HANC Newsletter | May 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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Remembering Kaijson Noilmar: Former HANC Legacy Project Manager and Dedicated HIV Advocate
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The Office of HIV/AIDS Network Coordination (HANC) is deeply saddened to share the news that our former staff member and colleague, Kaijson Noilmar, died unexpectedly in April.
We extend our condolences to his family, friends, and colleagues. Kaijson served as the first HANC Legacy Project Manager, where he oversaw the Legacy Project Working Group and the Legacy Community Engagement Coordinators. Kaijson was smart, fun, and committed to doing his part to help end HIV.
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Everyone Needs a Pathway to PrEP
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HANC would like to amplify a message from our colleagues and friends at PrEP4All, who are advocating for a national PrEP program in the US. In light of the recent and concerning court decision in Braidwood Management v. Becerra and ongoing struggles for health and sexual & reproductive justice in the US, it is more important than ever to stay aware and join together in these endeavors. Click
here to learn more.
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Join Us in Recognizing These Important HIV/AIDS Awareness Days This Month!
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May 18: HIV Vaccine Awareness Day
This day is a chance to thank the volunteers, community members, health professionals, and scientists working together to find a safe and effective preventive HIV vaccine. It is also a time to educate communities about the importance of preventive HIV vaccine research. Learn more here.
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May 19: National Asian & Pacific Islander HIV/AIDS Awareness Day
Founded by the Banyan Tree Project, NAPIHAAD educates the public about the impact of HIV stigma among Asian and Pacific Islander people.
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ACTG REPRIEVE Study Stopped Early
The
ACTG is excited to share the news that the REPRIEVE study was stopped early after a daily statin medication was found to reduce the risk of cardiovascular disease among people living with HIV. REPRIEVE is the first clinical trial to study a preventive approach to cardiovascular disease among people living with HIV who were considered to be at low-to-moderate risk of cardiovascular disease events, including heart attack and stroke. A planned interim analysis found that participants who took pitavastatin calcium (a daily statin pill that reduces cholesterol) lowered their risk of major adverse cardiovascular events by 35 percent compared to those who took a placebo. These findings were compelling enough that REPRIEVE’s independent Data Safety and Monitoring Board (DSMB) recommended that it be stopped early; the National Institutes of Health (NIH) accepted this recommendation.
The ACTG played a pivotal role in REPRIEVE, which began in 2015 – 52 of our sites enrolled more than half of the total 7,769 participants and ACTG investigators played key leadership roles in the core REPRIEVE team. For more information, please read our statement about this pivotal study.
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The 2023 HPTN Annual Meeting is fast approaching. Thank you to everyone who registered. If you plan to attend in person or virtually, there is still time to register. Please follow the link below.
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HVTN/CoPVN Full Group Meeting
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The annual HVTN/CoPVN Full Group Meeting convenes May 3-5, 2023 at the Omni Shoreham Hotel in Washington D.C., with virtual options to connect remotely. For more information, please visit https://www.hvtn.org/events.html . For any questions about the meeting, please email vtn.travel@hvtn.org.
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Accrual Resumed in IMPAACT 2021
As of 16 March 2023, 13 of 17 sites received approval to resume screening and enrollment for IMPAACT 2021. Of the four remaining sites, two sites have closed out of the study, one site is not participating this year, and one site is working to transition to protocol Version 3.0.
IMPAACT 2021 is a double-blind, randomized, placebo-controlled trial that will evaluate the safety and immunogenicity of recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120 ΔNS2/1030s, RSV 276 or placebo in children confirmed to be RSV-seronegative within 42 days prior to study product administration. Approximately 160 healthy RSV-seronegative children ≥6 months (180 days) to <25 months (750 days) of age will be enrolled. Eligible children will receive a single dose of RSV ΔNS2/Δ1313/I1314L vaccine, RSV 6120 ΔNS2/1030s vaccine, RSV 276 vaccine or placebo intranasally at entry.
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Upcoming SpotLight Webinar by the IMPAACT SBSC:
The SBSC SpotLight Series is a monthly webinar featuring guest speakers discussing various topics to support research development:
- 25 May 2023 at 10:00 a.m. ET | Michaile Anthony on measuring health-related quality of life among young children affected by respiratory illnesses, including TB, in a low-middle-income setting.
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Behavioral and Social Sciences
Greg Davis, HANC Project Manager
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Financial Disclosure Working Group: HANC is in the process of switching to a new financial disclosure collection system called Convey. The current site (fd.hanc.info) will be taken offline on May 30, 2023. Network investigators will receive an email that provides 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. We’ll be transitioning to the Convey system in the coming weeks. 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.
Behavioral Science Consultative Group: The Behavioral Science Consultative Group (BSCG) met on April 7, 2023 in Seattle, WA at Fred Hutch Cancer Center for its annual face-to-face meeting. The group was joined by several members of the NIAID-NIMH BSSPT (virtually) as well as Dr. Wafaa El-Sadr, co-PI of the HPTN. Several BSCG members are preparing for talks at upcoming Network annual meetings.
