HANC Newsletter | July 2022
|
|
|
|
|
Land, Labor, and Justice Acknowledgements
We
acknowledge the land we occupy today as the traditional home of the Duwamish, Tulalip, Muckleshoot, and Suquamish tribal nations, the original caretakers of this land who are still here. Without them we would not have access to this working, teaching, and learning environment. We commit to conducting ourselves with dignity and treating this land and all the life it sustains with respect. We ask you to join us in this commitment, wherever you may reside. We also acknowledge exploited labor and ongoing struggles for justice on this land. We reflect on the ancestors of our various peoples, nations, tribes, and families; ancestors whose struggles, pain, power, privilege, and strivings we hold in our very bodies.
HANC offices are located at Fred Hutch campus in Seattle, WA.
|
|
|
|
HANC Leadership Update
Jeffrey Schouten will be retiring from his position as HANC Director on July 1, 2022. The search for the next HANC Director is ongoing and evolving to ensure a diverse and equitable recruitment process. In the interim period the Network Leadership Group is pleased to announce that Russell Campbell, HANC Deputy Director, Legacy Project Director, and Community Partners Coordinator, has agreed to serve as the Acting HANC Director until the next HANC Director is hired.
Russell has been with HANC for over fourteen years and HANC Deputy Director for over six years, working closely with Jeff during that time. Jeff has also agreed to serve as a consultant starting August 1, 2022 to assist in the smooth transition during this interim period, and during the onboarding of the next HANC Director.
Note: Jeff’s current Fred Hutch email account will not be functional after July 1. His new contact email address is Jefftschouten@gmail.com.
|
|
|
Network Sessions at AIDS 2022
A new AIDS 2022 page
is now published on the HANC website. The AIDS 2022 page summarizes sessions, symposia, and satellites affiliated with the HIV/AIDS Clinical Trials Networks at the International AIDS Conference. More sessions will be added as information becomes available. Please check back closer to the conference dates for a complete listing of all HIV/AIDS Clinical Trials Network sessions.
|
|
|
|
|
From L-R: Dr. Carl Dieffenbach, Kathy Hinson, Dr. Myron Cohen, and Dr. Wafaa El-Sadr
Kathy Hinson received the 2022 Ward Cates Spirit Award during the 2022 HPTN Annual Meeting. As an HPTN Associate Director, Kathy has provided programmatic, managerial, and administrative support for the HPTN Leadership and Operations Center (LOC) since 1993 and the IMPAACT and MTN since their formation in 2006. Kathy was recognized for her outstanding commitment and leadership to health internationally and domestically, as well as personal values of integrity, honesty, loyalty, and unwavering and courageous devotion to doing what is right to ensure the dignity and rights of people. Kathy has been with FHI 360, HPTN’s LOC, for more than 35 years.
|
|
|
|
HVTN at AIDS 2022
This month, HVTN would like to include the scope of our presence at AIDS 2022 in Montreal. Linked here is the current list of accepted presentations, and below are two more worth mentioning:
Accepted for the Global Village:
"COVID-19 and HIV: community engagement lessons learned and applied from 2 pandemics"
Session number: 603
Gail Broder is the session organizer, and co-presenters will be Stephaun Wallace, Rafael Gonzalez, Luciana Kamel, Patricia Segura, and Kagisho Baepanye.
Booth in the Global Village:
"HIV Vaccine Trials Network: Help End HIV"
Application Reference Number: 306
Booth Type: Exhibition Booth
|
|
|
|
IMPAACT Annual Meeting
The 2022 IMPAACT Annual Meeting took place in Washington D.C. as a hybrid conference from 28 June to 1 July 2022. Over 650 in-person and virtual attendees from 24 countries converged over four days of plenary sessions, protocol meetings, and roundtable discussions. The hybrid format allowed greater flexibility and participation from researchers, community representatives, and collaborators around the globe. Recordings of plenary sessions and presentations will soon be available on the IMPAACT website.
IMPAACT at AIDS 2022 and the International Workshop on HIV & Pediatrics 2022
Three oral presentations and three poster exhibitions from the IMPAACT Network will be presented at the 24th International AIDS Conference in Montreal, Canada, and virtually from 29 July to 2 August 2022.
|
|
|
|
The HANC-facilitated COVID-19 CAB Coalition (CCC) formed in September 2020 to share information, share resources, and advocate on behalf of COVID-19 research efforts. Members represent the COVID-19 Prevention Network (CoVPN) Community Engagement Working Group, the ACTG's ACTIV-2 CAB, AVAC's COVID Advocates Advisory Board, the CFAR National CAB Coalition, the COVID-19 CAB at Stony Brook, DAIDS, and Community Partners.
