are related to a diagnosed event, please record primary event and do not grade or record related sign and symptoms. If Grade 3 or higher signs and symptoms occur independent of a related diagnosis, they should be recorded. 
 
Example: A participant reports gastroenteritis with nausea, vomiting, and diarrhea. Only the gastroenteritis is required to be recorded.
 
Example: A participant reports a diffuse macular rash, but no medical diagnosis was made. The rash should be recorded.

IMPORTANT TO NOTE!
Do NOT record the following on the REPRIEVE (A5332) AE log at post entry visits:
  • Signs and symptoms, including any laboratory values with a severity of Grade 2 or lower.
Example: A participant reports mild muscle soreness, there is no change in study  medication.  This should NOT be recorded on the AE log.

Adapted from the REPRIEVE (A5332) MOPS

TIPS from the MGH CT Core Lab


Don’t Forget the Paperwork!
1. CCTA CRF
Ask for help from the Imaging Team at your site! Questions # 6 - 16 on the CCTA Case Report Form (CRF) are imaging specific. The CT Technologist or CT MD will be able to assist with this section of the CRF. The REPRIEVE team suggests study coordinators bring a copy of the CCTA CRF to the imaging appointment and request the CT Tech of CT MD complete questions #6 – 16 while the participants undergoes imaging.  
 
REMINDER!
There is a 48 hour rule for completion of the CCTA CRF in OpenClinica.
 

2. CCTA Performed Data Tracking Sheet
This is a simple tracking form and should be submitted at the time of each scan. This sheet can be found on page 14 of the A5333s MOPs or on the A5333s PSWP.  
 
All about the Image Query
The MGH CT Core Lab is responsible for the collection of all CCTA data for the Mechanistic Substudy (A5333s). For every CCTA submitted the site will receive a Case Acceptance Notification OR a Case Query Notification. Site responsibilities are complete upon receipt of a Case Acceptance Notification! A Case Query indicates that the CCTA does not meet the REPRIEVE CCTA Imaging Protocol (A5333s MOPs Section 2.4.2) and there is more work to be done to achieve case acceptance.
 
How to Avoid the Case Query Notification 
The most common reason for a case query is a missing "Patient Protocol Page." This page contains important radiation dose information and is typically called the Patient Protocol OR Dose Report Page.

Sample: Dose Report/Patient Protocol Page

Featured Site!  Greensboro CRS

 
Our research staff has shared some tips for successful recruitment:
 
 #1 Optimizing provider engagement, enthusiasm for REPRIEVE
The site leader and our 4 other Infectious Disease Physicians have been very proactive in recruiting their own patients during regular clinic visits. At the end of a clinic visit, providers will frequently walk a patient from the exam room to the research offices to introduce them to research staff.
 
#2: Engage CAB members, former and current study participants
Many of the REPRIEVE enrollees are current or previous research study participants, who ardently enjoy participating in research trials. Most know the study staff very well, and are eager to do anything they can to help the cause of research at our site.
 
#3 Increase awareness in the clinic and in the community
We have placed flyers in the lab, in all exam rooms and all provider work pods to prompt interest in REPRIEVE. 

By presenting a Journal Club on HIV and CVD risk, our Site Leader, Dr. Van Dam was able to promote the REPRIEVE trial to the Internal Medicine Faculty and House-staff.

Reach out to local media. While we have not yet landed a TV spot for REPRIEVE, in the past, TV appearances have helped us promote and recruit patients for large trials.

 #4 Flexing research staff knowledge of patients
Our research staff, in particular Kim and Elisha Epperson, know our current and former research participants very well. This is invaluable in not just identifying a subject who might look “good on paper”, but in knowing who is going to actually be a fully engaged future research participant.

#5 Query the EMR
We plan on querying our EMR for eligible patients.  Our research staff have already been very successful by simply reviewing records of patients with upcoming scheduled clinic visits to identify eligible patients and prompt the attention of the ID provider before a clinic visit takes place.
 