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Community Partners
Greg Davis, HANC Project Manager
Russell Campbell, HANC Director
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Community Partners is preparing to update the document, “How to critically (and quickly) read a protocol”
for cure studies. Several CP members have volunteered to assist with the revision. The work will begin in early May. Once the revisions are complete, the document will be shared on the HANC website. Community Partners is also in the process of electing two new co-chairs for the group. More information will be provided in the next newsletter.
On March 23, 2023, Community Partners hosted Dr. Ashwini Deshpande to provide an overview of ACTG’s tuberculosis research agenda and community engagement efforts. Watch the webinar here.
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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) met in April to discuss changes to survey software tools and study enrollment systems. The group shared recent experiences with EMA inspections.
The Cross-Network Protocol Deviation Working Group (PDWG) continues to refine the Cross Network Protocol Deviation Reference Guide for major and critical protocol deviations in network studies. The Cross Network Protocol Deviation Reference Guide is now in the final stages of review and sign-off.
The Cross-Network Site Coordinators Working Group (SCWG) plans to incorporate HANC in the Annual Network Meeting agendas to gather input regarding the development of new resources, and to present information on where resources can best be accessed by site coordinators.
Reminder: In March the DAIDS Office for Policy in Clinical Research Operations (OPCRO) announced that the following policies have been updated: Requirements for Informed Consent Forms (DAIDS-OPC-A15-POL-00005) and Requirements for Essential Documents for DAIDS Sponsored Network Clinical Trials (DAIDS-OPC-A15-POL-00019). Both policies are available on the following DAIDS Clinical Research Policies webpage
here.
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Laboratory Coordination
Tyler Brown, HANC Laboratory Project Manager
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Recent activities:
- The Lab Technologists SOP Working Group met in April to revise the Guidelines for Shipping and Receiving Biological Substance, Category B Specimens. An updated version of this SOP will be published by the end of June.
- The CPQA Cross-Network Clinical Pharmacology Forum (CNCPL Forum) convened a meeting in April to discuss CPQA proficiency testing rounds, network study compounds, and updates on the CPQA AVR/SOP Review Program. Rich Haaland (of the CDC Division of HIV Prevention) delivered a presentation during the meeting on the work of the CDC Division of HIV Prevention (DHP) Laboratory Branch.
- In April, the Lab Focus Group (LFG) held a meeting to discuss the impact of current lab supply and reagent shortages on ongoing and upcoming studies, as well as to discuss experiences and lessons learned from the recent European Medicines Agency (EMA) audit of HPTN 084.
Looking ahead:
- May 19: HANC will re-convene the Cross-Network PBMC Processing SOP Working Group to begin revising and 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 summer.
- May 22: The Laboratory Focus Group (LFG) has scheduled a meeting with the DAIDS Clinical Laboratory Oversight Team (DCLOT) to address key issues related to cross-network lab activities.
- May 31: At the next Clinical Pharmacology Quality Assurance Advisory Board (CPQAAB) meeting, Dr. Marina Caskey from Rockefeller University will deliver a presentation on the latest developments and research on HIV-1 broadly neutralizing antibodies (bNAbs).
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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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April 11-12: The Legacy Project participated at the Biomedical HIV Prevention Summit 2023 in Las Vegas, NV with three workshops and an Affinity Session with fellows from the NMAC Gay Men of Color program (GMoC) focused on HIV research advocacy.
May 6-7: Brian Minalga will participate in the National Transgender Health Summit hosted by the University of California-San Francisco, including an oral presentation on Saturday, May 6: “Comparing Two-Step Approaches to Measuring Gender Identity: Ascertaining Sex Assigned at Birth versus Transgender Self-Identification.”
May 17: New Investigators Working Group webinar series. The NIH Grant Lifecycle: From Submission to Notice of Award (Part 2). To register for Part 2 of this webinar click here.
May 19: HANC observes National Asian & Pacific Islander HIV/AIDS Awareness Day.
New Investigators Working Group (NIWG):
- ACTG International HIV/AIDS Investigator Mentoring Program (IHIMP) and the HIV/AIDS Investigator Mentoring Program (HIMP) 2021-2023 is coming to an end and mentees will present their study results to the Underrepresented Populations Committee at the ACTG Meeting in June in Washington DC.
- The IMPAACT Early Career Investigator program award recipients for 2023 are Clement Gascua Adu-Gyamfi, PhD from University of the Witwatersrand, South Africa; Brenda Catherine Kakayi, BPharm, from MU-JHU Research Collaboration CRS, Uganda; and Allen Matubu, PhD, from University of Zimbabwe Clinical Trials Research Center, Zimbabwe.
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Join the Legacy Project and NMAC in Supporting the CDC's "Let's Stop HIV Together" Campaign
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The Legacy Project has partnered with NMAC (former National Minority AIDS Council) to support CDC’s Let’s Stop HIV Together (Together) campaign. Together aims to empower communities, partners, and health care providers to reduce HIV stigma and promote HIV
testing, prevention and treatment
. Join us to spread the word!
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2023 HVTN Full Group Meeting (Washington DC, USA)
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HPTN Annual Meeting (Washington DC, USA)
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Annual ACTG Network Meeting (Washington DC, USA)
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International AIDS Society Conference on HIV Science (IAS) 2023 (Brisbane, Australia)
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Annual IMPAACT Network Meeting (Washington DC, USA)
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