HANC Newsletter | August 2023
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The Office of HIV/AIDS Network Coordination (HANC) is located at the Fred Hutchinson Cancer Center in Seattle, WA. We acknowledge the Coast Salish peoples of this land, the land which touches the shared waters of all tribes and bands within the Duwamish, Puyallup, Suquamish, Tulalip and Muckleshoot nations.
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HANC's Brian Minalga & HIV.gov Collaborate for Interview Series at IAS Conference
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Last week, during the 2023 IAS Conference in Brisbane, Australia, an exciting collaboration took place between HIV.gov and Brian Minalga/Miss Molly Moon, HANC Deputy Director. They conducted interviews with prominent HIV clinical research leaders, including Dr. Carl Dieffenbach, Director of the Division of AIDS and Dr. Steven Grinspoon, Principal Investigator of the REPRIEVE study that made headlines during the conference.
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Throughout the interviews, they delved into vital topics central to the ongoing response to the global HIV pandemic. Discussions covered the crucial role of community engagement in research, the groundbreaking findings from the REPRIEVE Trial, advancements in long-acting treatment & prevention, and so much more.
Check out the interviews by clicking the links below.
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Streamlining Financial Disclosures: HANC Adopts AAMC's Convey System
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As of May 30, 2023, HANC has switched to a new financial disclosure collection system called Convey. The former disclosure site (fd.hanc.info) was taken offline on May 30, 2023. Over the course of the next few months, Network investigators will receive emails that provide more information about the new financial disclosure collection system. Convey, a global disclosure system developed by the Association of American Medical Colleges (AAMC),
will help us centralize and streamline the data collection and review process. Network investigators will receive information on how to create their personal AAMC Convey account. Please monitor your email for these important instructions. Learn more about Convey and its system by watching this brief video demonstration.
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ACTG Announces Publication of REPRIEVE Trial in New England Journal of Medicine and Presentation at IAS 2023
Last
month, ACTG announced the publication of “Pitavastatin to Prevent Cardiovascular Disease in HIV Infection” in the New England Journal of Medicine. This publication coincided with the symposium “The REPRIEVE trial: Developing a Cardiovascular Disease Prevention Strategy for People Living with HIV,” which took place last month at IAS 2023 in Brisbane, Australia. The publication and presentation reported the key findings from REPRIEVE that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of major adverse cardiovascular events by 35 percent compared with those receiving a placebo over a median duration of five years of follow up. Full announcement
here.
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Jane M. Simoni, Ph.D., Appointed as NIH Associate Director for Behavioral and Social Sciences Research and Director of OBSSR, Elevating Behavioral Science Research at NIH
The ACTG is excited to announce that Jane M. Simoni, Ph.D. has been selected as NIH Associate Director for Behavioral and Social Sciences Research and Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR). She will lead OBSSR’s efforts to advance and coordinate behavioral and social sciences research at NIH, working closely with NIH Institutes and Centers. Full announcement here
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Dr. Sinead Delany-Moretlwe Leads Special Issue on Long-Acting HIV Prevention and Treatment in Journal of the International AIDS Society
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Dr. Sinead Delany-Moretlwe, HPTN 084 protocol chair, was a guest editor for the Journal of the International AIDS Society (JIAS) special issue focused on advancing the use of long-acting and extended delivery (LAED) HIV prevention and treatment regimens. Several HPTN members contributed to the issue, including the following:
- Dr. Nyaradzo Mgodi, an HPTN Executive Committee member, authored a commentary on advancing the use of LAED in sub-Saharan Africa.
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- Dr. Sarah Stansfield, HPTN 094 team member, authored an article regarding the population-level impact of expanding PrEP coverage by offering long-acting injectable PrEP to men who have sex with men in three high-resource settings.
- Dr. Connie Celum, HPTN 082 protocol chair, and Dr. Beatriz Grinsztejn, HPTN 083 protocol chair, co-authored a commentary on preparing for long-acting PrEP delivery.
- Dr. Sybil Hosek, HPTN 083-01 protocol chair, and Dr. Lynda Stranix-Chibanda, HPTN 083-01 and HPTN 084-01 co-chair, co-authored a viewpoint on what it will take to bring LAED medication regimens to young people.
- HPTN Community Programs’ Rhonda White and Molly Dyer, Dr. Mina Hosseinipour, HPTN 084 protocol co-chair, and Dr. Delany-Moretlwe co-authored a viewpoint on including pregnant and breastfeeding people in trials of novel LAED PrEP agents.
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IMPAACT at IAS 2023 & The International Workshop on HIV & Pediatrics 2023
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2023 IMPAACT Annual Meeting
The 2023 IMPAACT Annual Meeting will take place in Washington, D.C., and virtually from 22-27 October 2023. Additional details, including registration and the agenda, will soon be available. We recommend submitting a
visa letter request for those traveling from outside the United States as early as possible.
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Behavioral and Social Sciences
Greg Davis, HANC Project Manager
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Financial Disclosure Working Group: Please see the financial disclosure announcement under “HANC Announcements” regarding a change to the way Network investigators will report their financial disclosure statements going forward. More information will be shared as we get closer to the annual solicitation date.
Behavioral Science Consultative Group: The Behavioral Science Consultative Group (BSCG) congratulates former BSCG co-chair and ACTG representative, Dr. Jane Simoni, on her recent hiring as NIH Associate Director for Behavioral and Social Sciences Research and Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR). Jane joined NIH on July 30, 2023, to lead OBSSR’s efforts to advance and coordinate behavioral and social sciences research at NIH. Dr. Ivan Balan will join the BSCG to represent the ACTG.
