Site Newsletter 11/23/2015

Table of Contents

Trial Status: 11/16/2015-11/23/2015

Thank you for all your hard work to enroll participants in REPRIEVE!  We enrolled 43 participants last week, therefore achieving our first enrollment milestone and our 2nd best enrollment week so far!!! Please read the thank you note below from the REPRIEVE NIH Team.

Thank You from the NHLBI-NIAID REPRIEVE Team!
NHLBI and NIAID want to congratulate you on enrolling 644 patients in 7.5 months and achieving the first enrollment milestone for REPRIEVE!!!

We recognize that this achievement is due to the tremendous collective efforts of each and every member of the REPRIEVE team and we want to thank you for your time, efforts, and dedication to this trial!

The next milestone is on June 30, 2016 at which time the target enrollment is 2867 patients. We know it’s a steep climb, but based on the team’s incredible performance, we are fully confident that this next goal will also be achieved! The REPRIEVE investigators are setting an amazing example of teamwork, creative thinking, and accomplishing goals!

Congratulations again for the terrific work and we are looking forward to continued momentum! Happy Thanksgiving to everyone!
Monica, Sarah, Patrice, Katharine, Myron, Beverly, Karin, and Trinh (the NHLBI-NIAID REPRIEVE Team)

Congratulations to Sites Enrolling Participants
Week of 11/23/15

UCSD Antiviral Research Center CRS
Thai Red Cross AIDS Research Center
Greensboro CRS
Chapel Hill CRS
University of Colorado Hospital CRS
Cincinnati CRS
Penn Therapeutics CRS
Weill Cornell Uptown CRS
Massachusetts General Hospital CRS
Chiang Mai University HIV Treatment CRS
Case CRS
Northwestern University CRS
University of Washington AIDS CRS
Whitman-Walker Health CRS
New Jersey Medical School - Clinical Research Center CRS
Johns Hopkins University CRS
University of Rochester Adult HIV Therapeutic Network CRS
University of Miami AIDS Clinical Research Unit CR
UT Southwestern
University of Illinois at Chicago
Denver Public Health
Mt. Sinai Clinical and Translational Research Center
Orlando Immunology Center CRS
Baystate Infectious Diseases Clinical Research
Medical College of Wisconsin
St. John Newland Medical Associates
Los Angeles LGBT Center
Drexel University
Mt. Sinai St. Lukes Morningside Clinic
How do I assure that the pill count I am doing is hygienic?

There are a few different ways to perform a pill count. The most important aspects of the pill count are cleanliness and accuracy. Here are some suggestions from the REPRIEVE team.

Step 1. Gather all necessary materials. This could be your pill counter (a chux and a clean/sterile tongue depressor are alternatives to using a pill counter).
Step 2. If using a pill counter, use an alcohol pad or gauze and IPA 70 to clean all parts of the tray and spatula and allow to air dry.
Step 3. Pour pills onto the try
Step 4. Count by fives, place correct amount of pills into dispensing chute of pill counter.
Step 5. Close chute and pour pills into bottle and close the pill bottle.

When should I clean the pill counter tray?
At the beginning of the day, end of the day, when dirty, after using the tray for drugs know to be common allergens.

If your site does not have a pill counter please contact Katie Fitch, Project Manager at the Clinical Coordinating Center (CCC) at
Reminder! Data Query Resolution Deadline for This Week!

Please note that Friday, November 27th is the data query resolution deadline for the upcoming DSMB review.

The timeline below lists important tasks and deadlines for the upcoming Data and Safety Monitoring Board (DSMB) review of the REPRIEVE trial. This timeline will be posted under the Study Monitoring tab on REPRIEVE (A5332) PSWP for future reference.

Please make a note of this date in your calendar and thank you for your attention to this timeline in the weeks ahead.
Sites are Beginning to Share Their Successful Recruitment Tips for REPRIEVE!  
Recruitment Tip
This week's tip: Send REPRIEVE recruitment materials to nearby clinics (not already recruiting for REPRIEVE)

One site recently shared with us that they have sent flyers and other REPRIEVE recruitment materials to nearby clinics that are not REPRIEVE sites.  