Updates from the CCC are shared below:
|
|
|
|
|
|
COVID-19 CAB Coalition Update
The COVID-19 CAB Coalition is meeting every other month. The next call will be in July. Earlier in the year, the group formed an ad-hoc group to write scripts on understanding science. In June, a vendor was selected to turn the scripts into short, animated videos. All five videos are expected to be completed by June 30. The videos will be posted on the HANC website under resources, shared with our HANC collaborators, and shared via social media.
|
FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 months of Age
On June 17, the US FDA announced that it has authorized emergency use of Moderna's and Pfizer's COVID-19 vaccine in children under five down to six months old. Read the announcement here.
|
Moderna's COVID-19 Booster Provides Stronger Protection Against Omicron
Moderna has updated it's COVID-19 vaccine and it appears to work against omicron subvariants BA.4 and BA.5 "The bivalent vaccine, which Moderna has said it hopes will be authorized for use in the United States this fall, is designed to target both the original omicron variant and the original coronavirus strain in a single shot." Learn more
here.
|
|
|
|
Behavioral and Social Sciences
Greg Davis, HANC Project Manager
|
The Behavioral Science Consultative Group (BSCG) continues to meet monthly. The BSCG reviewed and edited 2022 Network Meeting presentations on the last two calls. The group plans to meet with NIH Program Officers later in the year.
The Youth Prevention Research Working Group (YPRWG) co-chairs, Audrey Pettifor and Sybil Hosek, joined the June Network Leaders call to highlight results from the 2021 YPRWG Site Survey that the group conducted in Q2 and Q3 of 2021.
The Financial Disclosure Working Group is preparing for the 2022 solicitation. The group is currently reviewing the companies list. Once that review is completed, the group will start reviewing the Network Investigators lists.
|
|
|
|
Community Partners
Russell Campbell, HANC Deputy Director
|
Community Partners is excited to welcome Maria del Rosario (MaR) Leon back as the new CP representative for the HPTN!
Community Partners reps will be presenting to the ACTG, IMPAACT and HPTN GCABs to highlight the role of CP and the various community engagement resources developed to assist CABs.
|
|
|
|
Cross-Network Coordination
Milan Vu, HANC Project Manager
|
The Cross-Network Protocol Deviation Working Group (PDWG) continues to meet on a monthly basis to monitor the rollout of the harmonized, generic Protocol Deviation eCRF for collecting protocol deviations in NIAID/DAIDS clinical trials and to discuss sponsor- and network-level processes for monitoring and review of protocol deviation data. Network protocols reaching version 1.0 on or after May 1, 2022 are expected to report major and critical deviations using the generic eCRF. Sites should refer to communications from their respective networks and data management centers regarding implementation.
Updated DAIDS Protocol/Sample Informed Consent Template - General Use
A new version of the DAIDS Protocol/Sample Informed Consent Template - General Use is now available on the NIAID website.
The template was updated to 1) Ensure consistency with the revised Common Rule, related policies, and best practices 2) Address data-sharing issues, including what type of information may be shared and with whom, and related country-specific consent requirements 3) Include co-enrollment prevention/age and identity verification process information (see the SCORE Manual). This template is intended to be used as a tool to the
Requirements for Informed Consent Forms policy.
|
|
|
|
Laboratory Coordination
Tyler Brown, HANC Project Manager
|
|
|
New DAIDS GCLP Training Frequently Asked Questions
In June DAIDS announced the availability of the DAIDS Good Clinical Laboratory Practice Training Related FAQs, a new guidance document that addresses common questions about GCLP training requirements. Access the GCLP Training Related FAQs on the NIAID website.
Attention ACTG/IMPAACT Labs: A new version of the ACTG/IMPAACT Shipment Evaluation Procedure (v8.0, 12May2022) is now published on the HANC website.
The purpose of the Shipment Evaluation Procedure is to provide guidance for evaluating specimen shipments received by the NIAID Repository, Biomedical Research Institute (BRI). Updates in v.8.0 address barcode scanning errors and provide new guidance for specimens received thawed at BRI.
Attention Pharmacology Labs: A new version of the ICH Harmonised Guideline for Bioanalytical Method Validation and Study Sample Analysis (ICH M10) is now available on the ICH website. The ICH M10 guidelines provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the analysis of study samples.
|
|
|
|
The Legacy Project
Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
|
July 28: Legacy Project’s American Indian/Alaska Native Working Group will be presenting on the role of HANC in the conduct of HIV/AIDS clinical research funded by DAIDS at the 9th International Indigenous Pre-Conference on HIV & AIDS.
July 29 - August 2: Join the Legacy Project at AIDS 2022 in Montreal (and virtually), where our work will be featured:
- The Representative Studies Rubric: “12 Steps to Address Underrepresentation in HIV Clinical Research” (a poster by Brian Minalga and Rona Siskind)
- “Beyond Ain’t It Awful/Addictophobia in HIV/AIDS Clinical Research: addressing injection risks and drug-linked sexual behaviors in HIV prevention science and care” (a global village session by Drs. Wafaa El-Sadr, Steve Shoptaw, Alex Dubov and Russell Campbell)
Representative Studies Rubric (RSR) Updates
Representative Studies Rubric (RSR) evaluation reports are complete for the ACTG, HPTN, HVTN, and IMPAACT. These reports cover protocol-specific findings and overall recommendations from the RSR evaluation of all protocols that were enrolling participants in these networks in September 2021. These reports have been shared with HANC’s RSR working group members, and they are available on request (contact
bminalga@fredhutch.org).
