Site Newsletter 09/12/2016

Table of Contents
  

Enrollment Updates

Thank you to every site enrolling participants in REPRIEVE. With your help, 1915 participants are now enrolled in REPRIEVE! There are 90 sites currently enrolling, 2673 total screenings, and 180 potential participants in screening. 

If 50 participants are enrolled each week, REPRIEVE's enrollment will tip to 2,000+ in only two weeks, this is a huge accomplishment. We can make this happen!

Important Message About the Mechanistic Substudy of REPRIEVE (A5333s)

If your site is enrolling participants in the Mechanistic Substudy please remember to ask all participants screening for REPRIEVE (A5332) if they would also like to screen for the Mechanistic Substudy.  Enrollment has been strong and it is important to keep it strong!
Thank You to All Sites Enrolling Participants Week of 09/05/2016!
  • Thai Red Cross AIDS Research Center
  • UCSD Antiviral Research Center CRS
  • University of Southern California CRS
  • UT Southwestern
  • University of Illinois at Chicago
  • Denver Public Health
  • Orlando Immunology Center CRS
  • 550 Clinic at U Louisville
  • Los Angeles LGBT Center
  • University of Kentucky
  • University of Nebraska Medical Center
  • Mount Sinai Clinical and Translational Research Center
  • Mt Sinai St Lukes Samuels Clinic
  • Mt Sinai St Lukes Morningside Clinic
  • Michael D. DeBakey VAMC
  • University of Iowa
  • University of Toledo Medical Center CRS

Meet New Members of the MGH Data Coordinating Center/Mechanistic Substudy of REPRIEVE Team!
Lisa DiGianni, PhD is the new Project Manager for the MGH Data Coordinating Center/Mechanistic Substudy.  She is a seasoned social scientist researcher with over 20 years experience directing research programs and operations.  She was a Senior Research Scientist in the Center for Cancer Genetics and Prevention at the Dana-Farber Cancer Institute in Boston. She was also Principal investigator for a research program focused on complementary medicine and physical activity interventions for women at hereditary cancer risk, and has published several academic articles in this field.  
 
Katie Regan, BA is a Clinical Research Coordinator and is responsible for image processing for the Mechanistic Substudy. Image processing involves the QA/QC of all REPRIEVE Substudy CT scans and communication with study sites to ensure the receipt of all needed images. Katie also writes a CT Summary Report for the substudy each week in order to outline enrollment, QA/QC patterns, and incidental findings. Additionally, she is responsible for assembling adjudication packets for REPRIEVE (A5332). 
 
The Next Monthly Site Call is only for Sites Participating in the Mechanistic Substudy of REPRIEVE (A5333s)
The focus of the REPRIEVE team-site call on September 20th will be The Mechanistic Substudy of REPRIEVE (A5333s), there is no need to attend unless you are an ACTG site participating in or eligible to participate in A5333s. The agenda for this call will be forthcoming.
 
The usual agenda for monthly team-site calls will resume in October.
Don't Forget! Assessing for Adjudicated Events is Essential in REPRIEVE!
It is important in REPRIEVE that all adjudicated events/REPRIEVE MACE are captured.Don't forget to complete the Adjudicated Events Tracking CRF (TRK0150) at every visit post screen.  

The team has developed this tool, located in the Protocol Training folder on the REPRIEVE (A5332) PSWP.  The tool contains descriptive terms for adjudicated events and may be helpful when completing the Adjudicated Events Tracking CRF.
Hot Off the Press: Barbara Streisand & Dr. Anthony Fauci Highlight REPRIEVE  
 
In the article, "A Reprieve for Women: Embracing Inclusive Scientific Research", Barbara Streisand and Dr. Anthony Fauci underscore REPRIEVE as a unique, well-designed study that takes sex and gender into account from recruitment to study data analysis. Read the full article here!

REPRIEVE Referenced in Ryan White Conference Interview
REPRIEVE was mentioned in a Facebook Live interview on August 26th!  Check out the interview with Dr. Carl Dieffenbach, Director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases.


 
 
Join Us for the Next Twitter Chat!  #HIVAgingChat
In observance of National HIV/AIDS & Aging Awareness Day, the REPRIEVE team is partnering with the AIDS Clinical Trial Network (ACTG), the National Library of Medicine (NLM), and ACRIA to host an HIV & Aging Twitter Chat on Friday, September 16 between 3:00-4:00 PM ET.

The purpose of this chat is to raise awareness for aging with HIV, discuss the challenges associated with it, and to provide resources for people living with HIV. 

We are trying to reach a wide audience and would love it if you could join the conversation and/or spread the word to those who would benefit from learning about aging with HIV. A number of top physician-researchers, HIV nonprofits, the NIH, and more will be participating. If you or your site is interested in participating, please contact Laura Sanchez, lsanchez12@partners.org. She can provide more information and help facilitate your participation!  
Want to learn even more about the upcoming Twitter chat? Check out AIDS.gov's latest blog post.
Can't Join the Twitter Chat?
Here are some ways for your site to increase awareness of National HIV/AIDS & Aging Awareness Day and the REPRIEVE trial during the month of September
 
Set up a table in your patient waiting area with information on healthy aging including heart health and the REPRIEVE trial! This was a successful strategy for both the MGH and Puerto Rico CRSs!










Share slides created by the REPRIEVE study team about HIV and aging specifically for patients and consumers! Click here to download slides.

Share the REPRIEVE video and the REPRIEVE Follow YOUR Heart video* with patients and staff, or play continuously in your waiting area! These are available at: www.reprievetrial.org and followyourheart.reprievetrial.org

Reach out to patients via your site newsletter, social media or website to share important information about National HIV/AIDS & Aging Awareness Day available at the following websites:
               https://www.aids.gov/news-and-events/awareness-days/aging/
               http://www.nhaad.org/

 
Click here for additional ideas!
 
*Contact Katie Fitch at kfitch@partners.org if you would like a digital copy of these videos.
NEW Data Management Training Videos are Now Available!
Check out these excellent training videos just posted on the FSTRF portal.  The videos are listed under the Site Support tab.  
  • Changing Previously Saved Data
  • Entering Logs
  • Entering Missed Visits
  • Answering Notes and Discrepancies
  • Entering Out of Window Visit
  • Entering Unknown or Missing Values
 

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)
Letter of Amendment, Version 3.0 #1 dated 08/17/16 (new!)
MOPS:
Version 3.0, revision 1, dated 09/09/16 (new!)
A5332 LPC for ACTG Sites:
Version 3.0 dated 08/03/2016 (new!)
A5332 LPC for Non-ACTG Sites:
Version 3.0 dated 08/03/2016 (new!)


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 (new!)
A5333s LPC : Version 3.0 dated 08/03/2016 (new!) 


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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