Background on the Greensboro CRS and the Regional Center for Infectious Diseases:
 
The Greensboro CRS is co-housed within the Regional Center for Infectious Diseases (RCID), in Greensboro, NC. The RCID cares for over 1400 HIV positive individuals, with African Americans and Hispanics representing 69% and 4% of this population, respectively. The male to female ratio is approximately 3 to 1. At least 152 of our HIV positive patients are also co-infected with Hepatitis C.  In addition to being co-housed with the Greensboro CRS, the RCID Clinic shares its roof with several powerful AIDS Service Organizations such as Triad Health Project, Central Carolina Health Network, and Family Health Services of the Piedmont that help to provide case management, “bridge-counseling,” counseling, and substance abuse treatment.
 
It was in 1990, that the Greensboro CRS enrolled its first patient into an ACTG trial. Working closely with our parent CTU, the University of North Carolina at Chapel Hill, the Greensboro CRS have been a highly efficient, fervent and productive site in the ACTG for more than two decades. Our six member staff is small but cohesive, efficient and experienced.  Dr. Cornelius (“Kees”) Van Dam is the Site Leader, Kim Epperson, RN, CCRC, our Site Coordinator, Elisha Epperson, RN and Study Coordinator, along with Marlene Allen who serves as both Data Manager and Regulatory Coordinator, Philip Bozovich our Pharmacist and Charles Hansen provides further administrative leadership.
 
In addition to participating in the ACTG, we have been one of the top enrolling sites for the Strategic Timing of Anti-Retroviral Treatment (START) Trial from the INSIGHT Network. We have additional interest in HIV Prevention Trials Network Studies, especially given our keen awareness that Greensboro-High Point was recently ranked 20th on the list of major metropolitan areas in numbers of new infections per capita.
REPRIEVE (A5332)
Are you up to date? 

 
For A5332 please use
Protocol: Version 2.0 dated 12/19/14
MOPS: dated 6/15/2015 (revised version!)
A5332 LPC for ACTG Sites:
dated 05/06/2015
A5332 LPC for Non-ACTG Sites:
dated 5/06/2015


These documents are on the A5332 PSWP
What's New on the A5332 PSWP?
 
ELI 150C Quick Guide, Version 4 dated 6/11/2015
 
REPRIEVE ECG Waveform shipping instructions (if you have paper ECGs to send to Quintiles, use these instructions posted on the PSWP)
 
REPRIEVE Site Performance Plan, dated 6/03/15
 
These documents are on the A5332 PSWP
Mechanistic Substudy (A5333s)
Are you up to date?

For A5333s please use
MOPS: dated 03/16/2015
A5333s LPC: dated 05/07/2015


Questions on CT Activation?
Contact the MGH CT Core Lab

MGHReprieve@partners.org



 
These documents are on the A5333s PSWP
What's New on the A5333s PSWP?
 
SF-36V2
The SF-36V2 posted to the A5333s PSWP has been updated to match the the SF-36V2 which is on OpenClinica and also that which is posted on the FSTRF Portal (https://www.fstrf.org/portal). If you used the PSWP to obtain the SF-36V2 please download the version no posted on the PSWP. 
 
These documents are on the A5333s PSWP

Training Opportunities

Need a A5332 or A5333s Site Training Call Refresher?
  • Slides from the A5332 training calls are available in the Training Folder of the A5332 PSWP, there is also an audio recording available.  
  • Slides from the A5333s training calls are available in the Training Folder of the A5333s PSWP.
WebLDMS
  • Webinar for those sites/labs who will be using the web LDMS platform; sites will be contacted by the Data Management Center (DMC).
    • July 2nd @ 1pm EST
    • July 16th @ 9am EST
    • July 30th @ 1pm EST
Please see the REPRIEVE Calendar for additional training opportunities
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.

 
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