The REPRIEVE (A5332) PSWP has some recruitment materials available to use for this purpose and we are working very hard to create new recruitment materials for sites such as postcards, flyers, and brochures, these materials will be able to be customized. Please watch for announcements about these materials soon!

If you have recruitment tips you would like to share in future newsletters, please email Katie Fitch, Project Manager, at the REPRIEVE CCC at kfitch@partners.orgelrk
Need to Email a Question to the Protocol Team?
If you are sending a question to the protocol team (for example, questions about eligibility), it is really helpful if you include “REPRIEVE” in the subject line of the email, and if the issue is about a participant, include the patient identification number. This will help the message pop in our inboxes and make it easier to search and follow up.

We welcome your questions at any time. The correct email address for sending questions to the protocol team is, and for substudy questions,
Please do not send email to the protocol site email logon - – because it includes all site staff at all REPRIEVE sites. You’ll be inundated with out of office messages!!!
Thank you!
REPRIEVE in the News
REPRIEVE continues to get some really good press. Check out the latest in LGBT Weekly and 2 more detailed articles are in the recent issue of Healio Infectious Disease News--Carlos Malvestutto, MD, MPH and Steve Grinspoon, MD are featured in these articles!
Save the Date!
For all new sites working toward enrolling for REPRIEVE, there will be a REPRIEVE Site Initiation Call on Tuesday, December 8th from 9:00-10:00AM EDT.  

This call will provide a brief overview of REPRIEVE, review the DAIDS Site Approval process, Protocol Activation, and contracting. We will also provide a brief orientation to the ACTG website and the OpenClinica electronic data capture system used for REPRIEVE.

Call details will be emailed shortly, watch for the email from Laura Moran!
Lab Tips
Please Notify BRI Before you Ship Using the Most Up to Date Shipping Notification Form!
US sites/laboratories must fax or e-mail a notification to the Repository prior to shipping. Use the “Shipping Notice for Ambient, Refrigerated, and Frozen Shipment” form (current version is Version 4.0, April 8, 2015) located on the ACTG web site.

Non-US sites/laboratories need to complete and fax or e-mail an “ACTG International Shipping Checklist” (current version is Version 3.0, September 1, 2105 to the Repository prior to shipping specimens. This document can be found on the ACTG web site.

For non-ACTG Sites Only, Important Note about Lab Supplies
On page 1 of the non-network A5332 Lab Processing Chart (LPC) located on the REPRIEVE PSWP, you will find ordering information for cryovials, freezer boxes, and labels.
Also, Section 5: Helpful Links, Shipping Addresses, and Shipping Instructions, includes detailed information about shipping schedule, shipping containers storage box requirements, and a lot more useful information, please read this section of the non-ACTG LPC!


A5332 Manual of Procedures, dated 11/09/15
Revisions are listed in Appendix IV, Section D!

The MOPS is on the A5332 PSWP

What's in the Folders on the REPRIEVE (A5332) PSWP?

What's in the Site Performance folder?
PPD Mini-Session Slides, ACTG Network meeting, June 2015
REPRIEVE Site Performance Plan Dated: 08/06/2015

What's in the Coenrollment Guidelines folder?
Coenrollment Guidelines Dated: 10/09/2015
Coenrollment in ACTG 5128, observational studies, or studies that do not involve a random treatment assignment does not require permission from the REPRIEVE (A5332) protocol team. For specific questions and approval for coenrollment in other studies (including HCV or HIV treatment trials and adjunctive treatment trials), sites should first check the PSWP Coenrollment Guidelines or contact the protocol core team at

REPRIEVE (A5332):  Are you up to date? 

For A5332 please use
Protocol: Version 2.0 dated 12/19/14
MOPS: Revised Version 2.0 11/09/2015
A5332 LPC for ACTG Sites:
dated 9/17/15
A5332 LPC for Non-ACTG Sites:
dated 9/17/15

These documents are on the A5332 PSWP

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

For A5333s please use
Protocol: Version 2.0 dated 12/19/14
MOPS: Version 2.0 dated 11/10/15

A5333s LPC : dated 9/21/15

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