Site Newsletter 02/27/2017

Table of Contents
  
REPRIEVE Trial Status: February 27th 
 2871 participants are enrolled
 232 participants are in screening
108 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 of reaching 50% of REPRIEVE's total enrollment.

Less than 500 participants need to be enrolled to reach this goal, if at least 50 participants are enrolled each week we will reach this major milestone by mid-April!.
Welcome!!!
A warm welcome to the newest site open for enrollment
Durban International Clinical Research Site

Thank You to REPRIEVE Super Sites!
These sites are enrolling at least 10 participants per month
Family Clinical Research Unit
WITS Helen Joseph Hospital CRS
Instituto de Pesquisa Clinica Evendor Chagas
Soweto
Thai Red Cross AIDS Research Center
School of Medicine, Federal University of Minas Gerais CRS
 
Thank You to All Sites Enrolling Participants Week of 02/20/2017!
Massachusetts General Hospital (MGH) CRS
Boston Medical Center
Johns Hopkins University CRS
UCLA CARE Center CRS
UCSF HIV/AIDS CRS
Cincinnati CRS
Case CRS
Chapel Hill CRS
Puerto Rico AIDS Clinical Trials Unit CRS
The Ponce de Leon Ctr. CRS
University of Colorado Hospital CRS
Family Clinical Research Unit
Wits Helen Joseph Hospital CRS (Wits HJH CRS)
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
SOWETO
Gaborone CRS
Columbia Physicians and Surgeons CRS
UIC Project WISH CRS
Orlando Immunology Center CRS
University of Cape Town Lung Institute
Thai Red Cross AIDS Research Center
Kinder Medical Group
UT Southwestern
Mount Sinai Downtown CRS
Mount Sinai St. Luke's CRS
Postive Health Clinic
Eisenhower Health Center at Rimrock
Abbott Northwestern Hospital
Inova Heart and Vascular Institute
 
FAQ
Q. A participant came in for their 12 month visit and reported they are taking fish oil. How do I proceed?
  • Fish oil/omega 3 is not exclusionary at entry nor is it prohibited or precautionary during study participation.
  • Please document use on the Medications Log.

Q. We recently discovered that a participant is incarcerated. How do we proceed?
  • Keep trying to get in touch with the participant on a regular basis.
  • If the participant has remained incarcerated, keep reporting the missed visits at the time points noted in the protocol until one year has passed.
  • If one year has passed and the participant is still incarcerated/missing, inform the protocol team and consult the REPRIEVE site PI to see whether or not she/he would like to keep the participant in the study.
The REPRIEVE (A5332) MOPS provides guidance on this topic:
Incarceration/involuntary confinement
If a participant returns to
care after incarceration/involuntary confinement and would like to resume study participation, it is at the discretion of the site PI whether or not to allow the participant to resume study participation. That individual will be required to provide written informed consent at time of re-entry into the study.

NOTE: No study procedures may be completed and no study medications may be dispensed while the participant is incarcerated.

Return to care 
If a participant returns to
care after >1 year and would like to resume study participation, it is at the discretion of the site PI whether or not to discontinue the subject from study participation.
 
 Is Your REPRIEVE Contact Info Correct?
The site map on the REPRIEVE website is updated every few months, but sometimes the CRS coordinator is not always the REPRIEVE coordinator, or coordinators have changed and we have not received the updated information.

To ensure that the right person and phone number is listed, please click this link and locate your site. If there are any updates or corrections required, please email Laura Sanchez at lsanchez12@partners.org with the correct info. 
Check Out the Latest REPRIEVE Video 
A Conversation About REPRIEVE at the UW ACTU featuring REPRIEVE volunteers and Dr. Carl Dieffenbach, the Director of the Division of AIDS, NIAID.
Read About the University of Cincinnati's Approach to Enrollment
•According to the team at UC, this approach has been superior to giving providers lists of names, talking with providers one on one, and even giving presentations.

•UC's approach:
–Accrual goal is set for each month – 3 participants.
–Query is done every 2 weeks for upcoming appointments.  Click here for instructions on how to do this in Epic.
–Research nurses review query and confirm potentially eligible participants.
–Send Epic message on
day of visit to their doctor indicating that one or more of their patients are eligible (by name and MRN).
–IRB-approved printed material is put in sealed envelope with the patient’s name on it. This invites them to think about REPRIEVE and talk with their doctor or call us.
–Research nurses make contact when the 
participant is there to give them a copy of the consent and arrange follow up if they are interested. For some we call them in follow up. 

This will be discussed in more detail during the Monthly Site Call on Tuesday, March 21st at 1:00 PM ET, so please join us!
Investigator's Meeting at CROI

Thank you to everyone who was able to join the REPRIEVE Investigator's Meeting at CROI 2017, over 75 people attended this event!

If you were unable to attend, click here to download the slides for the meeting, and also click here to download the slides from Dr. Heidi Crane's keynote presentation on Type 1 and Type 2 MIs in the setting of HIV.
REPRIEVE in the News

REPRIEVE was recently featured in:

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 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
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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