Evidence2Practice (E2P): Increasing Interest HIV Science at HBCUs
Evidence2Practice (E2P) is an intensive on-campus workshop-based initiative to increase student interest in careers in HIV science by providing an experience-based introduction to implementation science. E2P developed out of a 4-year partnership between Dr. Nwora Lance Okeke, MD, MPH (Assistant Professor, Division of Infectious Diseases),
Dr. Kenric B. Ware, PharmD (Associate Professor of Pharmacy, South University) and Russell Campbell,
MA (Deputy Director, HANC). Through this collaboration, Dr. Okeke, Dr. Ware and Mr. Campbell created the Bringing PrEP to Campus (BPC) program in 2018 which created campus-specific strategies for HIV prevention at Historically Black Colleges and Universities (HBCUs).
BPC was anchored by the Legacy Project's Be the Generation
curriculum. E2P is a reconfiguration of the BPC program, evolved to better respond to CDEIPI’s call to increase HBCU students’ interest in HIV science careers. E2P’s 3-day interactive workshops will be held at six HBCUs in South Carolina, a priority jurisdiction of the Department of Health and Human Services Ending the HIV Epidemic, over Spring Semester 2021-22 and Fall Semester 2022-23. The third workshop was held at Benedict College 6/15-6/17 in Columbia, SC.
H=H Podcast: Episode Seven
New Investigators Working Group
HVTN Scientific Leadership Development 2022 Awardees
Dr.
Portia Hunidzarira, MBChB, MSc has been the Clinical Research Site Leader at the Seke South CRS in Harare, Zimbabwe, since 2015. In that time, she has served as an investigator on HVTN 107 and 120, as well as the site Investigator of Record for HVTN 703 (AMP study) and the site Principal Investigator for HVTN 705 (Imbokodo). Dr. Hunidzarira has also been active in other networks, including the MTN with trials of the Dapivirine ring, and is involved in CoVPN protocols at the site (CoVPN5001, HVTN405/HPTN1901, and CoVPN3008). She also received a Master’s degree in Public Health from the London School of Hygiene and Tropical Medicine. She works closely with at-risk populations, community activists, and CABs as part of her leadership. She also serves as a member of the HVTN Scientific Governance committee and the HVTN Scientific Review Committee.
|
|
|
|
July 12, 2022
The UW/Fred Hutch Center for AIDS Research (CFAR), UW Indigenous Wellness Research Institute (IWRI), and the University of Hawaii (UH) have launched a new project titled “Building Indigenuity, Generating HIV Science: HIV/AIDS Research Training (BIG HART).” This exciting new training opportunity will be led by Karina Walters, MSW, PhD (Choctaw Nation of Oklahoma), Co-Director of IWRI, Professor and Associate Dean in the School of Social Work, and Jen Balkus, PhD, MPH, CFAR DEI Lead and Assistant Professor in the Department of Epidemiology in the School of Public Health.
BIG
HART will host a six-part seminar series for Indigenous undergraduate and graduate students at UW and UH who are interested in learning more about HIV research and the various ways the epidemic impacts Indigenous communities across North America. The series will feature both scientists and practitioners working across the spectrum of HIV science, including former scholars from the Indigenous HIV/AIDS Research Training Program (IHART). The monthly sessions will be held in February through July of 2022. Among those who attend at least one session, interested students will be given the opportunity to participate in a one-on-one mentorship session with an IHART mentor and/or CFAR investigator. In addition, up to 10 graduate students will also have the opportunity to participate in the UW Principles of HIV/STI Research and Public Health Practice Course.
Interested students can join this BIG-HART listserv to stay up to date on all BIG HART activities and opportunities. The speaker list and schedule will be made available on the website once finalized, and
Zoom registration is now open to all! Please reach out to Jen Balkus (jbalkus@uw.edu) or Karina Walters (kw5@uw.edu) with any questions about the project, or Anya Lewin (lewina@uw.edu) with any administrative questions.
|
|
|
|
ACTG/IMPAACT Laboratory Center Positions
The Laboratory Center at UCLA is seeking highly motivated, detail-oriented individuals with clinical trials project management experience to assist in laboratory specific regulatory support and oversight of ACTG and IMPAACT clinical trials. If this is you, please send a copy of your CV to kferbas@milabcentral.org.
|
HANC Director
The Office of HIV/AIDS Network Coordination (HANC) is recruiting for its next HANC Director. The HANC Director is responsible for managing and supervising all aspects of the activities of HANC, and reports to the principal investigators of the four NIH-funded HIV/AIDS Clinical Trial Networks and the Director of the Division of DAIDS at NIAID. Please note that the job listing is temporarily down, but will be posted on the
Fred Hutch Careers page once available.
|
|
|
|
|