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Community Partners
Greg Davis, HANC Project Manager
Russell Campbell, HANC Director
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Community Partners: Community Partners will host a webinar on cure research on August 22, 2023 at 11am PT/2pm ET. The webinar is currently being planned. More information will be shared in the coming weeks.
Community Partners Executive Committee: HANC is reactivating the Community Partners Executive Committee (CPEC). On Tuesday, July 26, HANC solicited current CP members that represent a Network to volunteer for one of the positions on the Executive Committee. Two members of the CPEC will be selected to join the HIV/AIDS Clinical Trials Strategic Working Group (SWG).
Announcement: HANC will be convening a new work group to engage the Networks and external collaborators to:
- Review documents and provide input into developing a plan to engage communities with limited knowledge around TB and/or vaccines.
- Discuss and develop materials, resources and trainings for site staff and communities for upcoming and future TB vaccine trials.
- Develop a TB Participant Bill of Rights and Responsibilities document modeled after the HIV Participant Bill of Rights and Responsibilities document.
Three of the four NIH HIV/AIDS Clinical Trials Networks (ACTG, HVTN and IMPAACT) are going to be involved in TB vaccine research. The group will discuss what this means for the communities where the research will happen. A solicitation will be shared with HANC collaborators soon.
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Cross-Network Coordination
Kathleen Pescasio, HANC Cross-Network Project Manager
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The Cross-Network Data Management Center Working Group (DMCWG) held a meeting to discuss current ongoing efforts to switch to direct data entry, and shared recent experiences with changes to survey software tools and study enrollment systems.
The Cross-Network Protocol Deviation Working Group (PDWG) has completed the review and sign-off of the Protocol Deviation Reporting Guide. The group is working on sharing the updated guidelines and determining next steps for the management and processing of protocol deviations.
The Cross-Network Site Coordinators Working Group (SCWG) continues to revise the Onboarding/Training Checklist, which will be used as a resource for new Site Coordinators at DAIDS-sponsored clinical trial sites. The group is also discussing plans for a mentorship program for study coordinators at a cross-network level.
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Laboratory Coordination
Tyler Brown, HANC Laboratory Project Manager
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The Lab Technologists SOP Working Group met in July to revise the Guidelines for Shipping and Receiving Biological Substance, Category B Specimens. The group aims to publish an updated version of this SOP by the end of September.
In July, the Lab Focus Group (LFG) convened to tackle key issues related to cross-network lab activities, specifically addressing lab supply shortages and upcoming policy changes.
In July, the Cross-Network PBMC Processing SOP Working Group held a meeting to continue updating the current Cross-Network PBMC Processing SOP. The working group is comprised of experts in PBMC processing from each network, DAIDS and the IQA. The revised SOP is expected to be published this fall.
Reminders:
- Earlier this year, the DAIDS Office for Policy in Clinical Research Operations (OPCRO) published DAIDS GCLP Training Related FAQs (Version 2.0). Find the updated document on the DAIDS Clinical Research Policies webpage: DAIDS Clinical Research Policies.
- In June, the Lab Technologists SOP Working Group released an updated version of the ACTG/IMPAACT Standard Operating Procedure (SOP) for Dried Blood Spot Card Preparation. You can access this SOP on the ACTG/IMPAACT Laboratory Manual webpage, under Resources.
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HANC Leadership
Russell Campbell, HANC Director
Brian Minalga, HANC Deputy Director
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Announcement: HANC would like to congratulate Dr. Jeanne Marrazzo on her selection as the new Director of NIAID! Dr. Marrazzo is currently the director of the Division of Infectious Diseases at the University of Alabama at Birmingham. Dr. Marrazzo is an outstanding physician, researcher, and expert in her field. Dr. Marrazzo was the Protocol Co-Chair for the VOICE Study (MTN-003), a placebo-controlled trial that randomized over 5,000 women in South Africa, Uganda, and Zimbabwe to oral or vaginal tenofovir-based HIV pre-exposure prophylaxis. Dr. Marrazzo is openly gay and is the first woman in this position. We look forward to working with Dr. Marrazzo in her new role.
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The Legacy Project
Brian Minalga, HANC Deputy Director
Pedro Goicochea, HANC Community Engagement Officer
Gabriella Olague, HANC Project Coordinator
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7/12: Webinar. Diversity and Inclusion in HIV/AIDS Clinical Research: The Role of Language Justice (Part 1). If you missed the webinar, you can watch it on the HANC website by clicking here under “Community Engagement in HIV Clinical Research.”
8/2: Webinar. Diversity and Inclusion in HIV/AIDS Clinical Research: The Role of Language Justice (Part 2). If you missed the webinar, you can watch it on the HANC website by clicking here under “Community Engagement in HIV Clinical Research.”
8/10: H=H podcast Episode 14: HIV Stigma. Download Episode 14 by clicking here.
- Wednesday, September 6 from 8 to 11 a.m.: “Engaging HBCUs to diversify the HIV Workforce: Evidence2Practice (E2P) Program” (Institute)
- Thursday, September 7 from 8 to 11 a.m.: “Implementación de la Justicia del Lenguaje para el Enrolamiento de Hispanos en la Investigación de VIH/SIDA” (Institute)
- Thursday, September 7 from 1:30 to 2 p.m.: “Still We Rise: Forging a Women-Centered HIV Research Paradigm” (Poster)
- Thursday, September 7 from 2 to 4 p.m.: “Addressing Drug Use Bias & Stigma in HIV Settings” (Workshop)
- Friday, September 8 from 1:30 to 2 p.m.: “Still We Rise: Forging a Women-Centered HIV Research Paradigm” (Poster)
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The US Conference on HIV & AIDS (Washington DC, USA)
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Annual HVTN Conference (Seattle, USA)
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Annual IMPAACT Network Meeting (Washington DC, USA)
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